Fasenra
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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions.

1. NAME OF THE MEDICINAL PRODUCT

Fasenra 30 mg solution for injection in pre-filled syringe
Fasenra 30 mg solution for injection in pre-filled pen

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Pre-filled syringe
Each pre-filled syringe contains 30 mg benralizumab* in 1 mL.

Pre-filled pen
Each pre-filled pen contains 30 mg benralizumab* in 1 mL.

*Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells
by recombinant DNA technology.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection in pre-filled syringe (injection)
Solution for injection in pre-filled pen (injection) (Fasenra Pen)

Clear to opalescent, colourless to yellow solution and may contain translucent or white to off-white 
particles.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic 
asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists 
(see section 5.1).

4.2 Posology and method of administration

Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of 
severe asthma.

After proper training in the subcutaneous injection technique and education about signs and symptoms 
of hypersensitivity reactions (see section 4.4), patients with no known history of anaphylaxis or their
caregivers may administer Fasenra if their physician determines that it is appropriate, with medical 
follow-up as necessary. Self-administration should only be considered in patients already experienced 
with Fasenra treatment.



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Posology

The recommended dose of benralizumab is 30 mg by subcutaneous injection every 4 weeks for the 
first 3 doses, and then every 8 weeks thereafter. If an injection is missed on the planned date, dosing 
should resume as soon as possible on the indicated regimen; a double dose must not be administered.

Fasenra is intended for long-term treatment. A decision to continue the therapy should be made at least 
annually based on disease severity, level of exacerbation control and blood eosinophil counts.

Elderly
No dose adjustment is required for elderly patients (see section 5.2).

Renal and hepatic impairment
No dose adjustment is required for patients with renal or hepatic impairment (see section 5.2).

Paediatric population
The safety and efficacy of Fasenra in children aged 6 to 18 years have not been established.

No data are available for children aged 6 to 11 years old. Currently available data in children 12 to less 
than 18 years old are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can 
be made.

Method of administration 

Fasenra is administered as a subcutaneous injection.

It should be injected into the thigh or abdomen. If the healthcare professional or caregiver administers 
the injection, the upper arm can also be used. It should not be injected into areas where the skin is 
tender, bruised, erythematous, or hardened.

Comprehensive instructions for administration using the pre-filled syringe/pre-filled pen (Fasenra Pen) 
are provided in the ‘Instructions for Use’.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Fasenra should not be used to treat acute asthma exacerbations.

Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens
after initiation of treatment.

Abrupt discontinuation of corticosteroids after initiation of Fasenra therapy is not recommended. 
Reduction in corticosteroid doses, if appropriate, should be gradual and performed under the 
supervision of a physician.

Hypersensitivity reactions 

Acute systemic reactions including anaphylactic reactions and hypersensitivity reactions 
(e.g. urticaria, papular urticaria, rash) have occurred following administration of benralizumab (see 
section 4.8). These reactions may occur within hours of administration, but in some instances have a 
delayed onset (i.e. days).



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A history of anaphylaxis unrelated to benralizumab may be a risk factor for anaphylaxis following 
Fasenra administration (see section 4.3). In line with clinical practice, patients should be monitored for 
an appropriate time after administration of Fasenra.

In the event of a hypersensitivity reaction, Fasenra should be discontinued permanently and 
appropriate therapy initiated. 

Parasitic (Helminth) Infection

Eosinophils may be involved in the immunological response to some helminth infections. Patients 
with known helminth infections were excluded from participation in clinical trials. It is unknown if 
Fasenra may influence a patient’s response against helminth infections.

Patients with pre-existing helminth infections should be treated before initiating therapy with Fasenra. 
If patients become infected, while receiving treatment with Fasenra and do not respond to 
anti-helminth treatment, treatment with Fasenra should be discontinued until infection resolves.

4.5 Interaction with other medicinal products and other forms of interaction

In a randomized, double-blind parallel-group study of 103 patients aged between 12 and 21 years with 
severe asthma, the humoral antibody responses induced by seasonal influenza virus vaccination do not 
appear to be affected by benralizumab treatment. An effect of benralizumab on the pharmacokinetics 
of co-administered medicinal products is not expected (see section 5.2).

Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the 
clearance of benralizumab. There is no evidence of IL-5Rα expression on hepatocytes. Eosinophil 
depletion does not produce chronic systemic alterations of proinflammatory cytokines. 

4.6 Fertility, pregnancy and lactation

Pregnancy

There is a limited amount of data (less than 300 pregnancy outcomes) from the use of benralizumab in 
pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity 
(see section 5.3).

Monoclonal antibodies, such as benralizumab, are transported across the placenta linearly as 
pregnancy progresses; therefore, potential exposure to a fetus is likely to be greater during the second 
and third trimester of pregnancy. 

It is preferable to avoid the use of Fasenra during pregnancy. Its administration to pregnant women 
should only be considered if the expected benefit to the mother is greater than any possible risk to the 
fetus.

Breast-feeding

It is unknown whether benralizumab or its metabolites are excreted in human or animal milk. Risk to 
the breast-fed child cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from using 
Fasenra taking into account the benefit of breast-feeding for the child and the benefit of therapy for the 
woman.

Fertility



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There are no fertility data in humans. Animal studies showed no adverse effects of benralizumab 
treatment on fertility (see section 5.3).

4.7 Effects on ability to drive and use machines

Fasenra has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Summary of the safety profile

The most commonly reported adverse reactions during treatment are headache (8%) and pharyngitis
(3%). Anaphylactic reactions have been reported.

Tabulated list of adverse reactions

A total of 2,514 patients, out of whom 1,663 patients had severe uncontrolled eosinophilic asthma, 
received benralizumab during clinical studies of 48 to 56 weeks duration. 

The frequency of adverse reactions is defined using the following convention: very common (≥1/10); 
common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 
(<1/10,000); and not known (cannot be estimated from available data). Within each frequency 
grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1. Tabulated list of adverse reactions

System organ class Adverse reaction Frequency

Infections & infestations Pharyngitis* Common

Immune system disorders Hypersensitivity reactions**

Anaphylactic reaction

Common

Not known

Nervous system disorders Headache Common

General disorders and 
administration site conditions

Pyrexia

Injection site reaction 

Common

* Pharyngitis was defined by the following grouped preferred terms: ‘Pharyngitis’, ‘Pharyngitis bacterial’, ‘Viral 
pharyngitis’, ‘Pharyngitis streptococcal’. 
** Hypersensitivity reactions were defined by the following grouped preferred terms: ‘Urticaria’, ‘Papular 
urticaria’, and ‘Rash’. For examples of the associated manifestations reported and a description of the time to 
onset, see section 4.4.

Description of selected adverse reaction

Injection site reactions 
In placebo-controlled studies, injection site reactions (e.g. pain, erythema, pruritus, papule) occurred at 
a rate of 2.2% in patients treated with the recommended benralizumab dose compared with 1.9% in 
patients treated with placebo.

Long-term safety 

In a 56-week extension trial in patients with asthma from Trials 1, 2 and 3, 842 patients were treated 
with Fasenra at the recommended dose and remained in the trial. The overall adverse event profile was 
similar to the asthma trials described above.

Paediatric population



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There are limited data in paediatric patients (see section 5.1). The frequency, type and severity of 
adverse reactions in the adolescent population were observed to be similar to those seen in adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

Doses of up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic 
asthma without evidence of dose-related toxicities.

There is no specific treatment for an overdose with benralizumab. If overdose occurs, the patient 
should be treated supportively with appropriate monitoring as necessary. 

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for 
obstructive airway diseases, ATC code: R03DX10

Mechanism of action

Benralizumab is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa). It
binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity and 
specificity. The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils. 
The absence of fucose in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors 
on immune effector cells such as natural killer (NK) cells. This leads to apoptosis of eosinophils and 
basophils through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), which reduces 
eosinophilic inflammation. 

Pharmacodynamic effects

Effect on blood eosinophils
Treatment with benralizumab results in near complete depletion of blood eosinophils within 24 hours 
following the first dose which is maintained throughout treatment. The depletion of blood eosinophils 
is accompanied by a reduction in serum eosinophil granule proteins eosinophil derived neurotoxin 
(EDN) and eosinophil cationic protein (ECP) and a reduction in blood basophils.

Effect on eosinophils in the airway mucosa
The effect of benralizumab on eosinophils in the airway mucosa in asthmatic patients with elevated 
sputum eosinophil counts (at least 2.5%) was evaluated in a 12-week, phase 1, randomised, double-
blind, placebo-controlled clinical study with benralizumab 100 or 200 mg SC. In this study there was a 
median reduction from baseline in airway mucosa eosinophils of 96% in the benralizumab treated 
group compared to a 47% reduction in the placebo group (p=0.039).

Clinical efficacy

The efficacy of Fasenra was evaluated in 3 randomised, double-blind, parallel-group, 
placebo-controlled clinical trials between 28 to 56 weeks duration, in patients aged 12 to 75 years. 



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In these studies, Fasenra was administered at a dose of 30 mg once every 4 weeks for the first 3 doses, 
and then every 4 or 8 weeks thereafter as add-on to background treatment and was evaluated in 
comparison with placebo.

