AYVAKYT Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

AYVAKYT 100 mg film-coated tablets. AYVAKYT 200 mg film-coated tablets. AYVAKYT 300 mg film-coated tablets.

2. Qualitative and quantitative composition

AYVAKYT 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of avapritinib. AYVAKYT 200 mg film-coated tablets: Each film-coated tablet contains 200 mg of avapritinib. ...

3. Pharmaceutical form

Film-coated tablet. AYVAKYT 100 mg film-coated tablets: Round, white film-coated tablet of 9 mm diameter, printed with blue ink BLU on one side and 100 on the other. AYVAKYT 200 mg film-coated ...

4.1. Therapeutic indications

AYVAKYT is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha ...

4.2. Posology and method of administration

Therapy should be initiated by a physician experienced in the administration of anticancer therapy. Patient selection for treatment of unresectable or metastatic GIST harbouring the PDGFRA D842V mutation ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Haemorrhages In patients with unresectable or metastatic GIST, avapritinib has been associated with an increased incidence of haemorrhagic events, including serious and severe events, like gastrointestinal ...

4.5. Interaction with other medicinal products and other forms of interaction

Active substances that may have an effect on AYVAKYT Strong and moderate CYP3A inhibitors Co-administration of AYVAKYT with a strong CYP3A inhibitor increased avapritinib plasma concentrations and may ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential / Contraception Women of childbearing potential should be informed that avapritinib may cause foetal harm (see section 5.3). The pregnancy status of women of reproductive ...

4.7. Effects on ability to drive and use machines

AYVAKYT may cause adverse reactions such as cognitive effects that may influence the ability to drive and use machines. Patients should be made aware of the potential for adverse reactions that affect ...

4.8. Undesirable effects

Summary of the safety profile The safety database includes a total of 585 patients with GIST (all doses), of which 550 patients received avapritinib at a starting dose of 300 mg or 400 mg, see section ...

4.9. Overdose

Symptoms No cases of overdose have been reported in clinical trials with avapritinib. The maximum dose of AYVAKYT studied clinically is 600 mg orally once daily. Adverse reactions observed at this dose ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor ATC code: L01EX18 Mechanism of action Avapritinib is a Type 1 kinase inhibitor that has demonstrated biochemical ...

5.2. Pharmacokinetic properties

Following administration of avapritinib once daily, steady state was reached by 15 days. After a single dose and repeat dosing of avapritinib, systemic exposure of avapritinib was dose-proportional over ...

5.3. Preclinical safety data

Repeat dose toxicology studies Repeat dose studies in dogs indicated haemorrhage and choroid plexus oedema in the brain at ≥0.4 times the human exposure at the clinical dose of 300 mg once daily. Rats ...

6.1. List of excipients

Tablet core: Microcrystalline cellulose Copovidone Croscarmellose sodium Magnesium stearate Tablet coat: Talc Macrogol 3350 Poly(vinyl alcohol) Titanium dioxide (E171) Printing ink: ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

30 months.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

High-density polyethylene (HDPE) bottle with child-resistant cap with foiled induction seal liner and a desiccant in canister. Each carton contains one bottle with 30 film-coated tablets.

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Blueprint Medicines (Netherlands) B.V., Gustav Mahlerplein 2, 1082 MA Amsterdam, Netherlands

8. Marketing authorization number(s)

AYVAKYT 100 mg film-coated tablets: EU/1/20/1473/001 AYVAKYT 200 mg film-coated tablets: EU/1/20/1473/002 AYVAKYT 300 mg film-coated tablets: EU/1/20/1473/003

9. Date of first authorization / renewal of the authorization

Date of first authorization: 24 September 2020

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