Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
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).
The recommended dose of Terrosa is 20 micrograms administered once daily.
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.
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.
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.
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.
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:}).
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 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.
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.
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.
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.
3 mL cartridge (siliconised Type I glass), with a plunger stopper 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).
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.
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.
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.
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