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SPC: BRAFTOVI Hard capsule (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Braftovi 50 mg hard capsules. Braftovi 75 mg hard capsules.

Qualitative and quantitative composition

Braftovi 50 mg hard capsules: Each hard capsule contains 50 mg of encorafenib. Braftovi 75 mg hard capsules: Each hard capsule contains 75 mg of encorafenib. For the full list of excipients, see section ...

Pharmaceutical form

Hard capsule (capsule). Braftovi 50 mg hard capsules: Orange opaque cap and flesh opaque body, printed with a stylised A on the cap and LGX 50mg on the body. The length of the capsule is approximately ...

Therapeutic indications

Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).

Posology and method of administration

Encorafenib treatment in combination with binimetinib should be initiated and supervised under the responsibility of a physician experienced in the use of anticancer medicinal products. Posology The recommended ...

Contraindications

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

Special warnings and precautions for use

Encorafenib is to be given in combination with binimetinib. For additional information on warnings and precautions associated with binimetinib treatment, see section 4.4 of binimetinib SmPC. BRAF mutation ...

Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on encorafenib Encorafenib is primarily metabolised by CYP3A4. CYP3A4 inhibitors Co-administration of moderate (diltiazem) and strong (posaconazole) CYP3A4 inhibitors ...

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in females Women of childbearing potential must use effective contraception during treatment with encorafenib and for at least 1 month following the last dose. ...

Effects on ability to drive and use machines

Encorafenib has minor influence on the ability to drive or use machines. Visual disturbances have been reported in some patients treated with encorafenib during clinical studies. Patients should be advised ...

Undesirable effects

Summary of safety profile The safety of encorafenib (450 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 274 patients with BRAF V600 mutant unresectable ...

Overdose

Symptoms At doses of encorafenib between 600 to 800 mg once daily, renal dysfunction (Grade 3 hypercreatinaemia) was observed in 3 out of 14 patients. The highest administered dose occurred as a dosing ...

Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor ATC code: L01XE46 Mechanism of action Encorafenib is a potent and highly selective ATP-competitive small molecule RAF kinase inhibitor. ...

Pharmacokinetic properties

The pharmacokinetics of encorafenib were studied in healthy subjects and patients with solid tumours, including advanced and unresectable or metastatic cutaneous melanoma harbouring a BRAF-V600E or K mutation. ...

Preclinical safety data

In the 4-week and 13-week rat toxicity studies, clinical signs, reduced body weight reduced epididymides and prostate weights and microscopic findings in testes, epididymides, stomach and skin were noted. ...

List of excipients

Capsule content: Copovidone (E1208) Poloxamer 188 Cellulose microcrystalline (E460i) Succinic acid (E363) Crospovidone (E1202) Silica colloidal anhydrous (E551) Magnesium stearate (E470b) Capsule shell: ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 30°C. Store in the original package in order to protect from moisture.

Nature and contents of container

Braftovi 50 mg hard capsules: Polyamide/aluminum/PVC/aluminum blister containing 4 capsules. Each pack contains either 28 or 112 hard capsules. Not all pack sizes may be marketed. Braftovi 75 mg hard capsules: ...

Special precautions for disposal and other handling

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

Marketing authorization holder

Pierre Fabre Médicament, 45, place Abel Gance, 92100, Boulogne-Billancourt, France

Marketing authorization number(s)

Braftovi 50 mg hard capsules: EU/1/18/1314/001 28 hard capsules EU/1/18/1314/003 112 hard capsules Braftovi 75 mg hard capsules: EU/1/18/1314/002 42 hard capsules EU/1/18/1314/004 168 hard capsules

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 September 2018

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: