Terrosa

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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 
 
Terrosa 20 micrograms/80 microliters solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each dose of 80 microliters contains 20 micrograms of teriparatide*. 
 
One cartridge of 2.4 mL of solution 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 for injection with a pH of 3.8 – 4.5. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Terrosa 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 
 

The recommended dose of Terrosa is 20 micrograms administered once daily. 
Posology 

 
Patients should receive supplemental calcium and vitamin D supplements if dietary intake is 
inadequate. 
 
The maximum total duration of treatment with teriparatide should be 24 months (see section 4.4). The 
24-month course of teriparatide should not be repeated over a patient’s lifetime. 
 
Following cessation of teriparatide therapy, patients may be continued on other osteoporosis therapies. 
 
Special populations 



 

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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. 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. 
 
Elderly 
Dosage adjustment based on age is not required (see section 5.2). 
 

Terrosa should be administered once daily by subcutaneous injection in the thigh or abdomen. 
Method of administration 

 
It should be administered exclusively with the Terrosa Pen reusable, multidose medicine delivery 
system and the injection needles which are listed as compatible in the instructions which are provided 
with the pen. The pen and injection needles are not included with Terrosa. However, for the treatment 
initiation a cartridge and pen pack should be used containing one carton of Terrosa cartridge and one 
carton of Terrosa Pen. Terrosa must not be used with any other pen. 
Patients must be trained to use the proper injection techniques (see section 6.6). An instruction for use 
which is included in the carton of the delivery system is also available to instruct patients on the 
correct use of the pen. 
 
The date of first injection should also be written on the outer carton of Terrosa (see the provided space 
on the box: {First use:}). 
 
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 
 

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 teriparatide injection. Routine calcium monitoring during therapy is not required. 

Serum and urine calcium 

 
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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Teriparatide has not been studied in patients with active urolithiasis. Teriparatide should be used with 
caution in patients with active or recent urolithiasis because of the potential to exacerbate this 
condition. 

Urolithiasis 

 

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. 

Orthostatic hypotension 

 

Caution should be exercised in patients with moderate renal impairment. 
Renal impairment 

 

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. 

Younger adult population 

 
Women of childbearing potential should use effective methods of contraception during use of 
teriparatide. If pregnancy occurs, teriparatide should be discontinued. 
 

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. 

Duration of treatment 

 

Batch (Lot) number of each cartridge and the date of its first injection should be recorded by the 
patient on a calendar. 

Documentation 

 

This medicinal product contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say 
essentially “sodium-free”. 

Excipient 

 
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, teriparatide 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 should use effective methods of contraception during use of 
teriparatide. If pregnancy occurs, Terrosa should be discontinued. 

Women of childbearing potential / Contraception in females 

 

Terrosa is contraindicated for use during pregnancy (see section 4.3). 
Pregnancy 



 

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Terrosa is contraindicated for use during breast-feeding. It is not known whether teriparatide is 
excreted in human milk. 

Breast-feeding 

 

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. 

Fertility 

 
4.7 Effects on ability to drive and use machines 
 
Teriparatide 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 
 

The most commonly reported adverse reactions in patients treated with teriparatide are nausea, pain in 
limb, headache and dizziness. 

Summary of the safety profile 

 

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. 

Tabulated list of adverse reactions 

 
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), and rare (≥1/10,000 to 
<1/1,000). 
 
Organ System 
Class 

Very common 
 

Common 
 

Uncommon 
 

Rare 
 

Blood and 
lymphatic system 
disorders 

 Anaemia   

Immune system 
disorders 

   Anaphylaxis  

Metabolism and 
nutrition 
disorders 

 Hypercholesterol-
aemia 

Hypercalcaemia 
greater than 
2.76 mmol/L, 
hyperuricaemia  

Hypercalcaemia 
greater than 
3.25 mmol/L 

Psychiatric 
disorders 

 Depression    

Nervous system 
disorders 

 Dizziness, 
headache, 
sciatica, syncope 

  

Ear and labyrinth 
disorders  

 Vertigo    

Cardiac disorders  Palpitations Tachycardia  

Vascular 
disorders 

 Hypotension   



 

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Organ System 
Class 

Very common 
 

Common 
 

Uncommon 
 

Rare 
 

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Dyspnoea Emphysema  

Gastrointestinal 
disorders 

 Nausea, vomiting, 
hiatus hernia, 
gastro-
oesophageal 
reflux disease  

Haemorrhoids  

Skin and 
subcutaneous 
tissue disorders 

 Sweating 
increased  

  

