Livogiva
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ANNEX I 

 
SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Livogiva 20 micrograms/80 microliters solution for injection in pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each dose of 80 microliters contains 20 micrograms of teriparatide*.  
Each pre-filled pen of 2.7 mL contains 675 micrograms of teriparatide (corresponding to 
250 micrograms per mL). 
 
*Teriparatide, rhPTH(1-34), produced in P. fluorescens, using recombinant DNA technology, is 
identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection.  
 
Colourless, clear solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Livogiva is indicated in adults.  
 
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see 
section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-
vertebral fractures but not hip fractures have been demonstrated.  
 
Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and 
men at increased risk for fracture (see section 5.1). 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended dose of Livogiva is 20 micrograms administered once daily.  
 
The maximum total duration of treatment with Livogiva should be 24 months (see section 4.4).  
The 24-month course of Livogiva should not be repeated over a patient’s lifetime.  
 
Patients should receive supplemental calcium and vitamin D supplements if dietary intake is 
inadequate.  
 
Following cessation of Livogiva therapy, patients may be continued on other osteoporosis therapies. 
 



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Special populations  
 
Elderly patients  
Dose adjustment based on age is not required (see section 5.2). 
 
Renal impairment  
Teriparatide must not be used in patients with severe renal impairment (see section 4.3). In patients 
with moderate renal impairment, teriparatide should be used with caution (see section 4.4). No special 
caution is required for patients with mild renal impairment. 
 
Hepatic impairment  
No data are available in patients with impaired hepatic function (see section 5.3). Therefore, 
teriparatide should be used with caution. 
 
Paediatric population and young adults with open epiphyses  
The safety and efficacy of teriparatide in children and adolescents less than 18 years have not been 
established. Teriparatide should not be used in paediatric patients (less than 18 years), or young adults 
with open epiphyses.  
 
Method of administration  
 
Livogiva should be administered once daily by subcutaneous injection in the thigh or abdomen.  
 
Patients must be trained to use the proper injection techniques (see section 6.6).  
Please also refer to the user manual for instructions on the correct use of the pen. 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
• Pregnancy and breast-feeding (see sections 4.4 and 4.6)  
• Pre-existing hypercalcaemia  
• Severe renal impairment  
• Metabolic bone diseases (including hyperparathyroidism and Paget’s disease of the bone) other 

than primary osteoporosis or glucocorticoid-induced osteoporosis.  
• Unexplained elevations of alkaline phosphatase  
• Prior external beam or implant radiation therapy to the skeleton  
• Patients with skeletal malignancies or bone metastases should be excluded from treatment with 

teriparatide.  
 
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. 
 
Serum and urine calcium  
 
In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been 
observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 
and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Therefore, if blood 
samples for serum calcium measurements are taken, this should be done at least 16 hours after the 
most recent Livogiva injection. Routine calcium monitoring during therapy is not required.  
 
Teriparatide may cause small increases in urinary calcium excretion, but the incidence of 
hypercalciuria did not differ from that in the placebo-treated patients in clinical trials. 
 



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Urolithiasis  
 
Teriparatide has not been studied in patients with active urolithiasis. Livogiva should be used with 
caution in patients with active or recent urolithiasis because of the potential to exacerbate this 
condition. 
 
Orthostatic hypotension  
 
In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension 
were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within 
a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the 
first several doses, was relieved by placing subjects in a reclining position, and did not preclude 
continued treatment. 
 
Renal impairment  
 
Caution should be exercised in patients with moderate renal impairment (see section 4.2).  
 
Younger adult population  
 
Experience in the younger adult population, including premenopausal women, is limited (see 
section 5.1). Treatment should only be initiated if the benefit clearly outweighs risks in this 
population.  
 
Women of childbearing potential should use effective methods of contraception during use of 
Livogiva. If pregnancy occurs, Livogiva should be discontinued.  
 
Duration of treatment 
  
Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of 
teriparatide (see section 5.3). Until further clinical data become available, the recommended treatment 
time of 24 months should not be exceeded. 
 
Excipients 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
In a study of 15 healthy subjects administered digoxin daily to steady state, a single teriparatide dose 
did not alter the cardiac effect of digoxin. However, sporadic case reports have suggested that 
hypercalcaemia may predispose patients to digitalis toxicity. Because teriparatide transiently increases 
serum calcium, Livogiva should be used with caution in patients taking digitalis.  
 
Teriparatide has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide. No 
clinically significant interactions were noted.  
 
Co-administration of raloxifene or hormone replacement therapy with teriparatide did not alter the 
effects of teriparatide on serum or urine calcium or on clinical adverse events. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential/Contraception in females  
 
Women of childbearing potential should use effective methods of contraception during use of 
Livogiva. If pregnancy occurs, Livogiva should be discontinued.  



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Pregnancy  
 
Livogiva is contraindicated for use during pregnancy (see section 4.3).  
 
Breast-feeding  
 
Livogiva is contraindicated for use during breast-feeding (see section 4.3). It is not known whether 
teriparatide is excreted in human milk.  
 
Fertility  
 
Studies in rabbits have shown reproductive toxicity (see section 5.3). The effect of teriparatide on 
human foetal development has not been studied. The potential risk for humans is unknown. 
 
4.7 Effects on ability to drive and use machines 
 
Livogiva has no or negligible influence on the ability to drive and use machines. Transient, orthostatic 
hypotension or dizziness was observed in some patients. These patients should refrain from driving or 
the use of machines until symptoms have subsided. 
 
4.8 Undesirable effects 
 
Summary of the safety profile  
 
The most commonly reported adverse reactions in patients treated with teriparatide are nausea, pain in 
limb, headache and dizziness.  
 
Tabulated list of adverse reactions  
 
Of patients in the teriparatide trials, 82.8% of the teriparatide patients and 84.5% of the placebo 
patients reported at least 1 adverse event.  
 
The adverse reactions associated with the use of teriparatide in osteoporosis clinical trials and post-
marketing exposure are summarised in the table below.  
 
The following convention has been used for the classification of the adverse reactions: 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). 
 
