Forsteo

1 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

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1. NAME OF THE MEDICINAL PRODUCT 
 
FORSTEO 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*. 
One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 
250 micrograms per mL).  
 
*Teriparatide, rhPTH(1-34), produced in E. coli, 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 
 
FORSTEO 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 has 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 FORSTEO is 20 micrograms administered once daily. 
 
The maximum total duration of treatment with FORSTEO should be 24 months (see section 4.4). The 
24-month course of FORSTEO 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 FORSTEO therapy, patients may be continued on other osteoporosis therapies. 
 
Special populations 
Patients with renal impairment 
FORSTEO must not be used in patients with severe renal impairment (see section 4.3.). In patients 
with moderate renal impairment, FORSTEO should be used with caution. No special caution is 
required for patients with mild renal impairment. 
 



 

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Patients with hepatic impairment 
No data are available in patients with impaired hepatic function (see section 5.3). Therefore, 
FORSTEO should be used with caution. 
 
Paediatric population and young adults with open epiphyses 
The safety and efficacy of FORSTEO in children and adolescents less than 18 years has not been 
established. FORSTEO should not be used in paediatric patients (less than 18 years), or young adults 
with open epiphyses. 
 
Elderly patients 
Dosage adjustment based on age is not required (see section 5.2). 
 
Method of administration 
FORSTEO 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). A user manual is also 
available to instruct patients 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 glucorticoid-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 
 
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 FORSTEO injection. Routine calcium monitoring during therapy is not required. 
 
FORSTEO 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. 
 
Urolithiasis 
FORSTEO has not been studied in patients with active urolithiasis. FORSTEO 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 FORSTEO, 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.  
 



 

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Renal impairment 
Caution should be exercised in patients with moderate renal impairment. 
 
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 
FORSTEO. If pregnancy occurs, FORSTEO 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. 
 
4.5 Interactions with other medicinal products and other forms of interaction 
 
In a study of 15 healthy subjects administered digoxin daily to steady state, a single FORSTEO dose 
did not alter the cardiac effect of digoxin. However, sporadic case reports have suggested that 
hypercalcaemia may predispose patients to digitalis toxicity. Because FORSTEO transiently increases 
serum calcium, FORSTEO should be used with caution in patients taking digitalis. 
 
FORSTEO has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide. No 
clinically significant interactions were noted. 
 
Co-administration of raloxifene or hormone replacement therapy with FORSTEO did not alter the 
effects of FORSTEO 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 
FORSTEO.  If pregnancy occurs, FORSTEO should be discontinued.   
 
Pregnancy  
FORSTEO is contraindicated for use during pregnancy (see section 4.3). 
 
Breast-feeding 
FORSTEO is contraindicated for use during breast-feeding. 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 
 
FORSTEO 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. 
 



 

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4.8 Undesirable effects  
 

Summary of the safety profile 
The most commonly reported adverse reactions in patients treated with FORSTEO are nausea, pain in 
limb, headache and dizziness.   
 
Tabulated list of adverse reactions 
Of patients in the teriparatide trials, 82.8 % of the FORSTEO 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). 
 
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 
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).  



 

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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. 
 
FORSTEO increases serum uric acid concentrations.  In clinical trials, 2.8 % of FORSTEO 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. 
 
In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8 % of women 
receiving FORSTEO.  Generally, antibodies were first detected following 12 months of treatment and 
diminished after withdrawal of therapy.  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 
FORSTEO 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 medication 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 FORSTEO. Treatment of suspected overdose should include 
transitory discontinuation of FORSTEO, monitoring of serum calcium, and implementation of 
appropriate supportive measures, such as hydration. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmaco-therapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: 
H05 AA02. 
 
Mechanism of action  
Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and 
phosphate metabolism in bone and kidney. FORSTEO (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 



 

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absorption of calcium and increasing the tubular re-absorption of calcium and excretion of phosphate 
by the kidney.  
 
Pharmacodynamic effects 
FORSTEO is a bone formation agent to treat osteoporosis. The skeletal effects of FORSTEO depend 
upon the pattern of systemic exposure. Once-daily administration of FORSTEO increases apposition 
of new bone on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic 
activity over osteoclastic activity.  
 
