Libtayo
1  

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 
 
LIBTAYO 350 mg concentrate for solution for infusion. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One ml of concentrate contains 50 mg of cemiplimab. 
 
Each vial contains 350 mg of cemiplimab in 7 ml of solution. 
 
Cemiplimab is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell 
suspension culture.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Concentrate for solution for infusion (sterile concentrate). 
 
Clear to slightly opalescent, colourless to pale yellow solution with a pH of 6.0 and osmolality 
between 300 and 360 mmol/kg. The solution may contain trace amounts of translucent to white 
particles in a single-use vial. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
LIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally 
advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for 
curative surgery or curative radiation. 
 
4.2 Posology and method of administration 
 
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer. 
 
Posology 
 
Recommended dose 
The recommended dose is 350 mg cemiplimab every 3 weeks (Q3W) administered as an intravenous 
infusion over 30 minutes. 
 
Treatment may be continued until disease progression or unacceptable toxicity.  
 
Dose modifications 
No dose reductions are recommended. Dosing delay or discontinuation may be required based on 
individual safety and tolerability. Recommended modifications to manage adverse reactions are 
provided in Table 1. 
 



 

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Detailed guidelines for the management of immune-related adverse reactions are described in Table 1 
(see also sections 4.4 and 4.8). 
 

Table 1: Recommended treatment modifications 

 

Adverse reactiona Severityb Dose modification Additional intervention 

Immune-related adverse reactions 

Pneumonitis 

Grade 2 

Withhold LIBTAYO 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Resume LIBTAYO if pneumonitis improves and 
remains at Grade 0 to 1 after corticosteroid taper to 
≤10 mg/day prednisone or equivalent 

Grade 3 or 4 
or 
recurrent Grade 2  

Permanently discontinue 

Initial dose of 2 to 
4 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Colitis 

Grade 2 or 3  

Withhold LIBTAYO 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Resume LIBTAYO if colitis or diarrhoea improves and 
remains at Grade 0 to 1 after corticosteroid taper to 
≤10 mg/day prednisone or equivalent 

Grade 4  
or 
recurrent Grade 3  

Permanently discontinue 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Hepatitis 

Grade 2 with AST or 
ALT >3 and ≤5×ULN 
or 
total bilirubin >1.5 and 
≤3×ULN 

Withhold LIBTAYO 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Resume LIBTAYO if hepatitis improves and remains at 
Grade 0 to 1 after corticosteroid taper to ≤10 mg/day 
prednisone or equivalent or returns to baseline AST or 
ALT after completion of corticosteroid taper 

Grade ≥3 with AST or 
ALT >5×ULN 
or 
total bilirubin >3×ULN  
 

Permanently discontinue 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Hypothyroidism Grade 3 or 4 

Withhold LIBTAYO 
Initiate thyroid hormone 
replacement as clinically 
indicated 

Resume LIBTAYO when hypothyroidism returns to 
Grade 0 to 1 or is otherwise clinically stable 

Hyperthyroidism Grade 3 or 4 

Withhold LIBTAYO 
Initiate symptomatic 
management 

Resume LIBTAYO when hyperthyroidism returns to 
Grade 0 to 1 or is otherwise clinically stable 



 

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Hypophysitis Grade 2 to 4 

Withhold LIBTAYO 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper and hormone 
replacement as clinically 
indicated 

Resume LIBTAYO if hypophysitis improves and 
remains at Grade 0 to 1 after corticosteroid taper to 
≤10 mg/day prednisone or equivalent or is otherwise 
clinically stable 

Adrenal insufficiency Grade 2 to 4 

Withhold LIBTAYO 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper and hormone 
replacement as clinically 
indicated 

Resume LIBTAYO if adrenal insufficiency improves 
and remains at Grade 0 to 1 after corticosteroid taper to 
≤10 mg/day prednisone or equivalent or is otherwise 
clinically stable 

Type 1 diabetes mellitus 
Grade 3 or 4 
(hyperglycaemia) 

Withhold LIBTAYO 
Initiate treatment with 
anti-hyperglycaemics as 
clinically indicated 

Resume LIBTAYO when diabetes mellitus returns to 
Grade 0 to 1 or is otherwise clinically stable 

Skin adverse reactions 

Grade 2 lasting longer 
than 1 week, 
Grade 3  
or 
suspected 
Stevens-Johnson 
syndrome (SJS) or toxic 
epidermal necrolysis 
(TEN) 

Withhold LIBTAYO 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Resume LIBTAYO if skin reaction improves and 
remains at Grade 0 to 1 after corticosteroid taper to 
≤10 mg/day prednisone or equivalent 

Grade 4 or confirmed 
SJS or TEN 

Permanently discontinue 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Immune-related skin 
reaction or other 
immune-related adverse 
reactions in patients with 
prior treatment with 
idelalisib  

Grade 2 

Withhold LIBTAYO 
 

Initiate management 
immediately, including 
initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Resume LIBTAYO if skin reaction or other 
immune-related adverse reaction improves and remains 
at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day 
prednisone or equivalent 

Grade 3 or 4 (excluding 
endocrinopathies) 
or recurrent Grade 2 

Permanently discontinue  

Initiate management 
immediately, including 
initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Nephritis 
with renal dysfunction 

Grade 2 creatinine 
increased 

Withhold LIBTAYO 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 



 

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Resume LIBTAYO if nephritis improves and remains at 
Grade 0 to 1 after corticosteroid taper to ≤10 mg/day 
prednisone or equivalent 

Grade 3 or 4 creatinine 
increased 

Permanently discontinue 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent followed by 
a taper 

Other immune-related 
adverse reactions  
 
(including but not limited to 
paraneoplastic 
encephalomyelitis, 
meningitis, myositis, solid 
organ transplant rejection, 
graft-vs-host disease, 
Guillain-Barre syndrome, 
central nervous system 
inflammation, chronic 
inflammatory demyelinating 
polyradiculoneuropathy, 
encephalitis, myasthenia 
gravis, neuropathy 
peripheral, myocarditis, 
pericarditis, immune 
thrombocytopenic purpura, 
vasculitis, arthralgia, 
arthritis, muscular 
weakness, myalgia, 
polymyalgia rheumatica, 
Sjogren’s syndrome, 
keratitis, stomatitis, 
thyroiditis) 

Grade 2 or 3 based on 
type of reaction  

Withhold LIBTAYO 

Initiate symptomatic 
management including 
initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent as clinically 
indicated followed by a 
taper  

Resume LIBTAYO if other immune-related adverse 
reaction improves and remains at Grade 0 to 1 after 
corticosteroid taper to ≤10 mg/day prednisone or 
equivalent 

– Grade 3 based on type 
of reaction or Grade 4 
(excluding 
endocrinopathies) 
 

– Grade 3 or 4 
neurologic toxicity 

 
– Grade 3 or 4 

myocarditis or 
pericarditis 
 

– Recurrent Grade 3 
immune-related 
adverse reaction 

– Persistent Grade 2 or 3 
immune-related 
adverse reactions 
lasting 12 weeks or 
longer (excluding 
endocrinopathies) 

– Inability to reduce 
corticosteroid dose to 
10 mg or less of 
prednisone or 
equivalent per day 
within 12 weeks 

Permanently discontinue 

Initial dose of 1 to 
2 mg/kg/day prednisone 
or equivalent as clinically 
indicated followed by a 
taper  

Infusion-related reactionsa 

Infusion-related reaction 
Grade 1 or 2 

Interrupt or slow rate of 
infusion Initiate symptomatic 

management 
Grade 3 or 4 Permanently discontinue 

ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal. 
a. See also sections 4.4 and 4.8 
b.  Toxicity should be graded with the current version of National Cancer Institute Common Terminology 

Criteria for Adverse Events (NCI CTCAE). 
 
Patient Alert Card 
 
All prescribers of LIBTAYO should be familiar with the educational materials and inform the patients 
about the Patient Alert Card explaining what to do should they experience any symptom of immune-



 

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related adverse reactions and infusion-related reactions. The physician will provide the Patient Alert 
Card to each patient. 
 
Special populations 
 
Paediatric population 
The safety and efficacy of LIBTAYO in children and adolescents below the age of 18 years have not 
been established. No data are available. 
 
Elderly 
No dose adjustment is recommended for elderly patients. Cemiplimab exposure is similar across all 
age groups (see sections 5.1 and 5.2). 
 
Renal impairment 
No dose adjustment of LIBTAYO is recommended for patients with renal impairment. There are 
limited data for LIBTAYO in patients with severe renal impairment CLcr 15 to 29 ml/min (see 
section 5.2). 
 
Hepatic impairment 
No dose adjustment is recommended for patients with mild hepatic impairment. LIBTAYO has not 
been studied in patients with moderate or severe hepatic impairment. There are insufficient data in 
patients with moderate or severe hepatic impairment for dosing recommendations (see section 5.2). 
 
Method of administration 
 
LIBTAYO is for intravenous use. It is administered by intravenous infusion over 30 minutes through 
an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter 
(0.2 micron to 5 micron pore size). 
 
Other medicinal products should not be co-administered through the same infusion line. 
 
For instructions on dilution of the medicinal product before administration, see section 6.6. 
 
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 
 
Traceability 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Immune-related adverse reactions 
Severe and fatal immune-related adverse reactions have been observed with cemiplimab (see 
section 4.2 and section 4.8). These immune-related reactions may involve any organ system. Most 
immune-related reactions initially manifest during treatment with cemiplimab; however, 
immune-related adverse reactions can occur after discontinuation of cemiplimab. 

Immune-related adverse reactions affecting more than one body system can occur simultaneously, 
such as myositis and myocarditis or myasthenia gravis, in patients treated with cemiplimab or other 
PD-1/PD-L1 inhibitors. 

Monitor patients for signs and symptoms of immune-related adverse reactions. Immune-related 
adverse reactions should be managed with cemiplimab treatment modifications, hormone replacement 
therapy (if clinically indicated), and corticosteroids. For suspected immune-related adverse reactions, 
patients should be evaluated to confirm an immune-related adverse reaction and to exclude other 



 

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possible causes, including infection. Depending upon the severity of the adverse reaction, cemiplimab 
should be withheld or permanently discontinued (see section 4.2). 