Musculoskeletal 
and connective 
tissue disorders 

Pain in limb  Muscle cramps  Myalgia, 
arthralgia, back 
cramp/pain* 

 

Renal and 
urinary disorders  

  Urinary 
incontinence, 
polyuria, 
micturition 
urgency, 
nephrolithiasis 

Renal 
failure/impairment 

General disorders 
and 
administration 
site condition 

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

Injection site 
erythema, 
injection site 
reaction 

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

Investigations  
 

  Weight increased, 
cardiac murmur, 
alkaline 
phosphatase 
increased  

 

*Serious cases of back cramp or pain have been reported within minutes of the injection. 
 

In clinical trials the following reactions were reported at a ≥1% difference in frequency from placebo: 
vertigo, nausea, pain in limb, dizziness, depression, dyspnoea. 

Description of selected adverse reactions 

 
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 hyperuricaemia 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 teriparatide. 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 



 

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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 
 

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. 

Signs and symptoms 

The effects of overdose that might be expected include delayed hypercalcaemia and risk of orthostatic 
hypotension. Nausea, vomiting, dizziness, and headache can also occur. 
 

In post-marketing spontaneous reports, there have been cases of medication error where the entire 
contents (up to 800 micrograms) of a 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 experience based on post-marketing spontaneous reports 

 

There is no specific antidote for teriparatide. Treatment of suspected overdose should include 
transitory discontinuation of teriparatide, monitoring of serum calcium, and implementation of 
appropriate supportive measures, such as hydration. 

Overdose management 

 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: 
H05AA02 
 
Terrosa is a biosimilar medicinal product. Detailed information is available on the website of the 
European Medicines Agency http://www.ema.europa.eu. 
 

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 
absorption of calcium and increasing the tubular re-absorption of calcium and excretion of phosphate 
by the kidney. 

Mechanism of action 

 

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. 

Pharmacodynamic effects 

 

Risk factors 
Clinical efficacy 

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 

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


 

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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 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 
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 1 

Fracture incidence in postmenopausal women 
 
 Placebo 

(N = 544) (%) 
Teriparatide 

(N = 541) (%) 
Relative risk (95% CI) 

vs. placebo 
New vertebral 
fracture (≥1) a 

14.3 5.0 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 teriparatide 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. 
 
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 
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, randomized, double-blind, comparator-controlled Phase 4 study included 1,360 
postmenopausal women with established osteoporosis. 680 subjects were randomised to teriparatide 



 

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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 
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 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 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 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 
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, 
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 month 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. 



 

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5.2 Pharmacokinetic properties 
 

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. 

Distribution 

 

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. 

Biotransformation 

 

Teriparatide is eliminated through hepatic and extra-hepatic clearance (approximately 62 L/hr in 
women and 94 L/hr in men). 

Elimination 

 

No differences in teriparatide pharmacokinetics were detected with regard to age (range 31 to 85 
years). Dosage adjustment based on age is not required. 

Elderly 

 
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 micrograms/kg. However, foetal resorption and reduced litter 
size occurred in pregnant rabbits administered daily doses of 3 to 100 micrograms/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 
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 
Mannitol 
Metacresol 
Sodium acetate trihydrate 
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. 



 

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6.3 Shelf life 
 
2 years. 
 
Chemical in-use stability has been demonstrated for 28 days at 2 – 8 °C. 
From a microbiological point of view, once opened, the product may be stored for a maximum of 
28 days within its shelf life 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). After insertion of the cartridge into the pen, the combined pen and 
cartridge should be returned to the refrigerator immediately after use. 
Do not freeze. Keep the cartridge in the outer carton in order to protect from light. 
 
Do not store the injection device with the needle attached. Do not remove the cartridge from the pen 
after first use. 
 
For storage conditions after first opening of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
3 mL cartridge (siliconised Type I glass), with a plunger stopper (bromobutyl) and disc seal 
(aluminium and rubber liner seals), packed in a plastic tray sealed with lid foil and packed in a carton. 
 
Each cartridge contains 2.4 mL of solution corresponding to 28 doses of 20 micrograms (per 
80 microliters). 
Pack sizes:  
Terrosa 20 micrograms/80 microliters solution for injection: 
1 or 3 cartridges. 
 