Table 1. Adverse reactions 
MedDRA system organ class Frequency Adverse reactions 

Blood and lymphatic system disorders  
 

Common Anaemia  

Immune system disorder 
 

Rare Anaphylaxis 

Metabolism and nutrition disorders  
 
 

Common Hypercholesterolaemia  

Uncommon Hypercalcaemia greater than 
2.76 mmol/L, hyperuricemia  

Rare  Hypercalcaemia greater than 
3.25 mmol/L  

Psychiatric disorders  
 

Common Depression  



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Nervous system disorders  
 

Common Dizziness, headache, sciatica, 
syncope  

Ear and labyrinth disorders  
  

Common Vertigo  

Cardiac disorders  
  
 

Common Palpitations  

Uncommon Tachycardia  

Vascular disorders  
 

Common Hypotension  

Respiratory, thoracic and mediastinal 
disorders  
 
 

Common Dyspnoea  

Uncommon Emphysema  

Gastrointestinal disorders  
 
 

Common Nausea, vomiting, hiatus hernia, 
gastroesophageal reflux disease  

Uncommon Haemorrhoids  

Skin and subcutaneous tissue disorders  
 

Common Sweating increased  

Musculoskeletal and connective tissue 
disorders  
 
 
 

Very common Pain in limb  

Common Muscle cramps  

Uncommon Myalgia, arthralgia, back 
cramp/pain*  

Renal and urinary disorders  
 

Uncommon Urinary incontinence, polyuria, 
micturition urgency, 
nephrolithiasis  

Rare Renal failure/impairment  

General disorders and administration 
site conditions  
  

Common Fatigue, chest pain, asthenia, mild 
and transient injection site events, 
including pain, swelling, 
erythema, localised bruising, 
pruritis and minor bleeding at 
injection site. 

Uncommon  Injection site erythema, injection 
site reaction  

Rare Possible allergic events soon after 
injection: acute dyspnoea, 
oro/facial oedema, generalised 
urticaria, chest pain, oedema 
(mainly peripheral).  

Investigations 
 

Uncommon  Weight increased, cardiac 
murmur, alkaline phosphatase 
increase  

*Serious cases of back cramp or pain have been reported within minutes of the injection. 
 
Description of selected adverse reactions  
 
In clinical trials, the following reactions were reported at a ≥1% difference in frequency from placebo: 
vertigo, nausea, pain in limb, dizziness, depression, dyspnoea.  
 



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Teriparatide increases serum uric acid concentrations. In clinical trials, 2.8% of teriparatide patients 
had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo 
patients. However, the hyperuricemia did not result in an increase in gout, arthralgia, or urolithiasis.  
 
Anti-drug antibodies were observed in line with other teriparatide containing medicinal products. 
There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or 
effects on Bone Mineral Density (BMD) response.  
 
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 
 
Signs and symptoms  
 
Teriparatide has been administered in single doses of up to 100 micrograms and in repeated doses of 
up to 60 micrograms/day for 6 weeks.  
 
The effects of overdose that might be expected include delayed hypercalcaemia and risk of orthostatic 
hypotension. Nausea, vomiting, dizziness, and headache can also occur.  
 
Overdose experience based on post-marketing spontaneous reports  
 
In post-marketing spontaneous reports, there have been cases of medicinal product error where the 
entire contents (up to 800 mcg) of the teriparatide pen have been administered as a single dose. 
Transient events reported have included nausea, weakness/lethargy and hypotension. In some cases, 
no adverse events occurred as a result of the overdose. No fatalities associated with overdose have 
been reported.  
 
Overdose management  
 
There is no specific antidote for teriparatide. Treatment of suspected overdose should include 
transitory discontinuation of Livogiva, monitoring of serum calcium, and implementation of 
appropriate supportive measures, such as hydration. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: 
H05AA02. 
 
Livogiva is a biosimilar medicinal product. Detailed information is available on the website 
of the European Medicines Agency http://www.ema.europa.eu. 
 
Mechanism of action 
 
Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and 
phosphate metabolism in bone and kidney. Teriparatide (rhPTH(1-34)) is the active fragment (1-34) of 
endogenous human parathyroid hormone. Physiological actions of PTH include stimulation of bone 
formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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absorption of calcium and increasing the tubular re-absorption of calcium and excretion of phosphate 
by the kidney.  
 
Pharmacodynamic effects 
 
Teriparatide is a bone formation agent to treat osteoporosis. The skeletal effects of teriparatide depend 
upon the pattern of systemic exposure. Once-daily administration of teriparatide increases apposition 
of new bone on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic 
activity over osteoclastic activity. 
 
Clinical efficacy and safety 
 
Risk factors  
 
Independent risk factors, for example, low BMD, age, the existence of previous fracture, family 
history of hip fractures, high bone turnover and low body mass index should be considered in order to 
identify women and men at increased risk of osteoporotic fractures who could benefit from treatment.  
 
Premenopausal women with glucocorticoid-induced osteoporosis should be considered at high risk for 
fracture if they have a prevalent fracture or a combination of risk factors that place them at high risk 
for fracture (e.g., low bone density [e.g., T score ≤−2], sustained high dose glucocorticoid therapy 
[e.g., ≥7.5 mg/day for at least 6 months], high underlying disease activity, low sex steroid levels).  
 
Postmenopausal osteoporosis  
 
The pivotal study included 1,637 postmenopausal women (mean age 69.5 years). At baseline, ninety 
percent of the patients had one or more vertebral fractures, and on average, vertebral BMD was 
0.82 g/cm2 (equivalent to a T score = - 2.6). All patients were offered 1,000 mg calcium per day and at 
least 400 IU vitamin D per day. Results from up to 24 months (median: 19 months) treatment with 
teriparatide demonstrate statistically significant fracture reduction (Table 1). To prevent one or more 
new vertebral fractures, 11 women had to be treated for a median of 19 months. 
 
