ZONTIVITY Film-coated tablet Ref.[9380] Active ingredients: Vorapaxar

Posology

MI

The recommended dose of Zontivity is 2.08 mg to be taken once daily. Zontivity should be initiated at least 2 weeks after a MI and preferably within the first 12 months from the acute event (see section 5.1). A delayed onset of action (at least 7 days) should be expected when starting therapy with Zontivity. There are limited data on the efficacy and safety of Zontivity beyond 24 months. Continued therapy after this time must be based on a re-evaluation of the benefits and risks for the individual of further therapy.

PAD

The recommended dose of Zontivity is 2.08 mg to be taken once daily. For patients being started on Zontivity due to symptomatic PAD, therapy may be initiated at any time.

If a dose is missed: A patient who misses a dose of Zontivity should skip the missed dose if it is within 12 hours of the next scheduled dose and take the next dose at the regular scheduled time.

Coadministration with other antiplatelet medicinal products

MI

Patients taking Zontivity should also take acetylsalicylic acid with or without clopidogrel according to their indications or standard of care. There is limited clinical experience with prasugrel and no experience with ticagrelor in the Phase 3 studies. Therefore, vorapaxar should not be used with prasugrel or ticagrelor. Vorapaxar should not be initiated in patients taking prasugrel or ticagrelor and in case of need for additional therapy with these agents, vorapaxar should be stopped.

PAD

Patients taking Zontivity should also take acetylsalicylic acid or clopidogrel according to their indications or standard of care.

Elderly

No dose adjustment is necessary in the elderly (see sections 4.4 and 5.2).

Renal impairment

No dose adjustment is required in patients with renal impairment (see section 5.2). However, reduced renal function is a risk factor for bleeding and should be considered before initiating Zontivity. There is limited therapeutic experience in patients with severe renal impairment or end stage renal disease. Therefore, Zontivity should be used with caution in such patients.

Hepatic impairment

Reduced hepatic function is a risk factor for bleeding and should be considered before initiating Zontivity. No dose adjustment is required in patients with mild hepatic impairment. Zontivity should be used with caution in patients with moderate hepatic impairment. Because of the limited therapeutic experience and the increased inherent risk of bleeding in patients with severe hepatic impairment, Zontivity is contraindicated in such patients (see sections 4.3, 4.4, and 5.2).

Paediatric population

The safety and efficacy of Zontivity in children aged less than 18 years have not yet been established. No data are available.

Method of administration

Oral use. The tablet may be taken with or without food

Platelet inhibition with vorapaxar is gradual and reversible. Treatment of presumed overdose should address signs and symptoms.

As vorapaxar is highly protein-bound, haemodialysis is unlikely to be effective in the treatment of an overdose.

In humans, vorapaxar has been administered in single doses up to 120 mg and daily doses of 5 mg for up to 4 weeks without observation of dose-associated adverse events or identification of a specific risk.

Platelet transfusion may be considered as supportive therapy should bleeding occur (see section 5.3).

2 years.

Store in the original package in order to protect from moisture.

This medicinal product does not require any special temperature storage conditions.

Packs of 7, 28, 30 and 100 film-coated tablets in aluminium/aluminium blister cards.

Packs of 10 and 50 film-coated tablets in aluminium/aluminium unit-dose blister cards.

Not all pack sizes may be marketed.

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