Qutavina

1

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

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

1. NAME OF THE MEDICINAL PRODUCT

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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Each pre-filled pen of 2.7 mL contains 675 micrograms of teriparatide (corresponding to
250 micrograms per mL).

*Teriparatide, rhPTH(1-34), produced in P. fluorescens, using recombinant DNA technology, is
identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Colourless, clear solution.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Qutavina is indicated in adults.

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see
section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-
vertebral fractures but not hip fractures have been demonstrated.

Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and
men at increased risk for fracture (see section 5.1).

4.2 Posology and method of administration

Posology

The recommended dose of Qutavina is 20 micrograms administered once daily.

The maximum total duration of treatment with Qutavina should be 24 months (see section 4.4).
The 24-month course of Qutavina 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 Qutavina therapy, patients may be continued on other osteoporosis therapies.

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Special populations

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

Renal impairment
Teriparatide must not be used in patients with severe renal impairment (see section 4.3). In patients
with moderate renal impairment, teriparatide should be used with caution (see section 4.4). No special
caution is required for patients with mild renal impairment.

Hepatic impairment
No data are available in patients with impaired hepatic function (see section 5.3). Therefore,
teriparatide should be used with caution.

Paediatric population and young adults with open epiphyses
The safety and efficacy of teriparatide in children and adolescents less than 18 years have not been
established. Teriparatide should not be used in paediatric patients (less than 18 years), or young adults
with open epiphyses.

Method of administration

Qutavina should be administered once daily by subcutaneous injection in the thigh or abdomen.

Patients must be trained to use the proper injection techniques (see section 6.6).
Please also refer to the user manual for instructions on the correct use of the pen.

4.3 Contraindications

 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
 Pregnancy and breast-feeding (see sections 4.4 and 4.6)
 Pre-existing hypercalcaemia
 Severe renal impairment
 Metabolic bone diseases (including hyperparathyroidism and Paget’s disease of the bone) other

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

teriparatide.

4.4 Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number
of the administered product should be clearly recorded.

Serum and urine calcium

In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been
observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4
and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Therefore, if blood
samples for serum calcium measurements are taken, this should be done at least 16 hours after the
most recent Qutavina injection. Routine calcium monitoring during therapy is not required.

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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.

Urolithiasis

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

Orthostatic hypotension

In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension
were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within
a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the
first several doses, was relieved by placing subjects in a reclining position, and did not preclude
continued treatment.

Renal impairment

Caution should be exercised in patients with moderate renal impairment (see section 4.2).

Younger adult population

Experience in the younger adult population, including premenopausal women, is limited (see
Section 5.1). Treatment should only be initiated if the benefit clearly outweighs risks in this
population.

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

Duration of treatment

Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of
teriparatide (see section 5.3). Until further clinical data become available, the recommended treatment
time of 24 months should not be exceeded.

Excipients

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially
‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

In a study of 15 healthy subjects administered digoxin daily to steady state, a single teriparatide dose
did not alter the cardiac effect of digoxin. However, sporadic case reports have suggested that
hypercalcaemia may predispose patients to digitalis toxicity. Because teriparatide transiently increases
serum calcium, Qutavina 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

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Women of childbearing potential/Contraception in females

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

Pregnancy

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

Breast-feeding

Qutavina is contraindicated for use during breast-feeding (see section 4.3). It is not known whether
teriparatide is excreted in human milk.

Fertility

Studies in rabbits have shown reproductive toxicity (see section 5.3). The effect of teriparatide on
human foetal development has not been studied. The potential risk for humans is unknown.

4.7 Effects on ability to drive and use machines

Qutavina has no or negligible influence on the ability to drive and use machines. Transient, orthostatic
hypotension or dizziness was observed in some patients. These patients should refrain from driving or
the use of machines until symptoms have subsided.

4.8 Undesirable effects

Summary of the safety profile

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

Tabulated list of adverse reactions

Of patients in the teriparatide trials, 82.8% of the teriparatide patients and 84.5% of the placebo
patients reported at least 1 adverse event.

The adverse reactions associated with the use of teriparatide in osteoporosis clinical trials and post-
marketing exposure are summarised in the table below.