Table 2. Fracture incidence in postmenopausal women 
 Placebo 

(N = 544) (%) 
Teriparatide 

(N = 541) (%) 
Relative risk 

(95% CI) 
vs. placebo 

 
New vertebral fracture (≥1)a  14.3 5.0b 0.35 

(0.22, 0.55) 
Multiple vertebral fractures (≥2)a  4.9 1.1b 0.23 

(0.09, 0.60) 
Non-vertebral fragility fracturesc  5.5% 2.6%d 0.47 

(0.25, 0.87) 
Major non-vertebral fragility 
fracturesc (hip, radius, humerus, ribs 
and pelvis)  

3.9% 1.5%d 0.38 
(0.17, 0.86) 

Abbreviations: N = number of patients randomly assigned to each treatment group; CI = Confidence Interval. 
aThe incidence of vertebral fractures was assessed in 448 placebo and 444 teriparatide patients who had baseline and follow-
up spine radiographs. 
bp≤0.001 compared with placebo  
cA significant reduction in the incidence of hip fractures has not been demonstrated  
dp≤0.025 compared with placebo. 
 
After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine 
and total hip, respectively, by 9% and 4% compared with placebo (p<0.001).  
 
Post-treatment management: Following treatment with teriparatide, 1,262 postmenopausal women 
from the pivotal trial enrolled in a post-treatment follow-up study. The primary objective of the study 



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was to collect safety data of teriparatide. During this observational period, other osteoporosis 
treatments were allowed and additional assessment of vertebral fractures was performed.  
 
During a median of 18 months following discontinuation of teriparatide, there was a 41% reduction 
(p=0.004) compared with placebo in the number of patients with a minimum of one new vertebral 
fracture.  
 
In an open-label study, 503 postmenopausal women with severe osteoporosis and a fragility fracture 
within the previous 3 years (83% had received previous osteoporosis therapy) were treated with 
teriparatide for up to 24 months. At 24 months, the mean increase from baseline in lumbar spine, total 
hip and femoral neck BMD was 10.5%, 2.6% and 3.9% respectively. The mean increase in BMD from 
18 to 24 months was 1.4%, 1.2%, and 1.6% at the lumbar spine, total hip and femoral neck, 
respectively. 
 
A 24-month, randomised, double-blind, comparator-controlled Phase 4 study included 1,360 
postmenopausal women with established osteoporosis. 680 subjects were randomised to teriparatide 
and 680 subjects were randomised to oral risedronate 35 mg/week. At baseline, the women had a mean 
age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received 
previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study. 1,013 
(74.5%) patients completed the 24-month follow-up. The mean (median) cumulative dose of 
glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate 
arm. The mean (median) vitamin D intake for the teriparatide arm was 1,433 IU/day (1,400 IU/day) 
and for the risedronate arm was 1,191 IU/day (900 IU/day). For those subjects who had baseline and 
follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in 
teriparatide- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-
0.68), P<0.0001. The cumulative incidence of pooled clinical fractures (clinical vertebral and non-
vertebral fractures) was 4.8% in teriparatide and 9.8% in risedronate-treated patients, hazard ratio 
(95% CI) = 0.48 (0.32-0.74), P=0.0009 
 
Male osteoporosis  
 
437 patients (mean age 58.7 years) were enrolled in a clinical trial for men with hypogonadal (defined 
as low morning free testosterone or an elevated FSH or LH) or idiopathic osteoporosis. Baseline spinal 
and femoral neck bone mineral density mean T-scores were -2.2 and -2.1, respectively. At baseline, 
35% of patients had a vertebral fracture and 59% had a non-vertebral fracture.  
 
All patients were offered 1,000 mg calcium per day and at least 400 IU vitamin D per day. Lumbar 
spine BMD significantly increased by 3 months. After 12 months, BMD had increased in the lumbar 
spine and total hip by 5% and 1%, respectively, compared with placebo. However, no significant 
effect on fracture rates was demonstrated. 
 
Glucocorticoid-induced osteoporosis  
 
The efficacy of teriparatide in men and women (N=428) receiving sustained systemic glucocorticoid 
therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18-
month primary phase of a 36 month, randomised, double-blind, comparator-controlled study 
(alendronate 10 mg/day). Twenty-eight percent of patients had one or more radiographic vertebral 
fractures at baseline. All patients were offered 1,000 mg calcium per day and 800 IU vitamin D per 
day.  
This study included postmenopausal women (N=277), premenopausal women (N=67), and men 
(N=83). At baseline, the postmenopausal women had a mean age of 61 years, mean lumbar spine 
BMD T score of −2.7, median prednisone equivalent dose of 7.5 mg/day, and 34% had one or more 
radiographic vertebral fractures; premenopausal women had a mean age of 37 years, mean lumbar 
spine BMD T score of −2.5, median prednisone equivalent dose of 10 mg/day, and 9% had one or 
more radiographic vertebral fractures; and men had a mean age of 57 years, mean lumbar spine BMD 
T score of −2.2, median prednisone equivalent dose of 10 mg/day, and 24% had one or more 
radiographic vertebral fractures.  



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Sixty-nine percent of patients completed the 18-month primary phase. At the 18-month endpoint, 
teriparatide significantly increased lumbar spine BMD (7.2%) compared with alendronate (3.4%) 
(p<0.001). Teriparatide increased BMD at the total hip (3.6%) compared with alendronate (2.2%) 
(p<0.01), as well as at the femoral neck (3.7%) compared with alendronate (2.1%) (p<0.05). In 
patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 
and 24 months by an additional 1.7%, 0.9%, and 0.4%, respectively. 
 
At 36 months, analysis of spinal X-rays from 169 alendronate patients and 173 teriparatide patients 
showed that 13 patients in the alendronate group (7.7%) had experienced a new vertebral fracture 
compared with 3 patients in the teriparatide group (1.7%) (p=0.01). In addition, 15 of 214 patients in 
the alendronate group (7.0%) had experienced a non-vertebral fracture compared with 16 of 214 
patients in the teriparatide group (7.5%) (p=0.84).  
 