Terrosa cartridge and pen pack: 
1 carton of Terrosa cartridge (containing 1 cartridge) and 1 carton of Terrosa Pen (containing 1 pen). 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Terrosa is supplied in a cartridge. Terrosa cartridges are to be used in Terrosa Pen reusable, multidose 
pen device exclusively and must not be used with any other pen. No needles are supplied with this 
medicinal product. 
Each cartridge and pen should be used by only one patient. The pen can be used with compatible pen 
needles. These are listed in the instruction for use for the pen. A new, sterile pen needle must be used 
for every injection. 
 
The expiry date on the cartridge label must always be checked before inserting the cartridge into 
Terrosa Pen. To avoid medication errors make sure that the date when starting to use a new cartridge 
is at least 28 days before its expiry date. 
 
Before using the pen device for the first time, the patient should read and understand the instructions 
on how to use the pen which are provided with the pen. 
 
After each injection, the pen should be returned to the refrigerator. After the first use, the cartridge 
should not be removed from the pen during the 28 days of usage. 
Terrosa must not be transferred to a syringe. 
Empty cartridges must not be refilled. 



 

12 

 
Terrosa should not be used if the solution is cloudy, coloured or contains visible particles. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Gedeon Richter Plc. 
Gyömrői út 19-21. 
1103 Budapest 
Hungary 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1159/001 [1 cartridge] 
EU/1/16/1159/002 [3 cartridges] 
EU/1/16/1159/003 [cartridge and pen pack] 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 04 January 2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this product 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 

Richter-Helm BioLogics GmbH & Co. KG 
Dengelsberg 
24796 Bovenau 
GERMANY 
 

 
Name and address of the manufacturer responsible for batch release 

Gedeon Richter Plc. 
Gyömrői út 19-21  
1103 Budapest 
HUNGARY 
 
 
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.  



 

15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 

16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 

17 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING   
 
OUTER CARTON FOR CARTRIDGE AND PEN PACK 
 
1. NAME OF THE MEDICINAL PRODUCT  
 
Terrosa 20 micrograms/80 microliters solution for injection  
teriparatide  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S)  
 
Each dose of 80 microliters contains 20 micrograms of teriparatide. 
Each cartridge contains 28 doses of 20 micrograms (per 80 microliters). 
 
 
3. LIST OF EXCIPIENTS  
 
Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, water for injections, hydrochloric 
acid (for pH adjustment) and sodium hydroxide (for pH adjustment). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS  
 
Solution for injection 
 
1 Terrosa cartridge  
1 Terrosa Pen 
 
Not to be sold separately. 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION  
 
The cartridge and pen pack should be used for treatment initiation. Do not remove the cartridge from 
the pen during the 28 days of use. 
 
Read both the package leaflet of Terrosa cartridge and the instructions for use of the Terrosa Pen 
before use. 
Subcutaneous use. 
 
QR code to be included 

 
www.terrosapatient.com 

 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT  
OF THE SIGHT AND REACH OF CHILDREN  
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY  
 
 
 
8. EXPIRY DATE  

http://www.terrosapatient.com/�


 

18 

 
EXP: 
 
 
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  
 
  

Gedeon Richter Plc. 
Gyömrői út 19-21. 
1103 Budapest 
Hungary 

 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1159/003    [cartridge and pen pack] 
 
 
13. BATCH NUMBER  
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY  
 
 
15. INSTRUCTIONS ON USE  
 
 
16. INFORMATION IN BRAILLE  
 
Terrosa cartridge and pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



 

19 

 



 

20 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING   
 
OUTER CARTON FOR CARTRIDGE 
 
1. NAME OF THE MEDICINAL PRODUCT  
 
Terrosa 20 micrograms/80 microliters solution for injection 
teriparatide  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S)  
 
Each dose of 80 microliters contains 20 micrograms of teriparatide. 
Each cartridge contains 28 doses of 20 micrograms (per 80 microliters). 
 
 
3. LIST OF EXCIPIENTS  
 
Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, water for injections, hydrochloric 
acid (for pH adjustment) and sodium hydroxide (for pH adjustment). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS  
 
Solution for injection 
 
1 cartridge 
3 cartridges 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION  
 
Use only with Terrosa Pen. 
Read the package leaflet before use. 
Subcutaneous use. 
 
QR code to be included 

 
www.terrosapatient.com 

 
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  
 
Do not remove the cartridge from the pen during the 28 days of use. 
 