The following convention has been used for the classification of the adverse reactions: very common
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
very rare (<1/10,000).

Table 1. Adverse reactions
MedDRA system organ class Frequency Adverse reactions

Blood and lymphatic system disorders Common Anaemia

Immune system disorder Rare Anaphylaxis

Metabolism and nutrition disorders Common Hypercholesterolaemia

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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).

Investigations Uncommon Weight increased, cardiac murmur,
alkaline phosphatase increase

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

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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.

Teriparatide increases serum uric acid concentrations. In clinical trials, 2.8% of teriparatide patients
had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo
patients. However, the hyperuricemia did not result in an increase in gout, arthralgia, or urolithiasis.

Anti-drug antibodies were observed in line with other teriparatide containing medicinal products.
There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or
effects on Bone Mineral Density (BMD) response.

Reporting of suspected adverse reactions

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

4.9 Overdose

Signs and symptoms

Teriparatide has been administered in single doses of up to 100 micrograms and in repeated doses of
up to 60 micrograms/day for 6 weeks.

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

Overdose experience based on post-marketing spontaneous reports

In post-marketing spontaneous reports, there have been cases of medicinal product error where the
entire contents (up to 800 mcg) of the teriparatide pen have been administered as a single dose.
Transient events reported have included nausea, weakness/lethargy and hypotension. In some cases,
no adverse events occurred as a result of the overdose. No fatalities associated with overdose have
been reported.

Overdose management

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

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code:
H05AA02.

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

Mechanism of action

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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.

Pharmacodynamic effects

Teriparatide is a bone formation agent to treat osteoporosis. The skeletal effects of teriparatide depend
upon the pattern of systemic exposure. Once-daily administration of teriparatide increases apposition
of new bone on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic
activity over osteoclastic activity.

Clinical efficacy and safety

Risk factors

Independent risk factors, for example, low BMD, age, the existence of previous fracture, family
history of hip fractures, high bone turnover and low body mass index should be considered in order to
identify women and men at increased risk of osteoporotic fractures who could benefit from treatment.

Premenopausal women with glucocorticoid-induced osteoporosis should be considered at high risk for
fracture if they have a prevalent fracture or a combination of risk factors that place them at high risk
for fracture (e.g., low bone density [e.g., T score ≤−2], sustained high dose glucocorticoid therapy
[e.g., ≥7.5 mg/day for at least 6 months], high underlying disease activity, low sex steroid levels).

Postmenopausal osteoporosis

The pivotal study included 1,637 postmenopausal women (mean age 69.5 years). At baseline, ninety
percent of the patients had one or more vertebral fractures, and on average, vertebral BMD was
0.82 g/cm2 (equivalent to a T score = - 2.6). All patients were offered 1,000 mg calcium per day and at
least 400 IU vitamin D per day. Results from up to 24 months (median: 19 months) treatment with
teriparatide demonstrate statistically significant fracture reduction (Table 1). To prevent one or more
new vertebral fractures, 11 women had to be treated for a median of 19 months.

Table 2. Fracture incidence in postmenopausal women
Placebo

(N = 544) (%)
Teriparatide

(N = 541) (%)
Relative risk

(95% CI)
vs. placebo

New vertebral fracture (≥1)a 14.3 5.0b 0.35
(0.22, 0.55)

Multiple vertebral fractures (≥2)a 4.9 1.1b 0.23
(0.09, 0.60)

Non-vertebral fragility fracturesc 5.5% 2.6%d 0.47
(0.25, 0.87)

Major non-vertebral fragility fracturesc

(hip, radius, humerus, ribs and pelvis)
3.9% 1.5%d 0.38

(0.17, 0.86)
Abbreviations: N = number of patients randomly assigned to each treatment group; CI = Confidence Interval.
aThe incidence of vertebral fractures was assessed in 448 placebo and 444 teriparatide patients who had baseline and follow-
up spine radiographs.
bp≤0.001 compared with placebo
cA significant reduction in the incidence of hip fractures has not been demonstrated
dp≤0.025 compared with placebo.