In premenopausal women, the increase in BMD from baseline to 18 months endpoint was significantly 
greater in the teriparatide group compared with the alendronate group at the lumbar spine (4.2% versus 
−1.9%; p<0.001) and total hip (3.8% versus 0.9%; p=0.005). However, no significant effect on 
fracture rates was demonstrated. 
 
5.2 Pharmacokinetic properties 
 
Distribution 
 
The volume of distribution is approximately 1.7 L/kg. The half-life of teriparatide is approximately 1 
hour when administered subcutaneously, which reflects the time required for absorption from the 
injection site.  
 
Biotransformation 
 
No metabolism or excretion studies have been performed with teriparatide but the peripheral 
metabolism of parathyroid hormone is believed to occur predominantly in liver and kidney. 
 
Elimination 
 
Teriparatide is eliminated through hepatic and extra-hepatic clearance (approximately 62 L/hr in 
women and 94 L/hr in men).  
 
Elderly  
 
No differences in teriparatide pharmacokinetics were detected with regard to age (range 31 to 85 
years). Dosage adjustment based on age is not required. 
 
5.3 Preclinical safety data 
 
Teriparatide was not genotoxic in a standard battery of tests. It produced no teratogenic effects in rats, 
mice or rabbits. There were no important effects observed in pregnant rats or mice administered 
teriparatide at daily doses of 30 to 1,000 μg/kg. However, fetal resorption and reduced litter size 
occurred in pregnant rabbits administered daily doses of 3 to 100 μg/kg. The embryotoxicity observed 
in rabbits may be related to their much greater sensitivity to the effects of PTH on blood ionised 
calcium compared with rodents. 
 
Rats treated with near-life time daily injections had dose-dependent exaggerated bone formation and 
increased incidence of osteosarcoma most probably due to an epigenetic mechanism. Teriparatide did 
not increase the incidence of any other type of neoplasia in rats. Due to the differences in bone 
physiology in rats and humans, the clinical relevance of these findings is probably minor. No bone 
tumours were observed in ovariectomised monkeys treated for 18 months or during a 3-year follow-up 



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period after treatment cessation. In addition, no osteosarcomas have been observed in clinical trials or 
during the post treatment follow-up study.  
 
Animal studies have shown that severely reduced hepatic blood flow decreases exposure of PTH to the 
principal cleavage system (Kupffer cells) and consequently clearance of PTH (1-84). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Glacial acetic acid  
Sodium acetate trihydrate 
Mannitol  
Metacresol  
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
2 years 
 
Chemical, physical and microbiological in-use stability has been demonstrated for 28 days at 2-8°C. 
Once opened, the medicinal product may be stored for a maximum of 28 days at 2°C to 8°C. Other in-
use storage times and conditions are the responsibility of the user. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C - 8°C) at all times. The pen injector should be returned to the refrigerator 
immediately after use.  
 
Do not freeze.  
 
Do not store the pen injector with the needle attached. 
 
Always store the pen injector with the white cap on after use, in order to protect from light.  
 
6.5 Nature and contents of container  
 
2.7 mL solution in cartridge (siliconised Type I glass) sealed at one end with a bromobutyl rubber 
plunger and at the other end crimp-sealed with a bi-layer combi-seal (polyisoprene/ bromobutyl rubber 
laminate with aluminium over cap). The cartridges are an integral and non-replaceable part of the pen 
injector. 
 
The pen injector is composed of a clear cartridge holder, white protective cap to cover the cartridge 
holder and injector body with a black injection button. 
 
Livogiva is available in pack sizes of 1 or 3 pre-filled pens. Each pre-filled pen contains 28 doses of 
20 micrograms (per 80 microliters).  
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 



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Each pen should be used by only one patient. A new, sterile needle must be used for every injection. 
No needles are supplied with the medicinal product. The device can be used with insulin pen injection 
needles. After each injection, the Livogiva pen should be returned to the refrigerator.  
 
Livogiva should not be used if the solution is cloudy, coloured or contains particles.  
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 

 Theramex Ireland Limited  
 3rd Floor Kilmore House, Park Lane, Spencer Dock  
 DO1 YE64 Dublin 1  

Ireland  
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1462/001-002 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation:  
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information is available on the website of the European Medicines Agency 
http://www.ema.europa.eu. 
 
 
  

http://www.ema.europa.eu/


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ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER 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 



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A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer of the biological active substance 
 
Cytovance Biologics Inc. 
3500 North Santa Fe Ave 
Oklahoma City, OK 73118 
United States 
 
Name and address of the manufacturer responsible for batch release 
 
Eurofins PROXY Laboratories (PRX) 
Archimedesweg 25 2333 CM Leiden 
Netherlands 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
 
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. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
• Risk management plan (RMP) 

 
The marketing authorisation holder (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. 



15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



17 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Livogiva 20 micrograms/80 microliters solution for injection in pre-filled pen 
teriparatide  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL contains 250 micrograms of teriparatide. 
Each pre-filled pen of 2.7 mL contains 675 micrograms of teriparatide (corresponding to 
250 micrograms per mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, water for injections. See leaflet 
for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
1 pen of 2.7 mL solution.  
3 pens of 2.7 mL solution. 
 
Each pre-filled pen contains 28 doses of 20 micrograms (per 80 microliters). 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
To open, lift and pull 
 
 
8. EXPIRY DATE 
 
EXP  
The pen should be discarded 28 days after the first use.  
Date of first use: 



18 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
 
 
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 
 

 Theramex Ireland Limited  
 3rd Floor Kilmore House, Park Lane, Spencer Dock  
 DO1 YE64 Dublin 1  
 Ireland  

 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1462/001 
EU/1/20/1462/002  
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Livogiva 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



19 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Livogiva 20 micrograms/80 microliters solution for injection in pre-filled pen 
teriparatide 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2.7 mL 
 
 
6. OTHER 
 
Store in a refrigerator 
 
 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



21 

Package leaflet: Information for the user 
 

Livogiva 20 micrograms/80 microliters solution for injection in pre-filled pen 
teriparatide 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Livogiva is and what it is used for  
2. What you need to know before you use Livogiva 
3. How to use Livogiva 
4. Possible side effects  
5. How to store Livogiva 
6. Contents of the pack and other information 
 
 
1. What Livogiva is and what it is used for 
 
Livogiva contains the active substance teriparatide that is used to make the bones stronger, and to 
reduce the risk of fractures by stimulating bone formation.  
 