Immune-related pneumonitis 
Immune-related pneumonitis, defined as requiring use of corticosteroids with no clear alternate 
aetiology, including fatal cases, has been observed in patients receiving cemiplimab (see section 4.8). 
Patients should be monitored for signs and symptoms of pneumonitis and causes other than immune-
related pneumonitis should be ruled out. Patients with suspected pneumonitis should be evaluated with 
radiographic imaging as indicated based on clinical evaluation and managed with cemiplimab 
treatment modifications and corticosteroids. (see section 4.2). 
 
Immune-related colitis 
Immune-related diarrhoea or colitis, defined as requiring use of corticosteroids with no clear alternate 
aetiology, has been observed in patients receiving cemiplimab (see section 4.8). Patients should be 
monitored for signs and symptoms of diarrhoea or colitis and managed with cemiplimab treatment 
modifications, anti-diarrhoeal agents, and corticosteroids (see section 4.2). 
 
Immune-related hepatitis 
Immune-related hepatitis, defined as requiring use of corticosteroids with no clear alternate aetiology, 
including fatal cases, has been observed in patients receiving cemiplimab (see section 4.8). Patients 
should be monitored for abnormal liver tests prior to and periodically during treatment as indicated 
based on clinical evaluation and managed with cemiplimab treatment modifications and corticosteroids 
(see section 4.2). 
 
Immune-related endocrinopathies 
Immune-related endocrinopathies, defined as treatment-emergent endocrinopathies with no clear 
alternate aetiology, have been observed in patients receiving cemiplimab (see section 4.8). 
 
Thyroid disorders (Hypothyroidism/Hyperthyroidism) 
Immune-related thyroid disorders have been observed in patients receiving cemiplimab. Thyroid 
disorders can occur at any time during the treatment. Patients should be monitored for changes in 
thyroid function at the start of treatment and periodically during the treatment as indicated based on 
clinical evaluation (see section 4.8). Patients should be managed with hormone replacement therapy (if 
indicated) and cemiplimab treatment modifications. Hyperthyroidism should be managed according to 
standard medical practice (see section 4.2). 
 
Hypophysitis 
Immune-related hypophysitis has been observed in patients receiving cemiplimab (see section 4.8). 
Patients should be monitored for signs and symptoms of hypophysitis and managed with cemiplimab 
treatment modifications, corticosteroids and hormone replacement, as clinically indicated (see 
section 4.2). 
 
Adrenal insufficiency 
Adrenal insufficiency has been observed in patients receiving cemiplimab (see section 4.8). Patients 
should be monitored for signs and symptoms of adrenal insufficiency during and after treatment and 
managed with cemiplimab treatment modifications, corticosteroids and hormone replacement, as 
clinically indicated (see section 4.2). 
 
Type 1 Diabetes mellitus 
Immune-related type 1 diabetes mellitus, including diabetic ketoacidosis, has been observed in patients 
receiving cemiplimab (see section 4.8). Patients should be monitored for hyperglycaemia and signs 
and symptoms of diabetes as indicated based on clinical evaluation and managed with oral 
anti-hyperglycaemics or insulin and cemiplimab treatment modifications (see section 4.2).  
 
Immune-related skin adverse reactions 
Immune-related skin adverse reactions, defined as requiring use of systemic corticosteroids with no 
clear alternate aetiology, including severe cutaneous adverse reactions (SCARs), such as 
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (some cases with fatal 



 

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outcome), and other skin reactions such as rash, erythema multiforme, pemphigoid, have been reported 
in association with cemiplimab treatment (see section 4.8).  
 
Patients should be monitored for evidence of suspected severe skin reactions and exclude other causes. 
Patients should be managed with cemiplimab treatment modifications and corticosteroids (see 
section 4.2). For symptoms or signs of SJS or TEN, refer the patient for specialised care for 
assessment and treatment and manage patient with treatment modifications (see section 4.2). 
 
Cases of SJS, fatal TEN and stomatitis occurred following 1 dose of cemiplimab in patients with prior 
exposure to idelalisib, who were participating in a clinical trial evaluating cemiplimab in Non-Hodgkin 
Lymphoma (NHL), and who had recent exposure to sulfa containing antibiotics (see section 4.8). 
Patients should be managed with cemiplimab treatment modifications and corticosteroids as described 
above (see section 4.2). 
 
Immune-related nephritis 
Immune-related nephritis, defined as requiring use of corticosteroids with no clear alternate aetiology, 
has been observed in patients receiving cemiplimab (see section 4.8). Monitor patients for changes in 
renal function. Patients should be managed with cemiplimab treatment modifications and 
corticosteroids (see section 4.2). 
 
Other immune-related adverse reactions 
Other fatal and life-threatening immune-related adverse reactions have been observed in patients 
receiving cemiplimab including paraneoplastic encephalomyelitis, meningitis and myositis (see 
section 4.8 for other immune-related adverse reactions). 
 
Evaluate suspected immune-related adverse reactions to exclude other causes. Patients should be 
monitored for signs and symptoms of immune-related adverse reactions and managed with cemiplimab 
treatment modifications and corticosteroids as clinically indicated (see section 4.2 and section 4.8). 
 
Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with 
PD-1 inhibitors. Treatment with cemiplimab may increase the risk of rejection in solid organ transplant 
recipients. The benefit of treatment with cemiplimab versus the risk of possible organ rejection should 
be considered in these patients. Cases of graft-versus-host disease have been reported in the post-
marketing setting in patients treated with other PD-1/PD-L1 inhibitors in association with allogeneic 
hematopoietic stem cell transplant. 
 
Infusion-related reactions 
Cemiplimab can cause severe or life-threatening infusion-related reactions (see section 4.8). Patients 
should be monitored for signs and symptoms of infusion-related reactions and managed with 
cemiplimab treatment modifications and corticosteroids. Cemiplimab should be interrupted or the rate 
of infusion slowed for mild or moderate infusion-related reactions. The infusion should be stopped and 
cemiplimab should be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) 
infusion-related reactions (see section 4.2). 
 
Patients excluded from clinical studies 
Patients that had active infections or that were immunocompromised were not included in the main 
study. For a full list of patients excluded from clinical trials, see section 5.1. 
 
In the absence of data, cemiplimab should be used with caution in these populations after careful 
evaluation of the balance of benefits and risks for the patient. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No pharmacokinetic (PK) drug-drug interaction studies have been conducted with cemiplimab. 
 
The use of systemic corticosteroids or immunosuppressants before starting cemiplimab, except for 
physiological doses of systemic corticosteroid (≤10 mg/day prednisone or equivalent), should be 



 

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avoided because of their potential interference with the pharmacodynamic activity and efficacy of 
cemiplimab. However, systemic corticosteroids or other immunosuppressants can be used after starting 
cemiplimab to treat immune-related adverse reactions (see section 4.2). 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential 
Women of childbearing potential should use effective contraception during treatment with cemiplimab 
and for at least 4 months after the last dose of cemiplimab. 
 
Pregnancy 
Animal reproduction studies have not been conducted with cemiplimab. There are no available data on 
the use of cemiplimab in pregnant women. Animal studies have demonstrated that inhibition of the 
PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing 
foetus resulting in foetal death (see section 5.3).  
 
Human IgG4 is known to cross the placental barrier and cemiplimab is an IgG4; therefore, cemiplimab 
has the potential to be transmitted from the mother to the developing foetus. Cemiplimab is not 
recommended during pregnancy and in women of childbearing potential not using effective 
contraception unless the clinical benefit outweighs the potential risk.  
 
Breast-feeding 
It is unknown whether cemiplimab is secreted in human milk. It is known that antibodies (including 
IgG4) are secreted in human milk; a risk to the breast-feeding newborn/infant cannot be excluded. 
 
If a woman chooses to be treated with cemiplimab, she should be instructed not to breast-feed while 
being treated with cemiplimab and for at least 4 months after the last dose. 
 
Fertility 
No clinical data are available on the possible effects of cemiplimab on fertility. No effects on fertility 
assessment parameters or in the male and female reproductive organs were observed in a 3-month 
repeat dose fertility assessment study with sexually mature cynomolgus monkeys. 
 
4.7 Effects on ability to drive and use machines 
 
Cemiplimab has no or negligible influence on the ability to drive and use machines. Fatigue has been 
reported following treatment with cemiplimab (see section 4.8). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
Immune-related adverse reactions can occur with cemiplimab. Most of these, including severe 
reactions, resolved following initiation of appropriate medical therapy or withdrawal of cemiplimab 
(see “Description of selected adverse reactions” below). 
 
The safety of cemiplimab has been evaluated in 591 patients with advanced solid malignancies 
including 219 advanced CSCC patients who received cemiplimab monotherapy in 2 clinical studies 
(R2810-ONC-1423 and R2810-ONC-1540). Of these 219 patients, 131 patients had mCSCC (nodal or 
distant) and 88 patients had laCSCC. Immune-related adverse reactions occurred in 20.3% of patients 
treated with cemiplimab in clinical trials including Grade 5 (0.7%), Grade 4 (1.2%) and Grade 3 
(6.3%). Immune-related adverse reactions led to permanent discontinuation of cemiplimab in 4.4% of 
patients. The most common immune-related adverse reactions were hypothyroidism (7.1%), 
pneumonitis (3.7%), cutaneous adverse reactions (2.0%), hyperthyroidism (1.9%) and hepatitis (1.9%) 
(see “Description of selected adverse reactions” below, Special warnings and precautions for use in 
section 4.4 and Recommended treatment modifications in section 4.2). Adverse reactions were serious 
in 8.6% of patients and led to permanent discontinuation of cemiplimab in 5.8% of patients. 
 



 

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Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic 
epidermal necrolysis (TEN) have been reported in association with cemiplimab treatment (see 
section 4.4). 
 
Tabulated list of adverse reactions 
Listed in Table 2 are adverse reactions by system organ class and by frequency. Frequencies are 
defined as: 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); not known (cannot be estimated from available 
data). Within each frequency grouping, adverse reactions are presented in the order of decreasing 
seriousness. 
 