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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 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, randomised, double-blind, comparator-controlled Phase 4 study included 1,360
postmenopausal women with established osteoporosis. 680 subjects were randomised to teriparatide
and 680 subjects were randomised to oral risedronate 35 mg/week. At baseline, the women had a mean
age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received
previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study. 1,013
(74.5%) patients completed the 24-month follow-up. The mean (median) cumulative dose of
glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate
arm. The mean (median) vitamin D intake for the teriparatide arm was 1,433 IU/day (1,400 IU/day)
and for the risedronate arm was 1,191 IU/day (900 IU/day). For those subjects who had baseline and
follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in
teriparatide- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-
0.68), P<0.0001. The cumulative incidence of pooled clinical fractures (clinical vertebral and non-
vertebral fractures) was 4.8% in teriparatide and 9.8% in risedronate-treated patients, hazard ratio
(95% CI) = 0.48 (0.32-0.74), P=0.0009

Male osteoporosis

437 patients (mean age 58.7 years) were enrolled in a clinical trial for men with hypogonadal (defined
as low morning free testosterone or an elevated FSH or LH) or idiopathic osteoporosis. Baseline spinal
and femoral neck bone mineral density mean T-scores were -2.2 and -2.1, respectively. At baseline,
35% of patients had a vertebral fracture and 59% had a non-vertebral fracture.

All patients were offered 1,000 mg calcium per day and at least 400 IU vitamin D per day. Lumbar
spine BMD significantly increased by 3 months. After 12 months, BMD had increased in the lumbar
spine and total hip by 5% and 1%, respectively, compared with placebo. However, no significant
effect on fracture rates was demonstrated.

Glucocorticoid-induced osteoporosis

The efficacy of teriparatide in men and women (N=428) receiving sustained systemic glucocorticoid
therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18-
month primary phase of a 36 month, randomised, double-blind, comparator-controlled study
(alendronate 10 mg/day). Twenty-eight percent of patients had one or more radiographic vertebral
fractures at baseline. All patients were offered 1,000 mg calcium per day and 800 IU vitamin D per
day.

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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 months endpoint was significantly
greater in the teriparatide group compared with the alendronate group at the lumbar spine (4.2% versus
−1.9%; p<0.001) and total hip (3.8% versus 0.9%; p=0.005). However, no significant effect on
fracture rates was demonstrated.

5.2 Pharmacokinetic properties

Distribution

The volume of distribution is approximately 1.7 L/kg. The half-life of teriparatide is approximately 1
hour when administered subcutaneously, which reflects the time required for absorption from the
injection site.

Biotransformation

No metabolism or excretion studies have been performed with teriparatide but the peripheral
metabolism of parathyroid hormone is believed to occur predominantly in liver and kidney.

Elimination

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

Elderly

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

5.3 Preclinical safety data

Teriparatide was not genotoxic in a standard battery of tests. It produced no teratogenic effects in rats,
mice or rabbits. There were no important effects observed in pregnant rats or mice administered
teriparatide at daily doses of 30 to 1,000 μg/kg. However, fetal resorption and reduced litter size
occurred in pregnant rabbits administered daily doses of 3 to 100 μg/kg. The embryotoxicity observed

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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
Sodium acetate trihydrate
Mannitol
Metacresol
Water for injections

6.2 Incompatibilities

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

6.3 Shelf life

30 months

Chemical, physical and microbiological in-use stability has been demonstrated for 28 days at 2-8°C.
Once opened, the medicinal product may be stored for a maximum of 28 days at 2°C to 8°C. Other in-
use storage times and conditions are the responsibility of the user.

6.4 Special precautions for storage

Store in a refrigerator (2°C - 8°C) at all times. The pen injector should be returned to the refrigerator
immediately after use.

Do not freeze.

Do not store the pen injector with the needle attached.

Always store the pen injector with the white cap on after use, in order to protect from light.

6.5 Nature and contents of container

2.7 mL solution in cartridge (siliconised Type I glass) sealed at one end with a bromobutyl rubber
plunger and at the other end crimp-sealed with a bi-layer combi-seal (polyisoprene/ bromobutyl rubber
laminate with aluminium over cap). The cartridges are an integral and non-replaceable part of the pen
injector.

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The pen injector is composed of a clear cartridge holder, white protective cap to cover the cartridge
holder and injector body with a black injection button.