Clinical efficacy 
 
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 1637 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 1000 mg calcium per day and at 
least 400 IU vitamin D per day. Results from up to 24 months (median: 19 months) treatment with 
FORSTEO 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 1 
 

Fracture Incidence in Postmenopausal Women:  
 

 Placebo 
(N = 544) (%) 

FORSTEO 
(N = 541) (%) 

Relative risk  
(95% CI)  

vs. placebo 
New vertebral 
fracture (≥1) a 

14.3 5.0 b 0.35 
(0.22, 0.55) 

Multiple vertebral 
fractures (≥2) a 

4.9 1.1 b 0.23 
(0.09, 0.60) 

Non-vertebral 
fragility fractures c 

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. 
 

 a The incidence of vertebral fractures was assessed in 448 placebo and 444 Forsteo patients who had baseline and follow-up 
spine radiographs. 
 b p≤0.001 compared with placebo 
c A significant reduction in the incidence of hip fractures has not been demonstrated 
d p≤0.025 compared with placebo. 
 
 



 

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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 FORSTEO, 1262 postmenopausal women from 
the pivotal trial enrolled in a post-treatment follow-up study. The primary objective of the study was to 
collect safety data of FORSTEO. 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 FORSTEO, 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 
FORSTEO 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, randomized, double-blind, comparator-controlled Phase 4 study included 1,360 
postmenopausal women with established osteoporosis. 680 subjects were randomised to Forsteo 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 1433 IU/day (1400 IU/day) and for the 
risedronate arm was 1191 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 Forsteo- 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 Forsteo 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 1000 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 FORSTEO 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 1000 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 



 

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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.  
 
Sixty-nine percent of patients completed the 18-month primary phase.  At the 18 month endpoint, 
FORSTEO significantly increased lumbar spine BMD (7.2 %) compared with alendronate (3.4 %) 
(p<0.001). FORSTEO 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 FORSTEO patients 
showed that 13 patients in the alendronate group (7.7 %) had experienced a new vertebral fracture 
compared with 3 patients in the FORSTEO 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 FORSTEO group (7.5 %) (p=0.84). 
 
In premenopausal women, the increase in BMD from baseline to 18 month endpoint was significantly 
greater in the FORSTEO 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 FORSTEO is approximately 1 
hour when administered subcutaneously, which reflects the time required for absorption from the 
injection site.  
 
Biostransformation 
No metabolism or excretion studies have been performed with FORSTEO but the peripheral 
metabolism of parathyroid hormone is believed to occur predominantly in liver and kidney. 
 
Elimination 
FORSTEO is eliminated through hepatic and extra-hepatic clearance (approximately 62 L/hr in women 
and 94 L/hr in men). 
 
Elderly  
No differences in FORSTEO 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 1000 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 (anhydrous) 
Mannitol 
Metacresol  
Hydrochloric acid (for pH adjustment) 
Sodium hydroxide (for pH adjustment) 
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 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 should be returned to the refrigerator 
immediately after use. Do not freeze. 
 
Do not store the injection device with the needle attached. 
 
6.5 Nature and contents of container 
 
2.4 mL solution in cartridge (siliconised Type I glass) with a plunger (halobutyl rubber), disc seal 
(polyisoprene/bromobutyl rubber laminate)/aluminium assembled into a disposable pen. 
 
FORSTEO is available in pack sizes of 1 or 3 pens. Each pen contains 28 doses of 20 micrograms (per 
80 microliters).  
 
Not all pack sizes may be marketed. 
 



 

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6.6 Special precautions for disposal 
 
FORSTEO is supplied in a pre-filled pen. Each pen should be used by only one patient. A new, sterile 
needle must be used for every injection. Each FORSTEO pack is provided with a user manual that 
fully describes the use of the pen. No needles are supplied with the product. The device can be used 
with insulin pen injection needles. After each injection, the FORSTEO pen should be returned to the 
refrigerator. 
 
FORSTEO should not be used if the solution is cloudy, coloured or contains particles. 
 
Please also refer to the user manual for instructions on how to use the pen. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands  
 
 
8. MARKETING AUTHORISATION NUMBERS  
 
EU/1/03/247/001-002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 10 June 2003 
Date of the latest renewal: 13 February 2013 
 
 
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 



 

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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 
 
Boehringer-Ingelheim RCV GmbH & Co KG, Dr.-Boehringer-Gasse 5-11, 1121 Vienna, Austria  
 
Name and address of the manufacturer responsible for batch release 
 
Lilly France S.A.S., rue du colonel Lilly, 67640 Fegersheim, France 
 
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 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal.  
 
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.  

 



 

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ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 

 
 



 

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A. LABELLING 



 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
FORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen 
Teriparatide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each mL contains 250 micrograms of teriparatide. 
 