Table 2: Tabulated list of adverse reactions in patients treated with cemiplimab 

System organ class 
preferred term 

Grades 1-5  
(Frequency 
category) 

Grades 1-5  
(%) 

Grades 3-5  
(%) 

Immune system disorders 

Infusion-related reaction Common 4.1 0 

Sjogren’s syndrome Uncommon 0.5 0 

Immune thrombocytopenic purpura Uncommon 0.2 0 

Vasculitis Uncommon 0.2 0 

Solid organ transplant rejectiona Not known -- -- 

Endocrine disorders 

Hypothyroidism Common 9.6 0 

Hyperthyroidism Common 2.7 0 

Type 1 diabetes mellitusb Uncommon 0.7 0.7 

Adrenal insufficiency Uncommon 0.5 0.5 

Hypophysitis Uncommon 0.5 0.5 

Thyroiditis Uncommon 0.2 0 

Nervous system disorders 

Paraneoplastic encephalomyelitis Uncommon 0.2 0.2 

Chronic inflammatory demyelinating 
polyradiculoneuropathy 

Uncommon 0.5 0 

Encephalitis Uncommon 0.5 0.5 

Meningitisc Uncommon 0.5 0.5 

Guillain-Barre syndrome Uncommon 0.2 0.2 

Central nervous system inflammation Uncommon 0.2 0 

Neuropathy peripherald Uncommon 0.5 0 

Myasthenia gravis Uncommon 0.2 0 

Eye disorders 

Keratitis Uncommon 0.5 0 

Cardiac disorders 

Myocarditise Uncommon 0.5 0.5 

Pericarditisf Uncommon 0.5 0.5 



 

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Respiratory, thoracic and mediastinal disorders 

Pneumonitis Common 5.9 2.3 

Dyspnoeag Common 2.6 0.3 

Gastrointestinal disorders 

Diarrhoeah Very common 13.2 0.5 

Stomatitis Common 2.4 0 

Hepatobiliary disorders 

Hepatitisi Common 1.4 1.4 

Skin and subcutaneous skin disorders 

Rashj Very common 23.3 1.4 

Pruritusk Very common 12.3 0 

Musculoskeletal and connective tissue disorders 

Arthralgia Common 5.0 0 

Musculoskeletal painl Common 4.1 0.5 

Arthritism Common 1.4 0.5 

Muscular weakness Uncommon 0.9 0 

Polymyalgia rheumatica Uncommon 0.5 0 

Myositisg Rare < 0.1 < 0.1 

Renal and urinary disorders 

Nephritis Uncommon 0.5 0 

General disorders and administration site conditions 

Fatiguen Very common 21.5 0.9 

Investigations 

Alanine aminotransferase increased Common 5.5 0.5 

Aspartate aminotransferase increased Common 5.0 0.9 

Blood alkaline phosphatase increased Common 2.7 0 

Blood creatinine increased Common 1.8 0 

Version 4.03 of NCI CTCAE was used to grade toxicity. 
a. Post-marketing event. 
b. Type 1 diabetes mellitus is a composite term that includes diabetes mellitus, diabetic ketoacidosis and 

type 1 diabetes mellitus. 
c. Meningitis is a composite term that includes meningitis and meningitis aseptic. 
d. Neuropathy peripheral is a composite term that includes neuropathy peripheral and neuritis. 
e. Myocarditis is a composite term that includes autoimmune myocarditis and myocarditis. 
f. Pericarditis is a composite term that includes autoimmune pericarditis and pericarditis. 
g. Frequency was based on 2184 patients in ongoing clinical studies across multiple cancer types. 
h. Diarrhoea is a composite term that includes diarrhoea and colitis. 
i. Hepatitis is a composite term that includes hepatitis and autoimmune hepatitis. 
j. Rash is a composite term that includes rash maculo-papular, rash, dermatitis, rash generalised, dermatitis 

bullous, drug eruption, erythema, pemphigoid, psoriasis, rash erythematous, rash macular, rash pruritic and 
skin reaction. 

k. Pruritus is a composite term that includes pruritus and pruritus allergic. 
l. Musculoskeletal pain is a composite term that includes back pain, musculoskeletal pain, myalgia, neck pain 

and pain in extremity. 
m. Arthritis is a composite term that includes arthritis and polyarthritis. 
n. Fatigue is a composite term that includes fatigue and asthenia. 



 

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Description of selected adverse reactions 
The selected adverse reactions described below are based on safety of cemiplimab in 591 patients in 
uncontrolled clinical studies.  
 
Immune-related adverse reactions (see section 4.2 and section 4.4) 
 
Immune-related pneumonitis 
Immune-related pneumonitis occurred in 22 (3.7%) of 591 patients receiving cemiplimab, including 
2 (0.3%) patients with Grade 5, 2 (0.3%) patients with Grade 4, and 6 (1.0%) patients with Grade 3 
pneumonitis. Immune-related pneumonitis led to permanent discontinuation of cemiplimab in 
11 (1.9%) of 591 patients. Among the 22 patients with immune-related pneumonitis, the median time 
to onset was 3.8 months (range: 7 days to 18 months) and the median duration of pneumonitis was 
21.5 days (range: 5 days to 6.5 months). Eighteen patients (3.0%) received high-dose corticosteroids 
for a median of 8.5 days (range: 1 day to 5.9 months). Resolution of pneumonitis had occurred in 
14 (63.6%) of the 22 patients at the time of data cut-off. 
 
Immune-related colitis 
Immune-related diarrhoea or colitis occurred in 7 (1.2%) of 591 patients receiving cemiplimab 
including 2 (0.3%) with Grade 3 immune-related diarrhoea or colitis. Immune-related diarrhoea or 
colitis led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients. Among the 
7 patients with immune-related diarrhoea or colitis, the median time to onset was 3.8 months 
(range: 15 days to 6.0 months) and the median duration of immune-related diarrhoea or colitis was 
30 days (range: 4 days to 8.6 months). Four patients (0.7%) with immune-related diarrhoea or colitis 
received high-dose corticosteroids for a median of 29 days (range: 19 days to 2.0 months). Resolution 
of immune-related diarrhoea or colitis had occurred in 4 (57.1%) of the 7 patients at the time of data 
cut-off. 
 
Immune-related hepatitis 
Immune-related hepatitis occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 
1 (0.2%) patient with Grade 5, 1 (0.2%) patient with Grade 4, and 9 (1.5%) patients with Grade 3 
immune-related hepatitis. Immune-related hepatitis led to permanent discontinuation of cemiplimab in 
5 (0.8%) of 591 patients. Among the 11 patients with immune-related hepatitis, the median time to 
onset was 1.0 month (range: 7 days to 4.2 months) and the median duration of hepatitis was 15 days 
(range: 8 days to 2.7 months). Ten (1.7%) patients with immune-related hepatitis received high-dose 
corticosteroids for a median of 10.5 days (range: 2 days to 1.9 months). Resolution of hepatitis had 
occurred in 8 (72.7%) of the 11 patients at the time of data cut-off. 
 
Immune-related endocrinopathies 
Hypothyroidism occurred in 42 (7.1%) of 591 patients receiving cemiplimab including 
1 (0.2%) patient with Grade 3 hypothyroidism. No patient discontinued cemiplimab due to 
hypothyroidism. Among the 42 patients with hypothyroidism, the median time to onset was 
4.2 months (range: 15 days to 18.9 months). 
 
Hyperthyroidism occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 
1 (0.2%) patient with Grade 3 hyperthyroidism. No patient discontinued cemiplimab due to 
hyperthyroidism. Among the 11 patients with hyperthyroidism, the median time to onset was 
1.9 months (range: 28 days to 14.8 months).  
 
Adrenal insufficiency occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 
1 (0.2%) patient with Grade 3 adrenal insufficiency. No patient discontinued cemiplimab due to 
adrenal insufficiency. Among the 3 patients with adrenal insufficiency, the median time to onset was 
11.5 months (range: 10.4 months to 12.3 months). One of the 3 patients was treated with systemic 
corticosteroids.  
 



 

 13  

Immune-related hypophysitis occurred in 1 (0.2%) of 591 patients receiving cemiplimab. The event 
was Grade 3 hypophysitis. 
 
Type 1 diabetes mellitus without an alternative aetiology occurred in 4 (0.7%) of 591 patients 
including 3 (0.5%) patients with Grade 4 and 1 (0.2%) patient with Grade 3 type 1 diabetes mellitus. 
Type 1 diabetes mellitus led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients. 
Among the 4 patients with type 1 diabetes mellitus, the median time to onset was 2.3 months 
(range: 28 days to 6.2 months). 
 
Immune-related skin adverse reactions 
Immune-related skin adverse reactions occurred in 12 (2.0%) of 591 patients receiving cemiplimab 
including 6 (1.0%) patients with Grade 3 immune-related skin adverse reactions. Immune-related skin 
adverse reactions led to permanent discontinuation of cemiplimab in 2 (0.3%) of 591 patients. Among 
the 12 patients with immune-related skin adverse reactions, the median time to onset was 1.5 months 
(range: 2 days to 10.9 months) and the median duration was 4.4 months (range: 14 days to 
9.6 months). Nine patients (1.5%) with immune-related skin adverse reactions received high-dose 
corticosteroids for a median of 16 days (range: 7 days to 2.6 months). Resolution had occurred in 
6 (50%) of 12 patients at the time of data cut-off. 
 
Immune-related nephritis 
Immune-related nephritis occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 
2 (0.3%) patients with Grade 3 immune-related nephritis. Immune-related nephritis led to permanent 
discontinuation of cemiplimab in 1 (0.2%) of 591 patients. Among the 3 patients with immune-related 
nephritis, the median time to onset was 1.8 months (range: 29 days to 4.1 months) and the median 
duration of nephritis was 18 days (range: 9 days to 29 days). Two (0.3%) patients with immune-related 
nephritis received high-dose corticosteroids for a median of 1.5 months (range: 16 days to 2.6 months). 
Resolution of nephritis had occurred in all patients at the time of data cut-off. 
 