The two exacerbation trials, SIROCCO (Trial 1) and CALIMA (Trial 2), enrolled a total of 2,510 
patients with severe uncontrolled asthma, 64% females, with a mean age of 49 years. Patients had a 
history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment (mean of 
3) in the past 12 months, ACQ-6 score of 1.5 or more at screening, and reduced lung function at 
baseline (mean predicted pre-bronchodilator forced expiratory volume in 1 second [FEV1] of 57.5%), 
despite regular treatment with high-dose inhaled corticosteroid (ICS) (Trial 1) or with medium or 
high-dose ICS (Trial 2) and a long-acting β-agonist (LABA); at least one additional controller was 
administered to 51% and 41% of these patients, respectively.

For the oral corticosteroid (OCS) reduction trial ZONDA (Trial 3), a total of 220 asthma patients (61% 
female; mean age of 51 years) were enrolled; they were treated with daily OCS (8 to 40 mg per day; 
median of 10 mg) in addition to regular use of high-dose ICS and LABA with at least one additional 
controller to maintain asthma control in 53% of the cases. The trial included an 8-week run-in period 
during which the OCS was titrated to the minimum effective dose without losing asthma control.
Patients had blood eosinophil counts ≥150 cells/μL and a history of at least one exacerbation in the 
past 12 months. 

While 2 dosing regimens were studied in Trials 1, 2, and 3, the recommended dosing regimen is 
Fasenra administered every 4 weeks for the first 3 doses, then every 8 weeks thereafter (see section 
4.2) as no additional benefit was observed by more frequent dosing. The results summarised below are 
those for the recommended dosing regimen.

Exacerbation trials

The primary endpoint was the annual rate of clinically significant asthma exacerbations in patients 
with baseline blood eosinophil counts ≥300 cells/μL who were taking high-dose ICS and LABA. 
Clinically significant asthma exacerbation was defined as worsening of asthma requiring use of 
oral/systemic corticosteroids for at least 3 days, and/or emergency department visits requiring use of 
oral/systemic corticosteroids and/or hospitalisation. For patients on maintenance oral corticosteroids, 
this was defined as a temporary increase in stable oral/systemic corticosteroids for at least 3 days or a 
single depo-injectable dose of corticosteroids.

In both trials, patients receiving Fasenra experienced significant reductions in annual exacerbation 
rates compared to placebo in patients with blood eosinophils ≥300 cells/μL. In addition, change from 
baseline in mean FEV1 showed benefit as early as 4 weeks, which was maintained through to end of 
treatment (Table 2).  

Reductions in exacerbation rates were observed irrespective of baseline eosinophil count; however, 
increasing baseline eosinophil counts was identified as a potential predictor of improved treatment 
response particularly for FEV1.

Table 2. Results of annual exacerbation rate and lung function at end of treatment of Trial 1 and 
2 by eosinophil count.

Trial 1 Trial 2

Fasenra Placebo Fasenra Placebo

Blood eosinophil count 
≥300 cells/μLa

n = 267 n =267 n =239 n =248

Clinically significant exacerbations

Rate 0.74 1.52 0.73 1.01



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Difference -0.78 -0.29

Rate ratio (95% CI) 0.49 (0.37, 0.64) 0.72 (0.54, 0.95)

p-value <0.001 0.019

Pre-bronchodilator FEV1 (L) 

Mean baseline 1.660 1.654 1.758 1.815

Improvement from baseline 0.398 0.239 0.330 0.215

Difference (95% CI) 0.159 (0.068, 0.249) 0.116 (0.028, 0.204)

p-value 0.001 0.010

Blood eosinophil count 
<300 cells/μLb

n =131 n =140 n =125 n =122

Clinically significant exacerbations

Rate 1.11 1.34 0.83 1.38

Difference -0.23 -0.55 

Rate ratio (95% CI) 0.83 (0.59, 1.16) 0.60 (0.42, 0.86)

Pre-bronchodilator FEV1 (L)

Mean change 0.248 0.145 0.140 0.156

Difference (95% CI) 0.102 (-0.003, 0.208) -0.015 (-0.127, 0.096)
a. Intent to treat population (patients on high-dose ICS and blood eosinophils ≥300 cells/μl).
b. Not powered to detect a treatment difference in patients with blood eosinophils <300 cells/μl. 

Across Trials 1 and 2 combined, there was a numerically greater exacerbation rate reduction and 
greater improvements in FEV1 with increasing baseline blood eosinophils. 

The rate of exacerbations requiring hospitalisation and/or emergency room visits for patients receiving 
Fasenra compared to placebo for Trial 1 were 0.09 versus 0.25 (rate ratio 0.37, 95% CI: 0.20, 0.67, 
p=<0.001) and for Trial 2 were 0.12 versus 0.10 (rate ratio 1.23, 95% CI: 0.64, 2.35, p=0.538). In Trial 
2, there were too few events in the placebo treatment arm to draw conclusions for exacerbations 
requiring hospitalisation or emergency room visits.

In both Trials 1 and 2, patients receiving Fasenra experienced statistically significant reductions in 
asthma symptoms (Total Asthma Score) compared to patients receiving placebo. Similar improvement 
in favour of Fasenra was observed for the Asthma Control Questionnaire-6 (ACQ-6) and Standardised 
Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) (Table 3).

Table 3. Treatment difference in mean change from baseline in total asthma symptom score, 
ACQ-6 and AQLQ(s)+12 at end of treatment - Patients on high-dose ICS and blood eosinophils
≥300 cells/μL

Trial 1 Trial 2
Fasenra

(na=267)

Placebo

(na=267)

Fasenra

(na=239)

Placebo

(na=248)

Total asthma symptom scoreb

Mean baseline 2.68 2.74 2.76 2.71

Improvement from 
baseline 

-1.30 -1.04 -1.40 -1.16

Difference (95% CI) -0.25 (-0.45, -0.06) -0.23 (-0.43, -0.04)



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Trial 1 Trial 2
Fasenra

(na=267)

Placebo

(na=267)

Fasenra

(na=239)

Placebo

(na=248)

p-value 0.012 0.019

ACQ-6

Mean baseline 2.81 2.90 2.80 2.75

Improvement from 
baseline 

-1.46 -1.17 -1.44 -1.19

Difference (95% CI) -0.29 (-0.48, -0.10) -0.25 (-0.44, -0.07)

AQLQ(S)+12

Mean baseline 3.93 3.87 3.87 3.93

Improvement from 
baseline 

1.56 1.26 1.56 1.31

Difference (95% CI) 0.30 (0.10, 0.50) 0.24 (0.04, 0.45)
a. Number of patients (n) varies slightly due to the number of patients for whom data were available for each 

variable. Results shown based on last available data for each variable.
b. Asthma symptom scale: total score from 0 (least) to 6 (most); day and night time asthma symptom scores 

from 0 (least) to 3 (most) symptoms. Individual day and night time scores were similar.  

Subgroup analyses by prior exacerbation history

Subgroup analyses from Trials 1 and 2 identified patients with higher prior exacerbation history as a 
potential predictor of improved treatment response. When considered alone or in combination with 
baseline blood eosinophils count, these factors may further identify patients who may achieve greater 
response from benralizumab treatment (Table 4).

Table 4. Exacerbation rate and pulmonary function (FEV1) at end of treatment by number of 
exacerbations in the previous year - Patients on high-dose ICS and blood eosinophils ≥300 
cells/μL

Trial 1 Trial 2

Fasenra
(N=267)

Placebo
(N=267)

Fasenra
(N=239)

Placebo
(N=248)

Baseline of 2 exacerbations
n 164 149 144 151

Exacerbation rate 0.57 1.04 0.63 0.62

Difference -0.47 0.01
Rate ratio (95% CI) 0.55 (0.37, 0.80) 1.01 (0.70, 1.46)

Pre-bronchodilator 
FEV1 mean change

0.343 0.230 0.266 0.236

Difference (95% CI) 0.113 (-0.002, 0.228) 0.029 (-0.079, 0.137)

Baseline of 3 or more exacerbations

n 103 118 95 97

Exacerbation rate 0.95 2.23 0.82 1.65

Difference -1.28 -0.84

Rate ratio (95% CI) 0.43 (0.29, 0.63) 0.49 (0.33, 0.74)

Pre-bronchodilator 
FEV1 mean change

0.486 0.251 0.440 0.174

Difference (95% CI) 0.235 (0.088, 0.382) 0.265 (0.115, 0.415)



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Oral corticosteroid dose reduction trial 

Trial 3 evaluated the effect of Fasenra on reducing the use of maintenance oral corticosteroids. The 
primary endpoint was percent reduction from baseline of the final OCS dose during Weeks 24 to 28, 
while maintaining asthma control. Table 5 summarizes the study results for Trial 3.

Table 5. Effect of Fasenra on OCS dose reduction, Trial 3

Fasenra
(N=73)

Placebo
(N=75)

Wilcoxon rank sum test (primary analysis method)

Median % reduction in daily OCS dose from baseline (95% CI) 75 (60, 88) 25 (0, 33)

Wilcoxon rank sum test p-value <0.001

Proportional odds model (sensitivity analysis)

Percent reduction in OCS from baseline at Week 28

≥90% reduction 27 (37%) 9 (12%)

≥75% reduction 37 (51%) 15 (20%)

≥50% reduction 48 (66%) 28 (37%)

>0% reduction 58 (79%) 40 (53%)

No change or no decrease in OCS 15 (21%) 35 (47%)

Odds ratio (95% CI) 4.12 (2.22, 7.63)

Reduction in the daily OCS dose to 0 mg/day* 22 (52%) 8 (19%)

Odds ratio (95% CI) 4.19 (1.58, 11.12)

Reduction in the daily OCS dose to ≤5 mg/day 43 (59%) 25 (33%)

Odds ratio (95% CI) 2.74 (1.41, 5.31)

Exacerbation rate 0.54 1.83

Rate ratio (95% CI) 0.30 (0.17, 0.53)

Exacerbation rate requiring hospitalisation/emergency room 
visit

0.02 0.32

Rate ratio (95% CI) 0.07 (0.01, 0.63)
* 

Only patients with an optimised baseline OCS dose of 12.5 mg or less were eligible to achieve a 100% reduction in OCS 

dose during the study.

