Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Theramex Ireland Limited, 3rd Floor Kilmore House, Park Lane, Spencer Dock, DO1 YE64 Dublin 1, Ireland
Livogiva 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 Livogiva is 20 micrograms administered once daily.
The maximum total duration of treatment with Livogiva should be 24 months (see section 4.4). The 24-month course of Livogiva 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 Livogiva therapy, patients may be continued on other osteoporosis therapies.
Dose adjustment based on age is not required (see section 5.2).
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.
No data are available in patients with impaired hepatic function (see section 5.3). Therefore, teriparatide should be used with caution.
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.
Livogiva 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.
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 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.
There is no specific antidote for teriparatide. Treatment of suspected overdose should include transitory discontinuation of Livogiva, 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 medicinal product may be stored for a maximum of 28 days at 2°C to 8°C. Other inuse storage times and conditions are the responsibility of the user.
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.
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.
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.
Livogiva is available in pack sizes of 1 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.
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 Livogiva pen should be returned to the refrigerator.
Livogiva 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.
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