Other immune-related adverse reactions 
The following clinically significant, immune-related adverse reactions occurred at an incidence of less 
than 1% of 591 (unless otherwise specified) patients treated with cemiplimab. The events were 
Grade 3 or less unless stated otherwise: 
 
Nervous system disorders: Meningitisa (Grade 4), paraneoplastic encephalomyelitis (Grade 5), 
Guillain-Barre syndrome, central nervous system inflammation, chronic inflammatory demyelinating 
polyradiculoneuropathy, encephalitisb, myasthenia gravis, neuropathy peripheralc. 
Cardiac Disorders: Myocarditisd, pericarditise 
Immune system disorders: Immune thrombocytopenic purpura 
Vascular disorders: Vasculitis 
Musculoskeletal and connective tissue disorders: Arthralgia (1.4%), arthritisf, muscular weakness, 
myalgia, polymyalgia rheumatica, Sjogren’s syndrome 
Eye disorders: Keratitis 
Gastrointestinal disorders: Stomatitis 
Endocrine: Thyroiditis 
a. includes meningitis and meningitis aseptic 
b. includes encephalitis and noninfective encephalitis 
c. includes neuritis and neuropathy peripheral 
d. includes autoimmune myocarditis and myocarditis 
e. includes autoimmune pericarditis and pericarditis 
f. includes arthritis and polyarthritis 
 
Infusion-related reactions 
Infusion-related reactions occurred in 54 (9.1%) of 591 patients treated with cemiplimab including 
1 (0.2%) patient with Grade 3 infusion-related reaction. Infusion-related reaction led to permanent 
discontinuation of cemiplimab in 2 (0.3%) patients. The most common symptoms of infusion-related 
reaction were nausea, pyrexia, vomiting, abdominal pain, chills and flushing. All patients recovered 
from the infusion-related reaction. 
 



 

 14  

Immunogenicity 
As with all therapeutic proteins, there is a potential for immunogenicity with cemiplimab. 
Approximately 1.1% of patients administered cemiplimab developed treatment-emergent antibodies, 
with approximately 0.2% exhibiting persistent antibody responses. No neutralizing antibodies have 
been observed. There was no evidence of an altered PK or safety profile with anti-cemiplimab 
antibody development. 
 
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 
 
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, 
and appropriate symptomatic treatment instituted. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies. ATC code: L01XC33 
 
Mechanism of action 
Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the 
programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and 
PD-L2. Engagement of PD-1 with its ligands PD-L1 and PD-L2, which are expressed by antigen 
presenting cells and may be expressed by tumour cells and/or other cells in the tumour 
microenvironment, results in inhibition of T cell function such as proliferation, cytokine secretion, and 
cytotoxic activity. Cemiplimab potentiates T cell responses, including anti-tumour responses, through 
blockade of PD-1 binding to PD-L1 and PD-L2 ligands. 
 
Clinical efficacy and safety 
The efficacy and safety of cemiplimab in patients with mCSCC (nodal or distant) or laCSCC who 
were not candidates for curative surgery or curative radiation were studied in clinical trial 
R2810-ONC-1540 (Study 1540). Study 1540 was a phase 2, open-label, multi-centre study that  
enrolled 193 patients with mCSCC or laCSCC with a combined median follow-up time of 9.4 months 
total. Median duration of follow-up was 16.5 months for the mCSCC 3 mg/kg every 2 weeks (Q2W) 
group, 9.3 months for the laCSCC 3 mg/kg Q2W group and 8.1 months for the mCSCC 350 mg Q3W 
group. 
 
Patients with any of the following were excluded: autoimmune disease that required systemic therapy 
with immunosuppressant agents within 5 years; history of solid organ transplant; history of 
pneumonitis within the last 5 years; prior treatment with anti-PD-1/PD-L1 or other immune checkpoint 
inhibitor therapy; active infection requiring therapy, including known infection with human 
immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus; chronic lymphocytic 
leukaemia (CLL); brain metastases or Eastern Cooperative Oncology Group (ECOG) performance 
score (PS) ≥ 2. 
 
In Study 1540, patients received cemiplimab until progression of disease, unacceptable toxicity or 
completion of planned treatment [3 mg/kg Q2W for 96 weeks or 350 mg Q3W for 54 weeks]. If 
patients with locally advanced disease showed sufficient response to treatment, surgery with curative 
intent was permitted. Tumour response assessments were performed every 8 or 9 weeks (for patients 
receiving 3 mg/kg Q2W or 350 mg Q3W, respectively). The primary endpoint of Study 1540 was 
confirmed objective response rate (ORR), as assessed by independent central review (ICR). For 



 

 15  

patients with mCSCC without externally visible target lesions, ORR was determined by Response 
Evaluation Criteria in Solid Tumours (RECIST 1.1). For patients with externally visible target lesions 
(laCSCC and mCSCC), ORR was determined by a composite endpoint that integrated ICR 
assessments of radiologic data (RECIST 1.1) and digital medical photography (WHO criteria). The 
key secondary endpoint was duration of response (DOR) by ICR. Other secondary endpoints included 
ORR and DOR by investigator assessment (IA), progression free survival (PFS) by ICR and IA, 
overall survival (OS), complete response rate (CR) by ICR, and change in scores in patient reported 
outcomes on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of 
Life Questionnaire (EORTC QLQ-C30). 
 
Results are presented from 193 patients in Study 1540. Of these 193 patients, 115 had mCSCC and 
78 had laCSCC. The median age was 72 years (range: 38 to 96): Seventy-eight (40.4%) patients were 
75 years or older, 66 patients (34.2%) were 65 to less than 75 years, and 49 patients (25.4%) were less 
than 65 years. A total of 161 (83.4 %) patients were male, and 187 (96.9%) patients were White; the 
ECOG PS was 0 (44.6%) and 1 (55.4%). Thirty-three and 7/10 per cent (33.7%) of patients had 
received at least 1 prior anti-cancer systemic therapy, 90.2% of patients had received prior cancer 
related surgery, and 67.9% of patients had received prior radiotherapy. Among patients with mCSCC, 
76.5% had distant metastases, and 22.6% had only nodal metastases. 
 
Efficacy results for Study 1540 are presented in Table 3. 
 

Table 3: Efficacy results – Study 1540 – metastatic CSCC by dosing group, locally advanced 

CSCC 

 mCSCC 
cemiplimab: 

3 mg/kg Q2W 
(Group 1) 
(N = 59) 

 

laCSCC 
cemiplimab: 

3 mg/kg Q2W 
(Group 2) 
(N = 78) 

mCSCC 
cemiplimab: 
350 mg Q3W 

(Group 3) 
(N = 56) 

 ICR ICR ICR 
Confirmed objective response rate (ORR)a    

ORR 49.2% 43.6% 41.1% 
95% CI for ORR  (35.9, 62.5) (32.4, 55.3) (28.1, 55.0) 

Complete response (CR)b 16.9% 12.8% 5.4% 
Partial response (PR) 32.2% 30.8% 35.7% 
Stable disease (SD) 15.3% 35.9% 14.3% 
Progressive disease (PD) 16.9% 11.5% 25.0% 

    
Duration of response (DOR)    

Medianc (months) NR  
 

NR 
 

NR 
 

Range (months) 2.8-21.6+ 1.9-24.2+ 2.1-11.1+ 
Patients with DOR ≥ 6 months, % 93.1% 67.6% 65.2% 
    

Time to response    
Median (months) range (min:max) 1.9 

(1.7: 9.1) 
1.9  

(1.8: 8.8) 
2.1  

(2.0: 8.3) 
    

Progression free survival (PFS)a, c    
6 months 
(95% CI) 

65.8% 
(51.8, 76.7) 

71.5% 
(58.9, 80.9) 

59.3% 
(45.0, 71.0) 

12 months 
(95% CI) 

52.9% 
(39.0, 65.0) 

58.1% 
(43.7, 70.0) 

47.4% 
(29.6, 63.3) 

    
Overall survivala, c    

12 months 
(95% CI) 

81.3% 
(68.7, 89.2) 

93.2% 
(84.4, 97.1) 

76.1% 
(56.9, 87.6) 

Data cut-off was Sep 20, 2018 for Groups 1 and 3 patients, and Oct 10, 2018 for Group 2 patients. 



 

 16  

CI: confidence interval; ICR: Independent Central Review; NR: Not Reached; +: Denotes ongoing at last 
assessment; Q2W: every 2 weeks; Q3W: every 3 weeks  

a. In Groups 1, 2, and 3, median durations of follow-up were 16.5, 9.3, and 8.1 months, respectively.  
b. Only includes patients with complete healing of prior cutaneous involvement; laCSCC patients in Study 

1540 required biopsy to confirm CR. 
c. Based on Kaplan Meier estimates. 
 

Efficacy and PD-L1 status 
Clinical activity was observed regardless of tumour PD-L1 expression status. The relationship between 
PD-L1 status and efficacy was analysed post-hoc in patients with available tissue samples. Overall in 
Studies 1423 and 1540, PD-L1 IHC results were available for 75 advanced CSCC patients. Among 
22 advanced CSCC patients with PD-L1 < 1%, ORR per ICR was 40.9% (9/22). Among 53 advanced 
CSCC patients with PD-L1 ≥ 1%, ORR was 54.7% (29/53). Among 21 mCSCC patients, ORR was 
60% (3/5) in patients with PD-L1 < 1% and 56.3% (9/16) among patients with PD-L1 ≥ 1%. Among 
54 patients with laCSCC, ORR was 35.3% (6/17) in patients with PD-L1 < 1% and 54.1% (20/37) 
among patients with PD-L1 ≥ 1%. 
 
Elderly population 
Of the 219 patients with mCSCC and laCSCC treated with cemiplimab, 25.1% (55/219) were less than 
65 years, 34.2% (75/219) were 65 to less than 75 years, and 40.6% (89/219) were 75 years or older. 
No overall differences in safety or effectiveness were observed between these subjects and younger 
subjects. 
 