Lung function, asthma symptom score, ACQ-6 and AQLQ(S)+12 were also assessed in Trial 3 and 
showed results similar to those in Trials 1 and 2.

Long-term extension trial

The long-term efficacy and safety of Fasenra was evaluated in a phase 3, 56-week extension trial 
BORA (Trial 4). The trial enrolled 2123 patients, 2037 adults and 86 adolescent patients (aged 
12 years and older) from Trials 1, 2 and 3. Trial 4 assessed the long-term effect of Fasenra on annual 
exacerbation rate, lung function, ACQ-6, AQLQ(S)+12 and maintenance of OCS reduction at the 
2 dosing regimens studied in the predecessor studies.

At the recommended dosing regimen, the reduction in annual rate of exacerbations observed in the 
placebo-controlled predecessor Trials 1 and 2 (in patients with baseline blood eosinophil counts 
≥300 cells/μL who were taking high-dose ICS) was maintained over the second year of treatment



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(Table 6). In patients who received Fasenra in predecessor Trials 1 and 2, 73% were exacerbation-free 
in the extension Trial 4.

Table 6. Exacerbations over an extended treatment perioda

Placebob

(N=338)

Fasenra

(N=318)

Trial 1 & 2 Trial 1 & 2 Trial 4 Trial 1, 2 & 4c

Rate 1.23 0.65 0.48 0.56
a. Patients that entered Trial 4 from predecessor Trials 1 and 2 with baseline blood eosinophil counts ≥300 cells/μL who 

were taking high-dose ICS.
b. Placebo patients in Trials 1 and 2 are included up to the end of the predecessor trial (Week 48 in Trial 1, Week 56 in 

Trial 2).
c. Total duration of treatment: 104 – 112 weeks

Similar maintenance of effect was observed throughout Trial 4 in lung function, ACQ-6 and 
AQLQ(S)+12 (Table 7).

Table 7. Change from baseline for lung function, ACQ-6, and AQLQ(S)+12a

Trial 1 & 2 
Baselineb

Trial 1 & 2 EOTc Trial 4 EOTd

Pre-bronchodilator FEV1 (L)

n 318 305 290

Mean baseline (SD) 1.741 (0.621) -- --

Change from baseline (SD) e -- 0.343 (0.507) 0.404 (0.555)

ACQ-6

n 318 315 296

Mean baseline (SD) 2.74 (0.90) -- --

Change from baseline (SD) e -- -1.44 (1.13) -1.47 (1.05)

AQLQ(S)+12

n 307 306 287

Mean baseline (SD) 3.90 (0.99) -- --

Change from baseline (SD) e -- 1.58 (1.23) 1.61 (1.21)

n= number of patients with data at timepoint. SD = standard deviation
a. Baseline blood eosinophil counts ≥300 cells/μL and taking high-dose ICS: Fasenra administered at the recommended 
dosage regimen.
b. Integrated analysis of Trial 1 and 2 baseline includes adults and adolescents.
c. Integrated analysis at End of Treatment (EOT) of Trial 1(Week 48) and Trial 2 (Week 56).
d. EOT for Trial 4 was Week 48 (the last timepoint for adults and adolescent data). 
e. Baseline is prior to Fasenra treatment in Trial 1 and 2.

Efficacy in Trial 4 was also evaluated in patients with baseline blood eosinophil counts <300 cells/µl 
and was consistent with Trials 1 and 2.

Maintenance of the reduction in daily OCS dose was also observed over the extension trial in patients 
enrolled from Trial 3 (Figure 1).



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Figure 1. Median percent reductions in daily OCS over time (Trial 3 and 4)a

a. Predecessor Trial 3 patients who continued Fasenra treatment into Trial 4. Patients were permitted to enter a second 
extension trial after a minimum of 8 weeks in Trial 4 without completing the 56-week extension period.

Immunogenicity

Overall, treatment-emergent anti-drug antibody response developed in 107 out of 809 (13%) patients 
treated with Fasenra at the recommended dosing regimen during the 48 to 56 week treatment period of 
the phase 3 placebo controlled exacerbation trials. Most antibodies were neutralising and persistent. 
Anti-benralizumab antibodies were associated with increased clearance of benralizumab and increased 
blood eosinophil levels in patients with high anti-drug antibody titres compared to antibody negative 
patients; in rare cases, blood eosinophil levels returned to pre-treatment levels. Based on current 
patient follow-up, no evidence of an association of anti-drug antibodies with efficacy or safety was 
observed.

Following a second year of treatment of these patients from the phase 3 placebo-controlled trials, an 
additional 18 out of 510 (4%) had newly developed treatment-emergent antibodies. Overall, in patients 
who were anti-drug antibody positive in the predecessor trials, titres remained stable or declined in the 
second year of treatment. No evidence of an association of anti-drug antibodies with efficacy or safety 
was observed.

Paediatric population 

There were 108 adolescents aged 12 to 17 with asthma enrolled in the phase 3 trials (Trial 1: n=53, 
Trial 2: n=55). Of these, 46 received placebo, 40 received Fasenra every 4 weeks for 3 doses, followed 
by every 8 weeks thereafter, and 22 received Fasenra every 4 weeks. In these trials, the asthma 
exacerbation rate in adolescent patients treated with Fasenra administered at the recommended dosing 
regimen was 0.70 (n=40, 95% CI: 0.42, 1.18) compared to 0.41 for placebo (n=46, 95% CI: 0.23, 
0.73) [rate ratio 1.70, 95% CI: 0.78, 3.69]. 

Adolescent patients aged 12 to 17 (n=86) from Trials 1 and 2 continued treatment with Fasenra in 
Trial 4 for up to 108 weeks. Efficacy and safety were consistent with the predecessor trials.

No conclusion can be drawn regarding asthma efficacy in the paediatric population.

Trial 4Trial 3

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The European Medicines Agency has waived the obligation to submit the results of studies with 
Fasenra in paediatric population aged from birth to less than 6 years in asthma (see section 4.2 for 
information on paediatric use).

The European Medicines Agency has deferred the obligation to submit the results of studies with
Fasenra in one or more subsets of the paediatric population in asthma (see section 4.2 for information 
on paediatric use).

5.2 Pharmacokinetic properties

The pharmacokinetics of benralizumab were dose-proportional in patients with asthma following 
subcutaneous administration over a dose range of 2 to 200 mg.

Absorption

Following subcutaneous administration to patients with asthma, the absorption half-life was 3.5 days. 
Based on population pharmacokinetic analysis, the estimated absolute bioavailability was 
approximately 59% and there was no clinically relevant difference in relative bioavailability in the 
administration to the abdomen, thigh, or upper arm. 

Distribution

Based on population pharmacokinetic analysis, central and peripheral volume of distribution of 
benralizumab was 3.1 L and 2.5 L, respectively, for a 70 kg individual.

Biotransformation

Benralizumab is a humanised IgG1 monoclonal antibody that is degraded by proteolytic enzymes 
widely distributed in the body and not restricted to hepatic tissue.

Elimination

From population pharmacokinetic analysis, benralizumab exhibited linear pharmacokinetics and no 
evidence of target receptor-mediated clearance pathway. The estimated systemic clearance (CL) for 
benralizumab was at 0.29 L/d. Following subcutaneous administration, the elimination half-life was 
approximately 15.5 days.

Special populations

Elderly patients (≥65 years old)
Based on population pharmacokinetic analysis, age did not affect benralizumab clearance. However, 
no data are available in patients over 75 years of age.

Paediatric
Based on the population pharmacokinetic analysis, the pharmacokinetics of benralizumab in 
adolescents aged 12 to 17 years were consistent with adults. Benralizumab has not been studied in 
children (5 to 11 years old) (see section 4.2).

Gender, Race
A population pharmacokinetics analysis, indicated that there was no significant effect of gender and 
race on benralizumab clearance.

Renal impairment
No formal clinical studies have been conducted to investigate the effect of renal impairment on 
benralizumab. Based on population pharmacokinetic analysis, benralizumab clearance was comparable 
in subjects with creatinine clearance values between 30 and 80 mL/min and patients with normal renal 
function. There are limited data available in subjects with creatinine clearance values less than 
30 mL/min; however, benralizumab is not cleared renally.



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Hepatic impairment
No formal clinical studies have been conducted to investigate the effect of hepatic impairment on 
benralizumab. IgG monoclonal antibodies are not primarily cleared via hepatic pathway; change in 
hepatic function is not expected to influence benralizumab clearance. Based on population 
pharmacokinetic analysis, baseline hepatic function biomarkers (ALT, AST, and bilirubin) had no 
clinically relevant effect on benralizumab clearance. 

Drug-Drug interaction
An effect of benralizumab on the pharmacokinetics of co-administered medicinal products is not 
expected. Based on the population pharmacokinetic analysis, commonly co-administered medicinal 
products (montelukast, paracetamol, proton pump inhibitors, macrolides and 
theophylline/aminophylline) had no effect on benralizumab clearance in patients with asthma. 

5.3 Preclinical safety data

As benralizumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been 
conducted.