Livogiva is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to 
become thin and fragile. This disease is especially common in women after the menopause, but it can 
also occur in men. Osteoporosis is also common in patients receiving corticosteroids. 
 
 
2. What you need to know before you use Livogiva 
 
Do not use Livogiva 
• if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in 

section 6). 
• if you suffer from high calcium levels (pre-existing hypercalcaemia). 
• if you suffer from serious kidney problems.  
• if you have ever been diagnosed with bone cancer or other cancers that have spread 

(metastasised) to your bones.  
• if you have certain bone diseases. If you have a bone disease, tell your doctor.  
• if you have unexplained high levels of alkaline phosphatase in your blood, which means you 

might have Paget’s disease of bone (disease with abnormal bone changes). If you are not sure, 
ask your doctor.  

• if you have had radiation therapy involving your bones.  
• if you are pregnant or breast-feeding.  
 
Warnings and precautions  
Livogiva may cause an increase in the amount of calcium in your blood or urine. 



22 

 
Talk to your doctor or pharmacist before or while using Livogiva:  
• if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These 

may be signs there is too much calcium in your blood.  
• if you suffer from kidney stones or have a history of kidney stones.  
• if you suffer from kidney problems (moderate renal impairment).  
 
Some patients get dizzy or get a fast heartbeat after the first few doses. For the first doses, inject 
Livogiva where you can sit or lie down right away if you get dizzy.  
The recommended treatment time of 24 months should not be exceeded.  
 
Livogiva should not be used in growing adults. 
 
Children and adolescents 
Livogiva should not be used in children and adolescents (less than 18 years). 
 
Other medicines and Livogiva 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart 
disease). 
 
Pregnancy and breast-feeding 
Do not use Livogiva if you are pregnant or breast-feeding. If you are a woman of child-bearing 
potential, you should use effective methods of contraception during use of Livogiva. If you become 
pregnant, Livogiva should be discontinued. Ask your doctor or pharmacist for advice before taking 
any medicine.  
 
Driving and using machines 
Some patients may feel dizzy after injecting Livogiva. If you feel dizzy you should not drive or use 
machines until you feel better 
 
Livogiva contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Livogiva 
 
Always use this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist 
if you are not sure.  
 
The recommended dose is 20 micrograms given once daily by injection under the skin (subcutaneous 
injection) in the thigh or abdomen. To help you remember to use your medicine, inject it at about the 
same time each day.  
 
Inject Livogiva each day for as long as your doctor prescribes it for you. The total duration of 
treatment with Livogiva should not exceed 24 months. You should not receive more than one 
treatment course of 24 months over your lifetime.  
 
Your doctor may advise you to use Livogiva with calcium and vitamin D. Your doctor will tell you 
how much you should take each day. 
 
Read the user manual, which is included in the carton for instructions on how to use the Livogiva pen.  
 
Injection needles are not included with the pen. Pen needles 29 to 31 gauge (diameter 0.25-0.33 mm) 
can be used. 



23 

You should use your Livogiva injection shortly after you take the pen out of the refrigerator as 
described in the user manual. Put the pen back into the refrigerator immediately after you have used it.  
Use a new injection needle for each injection and dispose of it after each use. Never store your pen 
with the needle attached. Never share your Livogiva pen with others.  
 
Livogiva can be given with or without food. 
 
If you use more Livogiva than you should 
If, by mistake, you have used more Livogiva than you should, contact your doctor or pharmacist.  
 
The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.  
 
If you forget or cannot take Livogiva at your usual time, use it as soon as possible on that day. Do 
not use a double dose to make up for a forgotten dose. Do not use more than one injection in the same 
day. Do not try to make up for a missed dose.  
 
If you stop taking Livogiva 
If you are considering stopping Livogiva treatment, please discuss this with your doctor. Your doctor 
will advise you and decide how long you should be treated with Livogiva.  
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The most common side effects are pain in limb (frequency is very common, may affect more than 1 in 
10 people) and feeling sick, headache and dizziness (frequency is common). If you become dizzy 
(light-headed) after your injection, you should sit or lie down until you feel better. If you do not feel 
better, you should call a doctor before you continue treatment. Cases of fainting have been reported in 
association with teriparatide use.  
If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor 
bleeding around the area of the injection (frequency is common), this should clear up in a few days or 
weeks. Otherwise tell your doctor as soon as possible.  
Some patients may have experienced allergic reactions soon after injection, consisting of 
breathlessness, swelling of the face, rash and chest pain (frequency is rare). In rare cases, serious and 
potentially life-threatening allergic reactions including anaphylaxis can occur. 
 
Other side effects include:  
Common: may affect up to 1 in 10 people  
• increase in blood cholesterol levels  
• depression  
• neuralgic pain in the leg  
• feeling faint  
• irregular heart beats  
• breathlessness  
• increased sweating  
• muscle cramps  
• loss of energy  
• tiredness  
• chest pain  
• low blood pressure  
• heartburn (painful or burning sensation just below the breast bone)  
• being sick (vomiting)  
• a hernia of the tube that carries food to your stomach  



24 

• low haemoglobin or red blood cell count (anaemia)  
 

Uncommon: may affect up to 1 in 100 people  
• increased heart rate  
• abnormal heart sound  
• shortness of breath  
• haemorrhoids (piles)  
• accidental loss or leakage of urine  
• increased need to pass water  
• weight increase  
• kidney stones  
• pain in the muscles and pain in the joints. Some patients have experienced severe back cramps 

or pain which lead to hospitalization.  
• increase in blood calcium level  
• increase in blood uric acid level  
• increase in an enzyme called alkaline phosphatase.  
 
Rare: may affect up to 1 in 1,000 people  
• reduced kidney function, including renal failure  
• swelling, mainly in the hands, feet and legs.  
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. 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 Livogiva 
 
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 pen after EXP. The 
expiry date refers to the last day of that month.  
 