In the 193 patients in the efficacy analysis, the ORR by ICR (95% CI) was 40.8% (27.0%, 55.8%) in 
patients less than 65 years, 48.5% (36.0%, 61.1%) in patients 65 to less than 75 years, and 43.6% 
(32.4%, 55.3%) in patients 75 years or older. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
cemiplimab in all subsets of the paediatric population in the treatment of all conditions included in the 
category of malignant neoplasms, except haematopoietic and lymphoid tissue (see section 4.2 for 
information on paediatric use). 
 
Conditional approval 
This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This 
means that further evidence on this medicinal product is awaited. The European Medicines Agency 
will review new information on this medicinal product at least every year and this SmPC will be 
updated as necessary. 
 
5.2 Pharmacokinetic properties 
 
Concentration data were collected in 548 patients with various solid tumours, including 178 patients 
with CSCC, who received cemiplimab. At dosing regimens of 1 mg/kg to 10 mg/kg Q2W and 350 mg 
Q3W, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation 
of the target-mediated pathway over the dosing interval. 
 
In patients with CSCC, cemiplimab exposure at steady-state at 350 mg Q3W (N=53) and at 3 mg/kg 
Q2W (N=135) is similar. At 350 mg Q3W, the mean cemiplimab concentrations at steady-state ranged 
between a Ctrough of 63 mg/l and a concentration at end of infusion (Cmax) of 151 mg/l. Steady-state 
exposure is achieved after approximately 4 months of treatment. 
 
Absorption 
Cemiplimab is administered via the intravenous route and hence is completely bioavailable. 
 
Distribution 
Cemiplimab is primarily distributed in the vascular system with a volume of distribution at 
steady-state (Vss) of 5.2 liters. 



 

 17  

 
Biotransformation 
Specific metabolism studies were not conducted because cemiplimab is a protein. Cemiplimab is 
expected to degrade to small peptides and individual amino acids. 
 
Elimination 
Clearance of cemiplimab is linear at doses of 1 mg/kg to 10 mg/kg every two weeks. Cemiplimab 
clearance after the first dose is approximately 0.33 l/day. The total clearance appears to decrease by 
approximately 35% over time, resulting in a steady state clearance (CLss) of 0.21 l/day; the decrease 
in CL is not considered clinically relevant. The within dosing interval half-life at steady state is 
19.4 days. 
 
Linearity/non-linearity 
At the dosing regimens of 1 mg/kg to 10 mg/kg every two weeks, kinetics of cemiplimab were 
observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway. 
 
Special populations 
A population PK analysis suggests that the following factors have no clinically significant effect on 
the exposure of cemiplimab: age, gender, body weight, race, cancer type, albumin level, mild hepatic 
impairment and renal impairment. 
 
Renal impairment 
The effect of renal impairment on the exposure of cemiplimab was evaluated by a population PK 
analysis in patients with mild (CLcr 60 to 89 ml/min; n= 197), moderate (CLcr 30 to 59 ml/min; 
n= 90), or severe (CLcr 15 to 29 ml/min; n= 4) renal impairment. No clinically important differences 
in the exposure of cemiplimab were found between patients with renal impairment and patients with 
normal renal function. Cemiplimab has not been studied in patients with CLcr <25 ml/min (see 
section 4.2). 
 
Hepatic impairment 
The effect of hepatic impairment on the exposure of cemiplimab was evaluated by population PK 
analysis. In patients with mild hepatic impairment (n= 5) (total bilirubin [TB] greater than 1.0 to 
1.5 times the upper limit of normal [ULN] and any aspartate aminotransferase [AST]); no clinically 
important differences in the exposure of cemiplimab were found compared to patients with normal 
hepatic function. Cemiplimab has not been studied in patients with moderate or severe hepatic 
impairment. There are insufficient data in patients with moderate or severe hepatic impairment for 
dosing recommendations (see section 4.2). 
 
5.3 Preclinical safety data 
 
No studies have been performed to test the potential of cemiplimab for carcinogenicity or genotoxicity. 
Animal reproduction studies have not been conducted with cemiplimab (see section 4.6). As reported 
in the literature, PD-1 / PD-L1 signalling pathway plays a role in sustaining pregnancy by maintaining 
immunological tolerance and studies have shown that PD-1 receptor blockade results in early 
termination of pregnancy. The increase of spontaneous abortion and/or resorption in animals with 
restricted PD-L1 expression (knock-out or anti-PD1 / PD-L1 monoclonal antibodies) has been shown 
in both mice and monkeys. These animal species have similar maternal-foetal interface to that in 
humans. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
L-histidine 
L-histidine monohydrochloride monohydrate 
Sucrose 



 

 18  

L-proline 
Polysorbate 80 
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products except those mentioned in section 6.6. 
 
6.3 Shelf life 
 
Unopened vial 
30 months 
 
After opening 
Once opened, the medicinal product should be diluted and infused immediately (see section 6.6 for 
instructions on dilution of the medicinal product before administration). 
 
After preparation of infusion 
Once prepared, administer the diluted solution immediately. If diluted solution is not administered 
immediately, it may be stored temporarily either: 

 at room temperature up to 25°C for no more than 8 hours from the time of infusion 
preparation to the end of infusion. 
Or 

 under refrigeration at 2°C to 8°C for no more than 24 hours from the time of infusion 
preparation to the end of infusion. Do not freeze. Allow the diluted solution to come to 
room temperature prior to administration. 

 
6.4 Special precautions for storage 
 
Unopened vial 
Store in a refrigerator (2°C to 8°C). 
 
Do not freeze. 
 
Store in the original carton in order to protect from light. 
 
For storage conditions after first opening or dilution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
LIBTAYO is provided in a 10 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with 
FluroTec coating and seal cap with a flip-off button. 
 
Each carton contains 1 vial. 
 
6.6 Special precautions for disposal and other handling 
 
Preparation and administration 

 Visually inspect medicinal product for particulate matter and discoloration prior to 
administration. LIBTAYO is a clear to slightly opalescent, colourless to pale yellow 
solution that may contain trace amounts of translucent to white particles 

 Discard the vial if the solution is cloudy, discoloured or contains extraneous particulate 
matter other than a few translucent to white particles. 

 Do not shake the vial. 



 

 19  

 Withdraw 7 ml (350 mg) from the vial of LIBTAYO and transfer into an intravenous 
infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 
50 mg/ml (5%) solution for injection. Mix the diluted solution by gentle inversion. Do not 
shake the solution. The final concentration of the diluted solution should be between 
1 mg/ml to 20 mg/ml. 

 LIBTAYO is administered by intravenous infusion over 30 minutes through an 
intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on 
filter (0.2 micron to 5 micron pore size). 

 Do not co-administer other medicinal products through the same infusion line. 
 
LIBTAYO is for single use only. Dispose of any unused medicinal product or waste material in 
accordance with local requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Regeneron Ireland Designated Activity Company (DAC) 
Europa House 
Harcourt Centre 
Harcourt Street 
Dublin 2 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1376/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 28 June 2019 
Date of latest renewal: 20 May 2020 
 
 
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. 

 



 

 20  

ANNEX II 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
SUBSTANCE(S) AND MANUFACTURER(S) 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 
 

E. SPECIFIC OBLIGATION TO COMPLETE POST-
AUTHORISATION MEASURES FOR THE CONDITIONAL 
MARKETING AUTHORISATION 

 



 

 21  

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer(s) of the biological active substance(s)  
 
Regeneron Pharmaceuticals, Inc. 
81 Columbia Turnpike 
Rensselaer, NY 12144 
United States 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Regeneron Ireland DAC 
Raheen Business Park 
Limerick 
Ireland 
 
 
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 (PSURs) 
 
The requirements for submission of PSURs 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 (MAH) shall submit the first PSUR 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. 
 
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. 

 
 Additional risk minimisation measures 
 
Prior to launch of LIBTAYO in each Member State, the MAH must agree about the content and 
format of the educational programme, including communication media, distribution modalities, and 



 

 22  

any other aspects of the programme, with the National Competent Authority.  
 
The MAH shall ensure that in each Member State where LIBTAYO is marketed, all healthcare 
professionals and patients/carers who are expected to prescribe and use LIBTAYO have access 
to/are provided with the following educational package: 
- A patient guide  
- A patient alert card  

 

 The patient guide shall contain the following key messages 

o Description of the main signs or symptoms of the immune-related adverse reactions 
(pneumonitis, colitis, hepatitis, endocrinopathies, immune-related skin adverse reactions, 
nephritis and other irARs) and infusion related reactions, and the importance of notifying 
their treating physician immediately if symptoms occur. 

o The importance of not attempting to self-treat any symptoms without consulting their 
healthcare professional first. 

o The importance of carrying the Patient Alert Card at all times and to show it at all medical 
visits to healthcare professionals other than the prescriber (e.g. emergency healthcare 
professionals). 

o A reminder that all known or suspected adverse drug reactions (ADRs) can also be 
reported to local regulatory authorities. 

 

 The patient alert card shall contain the following key messages:  

o A warning message for health care professionals treating the patient at any time, including 
in conditions of emergency, that the patient is treated with LIBTAYO. 

o Description of the main signs or symptoms of the immune-related adverse reactions 
(pneumonitis, colitis, hepatitis, endocrinopathies, immune-related skin adverse reactions, 
nephritis and other irARs) and infusion related reactions, and the importance of notifying 
their treating physician immediately if symptoms occur. 

o The contact details of their LIBTAYO prescriber. 

 
 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES 

FOR THE CONDITIONAL MARKETING AUTHORISATION  
 
This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) 
No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: 
 
Description Due date 
In order to confirm the efficacy and safety of cemiplimab for the treatment of 
patients with metastatic or locally advanced cutaneous squamous cell carcinoma 
who are not candidates for curative surgery or curative radiation, the MAH should 
provide interim data of a single-arm trial in the same population [study 1540 group 
6]. The MAH should investigate biomarkers in order to confirm that PD-L1 
expression is not predictive of efficacy.  

The study should be conducted according to an agreed protocol. 

31st March 
2023 



 

 23  

Description Due date 
In order to confirm the efficacy and safety of cemiplimab for the treatment of 
patients with metastatic or locally advanced cutaneous squamous cell carcinoma 
who are not candidates for curative surgery or curative radiation, the MAH should 
submit the final study report for Groups 1-3 in the phase 2 pivotal study 1540. 