Animal toxicology and/or pharmacology

Non-clinical data reveal no special hazards for humans based on conventional studies of safety 
pharmacology or repeated dose toxicity studies in monkeys. Intravenous and subcutaneous 
administration to cynomolgus monkeys was associated with reductions in peripheral blood and bone 
marrow eosinophil counts, with no toxicological findings.

Pregnancy

In a prenatal and postnatal development study in pregnant cynomolgus monkeys, there were no 
benralizumab-related maternal, embryo-foetal, or postnatal effects observed.

Fertility

No dedicated animal studies have been conducted. No benralizumab-related impairment was observed 
in reproductive parameters of male and female cynomolgus monkeys. Examination of surrogate 
fertility parameters (including organ weights and histopathology of reproductive tissues) in animals 
treated with benralizumab suggested no impairment of fertility. However, in the offspring of monkeys 
dosed while pregnant, there was a reduction in eosinophils.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Histidine
Histidine hydrochloride monohydrate
Trehalose dihydrate
Polysorbate 20
Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products.

6.3 Shelf life



15

3 years

6.4 Special precautions for storage

Store in a refrigerator (2°C to 8°C). Fasenra may be kept at room temperature up to 25°C for a 
maximum of 14 days. After removal from the refrigerator, Fasenra must be used within 14 days or 
discarded. Store the pre-filled syringe/pre-filled pen (Fasenra Pen) in the original package in order to 
protect from light. 

Do not freeze. Do not shake. Do not expose to heat.

6.5 Nature and contents of container 

Pre-filled syringe

One mL solution in a single-use pre-filled syringe made from type I glass with a staked 29-gauge 
½-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated plunger stopper in a 
passive safety device.

Pack containing 1 single-use pre-filled syringe.

Pre-filled pen

One mL solution in a sterile, single use pre-filled pen made from type I glass with staked 29-gauge 
½-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated stopper in a 
pre-filled pen. 

Pack containing 1 single-use pre-filled pen (Fasenra Pen).

6.6 Special precautions for disposal and other handling

Fasenra solution for injection is supplied in a sterile single-use pre-filled syringe or pre-filled pen for 
individual use. Do not shake. Do not freeze.

Prior to administration, warm Fasenra by leaving carton at room temperature. This generally takes 
30 minutes.

Visually inspect Fasenra for particulate matter and discolouration prior to administration. Fasenra is 
clear to opalescent, colourless to yellow, and may contain translucent or white to off-white particles. 
Do not use Fasenra if liquid is cloudy, discoloured, or if it contains large particles or foreign 
particulate matter.

Additional information and instructions for the preparation and administration of Fasenra using the 
pre-filled syringe or pre-filled pen (Fasenra Pen) are given in the package leaflet and ‘Instructions for 
Use’.

Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

7. MARKETING AUTHORISATION HOLDER

AstraZeneca AB
SE-151 85 Södertälje
Sweden



16

8. MARKETING AUTHORISATION NUMBER(S) 

EU/1/17/1252/001 1 pre-filled syringe
EU/1/17/1252/002 1 pre-filled pen

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 8 January 2018

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.



17

ANNEX II

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT



18

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC)
633 Research Court
Frederick, Maryland
21703
United States

Name and address of the manufacturers responsible for batch release

AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden

MedImmune UK Ltd
6 Renaissance Way 
Liverpool, L24 9JW
United Kingdom

MedImmune Pharma B.V., Nijmegen
Lagelandseweg 78
Nijmegen, 6545CG 
Netherlands

The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch.

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic safety update reports

The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines 
web-portal.

The marketing authorisation holder shall submit the first periodic safety update report for this 
product within 6 months following authorisation.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT  

 Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed 
subsequent updates of the RMP.



19

An updated RMP should be submitted:

 At the request of the European Medicines Agency;

 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached.



20

ANNEX III

LABELLING AND PACKAGE LEAFLET



21

A. LABELLING



22

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON- PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Fasenra 30 mg solution for injection in pre-filled syringe
benralizumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe contains 30 mg benralizumab in 1 mL.

3. LIST OF EXCIPIENTS

Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20, water 
for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 pre-filled syringe

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use
Read the instructions for use and the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.
Do not freeze, shake or expose to heat.
Keep the pre-filled syringe in the outer carton in order to protect from light.



23

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB
SE-151 85 Södertälje
Sweden

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/17/1252/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

fasenra 30 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC 
SN 
NN



24

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERED PRE-FILLED SYRINGE

1. NAME OF THE MEDICINAL PRODUCT

Fasenra 30 mg solution for injection in pre-filled syringe
benralizumab

2. NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca 

3. EXPIRY DATE

EXP

4. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

5. OTHER

Subcutaneous use
Store in a refrigerator. 
Do not freeze, shake or expose to heat.
Keep the pre-filled syringe in the outer carton in order to protect from light.



25

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Fasenra 30 mg
injection
benralizumab
SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 mL

6. OTHER



26

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON- PRE-FILLED PEN

1. NAME OF THE MEDICINAL PRODUCT

Fasenra 30 mg solution for injection in pre-filled pen
benralizumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled pen contains 30 mg benralizumab in 1 mL.

3. LIST OF EXCIPIENTS

Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20, water 
for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection
1 pre-filled pen
Each pack contains 1 Fasenra Pen

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use
Read the instructions for use and the package leaflet before use.
Open here
Important! Follow the enclosed instructions for use to prepare and deliver your dose.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.



27

Do not freeze, shake or expose to heat.
Keep the pre-filled pen in the outer carton in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB
SE-151 85 Södertälje
Sweden

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/17/1252/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

fasenra 30 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC 
SN 
NN



28

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Fasenra 30 mg
injection
benralizumab
Subcutaneous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 mL

6. OTHER

AstraZeneca



29

B. PACKAGE LEAFLET



30

Package leaflet: Information for the patient

Fasenra 30 mg solution for injection in pre-filled syringe
benralizumab

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 

What is in this leaflet 
1. What Fasenra is and what it is used for 
2. What you need to know before you use Fasenra
3. How to use Fasenra
4. Possible side effects 
5. How to store Fasenra
6. Contents of the pack and other information 

1. What Fasenra is and what it is used for   

What Fasenra is
Fasenra is a medicine containing the active substance benralizumab, which is a monoclonal antibody, 
a type of protein that recognises and attaches to a specific target substance in the body. The target of 
benralizumab is a protein called interleukin-5 receptor, which is found particularly on a type of white 
blood cell called an eosinophil.

What Fasenra is used for
Fasenra is used to treat severe eosinophilic asthma in adults. Eosinophilic asthma is a type of asthma 
where patients have too many eosinophils in the blood or lungs. 

Fasenra is used together with other medicines to treat asthma (high doses of ‘corticosteroid inhalers’
plus other asthma medicines) when the disease is not well controlled by those other medicines alone. 

How Fasenra works
Eosinophils are white blood cells involved in asthma inflammation. By attaching to the eosinophils, 
Fasenra helps to reduce their numbers. 

What are the benefits of using Fasenra
Fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and 
decrease your asthma symptoms. If you are taking medicines called ‘oral corticosteroids’, using
Fasenra may also allow you to reduce the daily dose or stop the oral corticosteroids you need to 
control your asthma.

2. What you need to know before you use Fasenra

Do not use Fasenra:
 If you are allergic to benralizumab or any of the other ingredients of this medicine (listed in 

section 6).  Check with your doctor, nurse or pharmacist if you think this applies to you.



31

Warnings and precautions 
Talk to your doctor, nurse or pharmacist before you are given Fasenra:

 if you have a parasitic infection or if you live in an area where parasitic infections are common 
or you are travelling to such a region. This medicine may weaken your ability to fight certain 
types of parasitic infections,

 if you have had an allergic reaction to an injection or medicine in the past (see section 4 for 
symptoms of an allergic reaction).

Also, talk to your doctor, nurse or pharmacist when you are given Fasenra:
 if your asthma remains uncontrolled or worsens during treatment with this medicine.
 if you have any symptoms of an allergic reaction (see section 4). Allergic reactions have 

occurred in patients receiving this medicine. 

Look out for signs of serious allergic reactions 
Fasenra can potentially cause serious allergic reactions. You must look out for signs of these reactions 
(such as hives, rash, breathing problems, fainting, dizziness, feeling lightheaded and/or swelling of 
your face, tongue or mouth) while you are taking Fasenra.

It is important that you talk to your doctor about how to recognise early symptoms of serious allergic 
reactions and how to manage these reactions if they occur.

Other medicines for asthma
Do not suddenly stop taking your preventer medicines for your asthma once you have started 
Fasenra. 

If your response to the treatment allows it, your doctor may try to reduce the dose of some of these 
medicines, especially ones called ‘corticosteroids’. This should be done gradually, under the direct 
supervision of your doctor.

Other medicines and Fasenra
Tell your doctor if you are taking, have recently taken or might take any other medicines before using 
Fasenra.

Children and adolescents
The safety and benefits of this medicine are not known in children below the age of 18. 

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for 
advice before using this medicine. 

Do not use Fasenra if you are pregnant unless your doctor tells you otherwise. It is not known whether 
Fasenra could harm your unborn baby. 

It is not known whether the ingredients of Fasenra can pass into breast milk. If you are 
breast-feeding or plan to breast-feed, talk to your doctor. 

Driving and using machines
It is unlikely that Fasenra will affect your ability to drive and use machines. 

3. How to use Fasenra

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or 
pharmacist if you are not sure.



32

Fasenra is given as an injection just under the skin (subcutaneously). You and your doctor or nurse 
should decide if you should inject Fasenra yourself. You should not inject Fasenra yourself if you have 
not received Fasenra previously and if you had previous allergic reaction with Fasenra.