 
3. LIST OF EXCIPIENTS 
 
Glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, water for injections. 
Hydrochloric acid solution and/or sodium hydroxide solution (for pH adjustment). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
1 pen of 2.4 mL solution. 
3 pens of 2.4 mL solution each. 
 
Each 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 here and pull. 
 
 
8. EXPIRY DATE 
 
EXP  
The pen should be discarded 28 days after the first use. 
Date of first use: 
 



 

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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 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/03/247/001 
EU/1/03/247/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
FORSTEO 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
FORSTEO 20 micrograms/80 microliters, injection 
Teriparatide 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot  
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2.4 mL 
 
 
6. OTHER 
 
Store in a refrigerator 
 



 

 19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
B. PACKAGE LEAFLET 



 

 20 

Package leaflet: Information for the user 
 

FORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen 
Teriparatide 

 
 

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 FORSTEO is and what it is used for 
2. What you need to know before you use FORSTEO 
3. How to use FORSTEO 
4. Possible side effects 
5 How to store FORSTEO 
6. Content of the pack and other information 
 
1. What FORSTEO is and what it is used for 
 
FORSTEO contains the active substance teriparatide that is used to make the bones stronger, and to 
reduce the risk of fractures by stimulating bone formation. 
 
FORSTEO 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 FORSTEO 
 
Do not use FORSTEO  
• 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 
 
FORSTEO may cause an increase in the amount of calcium in your blood or urine. 
 



 

 21 

Talk to your doctor or pharmacist before or while using FORSTEO:  
 

• 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 
FORSTEO where you can sit or lie down right away if you get dizzy. 
The recommended treatment time of 24 months should not be exceeded. 
 
FORSTEO should not be used in growing adults. 
 
Children and adolescents 
FORSTEO should not be used in children and adolescents (less than 18 years). 
 
Other medicines and FORSTEO 
Please 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 FORSTEO 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 FORSTEO.  If you become 
pregnant, FORSTEO 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 FORSTEO. If you feel dizzy you should not drive or use 
machines until you feel better. 
 
FORSTEO 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 FORSTEO 
 
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 take your medicine, inject it at about the 
same time each day. 
 
Inject FORSTEO each day for as long as your doctor prescribes it for you. The total duration of 
treatment with FORSTEO should not exceed 24 months. You should not receive more than one 
treatment course of 24 months over your lifetime. 
FORSTEO can be injected at meal times. 
 
Read the user manual booklet, which is included in the carton for instructions on how to use the 
FORSTEO pen.  
 
Injection needles are not included with the pen. Becton, Dickinson and Company pen needles can be 
used. 
 



 

 22 

You should take your FORSTEO 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 FORSTEO pen with others. 
 
Your doctor may advise you to take FORSTEO with calcium and vitamin D. Your doctor will tell you 
how much you should take each day.  
 
FORSTEO can be given with or without food. 
 
If you use more FORSTEO than you should 
If, by mistake, you have used more FORSTEO 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 FORSTEO at your usual time, take it as soon as possible on that day. 
Do not take a double dose to make up for a forgotten dose. Do not take more than one injection in the 
same day. Do not try to make up for a missed dose. 
 
If you stop taking FORSTEO 
If you are considering stopping FORSTEO treatment, please discuss this with your doctor. Your 
doctor will advise you and decide how long you should be treated with FORSTEO. 
 
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  



 

 23 

• heartburn (painful or burning sensation just below the breast bone)  
• being sick(vomiting) 
• a hernia of the tube that carries food to your stomach  
• 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 hospitalisation. 
• 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 FORSTEO 
 
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. 
 
FORSTEO should be stored in a refrigerator (2°C to 8°C) at all times. You can use FORSTEO for up 
to 28 days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C). 
 
Do not freeze FORSTEO. Avoid placing the pens close to the ice compartment of the refrigerator to 
prevent freezing. Do not use FORSTEO if it is, or has been, frozen. 
 
Each pen should be properly disposed of after 28 days, even if it is not completely empty. 
 
FORSTEO contains a clear and colourless solution. Do not use FORSTEO 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. 
 
 



 

 24 

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

250 micrograms of teriparatide. 
- The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, 

and water for injections. In addition, hydrochloric acid and/or sodium hydroxide solution may 
have been added for pH adjustment. 

