Cotellic

Cotellic

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Cobimetinib fumarate
Indications/Uses
In combination w/ vemurafenib for patients w/ unresectable or metastatic melanoma w/ BRAF V600 mutation.
Dosage/Direction for Use
60 mg once daily for 21 consecutive days followed by 7-day break.
Administration
May be taken with or without food: Swallow whole w/ water.
Contraindications
Special Precautions
Severe rash & other skin reactions. Patients w/ additional risk factors for bleeding eg, brain metastases; who have progressed on prior BRAF inhibitor. Perform prompt ophth exam in patients reporting new or worsening visual disturbances; withhold treatment until visual symptoms improve to grade ≤1 if serious retinopathy is diagnosed. Evaluate left ventricular ejection fraction prior to, after 1st mth & at least every 3 mth or as clinically indicated until treatment discontinuation. Monitor liver value abnormalities prior to & mthly during treatment or as clinically indicated. Interrupt treatment if rhabdomyolysis is diagnosed & monitor creatine phosphokinase (CPK) levels; measure serum CPK & creatinine levels prior to & mthly during treatment. Avoid sun exposure. Concomitant use w/ medications increasing risk of bleeding eg, antiplatelet or anticoagulants; CYP3A inducers & inhibitors. May affect ability to drive & use machines. Hepatic & severe renal impairment. Women of childbearing potential should use effective contraception during & at least 3 mth after last dose. Not recommended during pregnancy. Lactation. Childn & adolescents <18 yr.
Adverse Reactions
Anaemia; chorioretinopathy, blurred vision; diarrhoea, nausea, vomiting; pyrexia, chills; photosensitivity, maculopapular rash, dermatitis acneiform rash; HTN. Retinal detachment; decreased ejection fraction; dehydration; hyponatremia; basal cell carcinoma.
Drug Interactions
Increased AUC w/ potent CYP3A inhibitors eg, itraconazole. Lowered exposure w/ CYP3A inducers.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EE02 - cobimetinib ; Belongs to the class of mitogen-activated protein kinase (MEK) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Cotellic FC tab 20 mg
Packing/Price
63's
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