You or your caregiver should receive training on the right way to prepare and inject Fasenra. Read the 
‘Instructions for Use’ for the pre-filled syringe carefully before using Fasenra.

The recommended dose is an injection of 30 mg. The first 3 injections are every 4 weeks. After this, 
injections are 30 mg every 8 weeks. 

If a dose of Fasenra is missed
If you have forgotten to inject a dose of Fasenra, talk to your doctor, pharmacist or nurse as soon as 
possible.

Stopping treatment with Fasenra
Do not stop treatment with Fasenra unless your doctor advises you to. Interrupting or stopping the 
treatment with Fasenra may cause your asthma symptoms and attacks to come back.

If your asthma symptoms get worse while receiving injections of Fasenra, call your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious allergic reactions
Seek medical attention immediately if you think you may be having an allergic reaction. Such 
reactions may happen within hours or days after the injection.   

Not known (the frequency cannot be determined from the available data):
 anaphylaxis

symptoms usually include: 
o swelling of your face, tongue, or mouth 
o breathing problems
o fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)

Common (these may affect up to 1 in 10 people):
 hives
 rash

Other side effects
Common (these may affect up to 1 in 10 people) 
 headache
 pharyngitis (sore throat)
 fever (high temperature)
 injection site reaction (for example pain, redness, itching, swelling near where the injection  was 

given) 

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine.



33

5. How to store Fasenra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the 
last day of that month. 
Store in the original package to protect from light. 
Store in a refrigerator (2°C to 8°C). 
The syringe may be kept at room temperature up to 25°C for a maximum of 14 days. After removal 
from the refrigerator, Fasenra must be used within 14 days or discarded.
Do not shake, freeze or expose to heat.

Fasenra is for single use only. Do not throw away any medicines via wastewater. Ask your pharmacist 
how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fasenra contains 
The active substance is benralizumab. One pre-filled syringe of 1 mL solution contains 30 mg 
benralizumab. 

The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, 
polysorbate 20 and water for injections.

What Fasenra looks like and contents of the pack
Fasenra is a solution in a clear glass syringe. Its colour may vary from colourless to yellow. It may 
contain particles.   

Fasenra is available in a pack containing 1 pre-filled syringe. 

Marketing Authorisation Holder

AstraZeneca AB
SE-151 85 
Södertälje
Sweden

Manufacturer

AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden

MedImmune UK Ltd
6 Renaissance Way
Liverpool, L24 9JW
United Kingdom

MedImmune Pharma B.V., Nijmegen
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:



34

België/Belgique/Belgien
AstraZeneca S.A./N.V.
Tel: +32 2 370 48 11

Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660550

България
АстраЗенека България ЕООД
Тел.: +359 24455000

Luxembourg/Luxemburg
AstraZeneca S.A./N.V.
Tél/Tel: +32 2 370 48 11

Česká republika
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111

Magyarország
AstraZeneca Kft.
Tel.: +36 1 883 6500

Danmark
AstraZeneca A/S
Tlf: +45 43 66 64 62

Malta
Associated Drug Co. Ltd
Tel: +356 2277 8000

Deutschland
AstraZeneca GmbH
Tel: +49 41 03 7080

Nederland
AstraZeneca BV
Tel: +31 79 363 2222

Eesti
AstraZeneca 
Tel: +372 6549 600

Norge
AstraZeneca AS
Tlf: +47 21 00 64 00

Ελλάδα
AstraZeneca A.E.
Τηλ: +30 210 6871500

Österreich
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0

España
AstraZeneca Farmacéutica Spain, S.A.
Tel: +34 91 301 91 00

Polska
AstraZeneca Pharma Poland Sp. z o.o.
Tel.: +48 22 245 73 00

France
AstraZeneca
Tél: +33 1 41 29 40 00

Portugal
AstraZeneca Produtos Farmacêuticos, Lda.
Tel: +351 21 434 61 00

Hrvatska 
AstraZeneca d.o.o.
Tel: +385 1 4628 000

România
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41

Ireland
AstraZeneca Pharmaceuticals (Ireland) DAC
Tel: +353 1609 7100

Slovenija
AstraZeneca UK Limited
Tel: +386 1 51 35 600

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777 

Italia
AstraZeneca S.p.A.
Tel: +39 02 9801 1

Suomi/Finland
AstraZeneca Oy
Puh/Tel: +358 10 23 010

Κύπρος
Αλέκτωρ Φαρµακευτική Λτδ

Sverige
AstraZeneca AB



35

Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

United Kingdom
AstraZeneca UK Ltd
Tel: +44 1582 836 836

This leaflet was last revised in 

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

<------------------------------------------------------------------------------------------------------------------------



36

Instructions for use
Fasenra 30mg
Solution for Injection in Pre-filled Syringe
Benralizumab

For Subcutaneous Injection
Single-use Pre-filled Syringe

Before using your Fasenra pre-filled syringe, your healthcare provider should show you or your 

caregiver how to use it correctly.

Read this 'Instructions for Use' before you start using your Fasenra pre-filled syringe and each 
time you get a refill. There may be new information. This information does not take the place of 

talking to your healthcare provider about your medical condition or your treatment.

If you or your caregiver have any questions, talk to your healthcare provider.

Important information 

Store Fasenra in a refrigerator between 2°C to 8°C in its carton until you are ready to use it. 
Fasenra may be kept at room temperature up to 25oC for a maximum of 14 days. After removal from 
the refrigerator, Fasenra must be used within 14 days or discarded.

Do not use your Fasenra pre-filled syringe if:
 it has been frozen
 it has been dropped or damaged
 the security seal on the carton has been broken
 the expiry date (EXP) has passed

Do not:
 shake your pre-filled syringe

 share or re-use your pre-filled 

syringe

If any of the above happens, throw away the syringe in a puncture-resistant sharps container and use a 

new pre-filled syringe.

Each Fasenra pre-filled syringe contains 1 dose of Fasenra that is for one-time use only.

Keep Fasenra and all medicines out of the sight and reach of children.

Your Fasenra pre-filled syringe

Do not remove the needle cover until you have reached Step 6 of these instructions and are ready to 

inject Fasenra.

Do not touch the needle guard activation clips to keep from activating the safety device (needle guard) 

too soon.



37

Needle guard 
activation clips

Syringe 
body

Label with expiration 
date

Needle cover

Plunger head

Plunger Finger 
flange

Viewing 
window

Needle

Step 1 - Gather Supplies

 1 Fasenra pre-filled syringe from the refrigerator

 1 alcohol wipe

 1 cotton ball or gauze

 1 puncture-resistant sharps container.

(See Step 9 - Dispose the used pre-filled syringe)

Pre-filled syringe Alcohol wipe Cotton ball or gauze Sharps container

Step 2 - Prepare to use your pre-filled syringe

Check the expiry (EXP) date. Do not use if the expiry date has passed.

Let Fasenra warm up at room temperature 20°C to 25°C for about 

30 minutes before giving the injection.
Do not warm the pre-filled syringe in any other way. For example, do not 

warm it in a microwave or hot water, or put it near other heat sources.

Use Fasenra within 14 days of removing from the refrigerator.

Step 3 - Check the liquid

Grasp the syringe body (not the plunger) to remove the pre-filled 

syringe.

Look at the liquid through the viewing window. The liquid should 

be clear and colourless to yellow. It may contain small white particles.

Do not inject Fasenra if the liquid is cloudy, discoloured, or contains 

large particles.

You may see a small air bubble in the liquid. This is normal. You do 

not need to do anything about it.

30
min



38

Step 4 - Choose the injection site

The recommended injection site is the front of your thigh.

You may also use the lower part of your abdomen.

Do not inject:

 into the 5 cm area around your belly-button

 where the skin is tender, bruised, scaly or hard

 into scars or damaged skin

 through clothing

A caregiver may inject you in the upper-arm, thigh, or 

abdomen. Do not try to inject yourself in the arm.

For each injection, choose a different site that is at least 3 cm 

away from where you last injected.

Step 5 - Clean the injection site

Wash your hands well with soap and water.

Clean the injection site with an alcohol wipe in a circular motion. 

Let it air dry.

Do not touch the cleaned area before injecting.

Do not fan or blow on the cleaned area.

Step 6 - Pull off the needle cover

Hold the syringe body with 1 hand, and carefully pull the needle 

cover straight off with your other hand.

Do not hold the plunger or plunger head while removing the needle 

cover.

Put the needle cover aside to throw away later.

You may see a drop of liquid at the end of the needle. This is 

normal.

Do not use the syringe if it is dropped without the needle cover in 

place or if the needle is damaged or dirty.

Do not touch the needle, or let it touch any surface. 

Go straight on to the next steps, without delay.

Caregiver
site only



39

Step 7 - Inject Fasenra

Hold the pre-filled syringe in 1 hand as shown. 

Use your other hand to gently pinch and hold the area of skin 

where you want to inject. This creates a firmer surface.

Do not press down on the plunger until the needle is completely 

inserted into the skin.

Do not pull back on the plunger at any time.

Inject Fasenra by following the steps in figures a, b and c.

Use a quick, dart-like motion 

to insert the needle into the 

pinched skin. 

Insert the needle at an angle of 

45 degrees.

Use your thumb to push down 

on the plunger head. 

Keep pushing until it is down 

as far as it will go. This is to 

make sure you inject all of the 

medication.

Keep your thumb pressed down 

on the plunger head as you take 

the needle out of the skin.