31st October 
2022 



 

 24  

ANNEX III 

LABELLING AND PACKAGE LEAFLET 

 



 

 25  

A. LABELLING 

 



 

 26  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
LIBTAYO 350 mg concentrate for solution for infusion 
cemiplimab 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One ml contains 50 mg of cemiplimab. 
Each vial contains 350 mg of cemiplimab in 7 ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: L-histidine, L-histidine monohydrochloride monohydrate, L-proline, polysorbate 80, 
sucrose, and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
concentrate for solution for infusion 
350 mg/7 ml 
 
1 vial 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intravenous use 
For single use only. 
 
 
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.  
Store in the original carton in order to protect from light.  



 

 27  

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 
 
Regeneron Ireland DAC 
Europa House, Harcourt Centre 
Harcourt Street, Dublin 2, Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1376/001 
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
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 
LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
LIBTAYO 350 mg sterile concentrate 
cemiplimab 
IV  
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
350 mg/7 ml 
 
 
6. OTHER 
 



 

 29  

B. PACKAGE LEAFLET 



 

 30  

 

Package leaflet: Information for the patient 
 

LIBTAYO 350 mg concentrate for solution for infusion 
 

cemiplimab 
 

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 are given this medicine because it contains important 
information for you. 

 Keep this leaflet. You may need to read it again.  
 It is important that you keep the Patient Alert Card with you during treatment. 
 If you have any further questions, ask your doctor. 
 If you get any side effects, talk to your doctor. This includes any possible side effects not 

listed in this leaflet. See section 4.  
 
 

What is in this leaflet 
 

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

 
 
1. What LIBTAYO is and what it is used for 
 
LIBTAYO is an anti-cancer medicine that contains the active substance cemiplimab, which is a 
monoclonal antibody. 
 
LIBTAYO is used in adults to treat a type of skin cancer called advanced cutaneous squamous cell 
carcinoma or CSCC.  
 
LIBTAYO works by helping your immune system fight your cancer. 
 
 
2. What you need to know before you are given LIBTAYO 
 
You should not be given LIBTAYO if: 

 you are allergic to cemiplimab or any of the other ingredients of this medicine (listed in 
section 6). 

If you think you may be allergic, or you are not sure, talk to your doctor before you are given 
LIBTAYO. 

 
Warnings and precautions  
Talk to your doctor or nurse before you are given LIBTAYO if:  

 you have an autoimmune disease (a condition where the body attacks its own cells) 
 you have had an organ transplant, or you have received or plan to receive a bone marrow 

transplant using bone marrow from another person (allogeneic hematopoietic stem cell 
transplant) 



 

 31  

 you have lung or breathing problems 
 you have liver problems 
 you have kidney problems 
 you have diabetes 
 you have any other medical conditions. 

 
If any of the above apply to you, or you are not sure, talk to your doctor or nurse before you are given 
LIBTAYO. 
 
Look out for side effects 
LIBTAYO can cause some serious side effects that you need to tell your doctor about immediately. 
These problems may happen anytime during treatment or even after your treatment has ended. You 
may have more than one side effect at the same time. 
These serious side effects include: 

 Skin problems  
 Lung problems (pneumonitis)  
 Gut problems (colitis)  
 Liver problems (hepatitis)  
 Hormone gland problems - especially thyroid, pituitary, adrenal glands and the pancreas 
 Type 1 diabetes 
 Kidney problems (nephritis and kidney failure) 
 Central nervous system problems (such as meningitis) 
 Infusion-related reactions  
 Problems in other parts of the body (see ‘Possible side effects’) 
 Muscle problems (inflammation of the muscles called myositis). 

 
Look out for these side effects while you are receiving LIBTAYO. See ‘Possible side effects’ section 
in section 4. If you have any of these effects, talk to your doctor immediately.  
Your doctor may give you other medicines in order to stop more severe reactions and reduce your 
symptoms. Your doctor also may delay your next dose of LIBTAYO or stop your treatment. 
 
Children and adolescents 
LIBTAYO should not be used in children and adolescents below 18 years of age. 
 
Other medicines and LIBTAYO 
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
In particular, tell your doctor if you are taking or have ever taken any of the following medicines: 

 a cancer medicine called idelalisib 
 medicines that make your immune system weak - examples include corticosteroids, such 

as prednisone. These medicines may interfere with the effect of LIBTAYO. However, 
once you are treated with LIBTAYO, your doctor may give you corticosteroids to reduce 
the side effects that you may have with LIBTAYO.  

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

 LIBTAYO can harm your unborn baby. 
 Tell your doctor immediately if you become pregnant while you are being treated with 

LIBTAYO. 
 If you are able to become pregnant, you must use an effective method of contraception to 

avoid becoming pregnant: 
 while you are being treated with LIBTAYO and 
 for at least 4 months after the last dose. 

 Talk to your doctor about the contraception methods that you must use during this time. 



 

 32  

 
Breast-feeding 

 If you are breast-feeding or plan to breast-feed, ask your doctor for advice before you are 
given this medicine.  

 Do not breast-feed while you are being treated with LIBTAYO and for at least 4 months 
after the last dose.  

 It is not known if LIBTAYO passes into your breast milk.  
 
Driving and using machines 
LIBTAYO has no or minor influence on your ability to drive and use machines. If you feel tired, do 
not drive or use machines until you feel better.  
 
 
3. How you are given LIBTAYO 
 

 LIBTAYO will be given to you in a hospital or clinic - supervised by a doctor experienced 
in cancer treatment. 

 LIBTAYO is given as a drip into a vein (intravenous infusion).  
 The infusion will last about 30 minutes. 
 LIBTAYO is usually given every 3 weeks. 

 
How much you will receive 
The recommended dose of LIBTAYO is 350 mg. 
Your doctor will decide how much LIBTAYO you will receive and how many treatments you will 
need. 
Your doctor will test your blood for certain side effects during your treatment. 
 
If you miss an appointment 
Call your doctor as soon as possible to make another appointment. It is very important that you do not 
miss a dose of this medicine.  
 
If you stop receiving LIBTAYO 
Do not stop treatment of LIBTAYO unless you have discussed this with your doctor. This is because 
stopping your treatment may stop the effect of the medicine. 
 
Patient Alert Card 
The information in this Package Leaflet can be found in the Patient Alert Card you have been given by 
your doctor. It is important that you keep this Patient Alert Card and show it to your partner or 
caregivers. 
If you have any questions about your treatment, ask your doctor.  
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your 
doctor will discuss these with you and will explain the risks and benefits of your treatment. 
 
LIBTAYO acts on your immune system and may cause inflammation in parts of your body (see the 
conditions listed in ‘Look out for side effects’ in section 2). Inflammation may cause serious damage 
to your body and may need treatment or require you to stop treatment with LIBTAYO. Some 
inflammatory conditions may also lead to death. 
 
Seek urgent medical attention if you have any of the following signs or symptoms, or if they get 
worse: 

 Skin problems such as rash or itching, skin blistering or ulcers in mouth or other mucous 
membrane.  



 

 33  

 Lung problems (pneumonitis) such as new or worsening cough, being short of breath or 
chest pain.  

 Gut problems (colitis) such as frequent diarrhoea often with blood or mucus, more bowel 
movements than usual, stools that are black or tarry, and severe stomach (abdomen) pain 
or tenderness.  

 Liver problems (hepatitis) such as yellowing of your skin or the whites of your eyes, 
severe nausea or vomiting, pain on right side of your stomach (abdomen), feeling sleepy, 
dark urine (the colour of tea), bleeding or bruising more easily than normal and feeling 
less hungry than usual.  

 Hormone gland problems such as headache that will not go away or unusual headaches, 
fast heartbeat, increased sweating, feeling more cold or hot than usual, very tired, dizzy or 
fainting, weight gain or weight loss, feeling more hungry or thirsty than usual, hair loss, 
constipation, your voice gets deeper, very low blood pressure, passing water more often 
than usual, nausea or vomiting, stomach (abdomen) pain, changes in mood or behaviour 
(such as decreased sex drive, being irritable or forgetful).  

 Symptoms of type 1 diabetes such as feeling more hungry or thirsty than usual, needing 
to urinate more often, weight loss, and feeling tired.  

 Kidney problems (nephritis and kidney failure) such as passing water less often than 
usual, passing blood, swollen ankles and feeling less hungry than normal.  

 Infusion-related reactions (sometimes can be severe or life-threatening) such as chills, 
shaking or fever, itching or rash, flushing or swollen face, being short of breath or 
wheezing, feeling dizzy or feel like passing out and back or neck pain, nausea, vomiting or 
abdominal pain. 

 Problems in other parts of the body such as: 
 Nervous system problems such as headache or stiff neck, fever, feeling tired or 

weak, chills, vomiting, confusion, memory problems or feeling sleepy, fits (seizures), 
seeing or hearing things that are not really there (hallucinations), severe muscle 
weakness, tingling, numbness, weakness or burning pain in arms or legs, paralysis in 
the extremities 

 Muscle and joint problems such as joint pain or swelling, muscle pain, weakness or 
stiffness 

 Eye problems such as changes in eyesight, eye pain or redness, sensitivity to light  
 Heart and circulatory problems such as changes in heartbeat, heart beating fast, 

seeming to skip a beat or pounding sensation, chest pain, shortness of breath  
 Other: dryness in many parts of the body from mouth to eyes, nose, throat and the top 

layers of skin, bruises on the skin or bleeding.  
 
The following side effects have been reported in clinical trials of patients treated with 
cemiplimab: 
 
Very common (may affect more than 1 in 10 people): 

 rash, itching 
 feeling tired 
 diarrhoea (loose stools). 

 
Common (may affect up to 1 in 10 people): 

 thyroid gland problems 
 cough, inflammation of the lungs 
 increased liver enzymes in blood 
 joint pain, swelling, polyarthritis and joint effusion 
 abnormal kidney function test 
 infusion-related reactions 
 muscle or bone pain 
 shortness of breath 



 

 34  

 inflammation of the mouth 
 inflammation of the liver. 