 
8. EXPIRY DATE  
 

http://www.terrosapatient.com/�


 

21 

EXP   
 
Discard the cartridge 28 days after the first use. 
 
First use: 1. ......................./2. ......................../3. ........................{the grey-shaded text refers to the 3x 
pack size} 
 
9. SPECIAL STORAGE CONDITIONS  
 
Store in a refrigerator. 
Do not freeze. 
Keep the cartridge in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS  
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF  
APPROPRIATE  
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER  
 
Gedeon Richter Plc. 
Gyömrői út 19-21. 
1103 Budapest 
Hungary 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/16/1159/001 [1 cartridge]  
EU/1/16/1159/002 [3 cartridges]  
 
{Displayed in case of 1x and 3x cartridges only. Not applicable in case of cartridge and pen pack.} 
 
13. BATCH NUMBER  
 
Lot  
 
  
14. GENERAL CLASSIFICATION FOR SUPPLY  
 
 
15. INSTRUCTIONS ON USE  
 
 
 
16. INFORMATION IN BRAILLE  
 
Terrosa cartridge 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 



 

22 

{Not applicable in case of cartridge and pen pack.} 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
{Not applicable in case of cartridge and pen pack.} 
 



 

23 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS  
 
LID FOIL 
 
1. NAME OF THE MEDICINAL PRODUCT  
 
Terrosa 20 micrograms/80 microliters solution for injection 
teriparatide  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER  
 
Gedeon Richter Plc. 
 
 
3. EXPIRY DATE  
 
EXP  
 
 
4. BATCH NUMBER  
 
Lot  
 
 
5. OTHER  
 
Subcutaneous use {1x} 
SC   {3x} 
 
Store in a refrigerator. 
 



 

24 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS  
 
LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION  
 
Terrosa 20 mcg/80 mcL injection  
teriparatide 
 
SC  
 
 
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   
 
 



 

25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 

26 

Package leaflet: Information for the user 
 

Terrosa 20 micrograms/80 microliters solution for injection 
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 Terrosa is and what it is used for 
2. What you need to know before you use Terrosa 
3. How to use Terrosa 
4. Possible side effects 
5 How to store Terrosa 
6. Contents of the pack and other information 
 
 
1. What Terrosa is and what it is used for 
 
Terrosa contains the active substance teriparatide that is used to make the bones stronger, and to 
reduce the risk of fractures by stimulating bone formation. 
 
Terrosa 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 medicines called corticosteroids. 
 
 
2. What you need to know before you use Terrosa 
 
Do not use Terrosa: 
• if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in 

section 6). 
• if you have high levels of calcium in your blood (hypercalcaemia). 
• if you suffer from serious kidney problems. 
• if you have ever had bone cancer or if other cancers 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. 
 
Warning and precautions 
Terrosa may increase calcium in your blood or urine. 
Talk to your doctor before or while using Terrosa: 
• if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These 



 

27 

may be signs there is too much calcium in your blood. 
• if you suffer from kidney stones or have had 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 of Terrosa. For the first doses, 
inject Terrosa in a place where you can sit or lie down right away if you get dizzy. 
 
The recommended treatment time of 24 months should not be exceeded. 
 
Before inserting a cartridge in Terrosa Pen write down the batch (Lot) number of the cartridge and its 
first injection date on a calendar. The date of first injection should also be recorded on the outer carton 
of Terrosa (see the provided space on the box: {First use:}) (see section 3.). 
 
Terrosa should not be used in growing adults. 
 
Children and adolescents 
Terrosa should not be used in children and adolescents (aged less than 18 years). 
 
Other medicines and Terrosa 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
This is important, because some medicines (e.g. digoxin/digitalis, a medicine used to treat heart 
disease) may interact with teriparatide. 
 
Pregnancy and breast-feeding 
Do not use Terrosa 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 Terrosa. If you become 
pregnant while using Terrosa, Terrosa 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 Terrosa. If you feel dizzy you should not drive or use 
machines until you feel better. 
 
Terrosa contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 
“sodium-free”. 
 
 
3. How to use Terrosa 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. 
 
The recommended dose is 20 micrograms (corresponding to 80 microliters) given once a day 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. Terrosa can be 
injected at meal times. Inject Terrosa each day for as long as your doctor prescribes it for you. The 
total duration of treatment with Terrosa 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 take Terrosa with calcium and vitamin D. Your doctor will tell you 
how much you should take each day. 
 
