Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Accord Healthcare S.L.U., World Trade Centre, Moll de Barcelona s/n, Edifici Est, 6ª Planta, 08039, Barcelona, Spain
Sondelbay 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 nonvertebral 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).
The recommended dose of Sondelbay is 20 micrograms administered once daily.
The maximum total duration of treatment with Sondelbay should be 24 months (see section 4.4). The 24-month course of Sondelbay 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 Sondelbay therapy, patients may be continued on other osteoporosis therapies.
Dose adjustment based on age is not required (see section 5.2).
Sondelbay must not be used in patients with severe renal impairment (see section 4.3.). In patients with moderate renal impairment, Sondelbay 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, Sondelbay should be used with caution.
The safety and efficacy of teriparatide in children and adolescents less than 18 years has not been established. Sondelbay should not be used in paediatric patients (less than 18 years), or young adults with open epiphyses.
Sondelbay should be administered once daily by subcutaneous injection in the thigh or abdomen.
Patients must be trained to use the proper injection techniques For instructions of the medicinal product before administration (see section 6.6). A user manual is also available to instruct patients on the correct use of the pen.
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.
In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 micrograms) 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 teriparatide. Treatment of suspected overdose should include transitory discontinuation of teriparatide, monitoring of serum calcium, and implementation of appropriate supportive measures, such as hydration.
2 years.
After first opening:
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 2-8°C (refrigerated condition) temperature. Other in-use storage times and conditions are the responsibility of the user.
The medicinal product can be stored at temperature conditions up to 25°C for a maximum of 3 days when refrigeration is not available, after which it should be returned to the refrigerator and used within 28 days of the first injection. The Sondelbay pen should be discarded, if it has been kept out of refrigerator up to 25°C for more than 3 days.
Store in a refrigerator (2°C–8°C). Do not freeze. Store in the original package in order to protect from light
For storage conditions after first opening of the medicinal product, see section 6.3.
2.4 mL solution in cartridge (siliconised Type I glass) with a plunger (bromobutyl rubber), disc seal (bromobutyl lined aluminium seals), assembled into a disposable pen.
Sondelbay is available in pack sizes of 1 pre-filled pen or 3 pre-filled pens. Each pre-filled pen contains 28 doses of 20 micrograms (per 80 microliters).
Not all pack sizes may be marketed.
Sondelbay 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.. No needles are supplied with the product. The pen can be used with pen needles (31G or 32G; 4mm, 5mm or 8mm).
Sondelbay should not be used if the solution is cloudy, coloured or contains particles.
Sondelbay pen should be returned to the refrigerator (2⁰C-8⁰C) immediately after use. Recap the pen when not in use to protect the cartridge from physical damage and light. Do not use Sondelbay if it is, or has been, frozen.
Do not transfer the medicine into a syringe.
Do not store the pre-filled pen with the needle attached.
Date of the first injection should be written on the outer carton of Sondelbay (see the provided space: date of first use). 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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