 
Uncommon (may affect up to 1 in 100 people): 

 muscle pain, weakness or stiffness 
 type 1 diabetes that may include feeling more hungry or thirsty than usual, needing to 

urinate more often, weight loss, and feeling tired  
 inflammation of the heart muscle, which may present as shortness of breath, irregular 

heartbeat, feeling tired or chest pain 
 inflammation of the covering of the heart 
 inflammation of the kidneys 
 inflammation of the pituitary gland situated at the base of the brain; decreased secretion of 

hormones produced by the adrenal glands; inflammation of the thyroid  
 inflammation of brain and spinal cord membranes usually caused by infection 
 dryness in many parts of the body, from mouth to eyes, nose, throat and the top layers of 

skin 
 eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light 
 inflammation of the nerves causing tingling, numbness, weakness or burning pain of the 

arms or legs 
 a temporary inflammation of the nerves that causes pain, weakness, and paralysis in the 

extremities; a condition in which the muscles become weak and tire easily 
 bruises on the skin or bleeding. 

 
Rare (may affect up to 1 in 1000 people) 

 inflammation of the muscles which may include muscle pain or weakness (myositis) 
 
Other side effects that have been reported (frequency not known):  

 organ transplant rejection 
 

Reporting of side effects 
If you get any side effects, talk to your doctor. 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. 
 
 
5. How to store LIBTAYO 
 
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 carton and vial after EXP. The 
expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C to 8°C).  
 
Do not freeze. 
 
Store in the original container in order to protect from light. 
From time of preparation by diluting in an intravenous bag, LIBTAYO can be stored before use for no 
more than 8 hours at temperatures up to 25°C, and no more than 24 hours in a refrigerator (2°C to 
8°C). If refrigerated, the vials and/or intravenous bags must be allowed to reach room temperature 
prior to use.  
 
Do not store any unused portion of the infusion solution for re-use. Any unused portion of the infusion 
solution should not be re-used and should be disposed in accordance with local requirements. 
 



 

 35  

 
6. Contents of the pack and other information 
 
What LIBTAYO contains  
The active substance is cemiplimab:  

 One ml of concentrate contains 50 mg of cemiplimab. 
 Each vial contains 350 mg cemiplimab in 7 ml of concentrate. 

 
The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L-proline, 
sucrose, polysorbate 80 and water for injections. 
 
What LIBTAYO looks like and contents of the pack 
LIBTAYO concentrate for solution for infusion (sterile concentrate) is supplied as a clear to slightly 
opalescent, colourless to pale yellow sterile solution that may contain trace amounts of translucent to 
white particles. 
 
Each carton contains 1 glass vial with 7 ml of concentrate. 
 
Marketing Authorisation Holder  
Regeneron Ireland Designated Activity Company (DAC) 
Europa House 
Harcourt Centre 
Harcourt Street 
Dublin 2 
Ireland 
 
Manufacturer 
Regeneron Ireland DAC 
Raheen Business Park 
Limerick 
Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
  
België/Belgique/Belgien 
Sanofi Belgium 
Tél/Tel: +32 (0)2 710 54 00 
 

Lietuva 
UAB "SANOFI-AVENTIS LIETUVA"  
Tel: +370 5 2755224 
 

България 
SANOFI BULGARIA EOOD 
Тел.: +359 (0)2 970 53 00 
 

Luxembourg/Luxemburg 
Sanofi Belgium  
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 
 

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Magyarország 
SANOFI-AVENTIS Zrt. 
Tel.: +36 1 505 0050 
 

Danmark 
Sanofi A/S 
Tlf: +45 45 16 70 00 
 

Malta 
Sanofi S.p.A 
Tel: +39 02 39394275 
 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Tel.: 0800 04 36 996 
Tel. aus dem Ausland: +49 69 305 70 13 
 

Nederland 
sanofi-aventis Netherlands B.V. 
Tel: +31 20 245 4000 
 

Eesti Norge 



 

 36  

sanofi-aventis Estonia OÜ 
Tel: +372 627 34 88 
 

sanofi-aventis Norge AS 
Tlf: +47 67 10 71 00 
 

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 16 00 
 

Österreich 
sanofi-aventis GmbH 
Tel: +43 1 80 185 – 0 
 

España 
sanofi-aventis, S.A.  
Tel: +34 93 485 94 00 
 

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 280 00 00 
 

France 
sanofi-aventis France 
Tél: 0 800 222 555 
Appel depuis l’étranger: +33 1 57 63 23 23 
 

Portugal 
Sanofi - Produtos Farmacêuticos, Lda 
Tel: +351 21 35 89 400 
 

Hrvatska  
sanofi-aventis Croatia d.o.o. 
Tel: +385 1 600 34 00 

România 
Sanofi Romania SRL 
Tel: +40 (0) 21 317 31 36 

  
Ireland 
sanofi-aventis Ireland Ltd. T/A SANOFI 
Tel: +353 (0) 1 403 56 00 
 

Slovenija 
sanofi-aventis d.o.o. 
Tel: +386 1 560 48 00 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000  
 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel: +421 2 33 100 100 
 

Italia 
Sanofi S.p.A. 
Tel: 800.536 389 
 

Suomi/Finland 
Sanofi Oy 
Puh/Tel: +358 (0) 201 200 300 
 

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 

Sverige 
Sanofi AB 
Tel: +46 (0)8 634 50 00 
 

Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

United Kingdom 
Sanofi 
Tel: +44 (0) 845 372 7101 
 

 
This leaflet was last revised in  
 
This medicine has been given ‘conditional approval’. This means that there is more evidence to come 
about this medicine. The European Medicines Agency will review new information on this medicine at 
least every year and this leaflet will be updated as necessary. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
------------------------------------------------------------------------------------------------------------------------



 

37 

The following information is intended for healthcare professionals only: 
 
Instructions for use 
 
Preparation 

 Visually inspect the medicinal product for particulate matter and discoloration prior to 
administration. LIBTAYO is a clear to slightly opalescent, colourless to pale yellow 
solution that may contain trace amounts of translucent to white particles. 

 Discard the vial if the solution is cloudy, discoloured or contains extraneous particulate 
matter other than trace amounts of translucent to white particles. 

 Do not shake the vial. 
 Withdraw 7 ml (350 mg) from the vial of LIBTAYO and transfer into an intravenous 

infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 
50 mg/ml (5%) solution for injection. Mix the diluted solution by gentle inversion. Do not 
shake the solution. The final concentration of the diluted solution should be between 
1 mg/ml to 20 mg/ml. 

 LIBTAYO is for single use only. Dispose of any unused medicinal product or waste 
material in accordance with local requirements. 

 
Storage of diluted solution 
LIBTAYO does not contain a preservative. 
Once prepared, administer the diluted solution immediately. If diluted solution is not administered 
immediately, it may be stored temporarily either: 

 at room temperature up to 25°C for no more than 8 hours from the time of infusion 
preparation to the end of infusion.  

Or 
 under refrigeration at 2°C to 8°C for no more than 24 hours from the time of infusion 

preparation to the end of infusion. Allow the diluted solution to come to room 
temperature prior to administration. 

 
Do not freeze. 
 
Administration 

 LIBTAYO is for intravenous use. It is administered by intravenous infusion over 
30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein 
binding, in-line or add-on filter (0.2 micron to 5 micron pore size). 