Terrosa can be given with or without food. 
 
Terrosa cartridges are designed to be used only with the Terrosa Pen reusable, multidose delivery 
system and compatible pen needles. The pen and injection needles are not included with Terrosa. 
However, for treatment initiation a cartridge and pen pack should be used containing one carton of 



 

28 

Terrosa cartridge and one carton of Terrosa Pen. 
 
Before the first use, insert the cartridge into the pen. For the correct use of this medicine it is very 
important to closely follow the detailed Instructions for Use of your pen which are provided with the 
pen. 
 
Use a new injection needle for each injection to prevent contamination and safely dispose of the 
needle after use. 
Never store your pen with the needle attached. 
Never share your pen with others. 
Do not use your Terrosa Pen to inject any other medicine (e.g. insulin). 
The pen is customised for use with Terrosa only. 
Do not refill the cartridge. 
Do not transfer the medicine into a syringe. 
 
You should inject Terrosa shortly after you take the pen with inserted cartridge out of the refrigerator. 
Put the pen with inserted cartridge back into the refrigerator immediately after you have used it. Do 
not remove the cartridge from the pen after each use. Store it in the cartridge sleeve during the whole 
28-day treatment period. 
 
Preparing the pen for use 
- To ensure the correct administration of Terrosa always read the Instructions for Use of Terrosa 

Pen, which is included in the carton of the pen. 
- Wash your hands before handling the cartridge or pen. 
- Check the expiry date on the cartridge label before inserting the cartridge into the pen. Make 

sure that there are at least 28 days remaining before its expiry date. Insert the cartridge into the 
pen before the first use as detailed in the pen instructions. Write down the batch (Lot) number of 
each cartridge and its first injection date on a calendar. The date of first injection should also be 
recorded on the outer carton of Terrosa (see the provided space on the box: {First use:}). 

- After inserting a new cartridge and before the first injection from this cartridge prime the pen 
according to the instructions which are provided. Do not prime again after the first dose. 

 
Injecting Terrosa 
- Before you inject Terrosa, clean your skin where you intend to inject (thigh or abdomen) as 

instructed by your doctor. 
- Gently hold a fold of cleansed skin and insert the needle straight into the skin. Press the push 

button and hold it pressed in until the dose indication has returned to the start position. 
- After your injection, leave the needle in the skin for six seconds to make sure that you receive 

the whole dose. 
- As soon as you have finished the injection, attach the outer needle protective cap on the pen 

needle and screw the cap anti-clockwise to remove the pen needle. This will keep the remaining 
Terrosa sterile and prevent leaking from the pen. It will also stop air going back into the 
cartridge and the needle from clogging. 

- Replace the cap on your pen. Leave the cartridge in the pen. 
 
If you use more Terrosa than you should 
If, by mistake, you have used more Terrosa than you should, contact your doctor or pharmacist. 
The expected effects of overdose include nausea, vomiting, dizziness, and headache. 
 
If you forget to use Terrosa 
If you forget an injection or cannot use your medicine at your usual time, inject it as soon as possible 
on that day. Do not use a double dose to make up for a forgotten dose. Do not take more than one 
injection in the same day. 
 
If you stop using Terrosa 
If you are considering stopping Terrosa treatment, please discuss this with your doctor. Your doctor 
will advise you and decide how long you should be treated with Terrosa. 



 

29 

 
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 (which may affect more than 1 in 10 people). Other 
common side effects (affecting up to 1 in 10 people) include feeling sick, headache and dizziness. 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 occured after teriparatide use. 
 
If you have discomfort around the area of the injection such as redness of the skin, pain, swelling, 
itching, bruising or minor bleeding (which can occur in up to 1 in 10 people), this should clear up in a 
few days or weeks. Otherwise tell your doctor. 
 
Rarely, patients may suffer allergic reactions consisting of breathlessness, swelling of the face, rash 
and chest pain. These reactions usually occur soon after injection. 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 
• nerve pain in the leg 
• feeling faint 
• spinning sensation 
• irregular heartbeats 
• breathlessness 
• increased sweating 
• muscle cramps 
• loss of energy 
• tiredness 
• chest pain 
• low blood pressure 
• heartburn (painful or burning sensation just below the breast bone) 
• vomiting 
• a hernia of the tube that carries food to your stomach (hiatus hernia) 
• 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 
• piles (haemorrhoids) 
• leakage of urine 
• increased need to pass water 
• weight increase 
• kidney stones 
• pain in the muscles and pain in the joints. Some patients have had severe back cramps or pain 

which led to admission into hospital. 
• increase in blood calcium level 
• increase in blood uric acid level 
• increase in an enzyme called alkaline phosphatase. 
 