Slowly ease up on the plunger 

until the needle guard covers 

the needle.

Step 8 - Check the injection site

There may be a small amount of blood or liquid where you injected. 

This is normal.

Gently hold pressure over your skin with a cotton ball or gauze until 

the bleeding stops.

Do not rub the injection site.

If needed, cover the injection site with a small bandage.

a
45°

b c



40

Step 9 - Dispose the used pre-filled syringe

 Each pre-filled syringe contains a single dose of Fasenra and 

cannot be re-used.
 Put your used pre-filled syringe in a puncture-resistant sharps 

container right away after use. 

Do not throw away the pre-filled syringe in your household waste.

Do not re-cap the pre-filled syringe.

Throw away the cap and other used supplies in your household 

waste.

Disposal guidelines 

Dispose of the full container as instructed by your healthcare provider or pharmacist.

Do not recycle your used sharps container.



41

Package leaflet: Information for the patient

Fasenra 30 mg solution for injection in pre-filled pen
benralizumab

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you.
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 

What is in this leaflet 
1. What Fasenra is and what it is used for 
2. What you need to know before you use Fasenra
3. How to use Fasenra Pen
4. Possible side effects 
5. How to store Fasenra Pen
6. Contents of the pack and other information 

1. What Fasenra is and what it is used for   

What Fasenra is
Fasenra is a medicine containing the active substance benralizumab, which is a monoclonal antibody, 
a type of protein that recognises and attaches to a specific target substance in the body. The target of 
benralizumab is a protein called interleukin-5 receptor, which is found particularly on a type of white 
blood cell called an eosinophil.

What Fasenra is used for
Fasenra is used to treat severe eosinophilic asthma in adults. Eosinophilic asthma is a type of asthma 
where patients have too many eosinophils in the blood or lungs. 

Fasenra is used together with other medicines to treat asthma (high doses of ‘corticosteroid inhalers’
plus other asthma medicines) when the disease is not well controlled by those other medicines alone. 

How Fasenra works
Eosinophils are white blood cells involved in asthma inflammation. By attaching to the eosinophils, 
Fasenra helps to reduce their numbers. 

What are the benefits of using Fasenra
Fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and 
decrease your asthma symptoms. If you are taking medicines called ‘oral corticosteroids’, using
Fasenra may also allow you to reduce the daily dose or stop the oral corticosteroids you need to 
control your asthma.

2. What you need to know before you use Fasenra

Do not use Fasenra:
 If you are allergic to benralizumab or any of the other ingredients of this medicine (listed in 

section 6).  Check with your doctor, nurse or pharmacist if you think this applies to you.



42

Warnings and precautions 
Talk to your doctor, nurse or pharmacist before you are given Fasenra:

 if you have a parasitic infection or if you live in an area where parasitic infections are common 
or you are travelling to such a region. This medicine may weaken your ability to fight certain 
types of parasitic infections,

 if you have had an allergic reaction to an injection or medicine in the past (see section 4 for 
symptoms of an allergic reaction).

Also, talk to your doctor, nurse or pharmacist when you are given Fasenra:
 if your asthma remains uncontrolled or worsens during treatment with this medicine.
 if you have any symptoms of an allergic reaction (see section 4). Allergic reactions have 

occurred in patients receiving this medicine. 

Look out for signs of serious allergic reactions 
Fasenra can potentially cause serious allergic reactions. You must look out for signs of these reactions 
(such as hives, rash, breathing problems, fainting, dizziness, feeling lightheaded and/or swelling of 
your face, tongue or mouth) while you are taking Fasenra.

It is important that you talk to your doctor about how to recognise early symptoms of serious allergic 
reactions and how to manage these reactions if they occur.

Other medicines for asthma
Do not suddenly stop taking your preventer medicines for your asthma once you have started 
Fasenra. 

If your response to the treatment allows it, your doctor may try to reduce the dose of some of these 
medicines, especially ones called ‘corticosteroids’. This should be done gradually, under the direct 
supervision of your doctor.

Other medicines and Fasenra
Tell your doctor if you are taking, have recently taken or might take any other medicines before using 
Fasenra.

Children and adolescents
The safety and benefits of this medicine are not known in children below the age of 18. 

Pregnancy and breast-feeding 
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for 
advice before using this medicine. 

Do not use Fasenra if you are pregnant unless your doctor tells you otherwise. It is not known whether 
Fasenra could harm your unborn baby. 

It is not known whether the ingredients of Fasenra can pass into breast milk. If you are 
breast-feeding or plan to breast-feed, talk to your doctor. 

Driving and using machines
It is unlikely that Fasenra will affect your ability to drive and use machines. 

3. How to use Fasenra Pen

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or 
pharmacist if you are not sure.



43

Fasenra is given as an injection just under the skin (subcutaneously). You and your doctor or nurse 
should decide if you should inject Fasenra yourself. You should not inject Fasenra yourself if you have 
not received Fasenra previously and if you had previous allergic reaction with Fasenra.

You or your caregiver should receive training on the right way to prepare and inject Fasenra. Read the 
‘Instructions for Use’ for the Fasenra Pen carefully before using Fasenra.

The recommended dose is an injection of 30 mg. The first 3 injections are every 4 weeks. After this, 
injections are 30 mg every 8 weeks. 

If a dose of Fasenra is missed
If you have forgotten to inject a dose of Fasenra, talk to your doctor, pharmacist or nurse as soon as 
possible.

Stopping treatment with Fasenra
Do not stop treatment with Fasenra unless your doctor advises you to. Interrupting or stopping the 
treatment with Fasenra may cause your asthma symptoms and attacks to come back.

If your asthma symptoms get worse while receiving injections of Fasenra, call your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious allergic reactions
Seek medical attention immediately if you think you may be having an allergic reaction. Such 
reactions may happen within hours or days after the injection.   

Not known (the frequency cannot be determined from the available data):
 anaphylaxis

symptoms usually include: 
o swelling of your face, tongue, or mouth 
o breathing problems
o fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)

Common (these may affect up to 1 in 10 people):
 hives
 rash

Other side effects
Common (these may affect up to 1 in 10 people) 
 headache
 pharyngitis (sore throat)
 fever (high temperature)
 injection site reaction (for example pain, redness, itching, swelling near where the injection was 

given) 

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine.



44

5. How to store Fasenra Pen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the 
last day of that month. 
Store in the original package to protect from light. 
Store in a refrigerator (2°C to 8°C). 
The Fasenra Pen may be kept at room temperature up to 25°C for a maximum of 14 days. After 
removal from the refrigerator, Fasenra must be used within 14 days or discarded.
Do not shake, freeze or expose to heat.

Fasenra Pen is for single-use only. Do not throw away any medicines via wastewater. Ask your 
pharmacist how to throw away medicines you no longer use. These measures will help protect the 
environment.

6. Contents of the pack and other information

What Fasenra Pen contains 
The active substance is benralizumab. One pre-filled pen of 1 mL solution contains 30 mg 
benralizumab. 

The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, 
polysorbate 20 and water for injections.

What Fasenra looks like and contents of the pack
Fasenra is a solution which is colourless to yellow. It may contain particles.

Fasenra is available in a pack containing 1 pre-filled pen. 

Marketing Authorisation Holder

AstraZeneca AB
SE-151 85 
Södertälje
Sweden

Manufacturer

AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden

MedImmune UK Ltd
6 Renaissance Way
Liverpool, L24 9JW
United Kingdom

MedImmune Pharma B.V., Nijmegen
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:



45

België/Belgique/Belgien
AstraZeneca S.A./N.V.
Tel: +32 2 370 48 11

Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660550

България
АстраЗенека България ЕООД
Тел.: +359 24455000

Luxembourg/Luxemburg
AstraZeneca S.A./N.V.
Tél/Tel: +32 2 370 48 11

Česká republika
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111

Magyarország
AstraZeneca Kft.
Tel.: +36 1 883 6500

Danmark
AstraZeneca A/S
Tlf: +45 43 66 64 62

Malta
Associated Drug Co. Ltd
Tel: +356 2277 8000

Deutschland
AstraZeneca GmbH
Tel: +49 41 03 7080

Nederland
AstraZeneca BV
Tel: +31 79 363 2222

Eesti
AstraZeneca 
Tel: +372 6549 600

Norge
AstraZeneca AS
Tlf: +47 21 00 64 00

Ελλάδα
AstraZeneca A.E.
Τηλ: +30 210 6871500

Österreich
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0

España
AstraZeneca Farmacéutica Spain, S.A.
Tel: +34 91 301 91 00

Polska
AstraZeneca Pharma Poland Sp. z o.o.
Tel.: +48 22 245 73 00

France
AstraZeneca
Tél: +33 1 41 29 40 00

Portugal
AstraZeneca Produtos Farmacêuticos, Lda.
Tel: +351 21 434 61 00

Hrvatska 
AstraZeneca d.o.o.
Tel: +385 1 4628 000

România
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41

Ireland
AstraZeneca Pharmaceuticals (Ireland) DAC
Tel: +353 1609 7100

Slovenija
AstraZeneca UK Limited
Tel: +386 1 51 35 600

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777 

Italia
AstraZeneca S.p.A.
Tel: +39 02 9801 1

Suomi/Finland
AstraZeneca Oy
Puh/Tel: +358 10 23 010

Κύπρος
Αλέκτωρ Φαρµακευτική Λτδ

Sverige
AstraZeneca AB



46

Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

United Kingdom
AstraZeneca UK Ltd
Tel: +44 1582 836 836

This leaflet was last revised in 

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 



47

Instructions for Use
Fasenra 30mg
Solution for Injection in Pre-filled Pen
Benralizumab
For Subcutaneous Injection
Single-use Pre-filled Pen 

Before using your Fasenra Pen, your healthcare provider should show you or your caregiver how to 

use it correctly.