Livogiva should be stored in a refrigerator (2°C to 8°C) at all times. You can use Livogiva for up to 28 
days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C).  
 
Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. Do not use 
Livogiva if it is, or has been, frozen.  
 
Each pen should be properly disposed of after 28 days, even if it is not completely empty.  
 
Livogiva contains a clear and colourless solution. Do not use Livogiva if solid particles appear or if 
the solution is cloudy or coloured. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


25 

6. Contents of the pack and other information 
 
What Livogiva contains  
- The active substance is teriparatide. Each milliliter of the solution for injection contains 

250 micrograms of teriparatide. Each pre-filled pen of 2.7 mL contains 675 micrograms of 
teriparatide (corresponding to 250 micrograms per mL). 

- The other ingredients are glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, 
and water for injections. See section 2.  

 
What Livogiva looks like and contents of the pack 
Livogiva is a colourless and clear solution. It is supplied in a cartridge contained in a pre-filled 
disposable pen. Each pen contains 2.7 mL of solution enough for 28 doses. Livogiva is available in 
packs containing one or three pre-filled pens.  
 
Not all pack sizes may be available. 
 
Marketing Authorisation Holder  
Theramex Ireland Limited  
3rd Floor Kilmore House, Park Lane, Spencer Dock  
DO1 YE64 Dublin 1  
Ireland  
 
Manufacturer 
Eurofins PROXY Laboratories (PRX) 
Archimedesweg 25 2333 CM Leiden 
Netherlands 
 
This leaflet was last revised in  
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 



26 

USER MANUAL 
 
Livogiva 20 micrograms/80 microliters solution for injection in pre-filled pen 
 
IMPORTANT INFORMATION 
 
DO NOT start the administration procedure until you have read the Package leaflet and this User 
Manual contained in your Livogiva carton thoroughly. Follow the instructions carefully whenever 
using the Livogiva pen. 
 

Livogiva pen and parts 
Pen needles 29 to 31 gauge (diameter 0.25-0.33 mm) can be used. 
Needles not included. 

 
 
Instructions for use  
 
Prepare for injection 
 

Step 1 
Prepare site  
and remove the  
white cap 

A) Wash your hands before every 
injection. 

B) Prepare the injection site (thigh 
or abdomen) as recommended 
by your doctor or pharmacist. 

C) Remove the white cap by 
pulling it straight off the device 
(Figure B). 

 

 
 



27 

Step 2 
Check pen, pen 
label and 
medicine 
 

A) Check the pen. 
DO NOT use the Livogiva pen 
if it is damaged. 

B) Check the label on the pen. 
DO NOT use if the pen 
contains the incorrect medicine 
or if the medicine has expired 
(Figure C). 

C) Check the medicine cartridge. 
The liquid medication should be 
clear and colourless. 
DO NOT use the medicine if it 
is cloudy, coloured, or has 
floating particles. (Figure C). 

 

 
Step 3 
Attach new 
needle 
 

A) Peel off the paper tab 
(Figure D). 

 

 
 

B) Push needle straight onto 
medicine cartridge (Figure E).  

 
 

Screw on needle clockwise until 
firmly attached (Figure F). 
Do not over-tighten the needle. 

 

 

 
 

 
Step 4 
Remove outer 
needle cover 
 

Pull off large outer needle cover 
(Figure G) and save it for later (see 
Step 9). 
 

 
 

 



28 

Step 5 
Set dose 
 

Pull out the black injection button 
until it stops. (Figure H). 
 
 
 
 
  
Check to make sure red stripe shows. 
Additionally, the instruction window 
will show an arrow pointing towards 
the needle end of the pen (Figure I). 
 

 
Troubleshooting when setting the dose 

 
If the pen does not set fully or if you cannot pull back on the black injection button refer to 
Troubleshooting Problem E. 

 
Administer injection  
 

Step 6 
Remove inner 
needle cover 
 

Pull off small inner needle protector and 
throw it away (Figure J). The needle will 
be exposed. 
 
 

 

 
 

Step 7 
Inject dose 

 
 

 

A) Gently hold a fold of skin on your thigh or 
abdomen and insert the needle straight into 
the folded skin (Figure K). 

       
 

          
 
 



29 

B)   Press the black injection button down until 
it stops and hold (Figure L). 

 

          
 

C)   Hold it in and count to 5 s-l-o-w-l-y to 
make sure the full dose has been 
delivered (Figure M). You may not see 
the black injection button moving. To 
confirm that your dose has been 
delivered, see step 8 “Confirm dose”. 

 
 

     
 

D)   Remove the needle from the skin 
(Figure N). Once needle is removed from 
skin, take your thumb off the black injection 
button. 

  

        

 
After injection 
 

Step 8 
Confirm dose 
 

Check to make sure the black injection 
button is all the way down. The 
instruction window will show an arrow 
pointing TOWARDS the black 
button.  
 
If the yellow shaft does not show, you 
have finished the injection steps the 
right way. (Figure O) 
 

Important 
You should NOT see any of the yellow 
shaft. If you do and have already 

 



30 

injected the medicine, DO NOT inject 
yourself a second time in the same day. 
Instead, you MUST reset the pen. Go 
to Troubleshooting Problem A 

 
Step 9 
Remove needle 
and dispose 
 

 

A) Put the large outer needle 
cover on the needle by 
scooping it up and pressing it 
on (Figure P and Q). Do not 
try to put the needle cover 
back on with your hands.  

 

 

 
 

B) Unscrew the covered needle 
all the way by giving the large 
needle cover 3-5 counter-
clockwise turns. (Figure R) 
 
 
 
Pull the needle straight off. 
(Figure S) 

 

 

 
 

C) Dispose of the needle into a 
puncture resistant container 
according to local regulations 
(Figure T). 
DO NOT reuse needle. 

  
 

Disposal of  needles 
For more information about how to correctly dispose of the needle refer to the Disposal information 
section 

 
Step 10 
Recap pen and 
store 
 

A) Push white cap back on 
(Figure U). 