 
What FORSTEO looks like and contents of the pack 
FORSTEO is a colourless and clear solution. It is supplied in a cartridge contained in a pre-filled 
disposable pen. Each pen contains 2.4 mL of solution enough for 28 doses. The pens are available in 
cartons containing one or three pens. Not all pack sizes may be available. 
 
Marketing Authorisation Holder  
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands 
 
Manufacturer 
Lilly France S.A.S, Rue du Colonel Lilly, F-67640 Fegersheim, France. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32 (0) 2 548 84 84 

Lietuva 
Eli Lilly Lietuva 
Tel: + 370 (5) 2649600 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
Тел: + 359 2 491 41 40 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32 (0) 2 548 84 84  

Česká republika 
Eli Lilly ČR, s.r.o. 
Tel: + 420 234 664 111 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S 
Tlf: + 45 45 26 60 00 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel: + 49 (0) 6172 273 2222 

Nederland 
Eli Lilly Nederland B.V. 
Tel: + 31(0) 30 6025800 

Eesti 
Eli Lilly Nederland B.V.   
Tel: +372 6 817 280 

Norge 
Eli Lilly Norge A.S 
Tlf: + 47 22 88 18 00 

Ελλάδa 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. 
Τηλ: + 30 210 629 4600 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43 (0) 1 711 780 

España 
  Valquifarma, S.A.U.  
  Tel: + 34-91 623 1732 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: + 48 22 440 33 00 

France 
Lilly France SAS 
Tél: + 33 (0) 1 55 49 34 34 

Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351 21 412 66 00 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353 (0) 1 661 4377 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: + 386 (0) 1 580 00 10 

  



 

 25 

Ísland 
Icepharma hf. 
Sími: + 354 540 8000 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39 055 42571 

Suomi/Finland 
Oy Eli Lilly Finland Ab 
Puh/Tel: + 358 (0) 9 8545 250 

Κύπρος 
Phadisco Ltd  
Τηλ: + 357 22 715000 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46 (0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: + 
371 67364000 

United Kingdom 
Eli Lilly and Company Limited 
Tel: +44 (0) 1256 315000 

 
 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency web site. 
 



 

 26 

PEN USER MANUAL 
 
Forsteo 
FORSTEO 20 micrograms (µg)/ 80 microlitres solution for injection, in pre-filled pen 
 
Instructions for use 
 
Before you use your new pen, please read the section Instructions for use completely.  Follow the 
directions carefully when using the pen. 
Also read the package leaflet provided. 
 
Do not share your pen or your needles as this may risk transmission of infectious agents. 
 
 
Your pen contains 28 days of medicine. 
 
Forsteo parts* 
   

 
 
 
 
 
 
* Needles not included.  
Becton, Dickinson and 
Company pen needles can be 
used. Ask your doctor or 
pharmacist which needle 
gauge and length are best for 
you.  
 

 Yellow Shaft 
Black 
Injection 
button  
 Red Stripe      Blue Body   Medicine Cartridge   White Cap        
  
 Paper Tab   Needle                         Large Needle Cover 
 

                     
                               Small Needle Protector 

 
 
Always wash your hands before every injection.  Prepare the injection site as directed by your 
doctor or pharmacist. 
 
1 

Pull off white cap           

 

 
2 
Attach new 
needle    

 
 Pull off paper  

tab. 
Push needle straight 
onto medicine cartridge. 

Screw on needle 
until firmly attached. 

Pull off large 
needle cover 
and save it. 

 
 



 

 27 

3 
Set 
dose 

 

 

Red  
stripe 

 
 
Small 
needle 
protector 

 

 Pull out black 
injection  
button until it stops.   
 
If you cannot pull out 
the black injection 
button see 
Troubleshooting, 
Problem E. 

Check to 
make sure 
red stripe 
shows. 

  Pull off small 
needle 
protector and throw 
away. 

 
4 
Inject dose 

  
 Gently hold a fold of skin from thigh or 

abdomen and insert needle straight 
into skin. 

Push in black injection button until  
it stops.  Hold it in and count to 5 
s-l-o-w-l-y.  Then pull the needle 
from skin. 

 
                                                   IMPORTANT 
5 
Confirm 
dose 

 

After 
completing the 
injection: 
Once the needle 
is removed from 
the skin, check 
to make sure the 
black injection 
button is all the 
way in.  If the 
yellow shaft 
does not show, 
you have 
completed the 
injection steps 
correctly. 