Read this ‘Instructions for Use’ before you start using your Fasenra Pen and each time you get a 
refill. There may be new information. This information does not take the place of talking to your 

healthcare provider about your medical condition or your treatment.

If you or your caregiver have any questions, talk to your healthcare provider.

Important Information

Store Fasenra in a refrigerator between 2°C to 8°C in its carton until you are ready to use it.
Fasenra may be kept at room temperature up to 25oC for a maximum of 14 days. After removal from 

the refrigerator, Fasenra must be used within 14 days or discarded

Do not use your Fasenra Pen if:
 it has been frozen
 it has been dropped or damaged
 the security seal on the carton has been 

broken
 the expiry date (EXP) has passed

Do not:
 shake your Fasenra Pen

 share or re-use your Fasenra Pen

If any of the above happens, throw away the Fasenra Pen in a puncture-resistant sharps container and 

use a new Fasenra Pen.

Each Fasenra Pen contains 1 dose of Fasenra that is for one-time use only. 

Keep Fasenra and all medicines out of the sight and reach of children.

Your Fasenra Pen

Do not remove the cap until you have reached Step 6 of these instructions and are ready to inject 

Fasenra. 

Before Use After Use

Step 1 - Gather Supplies

 1 Fasenra Pen from the refrigerator

 1 alcohol wipe

 1 cotton ball or gauze
 1 puncture-resistant sharps container.

Needle 
Guard

Label with expiry 
date

Liquid 
medicine

Viewing 
window

Cap Green 
plunger



48

(See Step 10 – Dispose of the used Fasenra Pen safely)

Fasenra Pen Alcohol wipe Cotton ball or gauze Sharps container

Step 2 - Prepare to use your Fasenra Pen

Check the expiry date (EXP). Do not use if the expiry date has passed.

Let Fasenra warm up at room temperature 20°C to 25°C for about 

30 minutes before giving the injection.
Do not warm the Fasenra Pen in any other way. For example, do not warm it in a 

microwave or hot water, or put it near other heat sources.

Use Fasenra within 14 days of removing from the refrigerator.

Do not remove the cap until you have reached Step 6.

Step 3 - Check the liquid

Look at the liquid in the Fasenra Pen through the viewing 
window. The liquid should be clear and colourless to yellow. It may 

contain small white particles.

Do not inject Fasenra if the liquid is cloudy, discoloured, or

contains large particles.

You may see a small air bubble in the liquid. This is normal. You 

do not need to do anything about it.

Step 4 - Choose the injection site

The recommended injection site is the front of your thigh. You 

may also use the lower part of your abdomen.

Do not inject:

 into the 5 cm area around your belly-button

 where the skin is tender, bruised, scaly or hard

 into scars or damaged skin

 through clothing

A caregiver may inject you in the upper-arm, thigh, or abdomen. 

Do not try to inject yourself in the arm.

For each injection, choose a different site that is at least 3 cm 

away from where you last injected.

Caregiver
site only

30
min



49

Step 5 - Clean the injection site

Wash your hands well with soap and water.

Clean the injection site with an alcohol wipe in a circular motion. Let 

it air dry.

Do not touch the cleaned area before injecting.

Do not fan or blow on the cleaned area.

Step 6 - Pull off the cap

Hold the Fasenra Pen with 1 hand. Carefully pull the cap straight off 

with your other hand. 

Put the cap aside to throw away later.

The green needle guard is now exposed. It is there to prevent you 

from touching the needle. 

Do not try to touch the needle or push on the needle guard with your 

finger.

Do not try to put the cap back on the Fasenra Pen. You could cause 

the injection to happen too soon or damage the needle.

Complete the following steps right away after removing the cap.

Step 7 - Inject Fasenra

Follow your healthcare provider’s instructions on how to inject. You can either gently pinch at the 
injection site or give the injection without pinching the skin.

Inject Fasenra by following the steps in figures a, b, c and d.

Hold the Fasenra Pen in place for the entire injection. 
Do not change the position of the Fasenra Pen after the injection has started.

Position the Fasenra Pen at the injection site.
Place the needle guard of the Fasenra Pen flat against your skin (90-degree angle). Make sure you can 

see the viewing window.

a

90°



50

Press down firmly. 
You will hear a click. A ‘click’
tells you the injection has 
started. The green plunger will 
move down in the viewing 
window during the injection.

Hold down firmly for 
15 seconds.
You will hear a second ‘click’. 
The second click tells you the 
injection has finished. The green 
plunger will fill the viewing 
window.

Lift the Fasenra Pen straight
up.
The needle guard will slide 
down and lock into place over 
the needle.

Step 8 - Check the viewing window

Check the viewing window to make sure all the liquid has been 

injected.

If the green plunger does not fill the viewing window, you may 

not have received the full dose. If this happens or if you have any 

other concerns, call your healthcare provider.

Before
Injection

After
Injection

Step 9 - Check the injection site

There may be a small amount of blood or liquid where you injected. 

This is normal.

Gently hold pressure over your skin with a cotton ball or gauze until 

the bleeding stops. 

Do not rub the injection site.

If needed, cover the injection site with a small bandage. 

b c

15
sec

d



51

Step 10 - Dispose of the used Fasenra Pen safely

 Each Fasenra Pen contains a single dose of Fasenra and cannot 

be re-used.

 Put your used Fasenra Pen in a puncture-resistant sharps 

container right away after use. 

Do not throw away the Fasenra Pen in your household waste.

Throw away the cap and other used supplies in your household 

waste.

Disposal guidelines

Dispose of the full container as instructed by your healthcare provider or pharmacist. 

