Cotellic

Cotellic

Manufacturer:

Roche

Distributor:

Firma Chun Cheong
/
DKSH
Concise Prescribing Info
Contents
Cobimetinib
Indications/Uses
In combination w/ vemurafenib for the treatment of adult patients w/ unresectable or metastatic melanoma w/ a BRAF V600 mutation.
Dosage/Direction for Use
PO 60 mg once daily for 21 consecutive days followed by a 7-day break.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Patients must have BRAF V600 mutation +ve tumour status confirmed by a validated test before treatment. Assess symptoms of new or worsening visual disturbances. Evaluate LVEF before initiation, then after the 1st mth of treatment & at least every 3 mth or as clinically indicated until treatment discontinuation. Monitor liver value abnormalities. Diarrhoea, lactose intolerance; QT prolongation. Concomitant use w/ strong/moderate CYP3A inhibitors. Pregnancy & lactation.
Adverse Reactions
Anaemia; serous retinopathy; HTN, haemorrhage; diarrhoea, nausea, vomiting; photosensitivity, rash, maculo-papular rash, dermatitis acneiform, hyperkeratosis; pyrexia; increased blood CPK, ALT, AST, γ-glutamyltransferase (GGT) & blood ALP. Basal cell carcinoma, cutaneous squamous cell carcinoma, keratoacanthoma; dehydration, hypophosphataemia, hyponatremia, hyperglycaemia; blurred vision, visual impairment; pneumonitis; chills; decreased ejection fraction & blood bilirubin.
Drug Interactions
Increased AUC w/ strong/moderate CYP3A inhibitors & P-glycoprotein (P-gp) inhibitors. Reduced exposure w/ strong CYP3A inducers.
ATC Classification
L01XE38 - cobimetinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Cotellic FC tab 20 mg
Packing/Price
63's
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