Qutavina 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.

6.6 Special precautions for disposal and other handling

Each pen should be used by only one patient. A new, sterile needle must be used for every injection.
No needles are supplied with the medicinal product. The device can be used with insulin pen injection
needles. After each injection, the Qutavina pen should be returned to the refrigerator.

Qutavina should not be used if the solution is cloudy, coloured or contains particles.

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

7. MARKETING AUTHORISATION HOLDER

EuroGenerics Holdings BV
Locatellikade 1,
1076AZ Amsterdam
Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/20/1463/001-002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

10. DATE OF REVISION OF THE TEXT

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

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ANNEX II

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

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE
MARKETING AUTHORISATION

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

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

Name and address of the manufacturer of the biological active substance

Cytovance Biologics Inc.
3500 North Santa Fe Ave
Oklahoma City, OK 73118
United States

Name and address of the manufacturer responsible for batch release

Eurofins PROXY Laboratories (PRX)
Archimedesweg 25 2333 CM Leiden
Netherlands

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
AUTHORISATION

 Periodic safety update reports (PSURs)

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

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

 Risk management plan (RMP)

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

An updated RMP should be submitted:
 At the request of the European Medicines Agency;
 Whenever the risk management system is modified, especially as the result of new information

being received that may lead to a significant change to the benefit/risk profile or as the result of
an important (pharmacovigilance or risk minimisation) milestone being reached.
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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

1. NAME OF THE MEDICINAL PRODUCT

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

2. STATEMENT OF ACTIVE SUBSTANCE

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

3. LIST OF EXCIPIENTS

Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, water for injections. See leaflet
for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.
1 pen of 2.7 mL solution.
3 pens of 2.7 mL solution.

Each pre-filled pen contains 28 doses of 20 micrograms (per 80 microliters).

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Subcutaneous use

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

To open, lift and pull

8. EXPIRY DATE

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EXP
The pen should be discarded 28 days after the first use.
Date of first use:

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

EuroGenerics Holdings BV
Locatellikade 1,
1076AZ Amsterdam
Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/20/1463/001
EU/1/20/1463/002

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Qutavina

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

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SN
NN

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20

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL

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

Qutavina 20 micrograms/80 microliters solution for injection
teriparatide
Subcutaneous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.7 mL

6. OTHER

Store in a refrigerator

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B. PACKAGE LEAFLET

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Package leaflet: Information for the user

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

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

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

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

effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Qutavina is and what it is used for

Qutavina contains the active substance teriparatide that is used to make the bones stronger, and to
reduce the risk of fractures by stimulating bone formation.

Qutavina 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 Qutavina

Do not use Qutavina
 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

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Qutavina may cause an increase in the amount of calcium in your blood or urine.

Talk to your doctor or pharmacist before or while using Qutavina:
 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
Qutavina where you can sit or lie down right away if you get dizzy.
The recommended treatment time of 24 months should not be exceeded.

Qutavina should not be used in growing adults.

Children and adolescents
Qutavina should not be used in children and adolescents (less than 18 years).

Other medicines and Qutavina
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 Qutavina 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 Qutavina. If you become
pregnant, Qutavina 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 Qutavina. If you feel dizzy you should not drive or use
machines until you feel better

Qutavina 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 Qutavina

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

The recommended dose is 20 micrograms given once daily by injection under the skin (subcutaneous
injection) in the thigh or abdomen. To help you remember to use your medicine, inject it at about the
same time each day.

Inject Qutavina each day for as long as your doctor prescribes it for you. The total duration of
treatment with Qutavina should not exceed 24 months. You should not receive more than one
treatment course of 24 months over your lifetime.

Your doctor may advise you to use Qutavina with calcium and vitamin D. Your doctor will tell you
how much you should take each day.

Read the user manual, which is included in the carton for instructions on how to use the Qutavina pen.

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Injection needles are not included with the pen. Pen needles 29 to 31 gauge (diameter 0.25-0.33 mm)
can be used.
You should use your Qutavina 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 Qutavina pen with others.

Qutavina can be given with or without food.