Do not recycle your used sharps container. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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benefits of using fasenra fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and decrease your asthma symptoms. if you are taking medicines called 'oral corticosteroids', using fasenra may also allow you to reduce the daily dose or stop the oral corticosteroids you need to control your asthma.", 'Entity_Recognition': [{'Text': 'fasenra', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 1, 'BeginOffset': 5, 'EndOffset': 12, 'Score': 0.457462877035141, 'Text': 'fasenra', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 2, 'BeginOffset': 16, 'EndOffset': 23, 'Score': 0.6840746402740479, 'Text': 'fasenra', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a medicine', 'Type': 'TREATMENT', 'BeginOffset': 27, 'EndOffset': 37}, {'Id': 3, 'BeginOffset': 70, 'EndOffset': 82, 'Score': 0.9913744330406189, 'Text': 'benralizumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': 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{'Title': '2. what you need to know before you use fasenra', 'Section_Content': "do not use fasenra: if you are allergic to benralizumab or any of the other ingredients of this medicine (listed in section 6). check with your doctor, nurse or pharmacist if you think this applies to you. warnings and precautions talk to your doctor, nurse or pharmacist before you are given fasenra: if you have a parasitic infection or if you live in an area where parasitic infections are common or you are travelling to such a region. this medicine may weaken your ability to fight certain types of parasitic infections, if you have had an allergic reaction to an injection or medicine in the past (see section 4 for symptoms of an allergic reaction). also, talk to your doctor, nurse or pharmacist when you are given fasenra: if your asthma remains uncontrolled or worsens during treatment with this medicine. if you have any symptoms of an allergic reaction (see section 4). allergic reactions have occurred in patients receiving this medicine. look out for signs of serious allergic reactions fasenra can potentially cause serious allergic reactions. you must look out for signs of these reactions (such as hives, rash, breathing problems, fainting, dizziness, feeling lightheaded and/or swelling of your face, tongue or mouth) while you are taking fasenra. it is important that you talk to your doctor about how to recognise early symptoms of serious allergic reactions and how to manage these reactions if they occur. other medicines for asthma do not suddenly stop taking your preventer medicines for your asthma once you have started fasenra. if your response to the treatment allows it, your doctor may try to reduce the dose of some of these medicines, especially ones called 'corticosteroids'. this should be done gradually, under the direct supervision of your doctor. other medicines and fasenra tell your doctor if you are taking, have recently taken or might take any other medicines before using fasenra. children and adolescents the safety and benefits of this medicine are not known in children below the age of 18. pregnancy and breast-feeding if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. do not use fasenra if you are pregnant unless your doctor tells you otherwise. it is not known whether fasenra could harm your unborn baby. it is not known whether the ingredients of fasenra can pass into breast milk. if you are breast-feeding or plan to breast-feed, talk to your doctor. driving and using machines it is unlikely that fasenra will affect your ability to drive and use machines.", 'Entity_Recognition': [{'Text': 'fasenra', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 4, 'BeginOffset': 11, 'EndOffset': 18, 'Score': 0.6406208872795105, 'Text': 'fasenra', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.6728441715240479}]}, 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{'Title': '3. how to use fasenra', 'Section_Content': "always use this medicine exactly as your doctor has told you. check with your doctor, nurse or pharmacist if you are not sure. fasenra is given as an injection just under the skin (subcutaneously). you and your doctor or nurse should decide if you should inject fasenra yourself. you should not inject fasenra yourself if you have not received fasenra previously and if you had previous allergic reaction with fasenra. you or your caregiver should receive training on the right way to prepare and inject fasenra. read the 'instructions for use' for the pre-filled syringe carefully before using fasenra. the recommended dose is an injection of 30 mg. the first 3 injections are every 4 weeks. after this, injections are 30 mg every 8 weeks. if a dose of fasenra is missed if you have forgotten to inject a dose of fasenra, talk to your doctor, pharmacist or nurse as soon as possible. stopping treatment with fasenra do not stop treatment with fasenra unless your doctor advises you to. interrupting or stopping the treatment with fasenra may cause your asthma symptoms and attacks to come back. if your asthma symptoms get worse while receiving injections of fasenra, call your doctor. if you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.", 'Entity_Recognition': [{'Text': 'fasenra', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 11, 'EndOffset': 24}, {'Id': 1, 'BeginOffset': 127, 'EndOffset': 134, 'Score': 0.6306744813919067, 'Text': 'fasenra', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'ROUTE_OR_MODE', 'Score': 0.5285496115684509, 'RelationshipScore': 0.9999608993530273, 'RelationshipType': 'ROUTE_OR_MODE', 'Id': 2, 'BeginOffset': 181, 'EndOffset': 195, 'Text': 'subcutaneously', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'an injection', 'Type': 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. serious allergic reactions seek medical attention immediately if you think you may be having an allergic reaction. such reactions may happen within hours or days after the injection. not known (the frequency cannot be determined from the available data): anaphylaxis symptoms usually include: o swelling of your face, tongue, or mouth o breathing problems o fainting, dizziness, feeling lightheaded (due to a drop in blood pressure) common (these may affect up to 1 in 10 people): hives rash other side effects common (these may affect up to 1 in 10 people) headache pharyngitis (sore throat) fever (high temperature) injection site reaction (for example pain, redness, itching, swelling near where the injection was given) reporting of side effects if you get any side effects, talk to your doctor, pharmacist or nurse. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'fasenra', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 6, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9663315415382385, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.744464099407196}]}, {'Text': 'serious allergic reactions', 'Type': 'PROBLEM', 'BeginOffset': 92, 'EndOffset': 118}, {'Id': 36, 'BeginOffset': 142, 'EndOffset': 153, 'Score': 0.9999996423721313, 'Text': 'immediately', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_DX_NAME', 'Traits': [], 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'Text': 'redness', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9663217067718506}]}, {'Id': 29, 'BeginOffset': 762, 'EndOffset': 769, 'Score': 0.9995417594909668, 'Text': 'itching', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9643672108650208}]}, {'Id': 30, 'BeginOffset': 771, 'EndOffset': 779, 'Score': 0.9975461363792419, 'Text': 'swelling', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9501665234565735}]}, {'Text': 'the injection', 'Type': 'TREATMENT', 'BeginOffset': 791, 'EndOffset': 804}, {'Id': 31, 'BeginOffset': 829, 'EndOffset': 841, 'Score': 0.9144783616065979, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7744078636169434}]}, {'Id': 32, 'BeginOffset': 857, 'EndOffset': 869, 'Score': 0.9032650589942932, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.756637454032898}]}, {'Id': 33, 'BeginOffset': 940, 'EndOffset': 952, 'Score': 0.9447077512741089, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6545576453208923}]}, {'Id': 34, 'BeginOffset': 1001, 'EndOffset': 1013, 'Score': 0.8397085070610046, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6914311051368713}], 'Attributes': [{'Type': 'SYSTEM_ORGAN_SITE', 'Score': 0.4193044602870941, 'RelationshipScore': 0.7923214435577393, 'RelationshipType': 'SYSTEM_ORGAN_SITE', 'Id': 5, 'BeginOffset': 1067, 'EndOffset': 1075, 'Text': 'appendix', 'Category': 'ANATOMY', 'Traits': []}]}, {'Id': 5, 'BeginOffset': 1067, 'EndOffset': 1075, 'Score': 0.4193044602870941, 'Text': 'appendix', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 35, 'BeginOffset': 1092, 'EndOffset': 1104, 'Score': 0.7539317607879639, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7285459637641907}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1160, 'EndOffset': 1173}]}
{'Title': '5. how to store fasenra', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the label. the expiry date refers to the last day of that month. store in the original package to protect from light. store in a refrigerator (2 to 8). the syringe may be kept at room temperature up to 25 for a maximum of 14 days. after removal from the refrigerator, fasenra must be used within 14 days or discarded. do not shake, freeze or expose to heat. fasenra is for single use only. do not throw away any medicines via wastewater. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': [{'Text': 'fasenra', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': 'the syringe', 'Type': 'TREATMENT', 'BeginOffset': 277, 'EndOffset': 288}, {'Text': '25', 'Type': 'NUMBER', 'BeginOffset': 327, 'EndOffset': 329}, {'Text': '14', 'Type': 'NUMBER', 'BeginOffset': 347, 'EndOffset': 349}, {'Id': 0, 'BeginOffset': 362, 'EndOffset': 369, 'Score': 0.31994548439979553, 'Text': 'removal', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'PROCEDURE_NAME', 'Traits': []}, {'Text': 'the refrigerator', 'Type': 'TREATMENT', 'BeginOffset': 375, 'EndOffset': 391}, {'Text': 'fasenra', 'Type': 'TREATMENT', 'BeginOffset': 393, 'EndOffset': 400}, {'Text': '14', 'Type': 'NUMBER', 'BeginOffset': 421, 'EndOffset': 423}, {'Text': 'fasenra', 'Type': 'TREATMENT', 'BeginOffset': 483, 'EndOffset': 490}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what fasenra contains the active substance is benralizumab. one pre-filled syringe of 1 ml solution contains 30 mg benralizumab. the other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20 and water for injections. what fasenra looks like and contents of the pack fasenra is a solution in a clear glass syringe. its colour may vary from colourless to yellow. it may contain particles. fasenra is available in a pack containing 1 pre-filled syringe.', 'Entity_Recognition': [{'Text': 'fasenra', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 46, 'EndOffset': 58, 'Score': 0.9912310242652893, 'Text': 'benralizumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.8014837503433228, 'RelationshipScore': 0.9996373653411865, 'RelationshipType': 'DOSAGE', 'Id': 1, 'BeginOffset': 60, 'EndOffset': 74, 'Text': 'one pre-filled', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.506520688533783, 'RelationshipScore': 0.9982594847679138, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 75, 'EndOffset': 82, 'Text': 'syringe', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.5900787711143494, 'RelationshipScore': 0.9963926672935486, 'RelationshipType': 'DOSAGE', 'Id': 3, 'BeginOffset': 86, 'EndOffset': 90, 'Text': '1 ml', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.9883004426956177, 'RelationshipScore': 0.9965785145759583, 'RelationshipType': 'FORM', 'Id': 4, 'BeginOffset': 91, 'EndOffset': 99, 'Text': 'solution', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9577308893203735, 'RelationshipScore': 0.8199645280838013, 'RelationshipType': 'DOSAGE', 'Id': 5, 'BeginOffset': 109, 'EndOffset': 114, 'Text': '30 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'one pre-filled syringe', 'Type': 'TREATMENT', 'BeginOffset': 60, 'EndOffset': 82}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 86, 'EndOffset': 87}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 109, 'EndOffset': 111}, {'Id': 6, 'BeginOffset': 115, 'EndOffset': 127, 'Score': 0.9973105192184448, 'Text': 'benralizumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.8014837503433228, 'RelationshipScore': 0.9908429384231567, 'RelationshipType': 'DOSAGE', 'Id': 1, 'BeginOffset': 60, 'EndOffset': 74, 'Text': 'one pre-filled', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.506520688533783, 'RelationshipScore': 0.6513432860374451, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 75, 'EndOffset': 82, 'Text': 'syringe', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.9883004426956177, 'RelationshipScore': 0.9828597903251648, 'RelationshipType': 'FORM', 'Id': 4, 'BeginOffset': 91, 'EndOffset': 99, 'Text': 'solution', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9577308893203735, 'RelationshipScore': 0.9999980926513672, 'RelationshipType': 'DOSAGE', 'Id': 5, 'BeginOffset': 109, 'EndOffset': 114, 'Text': '30 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 7, 'BeginOffset': 155, 'EndOffset': 164, 'Score': 0.9354934096336365, 'Text': 'histidine', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 8, 'BeginOffset': 166, 'EndOffset': 201, 'Score': 0.9844034910202026, 'Text': 'histidine hydrochloride monohydrate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.5403728485107422}]}, {'Id': 9, 'BeginOffset': 203, 'EndOffset': 222, 'Score': 0.972258448600769, 'Text': 'trehalose dihydrate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.4530039131641388}]}, {'Id': 10, 'BeginOffset': 224, 'EndOffset': 235, 'Score': 0.521400511264801, 'Text': 'polysorbate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.22724688053131104, 'RelationshipScore': 0.9996428489685059, 'RelationshipType': 'DOSAGE', 'Id': 11, 'BeginOffset': 236, 'EndOffset': 238, 'Text': '20', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'ROUTE_OR_MODE', 'Score': 0.6327809691429138, 'RelationshipScore': 0.9982789754867554, 'RelationshipType': 'ROUTE_OR_MODE', 'Id': 12, 'BeginOffset': 253, 'EndOffset': 263, 'Text': 'injections', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '20', 'Type': 'NUMBER', 'BeginOffset': 236, 'EndOffset': 238}, {'Text': 'injections', 'Type': 'TREATMENT', 'BeginOffset': 253, 'EndOffset': 263}, {'Id': 13, 'BeginOffset': 270, 'EndOffset': 277, 'Score': 0.39813509583473206, 'Text': 'fasenra', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a solution in a clear glass syringe', 'Type': 'TREATMENT', 'BeginOffset': 325, 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