 

30 

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 Terrosa 
 
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 the cartridge after 
EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2 °C – 8 °C). Do not freeze. 
Keep the cartridge in the outer carton in order to protect from light. 
 
You can use Terrosa for up to 28 days after the first injection, as long as the cartridge/pen with the 
cartridge inserted is stored in a refrigerator (2 °C to 8 °C). 
 
Avoid placing the cartridge close to the ice compartment of the refrigerator to prevent freezing. Do not 
use Terrosa if it is, or has been, frozen. 
 
Each cartridge should be properly disposed of after 28 days of first use, even if it is not completely 
empty. 
 
Terrosa contains a clear and colourless solution. Do not use Terrosa 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 protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Terrosa contains 
- The active substance is teriparatide. Each dose of 80 microliters contains 20 micrograms of 

teriparatide. One cartridge of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 
250 micrograms per mL). 

- The other ingredients are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, 
hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for 
injections. 

 
What Terrosa looks like and contents of the pack 
Terrosa is a colourless and clear solution. It is supplied in a cartridge. Each cartridge contains 2.4 mL 
of solution, enough for 28 doses. 
 
Terrosa 20 micrograms/80 microliters solution for injection: 1 or 3 cartridge(s) packed in a plastic tray 
sealed with lid foil and packed in a carton. 
Terrosa cartridge and pen pack: 1 Terrosa cartridge packed in a plastic tray sealed with lid foil and 
packed in a carton and 1 Terrosa Pen packed into a separate carton. 
 
Not all pack sizes may be marketed. 

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


 

31 

 
Marketing Authorisation Holder and Manufacturer 
Gedeon Richter Plc. 
Gyömrői út 19-21. 
1103 Budapest 
Hungary 
 
This leaflet was last revised in 
 
 
Other sources of information 
 
Detailed and updated information on this product is available by scanning the QR code included below 
or the outer carton with a smartphone.The same information is also available on the following URL: 
www.terrosapatient.com 
 
QR code to be included 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 

 
http://www.ema.europa.eu 

http://www.terrosapatient.com/�
http://www.ema.europa.eu/�


 

32 

 
Instructions for use  
Terrosa Pen 
 
 
Always follow instructions provided below and on the back page when using the Terrosa Pen. 
 
Terrosa Pen parts 

 
push button; display window; threaded rod; flange; Terrosa cartridge; peel foil; pen needle; inner 
needle cap; outer needle cap; pen cap; cartridge holder, dosage knob, housing 
 
Pen preparation - First use/changing cartridges 
Follow the instructions every time you insert a new Terrosa cartridge into your Terrosa Pen. Do not 
repeat this before each daily injection, otherwise you will not have enough Terrosa for 28 days. 
Read the patient information leaflet for Terrosa cartridge provided separately. 
A: Remove the pen cap. 

 
B: Remove the cartridge holder by turning it (bayonet coupling).  



 

33 

 
C: Remove the empty cartridge, in the case of changing cartridge. Insert a new Terrosa cartridge into 
the cartridge holder, with the metal crimped cap of the cartridge first. 

 
Write down the first injection date of each new cartridge. This helps you to know when the 28 daily 
doses per cartridge are used.  
D: Push back the threaded rod carefully with your finger, in a straight line and as far as it will go. This 
is not necessary when the rod is already in the starting position, such as at the very first use. The 
threaded rod cannot be pushed back to the pen housing entirely. 

 
E: Attach the cartridge holder to the housing by turning it 90 degrees, until it stops. 

 
F: Attach a new pen needle as follows:  
• Pull off the peel foil. 

  



 

34 

• Screw the pen needle clockwise onto the cartridge holder. Make sure that the pen needle is attached 
correctly and sits firmly on the cartridge holder. 

 
• Remove the outer needle cap and save it. 

 
• Remove and dispose the inner needle cap. 

 
While attaching the needle some drops may escape, this is normal. 
 