 Do not co-administer other medicines through the same infusion line. 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) ANDMANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURESFOR THE CONDITIONAL MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you use libtayo', 'Section_Content': "you should not be given libtayo if: you are allergic to cemiplimab or any of the other ingredients of this medicine (listed in section 6). if you think you may be allergic, or you are not sure, talk to your doctor before you are given libtayo. warnings and precautions talk to your doctor or nurse before you are given libtayo if: you have an autoimmune disease (a condition where the body attacks its own cells) you have had an organ transplant, or you have received or plan to receive a bone marrow transplant using bone marrow from another person (allogeneic hematopoietic stem cell transplant) 31 you have lung or breathing problems you have liver problems you have kidney problems you have diabetes you have any other medical conditions. if any of the above apply to you, or you are not sure, talk to your doctor or nurse before you are given libtayo. look out for side effects libtayo can cause some serious side effects that you need to tell your doctor about immediately. these problems may happen anytime during treatment or even after your treatment has ended. you may have more than one side effect at the same time. these serious side effects include: skin problems lung problems (pneumonitis) gut problems (colitis) liver problems (hepatitis) hormone gland problems - especially thyroid, pituitary, adrenal glands and the pancreas type 1 diabetes kidney problems (nephritis and kidney failure) central nervous system problems (such as meningitis) infusion-related reactions problems in other parts of the body (see 'possible side effects') muscle problems (inflammation of the muscles called myositis). look out for these side effects while you are receiving libtayo. see 'possible side effects' section in section 4. if you have any of these effects, talk to your doctor immediately. your doctor may give you other medicines in order to stop more severe reactions and reduce your symptoms. your doctor 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{'Title': '3. how you are given libtayo', 'Section_Content': ' libtayo will be given to you in a hospital or clinic - supervised by a doctor experienced in cancer treatment. libtayo is given as a drip into a vein (intravenous infusion). the infusion will last about 30 minutes. libtayo is usually given every 3 weeks. how much you will receive the recommended dose of libtayo is 350 mg. your doctor will decide how much libtayo you will receive and how many treatments you will need. your doctor will test your blood for certain side effects during your treatment. if you miss an appointment call your doctor as soon as possible to make another appointment. it is very important that you do not miss a dose of this medicine. if you stop receiving libtayo do not stop treatment of libtayo unless you have discussed this with your doctor. this is because stopping your treatment may stop the effect of the medicine. patient alert card the information in this package leaflet can be found in the patient alert card you have been given by your doctor. it is important that you keep this patient alert card and show it to your partner or caregivers. if you have any questions about your treatment, ask your doctor.', 'Entity_Recognition': [{'Text': 'libtayo', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'cancer treatment', 'Type': 'TREATMENT', 'BeginOffset': 94, 'EndOffset': 110}, {'Text': 'a drip', 'Type': 'TREATMENT', 'BeginOffset': 132, 'EndOffset': 138}, {'Text': 'a vein (intravenous infusion', 'Type': 'TREATMENT', 'BeginOffset': 144, 'EndOffset': 172}, {'Text': 'the infusion', 'Type': 'TREATMENT', 'BeginOffset': 175, 'EndOffset': 187}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 204, 'EndOffset': 206}, {'Text': '3', 'Type': 'NUMBER', 'BeginOffset': 247, 'EndOffset': 248}, {'Id': 1, 'BeginOffset': 306, 'EndOffset': 313, 'Score': 0.24518820643424988, 'Text': 'libtayo', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.8445301055908203, 'RelationshipScore': 0.9999649524688721, 'RelationshipType': 'DOSAGE', 'Id': 2, 'BeginOffset': 317, 'EndOffset': 324, 'Text': '350 mg.', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '350', 'Type': 'NUMBER', 'BeginOffset': 317, 'EndOffset': 320}, {'Text': 'your blood', 'Type': 'TEST', 'BeginOffset': 444, 'EndOffset': 454}, {'Text': 'certain side effects', 'Type': 'PROBLEM', 'BeginOffset': 459, 'EndOffset': 479}, {'Text': 'your treatment', 'Type': 'TREATMENT', 'BeginOffset': 487, 'EndOffset': 501}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 648, 'EndOffset': 661}, {'Id': 3, 'BeginOffset': 685, 'EndOffset': 692, 'Score': 0.4116770327091217, 'Text': 'libtayo', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 4, 'BeginOffset': 718, 'EndOffset': 725, 'Score': 0.4163111746311188, 'Text': 'libtayo', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'your treatment', 'Type': 'TREATMENT', 'BeginOffset': 800, 'EndOffset': 814}, {'Text': 'the medicine', 'Type': 'TREATMENT', 'BeginOffset': 838, 'EndOffset': 850}, {'Text': 'your treatment', 'Type': 'TREATMENT', 'BeginOffset': 1115, 'EndOffset': 1129}]}
{'Title': '4. possible side effects', 'Section_Content': "like all medicines, this medicine can cause side effects, although not everybody gets them. your doctor will discuss these with you and will explain the risks and benefits of your treatment. libtayo acts on your immune system and may cause inflammation in parts of your body (see the conditions listed in 'look out for side effects' in section 2). inflammation may cause serious damage to your body and may need treatment or require you to stop treatment with libtayo. some inflammatory conditions may also lead to death. seek urgent medical attention if you have any of the following signs or symptoms, or if they get worse: skin problems such as rash or itching, skin blistering or ulcers in mouth or other mucous membrane. lung problems (pneumonitis) such as new or worsening cough, being short of breath or chest pain. gut problems (colitis) such as frequent diarrhoea often with blood or mucus, more bowel movements than usual, stools that are black or tarry, and severe stomach (abdomen) pain or tenderness. liver problems (hepatitis) such as yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on right side of your stomach (abdomen), feeling sleepy, dark urine (the colour of tea), bleeding or bruising more easily than normal and feeling less hungry than usual. hormone gland problems such as headache that will not go away or unusual headaches, fast heartbeat, increased sweating, feeling more cold or hot than usual, very tired, dizzy or fainting, weight gain or weight loss, feeling more hungry or thirsty than usual, hair loss, constipation, your voice gets deeper, very low blood pressure, passing water more often than usual, nausea or vomiting, stomach (abdomen) pain, changes in mood or behaviour (such as decreased sex drive, being irritable or forgetful). symptoms of type 1 diabetes such as feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired. kidney problems (nephritis and kidney failure) such as passing water less often than usual, passing blood, swollen ankles and feeling less hungry than normal. infusion-related reactions (sometimes can be severe or life-threatening) such as chills, shaking or fever, itching or rash, flushing or swollen face, being short of breath or wheezing, feeling dizzy or feel like passing out and back or neck pain, nausea, vomiting or abdominal pain. problems in other parts of the body such as: nervous system problems such as headache or stiff neck, fever, feeling tired or weak, chills, vomiting, confusion, memory problems or feeling sleepy, fits (seizures), seeing or hearing things that are not really there (hallucinations), severe muscle weakness, tingling, numbness, weakness or burning pain in arms or legs, paralysis in the extremities muscle and joint problems such as joint pain or swelling, muscle pain, weakness or stiffness eye problems such as changes in eyesight, eye pain or redness, sensitivity to light heart and circulatory problems such as changes in heartbeat, heart beating fast, seeming to skip a beat or pounding sensation, chest pain, shortness of breath other: dryness in many parts of the body from mouth to eyes, nose, throat and the top layers of skin, bruises on the skin or bleeding. the following side effects have been reported in clinical trials of patients treated with cemiplimab: very common (may affect more than 1 in 10 people): rash, itching feeling tired diarrhoea (loose stools). common (may affect up to 1 in 10 people): thyroid gland problems cough, inflammation of the lungs increased liver enzymes in blood joint pain, swelling, polyarthritis and joint effusion abnormal kidney function test infusion-related reactions muscle or bone pain shortness of breath 34 inflammation of the mouth inflammation of the liver. uncommon (may affect up to 1 in 100 people): muscle pain, weakness or stiffness type 1 diabetes that may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired or chest pain inflammation of the covering of the heart inflammation of the kidneys inflammation of the pituitary gland situated at the base of the brain; decreased secretion of hormones produced by the adrenal glands; inflammation of the thyroid inflammation of brain and spinal cord membranes usually caused by infection dryness in many parts of the body, from mouth to eyes, nose, throat and the top layers of skin eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light inflammation of the nerves causing tingling, numbness, weakness or burning pain of the arms or legs a temporary inflammation of the nerves that causes pain, weakness, and paralysis in the extremities; a condition in which the muscles become weak and tire easily bruises on the skin or bleeding. rare (may 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{'Title': '5. how to store libtayo', '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 carton and vial after exp. the expiry date refers to the last day of that month. store in a refrigerator (2 to 8). do not freeze. store in the original container in order to protect from light. from time of preparation by diluting in an intravenous bag, libtayo can be stored before use for no more than 8 hours at temperatures up to 25, and no more than 24 hours in a refrigerator (2 to 8). if refrigerated, the vials and/or intravenous bags must be allowed to reach room temperature prior to use. do not store any unused portion of the infusion solution for re-use. any unused portion of the infusion solution should not be re-used and should be disposed in accordance with local requirements.', 'Entity_Recognition': [{'Text': 'libtayo', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 240, 'EndOffset': 241}, {'Text': 'an intravenous bag', 'Type': 'TREATMENT', 'BeginOffset': 363, 'EndOffset': 381}, {'Text': 'libtayo', 'Type': 'TREATMENT', 'BeginOffset': 383, 'EndOffset': 390}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 433, 'EndOffset': 434}, {'Text': '25', 'Type': 'NUMBER', 'BeginOffset': 463, 'EndOffset': 465}, {'Text': '24', 'Type': 'NUMBER', 'BeginOffset': 484, 'EndOffset': 486}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 517, 'EndOffset': 518}, {'Text': 'the vials', 'Type': 'TREATMENT', 'BeginOffset': 538, 'EndOffset': 547}, {'Text': 'intravenous bags', 'Type': 'TREATMENT', 'BeginOffset': 555, 'EndOffset': 571}, {'Text': 'the infusion solution', 'Type': 'TREATMENT', 'BeginOffset': 663, 'EndOffset': 684}, {'Text': 'the infusion solution', 'Type': 'TREATMENT', 'BeginOffset': 719, 'EndOffset': 740}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what libtayo contains the active substance is cemiplimab: one ml of concentrate contains 50 mg of cemiplimab. each vial contains 350 mg cemiplimab in 7 ml of concentrate. the other ingredients are l-histidine, l-histidine monohydrochloride monohydrate, l-proline, sucrose, polysorbate 80 and water for injections. what libtayo looks like and contents of the pack libtayo concentrate for solution for infusion (sterile concentrate) is supplied as a clear to slightly opalescent, colourless to pale yellow sterile solution that may contain trace amounts of translucent to white particles. each carton contains 1 glass vial with 7 ml of concentrate.', 'Entity_Recognition': [{'Text': 'libtayo', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 46, 'EndOffset': 56, 'Score': 0.9911397099494934, 'Text': 'cemiplimab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 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mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '7', 'Type': 'NUMBER', 'BeginOffset': 150, 'EndOffset': 151}, {'Id': 8, 'BeginOffset': 158, 'EndOffset': 169, 'Score': 0.595519483089447, 'Text': 'concentrate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.962642252445221, 'RelationshipScore': 0.9416223168373108, 'RelationshipType': 'DOSAGE', 'Id': 5, 'BeginOffset': 129, 'EndOffset': 135, 'Text': '350 mg', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.970702588558197, 'RelationshipScore': 0.9999998807907104, 'RelationshipType': 'DOSAGE', 'Id': 7, 'BeginOffset': 150, 'EndOffset': 154, 'Text': '7 ml', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 9, 'BeginOffset': 197, 'EndOffset': 208, 'Score': 0.9921919703483582, 'Text': 'l-histidine', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 10, 'BeginOffset': 210, 'EndOffset': 251, 'Score': 0.9051415920257568, 'Text': 'l-histidine monohydrochloride monohydrate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'ROUTE_OR_MODE', 'Score': 0.43243059515953064, 'RelationshipScore': 0.8004531860351562, 'RelationshipType': 'ROUTE_OR_MODE', 'Id': 14, 'BeginOffset': 302, 'EndOffset': 312, 'Text': 'injections', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 11, 'BeginOffset': 253, 'EndOffset': 262, 'Score': 0.9762014150619507, 'Text': 'l-proline', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 12, 'BeginOffset': 264, 'EndOffset': 271, 'Score': 0.6820162534713745, 'Text': 'sucrose', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'ROUTE_OR_MODE', 'Score': 0.43243059515953064, 'RelationshipScore': 0.9990515112876892, 'RelationshipType': 'ROUTE_OR_MODE', 'Id': 14, 'BeginOffset': 302, 'EndOffset': 312, 'Text': 'injections', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 13, 'BeginOffset': 273, 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