KAULIV Solution for injection Ref.[50836] Active ingredients: Teriparatide

Posology

The recommended dose of Kauliv 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.

Special populations

Elderly

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. 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

Kauliv 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). For instructions of the medicinal product before administration (see section 6.6). Instructions for use which is included in the carton of the pen are also available to instruct patients on the correct use of the pen.

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 medication error where the entire contents (up to 750 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.

Overdose management

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.

24 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 within its shelf life at 2°C to 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 store the pen with the needle attached. Do not remove the cartridge from the pen after first use. The cartridge within the pen can additionally be placed in the pouch supplied with the pen in order to protect from light.

Other in-use storage times and conditions are the responsibility of the user.

Store in a refrigerator (2°C–8°C).

Do not freeze. Keep the cartridge in the outer carton in order to protect from light.

For storage conditions after first opening of the medicinal product, see section 6.3.

3 mL cartridge (USP type-1 glass cartridge), with a plunger stopper (bromobutyl) and disc seal (aluminium and rubber liner seals), packed in a plastic tray sealed with lid foil and supplied in a carton.

Each cartridge contains 3 mL solution for injection corresponding to 28 doses of 20 micrograms (per 80 microliters).

Pack sizes of 1 cartridge or 3 cartridges.

Not all pack sizes may be marketed.

Handling

Kauliv cartridges should be used exclusively within Kauliv reusable, multidose 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 32 G 4 mm single-use pen needles.

A new, sterile needle must be used for every injection.

The expiry date on the cartridge label must always be checked before inserting the cartridge into Kauliv 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 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. Do not use Kauliv if it is, or has been frozen.

Kauliv must not be transferred to a syringe. Empty cartridges must not be refilled.

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

The date of first injection should be written on the outer carton of Kauliv cartridge (see the provided space on the box: “First use”).

The Kauliv reusable pen features a dose selector with audible clicks and visual indicators to ensure correct dose is set for priming (P) and for setting the dose (D).

Disposal

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