Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
FORSTEO is indicated in adults.
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated.
Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).
The recommended dose of FORSTEO is 20 micrograms administered once daily.
The maximum total duration of treatment with FORSTEO should be 24 months (see section 4.4). The 24-month course of FORSTEO should not be repeated over a patient’s lifetime.
Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate.
Following cessation of FORSTEO therapy, patients may be continued on other osteoporosis therapies.
FORSTEO must not be used in patients with severe renal impairment (see section 4.3). In patients with moderate renal impairment, FORSTEO should be used with caution. No special caution is required for patients with mild renal impairment.
No data are available in patients with impaired hepatic function (see section 5.3). Therefore, FORSTEO should be used with caution.
The safety and efficacy of FORSTEO in children and adolescents less than 18 years has not been established. FORSTEO should not be used in paediatric patients (less than 18 years), or young adults with open epiphyses.
Dosage adjustment based on age is not required (see section 5.2).
FORSTEO should be administered once daily by subcutaneous injection in the thigh or abdomen.
Patients must be trained to use the proper injection techniques (see section 6.6). A user manual is also available to instruct patients on the correct use of the pen.
FORSTEO has been administered in single doses of up to 100 micrograms and in repeated doses of up to 60 micrograms/day for 6 weeks.
The effects of overdose that might be expected include delayed hypercalcaemia and risk of orthostatic hypotension. Nausea, vomiting, dizziness, and headache can also occur.
In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 mcg) of the teriparatide pen have been administered as a single dose. Transient events reported have included nausea, weakness/lethargy and hypotension. In some cases, no adverse events occurred as a result of the overdose. No fatalities associated with overdose have been reported.
There is no specific antidote for FORSTEO. Treatment of suspected overdose should include transitory discontinuation of FORSTEO, monitoring of serum calcium, and implementation of appropriate supportive measures, such as hydration.
2 years.
Chemical, physical and microbiological in-use stability has been demonstrated for 28 days at 2-8°C. Once opened, the product may be stored for a maximum of 28 days at 2°C to 8°C. Other in-use storage times and conditions are the responsibility of the user.
Store in a refrigerator (2°C–8°C) at all times. The pen should be returned to the refrigerator immediately after use. Do not freeze.
Do not store the injection device with the needle attached.
2.4 mL solution in cartridge (siliconised Type I glass) with a plunger (halobutyl rubber), disc seal (polyisoprene/bromobutyl rubber laminate)/aluminium assembled into a disposable pen.
FORSTEO is available in pack sizes of 1 or 3 pens. Each pen contains 28 doses of 20 micrograms (per 80 microliters).
Not all pack sizes may be marketed.
FORSTEO is supplied in a pre-filled pen. Each pen should be used by only one patient. A new, sterile needle must be used for every injection. Each FORSTEO pack is provided with a user manual that fully describes the use of the pen. No needles are supplied with the product. The device can be used with insulin pen injection needles. After each injection, the FORSTEO pen should be returned to the refrigerator.
FORSTEO should not be used if the solution is cloudy, coloured or contains particles.
Please also refer to the user manual for instructions on how to use the pen.
Any unused product or waste material should be disposed of in accordance with local requirements.
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