 

 
 

B) Always store the pen in the 
refrigerator with the white cap 
on after use. (Figure V) 
DO NOT store the pen with a 
needle attached. 
 

 



31 

 
Troubleshooting 

 
Problem 

 
Solution 

A The yellow shaft is still showing 
after pushing in the black injection 
button. How do I reset my Livogiva? 

To reset the Livogiva pen follow the steps below: 
1) If you have already injected, DO NOT inject 
yourself a second time on the same day. Use a new 
needle for your injection on the following day. 
2) Remove the needle.  
3) Attach a new needle, pull off the large needle cover 
and save it. 
4) Pull off the inner needle cover and throw away. 
5) Point the needle down into an empty container. Push 
in the black injection button until it stops. Hold it in 
and slowly count to 5 s-l-o-w-l-y. You may see a small 
stream or drop of fluid. When you have finished, the 
black injection button should be all the way in. 
6) If you still see the yellow shaft showing, do not use 
this pen; contact your doctor or pharmacist.  
7) Put the large needle cover on needle. Unscrew the 
needle all the way by giving the needle cover 3 to 5 
complete turns. Pull off needle cover and throw away 
as directed by your doctor or pharmacist. Push the 
white cap back on, and put your Livogiva in the 
refrigerator. 
 
You can prevent this problem by always using a NEW 
needle for each injection, and by pushing the black 
injection button all the way in and slowly counting 
to 5 s-l-o-w-l-y. 
 

B How can I tell if my Livogiva 
works? 

The Livogiva is designed to inject the full dose every 
time it is used according to the directions in the section 
Instructions for Use.  
The black injection button should be all the way in to 
show that the full dose of medicine has been injected 
from the Livogiva. Use a new needle every time you 
inject to be sure your Livogiva will work properly. 
 

C I see an air bubble in my Livogiva. A small air bubble will not affect your dose and it will 
not harm you. You can continue to use your dose as 
usual. 
 

D I cannot get the needle off. 1) Put the large needle cover on the needle. 
2) Use the large needle cover to unscrew the needle. 
3) Unscrew the needle all the way by giving the large 
needle cover 3 to 5 counter-clockwise turns. 
4) If you still cannot get the needle off, ask someone to 
help you. 
See step 9 “Remove needle and dispose”. 

E What should I do if I cannot pull out 
the black injection button? 

Change to a new Livogiva pen to use your dose as 
instructed by your doctor or pharmacist. 
When the black injection button becomes hard to pull 
out, this means there is not enough medicine in your 
Livogiva pen for another dose. You may still see some 
medicine left in the cartridge. 



32 

 
Cleaning and storage 

Cleaning your Livogiva pen 
• Wipe the outside of the Livogiva with a damp cloth. 
• Do not place the Livogiva in water, or wash or clean it with any liquid. 

 
Storing your Livogiva pen 

• Read and follow the instructions in the Information for the Patient leaflet on how to store 
your pen. 

• DO NOT store the Livogiva with a needle attached. Doing this may affect the sterility of 
the medicine during subsequent injections. 

• Store the Livogiva with the white cap on. 
If the Livogiva has been left out of the refrigerator, do not throw the pen away. Place the 
pen back in the refrigerator and contact your doctor or pharmacist. 

 
Disposal information 

Disposal of pen needles and Livogiva pen  
• Before disposing of the Livogiva pen, be sure to remove the pen needle.  
• Put used needles in a sharps container or a hard-plastic container with a secure lid. Do not 

throw needles directly into your household waste.  
• Do not recycle the filled sharps container.  

 
Other important notes 

• DO NOT transfer the medicine into a syringe.  
• During injection, you may hear one or more clicks – this is normal pen operation 
• The Livogiva is not recommended for use by the blind or visually impaired persons without 

the assistance from a person trained in the proper use of the pen. 
 