G: Priming 
The pen must be primed and tested after inserting a new cartridge and prior the first injection from 
each cartridge. 
• Turn the dose knob clockwise until you see a droplet sign on the dose display. Make sure that the 
two indicator stripes are aligned. During dose dialling the pen provides an audible clicking sound and 
a noticeable resistance. 

 
• Hold the pen with the needle pointing upwards. 
• Press the push button fully in. Hold it pressed in until the dose indication has turned back to the start 
position. Some drops of medicine must be expelled from the needle tip. 
If no drops emerge, repeat step G until you see some drops. Do not repeat step G more than four times, 
but follow the instructions given under Troubleshooting section on the back page.  
 



 

35 

 
Administration using the Terrosa Pen 
Wash your hands carefully with soap to minimise the risk of infection. 
Make sure you have ready: 
• your Terrosa Pen with inserted cartridge 
• a compatible pen needle 
• a puncture-resistant sharps disposal container for used needles. 
Do not use the pen if the cartridge is cloudy, discoloured or contains particles. 
Read the patient information leaflet for Terrosa cartridge provided separately. 
 
1. Attach the pen needle 
Use a new needle for every injection. Do not use the pen needle if the packaging is damaged or not 
opened by yourself. 
Note: There is no need to change the needle when using directly after the pen preparation. In this case 
continue with step “2. Setting the dose and injection”. 
• Pull off the peel foil. 

 
• Screw the pen needle clockwise onto the cartridge holder. Make sure that the pen needle is attached 
correctly and sits firmly on the cartridge holder. 

 
• Remove the outer needle cap and save it. 

 
• Remove and dispose the inner needle cap. 



 

36 

 
While attaching the needle some drops may escape, this is normal. 
 
2. Setting the dose and injection 
Warning: Ensure the use of the correct drug liquid. Check the label of the cartridge before its 
insertion into the cartridge holder. 
• To set the fixed daily dose of 80 microliters, turn the dose knob clockwise until it stops and cannot 
be rotated any further. Make sure the display shows an arrow sign and the two indicator stripes are 
aligned. During dose dialling the pen provides an audible clicking sound and a noticeable resistance. 
Do not try to force the dose knob any further. 

 
Note: If the cartridge contains less than 80 microliters, the dose knob cannot be turned clockwise up to 
the arrow sign. In this case, remove the pen needle, change the cartridge and proceed with priming 
according the pen preparation steps. 
• Select an appropriate injection site and prepare your skin as recommended by your doctor. Gently 
hold a skin fold between the thumb and index finger. Insert the needle straight and gently into the skin, 
as shown in the illustration. 

 
Warning: Prevent the pen needle from bending or breaking. Do not tilt the pen after the needle has 
been inserted into the skin. Tilting the pen may result in bending or breaking of the needle. Broken 
needles can get stuck in the skin. Immediately consult the doctor if a broken needle gets stuck in the 
skin. 
• Press the push button until the dose indication has returned to the start position. Keep the needle in 
the skin fold for a further 6 seconds. 



 

37 

 
 
• Pull out the pen slowly. Check if the display is at the start position to make sure that the full dose has 
been injected. 
 

 
 
3. Removing the pen needle 
• Carefully attach the outer needle cap on the pen needle. 

 
• Screw the needle cap anti-clockwise to remove the pen needle. Dispose of it correctly, for example, 
in a puncture-resistant sharps disposal container. 

 
 
4. Re-attach pen cap 
• Do not remove the cartridge from the Terrosa Pen before it is empty. 
• Re-attach the pen cap after each use. 



 

38 

 
• Put the Terrosa Pen, with the cartridge inserted, back into the refrigerator between 2 and 8 °C 
immediately after use. 
Note for healthcare professionals 
Local, healthcare professional or institutional policies may replace the instructions regarding needle 
handling and disposal. 
 
Additional information 
The reusable fixed dose pen is designed for easy administration of Terrosa to treat osteoporosis. Each 
Terrosa cartridge contains 28 doses of fixed 80 microlitres Terrosa.  
Use your Terrosa Pen only as prescribed by your doctor, in this instructions for use and the Terrosa 
package leaflet. 
The Terrosa Pen can be used by self-injecting patients above the age of 18 years, healthcare 
professionals or third parties such as, for instance, adult relatives. 
The Terrosa Pen must not be used by blind or visually impaired patients without help from a trained 
able-bodied person. Consult your doctor in the case of hearing or handling problems. 
If you have any questions concerning the use of the Terrosa Pen, contact our customer service at any 
time. 
telephone number: XXXXXXXXXXX 
e-mail: XXXXXXXXXXX 
 
Compatible pen needles 
• Ypsomed mylifeClickfine 29 to 31 gauge (diameter 0.25 – 0.33 mm) and 12, 10, 8 or 6 mm length 
• BD Micro-Fine Ultraneedles 29 to 31 gauge (diameter 0.25 – 0.33 mm) and 12.7, 8 or 5 mm length 
Pen needles from other manufacturers can be used according to their stated compatibility details. 
The pen needles must be used only once and the Terrosa cartridge must be used by one person only. 
 
