MEKTOVI Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Mektovi 15 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 15 mg of binimetinib. Excipient with known effect: Each film-coated tablet contains 133.5 mg of lactose monohydrate. For the full list of excipients, see section 6.1. ...
Pharmaceutical form
Film-coated tablet (tablet). Yellow to dark yellow, unscored biconvex, ovaloid film-coated tablets approximately 12 mm in length and 5 mm in width, with the A logo debossed on one side of the tablet and ...
Therapeutic indications
Binimetinib in combination with encorafenib 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
Binimetinib treatment in combination with encorafenib 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
Binimetinib is to be given in combination with encorafenib. For additional information on warnings and precautions associated with encorafenib treatment, see section 4.4 of encorafenib SmPC. BRAF mutation ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on binimetinib Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation. The extent of drug interactions mediated by UGT1A1 is unlikely to be clinically ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in females Women of childbearing potential must use effective contraception during treatment with binimetinib and for at least 1 month following the last dose. ...
Effects on ability to drive and use machines
Binimetinib has minor influence on the ability to drive or use machines. Visual disturbances have been reported in patients treated with binimetinib during clinical studies. Patients should be advised ...
Undesirable effects
Summary of safety profile The safety of binimetinib (45 mg orally twice daily) in combination with encorafenib (450 mg orally once daily) (hereafter referred to as Combo 450) was evaluated in 274 patients ...
Overdose
The highest dose of binimetinib evaluated as single agent in clinical studies was 80 mg administered orally twice daily and was associated with ocular (chorioretinopathy) and skin toxicities (dermatitis ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor ATC code: L01XE41 Mechanism of action Binimetinib is an ATP-uncompetitive, reversible inhibitor of the kinase activity of mitogen-activated ...
Pharmacokinetic properties
The pharmacokinetics of binimetinib were studied in healthy subjects and patients with solid tumours and advanced and unresectable or metastatic cutaneous melanoma. After repeat twice-daily dosing concomitantly ...
Preclinical safety data
Repeated oral administration of binimetinib in rats for up to 6 months was associated with soft tissue mineralisation, gastric mucosal lesions and reversible minimal to mild clinical pathology changes ...
List of excipients
Tablet core: Lactose monohydrate Cellulose microcrystalline (E460i) Silica colloidal anhydrous (E551) Croscarmellose sodium (E468) Magnesium stearate (E470b) Film-coating: Polyvinyl alcohol (E1203) Macrogol ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PVDC/Alu blister containing 12 tablets. Each pack contains either 84 or 168 tablets. Not all pack sizes may be marketed.
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)
EU/1/18/1315/001 84 film-coated tablets EU/1/18/1315/002 168 film-coated tablets
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 September 2018
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