This user manual was last revised in: 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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continuing nausea, vomiting, constipation, low energy, or muscle weakness. these may be signs there is too much calcium in your blood. if you suffer from kidney stones or have a history of kidney stones. if you suffer from kidney problems (moderate renal impairment). some patients get dizzy or get a fast heartbeat after the first few doses. for the first doses, inject livogiva where you can sit or lie down right away if you get dizzy. the recommended treatment time of 24 months should not be exceeded. livogiva should not be used in growing adults. children and adolescents livogiva should not be used in children and adolescents (less than 18 years). other medicines and livogiva tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease). pregnancy and breast-feeding do not use livogiva if you are pregnant or breast-feeding. if you are a woman of child-bearing potential, you should use effective methods of contraception during use of livogiva. if you become pregnant, livogiva should be discontinued. ask your doctor or pharmacist for advice before taking any medicine. driving and using machines some patients may feel dizzy after injecting livogiva. if you feel dizzy you should not drive or use machines until you feel better livogiva contains sodium this medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium- free'.", 'Entity_Recognition': [{'Text': 'livogiva', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 13, 'BeginOffset': 11, 'EndOffset': 19, 'Score': 0.8541128039360046, 'Text': 'livogiva', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.7687454223632812}]}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 31, 'EndOffset': 39}, {'Id': 14, 'BeginOffset': 43, 'EndOffset': 55, 'Score': 0.9703284502029419, 'Text': 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{'Title': '3. how to use livogiva', 'Section_Content': 'always use this medicine exactly as your doctor has told you to. check with your doctor or pharmacist if you are not sure. the recommended dose is 20 micrograms given once daily by injection under the skin (subcutaneous injection) in the thigh or abdomen. to help you remember to use your medicine, inject it at about the same time each day. inject livogiva each day for as long as your doctor prescribes it for you. the total duration of treatment with livogiva should not exceed 24 months. you should not receive more than one treatment course of 24 months over your lifetime. your doctor may advise you to use livogiva with calcium and vitamin d. your doctor will tell you how much you should take each day. read the user manual, which is included in the carton for instructions on how to use the livogiva pen. injection needles are not included with the pen. pen needles 29 to 31 gauge (diameter 0.25-0.33 mm) can be used. you should use your livogiva injection shortly after you take the pen out of the refrigerator as described in the user manual. put the pen back into the refrigerator immediately after you have used it. use a new injection needle for each injection and dispose of it after each use. never store your pen with the needle attached. never share your livogiva pen with others. livogiva can be given with or without food. if you use more livogiva than you should if, by mistake, you have used more livogiva than you should, contact your doctor or pharmacist. the effects of overdose that might be expected include nausea, vomiting, dizziness, and headache. if you forget or cannot take livogiva at your usual time, use it as soon as possible on that day. do not use a double dose to make up for a forgotten dose. do not use more than one injection in the same day. do not try to make up for a missed dose. if you stop taking livogiva if you are considering stopping livogiva treatment, please discuss this with your doctor. your doctor will advise you and decide how long you should be treated with livogiva. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'livogiva', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 11, 'EndOffset': 24}, {'Text': '20', 'Type': 'NUMBER', 'BeginOffset': 147, 'EndOffset': 149}, {'Text': 'the skin (subcutaneous injection', 'Type': 'TREATMENT', 'BeginOffset': 197, 'EndOffset': 229}, {'Id': 1, 'BeginOffset': 238, 'EndOffset': 243, 'Score': 0.9706858396530151, 'Text': 'thigh', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 2, 'BeginOffset': 247, 'EndOffset': 254, 'Score': 0.9789519309997559, 'Text': 'abdomen', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'your medicine', 'Type': 'TREATMENT', 'BeginOffset': 284, 'EndOffset': 297}, {'Id': 9, 'BeginOffset': 349, 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. the most common side effects are pain in limb (frequency is very common, may affect more than 1 in 10 people) and feeling sick, headache and dizziness (frequency is common). if you become dizzy (light-headed) after your injection, you should sit or lie down until you feel better. if you do not feel better, you should call a doctor before you continue treatment. cases of fainting have been reported in association with teriparatide use. if you experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection (frequency is common), this should clear up in a few days or weeks. otherwise tell your doctor as soon as possible. some patients may have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain (frequency is rare). in rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis can occur. other side effects include: common: may affect up to 1 in 10 people increase in blood cholesterol levels depression neuralgic pain in the leg feeling faint irregular heart beats breathlessness increased sweating muscle cramps loss of energy tiredness chest pain low blood pressure heartburn (painful or burning sensation just below the breast bone) being sick (vomiting) a hernia of the tube that carries food to your stomach 24 low haemoglobin or red blood cell count (anaemia) uncommon: may affect up to 1 in 100 people increased heart rate abnormal heart sound shortness of breath haemorrhoids (piles) accidental loss or leakage of urine increased need to pass water weight increase kidney stones pain in the muscles and pain in the joints. some patients have experienced severe back cramps or pain which lead to hospitalization. increase in blood calcium level increase in blood uric acid level increase in an enzyme called alkaline phosphatase. rare: may affect up to 1 in 1,000 people reduced kidney function, including renal failure swelling, mainly in the hands, feet and legs. reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'livogiva', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 21, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9657886028289795, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 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{'Title': '5. how to store livogiva', '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 pen after exp. the expiry date refers to the last day of that month. livogiva should be stored in a refrigerator (2 to 8) at all times. you can use livogiva for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2 to 8). avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. do not use livogiva if it is, or has been, frozen. each pen should be properly disposed of after 28 days, even if it is not completely empty. livogiva contains a clear and colourless solution. do not use livogiva if solid particles appear or if the solution is cloudy or coloured. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help to protect the environment.', 'Entity_Recognition': [{'Text': 'livogiva', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': 'livogiva', 'Type': 'TREATMENT', 'BeginOffset': 209, 'EndOffset': 217}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 259, 'EndOffset': 260}, {'Text': 'livogiva', 'Type': 'TREATMENT', 'BeginOffset': 288, 'EndOffset': 296}, {'Text': '28', 'Type': 'NUMBER', 'BeginOffset': 307, 'EndOffset': 309}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 395, 'EndOffset': 396}, {'Text': 'the pens', 'Type': 'TREATMENT', 'BeginOffset': 413, 'EndOffset': 421}, {'Text': 'the refrigerator', 'Type': 'TREATMENT', 'BeginOffset': 454, 'EndOffset': 470}, {'Text': 'freezing', 'Type': 'PROBLEM', 'BeginOffset': 482, 'EndOffset': 490}, {'Text': 'livogiva', 'Type': 'TREATMENT', 'BeginOffset': 503, 'EndOffset': 511}, {'Text': '28', 'Type': 'NUMBER', 'BeginOffset': 589, 'EndOffset': 591}, {'Text': 'livogiva', 'Type': 'TREATMENT', 'BeginOffset': 634, 'EndOffset': 642}, {'Text': 'a clear and colourless solution', 'Type': 'TREATMENT', 'BeginOffset': 652, 'EndOffset': 683}, {'Text': 'livogiva', 'Type': 'TREATMENT', 'BeginOffset': 696, 'EndOffset': 704}, {'Text': 'solid particles', 'Type': 'PROBLEM', 'BeginOffset': 708, 'EndOffset': 723}, {'Text': 'cloudy', 'Type': 'PROBLEM', 'BeginOffset': 753, 'EndOffset': 759}, {'Text': 'these measures', 'Type': 'TREATMENT', 'BeginOffset': 907, 'EndOffset': 921}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what livogiva contains - the active substance is teriparatide. each milliliter of the solution for injection contains 250 micrograms of teriparatide. each pre-filled pen of 2.7 ml contains 675 micrograms of teriparatide (corresponding to 250 micrograms per ml). - the other ingredients are glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, and water for injections. see section 2. what livogiva looks like and contents of the pack livogiva is a colourless and clear solution. it is supplied in a cartridge contained in a pre-filled disposable pen. each pen contains 2.7 ml of solution enough for 28 doses. livogiva is available in packs containing one or three pre-filled pens. not all pack sizes may be available.', 'Entity_Recognition': [{'Text': 'livogiva', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 49, 'EndOffset': 61, 'Score': 0.9937361478805542, 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