If you use more Qutavina than you should
If, by mistake, you have used more Qutavina 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 Qutavina at your usual time, use it as soon as possible on that day. Do
not use a double dose to make up for a forgotten dose. Do not use more than one injection in the same
day. Do not try to make up for a missed dose.

If you stop taking Qutavina
If you are considering stopping Qutavina treatment, please discuss this with your doctor. Your doctor
will advise you and decide how long you should be treated with Qutavina.

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

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 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 hospitalization.
 increase in blood calcium level
 increase in blood uric acid level
 increase in an enzyme called alkaline phosphatase.

Rare: may affect up to 1 in 1,000 people
 reduced kidney function, including renal failure
 swelling, mainly in the hands, feet and legs.

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

5. How to store Qutavina

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.

Qutavina should be stored in a refrigerator (2°C to 8°C) at all times. You can use Qutavina for up to
28 days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C).

Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. Do not use
Qutavina if it is, or has been, frozen.

Each pen should be properly disposed of after 28 days, even if it is not completely empty.

Qutavina contains a clear and colourless solution. Do not use Qutavina 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.

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6. Contents of the pack and other information

What Qutavina contains
- The active substance is teriparatide. Each milliliter of the solution for injection contains

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

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

What Qutavina looks like and contents of the pack
Qutavina is a colourless and clear solution. It is supplied in a cartridge contained in a pre-filled
disposable pen. Each pen contains 2.7 mL of solution enough for 28 doses. Qutavina is available in
packs containing one or three pre-filled pens.

Not all pack sizes may be available.

Marketing Authorisation Holder
EuroGenerics Holdings BV
Locatellikade 1, 1076AZ Amsterdam
Netherlands

Manufacturer
Eurofins PROXY Laboratories (PRX)
Archimedesweg 25 2333 CM Leiden
Netherlands

This leaflet was last revised in

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

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27

USER MANUAL

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

IMPORTANT INFORMATION

DO NOT start the administration procedure until you have read the Package leaflet and this User
Manual contained in your Qutavina carton thoroughly. Follow the instructions carefully whenever
using the Qutavina pen.

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

Instructions for use

Prepare for injection

Step 1
Prepare site
and remove the
white cap

A) Wash your hands before every
injection.

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

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

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Step 2
Check pen, pen
label and
medicine

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

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

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

Step 3
Attach new
needle

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

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

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

Step 4
Remove outer
needle cover

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

Step 5
Set dose

Pull out the black injection button until
it stops. (Figure H).

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Check to make sure red stripe shows.
Additionally, the instruction window
will show an arrow pointing towards the
needle end of the pen (Figure I).

Troubleshooting when setting the dose

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

Administer injection

Step 6
Remove inner
needle cover

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

Step 7
Inject dose

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

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

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

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

After injection

Step 8
Confirm dose

Check to make sure the black injection
button is all the way down. The
instruction window will show an arrow
pointing TOWARDS the black button.

If the yellow shaft does not show, you
have finished the injection steps the right
way. (Figure O)

Important
You should NOT see any of the yellow

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

Step 9
Remove needle
and dispose

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

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

Pull the needle straight off.
(Figure S)

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

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

Step 10
Recap pen and
store

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

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

Troubleshooting

Problem Solution

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

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

You can prevent this problem by always using a NEW
needle for each injection, and by pushing the black
injection button all the way in and slowly counting to
5 s-l-o-w-l-y.

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

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

D I cannot get the needle off. 1) Put the large needle cover on the needle.
2) Use the large needle cover to unscrew the needle.

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

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

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

Cleaning and storage
Cleaning your Qutavina pen

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

Storing your Qutavina pen
 Read and follow the instructions in the Information for the Patient leaflet on how to store your

pen.
 DO NOT store the Qutavina with a needle attached. Doing this may affect the sterility of the

medicine during subsequent injections.
 Store the Qutavina with the white cap on.

If the Qutavina has been left out of the refrigerator, do not throw the pen away. Place the pen
back in the refrigerator and contact your doctor or pharmacist.

Disposal information
Disposal of pen needles and Qutavina pen

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

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

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

the assistance from a person trained in the proper use of the pen.

This user manual was last revised in:

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A.MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D.CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A.LABELLING
	B.PACKAGE LEAFLET