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Important Safety Information & Indication
COTELLIC (cobimetinib) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with ZELBORAF (vemurafenib).
Important Safety Information
WARNINGS AND PRECAUTIONS
Review the Full Prescribing Information for ZELBORAF for information on the serious risks of ZELBORAF.
The following can occur in patients treated with COTELLIC:
- New primary malignancies, including cutaneous and non-cutaneous malignancies
- Hemorrhage, including major hemorrhages
- Cardiomyopathy, defined as symptomatic and asymptomatic decline in left ventricular ejection fraction
- Severe dermatologic reactions, including rash and other skin reactions
- Serous retinopathy and retinal vein occlusion
- Severe photosensitivity
- Embryo-fetal toxicity
USE IN SPECIFIC POPULATIONS: Lactation
Do not breastfeed while taking COTELLIC and for 2 weeks after the final dose.
Avoid concomitant administration of COTELLIC with strong or moderate CYP3A inducers or inhibitors.
Most Common Adverse Reactions
The most common (≥20%) adverse reactions with COTELLIC were diarrhea (60%), photosensitivity reaction (46%), nausea (41%), pyrexia (28%), and vomiting (24%). The most common (≥5%) Grade 3-4 laboratory abnormalities were increased GGT (21%), increased CPK (14%), hypophosphatemia (12%), increased ALT (11%), lymphopenia (10%), increased AST (8%), increased alkaline phosphatase (7%), and hyponatremia (6%).
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see Full COTELLIC Prescribing Information for additional Important Safety Information.