Storage and care of Terrosa Pen 
• Handle your pen with care. Do not drop your pen and avoid knocking it against hard surfaces. 
Protect it from water, dust and moisture.  
• A damp cloth is sufficient to clean the Terrosa Pen. Do not use alcohol, other solvents or cleaning 
agents. Never immerse the Terrosa Pen in water, as this could damage the pen. 
• Do not use your Terrosa Pen if it is damaged or if you have any doubts about its correct functioning. 
• Transport and store the Terrosa Pen with inserted cartridge at temperatures specified in the Terrosa 
package leaflet, provided separately. 
• Store your Terrosa Pen, cartridges and pen needles out of reach of children. 
• Do not store the Terrosa Pen with a needle attached as this may cause air bubbles to form in the 
cartridge. 
 
Disposal of Terrosa Pen and used accessories 
The Terrosa Pen has a service life of two years. Before disposing of the Terrosa Pen always remove 
the pen needle and the cartridge. Needles and used cartridges must be disposed of separately and 
safely. The Terrosa Pen can be disposed of according to the instructions of the local authorities.  
 
 



 

39 

Follow the instructions presented in this instructions for use. If the instructions are not followed, there 
are risks of incorrect medication, inaccurate dosage, disease transmission or infection. Seek immediate 
medical advice if you have any health concern. 

Warnings 

 
Warranty 
The warranty covers manufacturing and material defects of your Terrosa Pen for two years of use, 
from purchase. It is limited to replacement of the pen. The warranty does not cover damages caused 
by: 
• using cartridges other than Terrosa cartridges 
• improper or careless use, handling or cleaning 
• use contrary to the instructions for use  
• the pen being used with a medical device, accessories or consumables other than those recommended 
by Gedeon Richter Plc. 
• dropping, impact, application of force, contact with fluids 
• other cases of exposure and wear, not in accordance with the instructions for use. 
 
Troubleshooting 
Follow the instructions given in the table if you have any questions regarding the use of Terrosa Pen: 
 
Question Answer 
1. Small air bubbles are visible in the cartridge. A small air bubble will not affect the dose, or 

harm. 
2. Needle cannot be attached. Use another needle instead. Contact customer 

service if the second needle cannot be attached. 
3. Needle is broken/curved/kinked. Use another needle instead. 
4. During dose dialling the pen does not provide 
an audible signal. 

Do not use this pen; contact customer service. 

  
5. No medicine comes out of the needle during 
pen preparation step “G: Priming”. 

Change the needle and repeat the priming as 
described in pen preparation sections “F” and 
“G”. 
If still no medicine is expelled, do not use this 
pen; contact customer service. 

6. The dose knob cannot be turned clockwise up 
to the arrow sign. 

The amount of Terrosa left in the cartridge is 
less than 80 microlitres. Change the cartridge 
and the pen needle and perform priming 
according to the pen preparation. 

7. Display does not return to start position after 
injection. 

Do not repeat the injection on the same day. 
Use a new needle for your injection on the 
following day. 
Set the dose and complete the injection as 
described in section “2. Setting the dose and 
injection”. 
If the display still does not return to start 
position after injection, do not use this pen; 
contact customer service. 

8. Spillage from pen is observed. Do not use this pen; contact customer service. 
9. The dose knob inadvertently turned clockwise 
after completing the injection. 
How do I reset the dose knob to the start 
position? 

Do not press the push button. Reset the pen by 
simply turning back the dose knob anti-
clockwise to the start position. 

 
Distributor: 
Gedeon Richter Plc. 
Gyömrői út 19-21. 
1103 Budapest, Hungary 



 

40 

 
Legal manufacturer: 
Ypsomed AG 
Brunnmattstrasse 6 
3401 Burgdorf, Switzerland 
 
 
 


	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