 

You should NOT see any of 
the yellow shaft.  If you do 
and have already injected, do 
not inject yourself a second 
time on the same day.  
Instead, you MUST reset 
FORSTEO (see 
Troubleshooting Problem A).   

 



 

 28 

 
6 
Remove 
needle 

    
 Put large needle 

cover on needle. 
Unscrew the needle 
all the way by 
giving the large 
needle cover 3 to 5 
complete turns. 

Pull off needle and 
throw away as directed 
by your doctor or 
pharmacist. 

Push white cap back 
on. Place FORSTEO 
in the refrigerator 
immediately after 
use. 
 
 

The directions regarding needle handling are not intended to replace local, healthcare professional or 
institutional policies.  
 
 

 

Forsteo 
FORSTEO, 20 microgram (µg) 80 microlitres solution 
for injection, in pre-filled pen 
 
Troubleshooting 

Problem   Solution 
A.  The yellow shaft is 
still showing after I push 
in the black injection 
button.  How do I reset 
my FORSTEO? 

               

 
 

To reset the FORSTEO, follow the steps below. 
1) If you have already injected, DO NOT 

inject yourself a second time on the same 
day.  

2) Remove the needle. 
3) Attach a new needle, pull off the large needle 

cover and save it. 
4) Pull out the black injection button until it 

stops.  Check to make sure the red stripe 
shows. 

5) Pull off the small needle protector and throw 
away. 

6) Point the needle down into an empty 
container.  Push in the black injection button 
until it stops.  Hold it in and 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. 

7) If you still see the yellow shaft showing, 
please contact your doctor or pharmacist  

8) 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 place FORSTEO 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 counting 
to 5 s-l-o-w-l-y. 

   
B.  How can I tell if my 
FORSTEO works? 

 The FORSTEO is designed to inject the full dose 
every time it is used according to the directions in the 



 

 29 

section Instructions for Use.  The black injection 
button will be all the way in to show that the full dose 
has been injected from the FORSTEO.   
 
Remember to use a new needle every time you inject 
to be sure your FORSTEO will work properly. 

   
C.  I see an air bubble in 
my FORSTEO. 

 A small air bubble will not affect your dose nor will it 
harm you.  You can continue to take 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 complete turns. 
4) If you still cannot get the needle off, ask 

someone to help you. 
 
E.  What should I do if I 
cannot pull out the 
black injection button? 

 Change to a new FORSTEO to take your dose as 
directed by your doctor or pharmacist. 
 
This indicates that you have now used all the medicine 
that can be injected accurately even though you may 
still see some medicine left in the cartridge. 
 
 

 
 Cleaning and Storage 
Cleaning Your FORSTEO 

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

 
Storing Your FORSTEO 

• Refrigerate the FORSTEO immediately after every use.  Read and follow the instructions in 
the Information for the Patient leaflet on how to store your pen. 

• Do not store the FORSTEO with a needle attached as this may cause air bubbles to form in the 
cartridge. 

• Store the FORSTEO with the white cap on.  
• Never store the FORSTEO in the freezer. 
• If the medicine has been frozen, throw the device away and use a new FORSTEO. 
• If the FORSTEO 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 of Pen Needles and Device 

Disposal of Pen Needles and FORSTEO Device 
• Before disposing of the FORSTEO device, 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. 
• Ask your healthcare professional about options to dispose of the pen and the sharps container 

properly. 
• The directions regarding needle handling are not intended to replace local, healthcare 

professional or institutional policies. 
• Dispose of the device 28 days after first use. 



 

 30 

 
 

 
Other Important Notes 

• The FORSTEO contains 28 days of medicine. 
• Do not transfer the medicine into a syringe. 
• Write down your first injection date on a calendar. 
• Read and follow the instructions in the Information for the Patient leaflet for using the 

product. 
• Check the FORSTEO label to make sure you have the correct medicine. and that it has not 

expired. 
• Contact your doctor or pharmacist if you notice any of the following: 

- The FORSTEO appears damaged 
- The solution is NOT clear, colourless and free of particles 

• Use a new needle for each injection. 
• During injection, you may hear one or more clicks – this is a normal device operation. 
• The FORSTEO is not recommended for use by the blind or visually impaired persons without 

the assistance of a person trained in the proper use of the device. 
• Keep the FORSTEO out of the sight and reach of children. 
 

 
 
Manufactured by Lilly France, F-67640 Fegersheim, France 
for Eli Lilly and Company. 
This user manual was last revised in {MM/YYYY} 
 
 
 


	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