Side Effect Reporting
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.
Support & Resources
Indication
COTELLIC (cobimetinib) is a kinase inhibitor indicated:
- For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with ZELBORAF (vemurafenib).
- As a single agent for the treatment of adult patients with histiocytic neoplasms.
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
- Hepatotoxicity
- Rhabdomyolysis
- Severe photosensitivity
- Embryo-fetal toxicity
DRUG INTERACTIONS
- Avoid concomitant administration of COTELLIC with strong or moderate CYP3A inducers or inhibitors.
USE IN SPECIFIC POPULATIONS: Lactation
- Advise women not to breastfeed during treatment with COTELLIC for 2 weeks after the final dose.
Most Common Adverse Reactions
Unresectable or Metastatic Melanoma: The most common (≥20%) adverse reactions are diarrhea (60%), photosensitivity reaction (46%), nausea (41%), pyrexia (28%), and vomiting (24%).
The most common (≥5%) Grade 3-4 laboratory abnormalities are increased GGT (21%), increased CPK (14%), hypophosphatemia (12%), increased ALT (11%), lymphopenia (10%), increased AST (8%), increased alkaline phosphatase (7%), and hyponatremia (6%).
Histiocytic Neoplasms: The most common adverse reactions (≥20%) are acneiform dermatitis (65%), diarrhea (62%), infection (62%), fatigue (42%), nausea (46%), edema (42%), dry skin (31%), maculopapular rash (31%), pruritus (31%), dyspepsia (27%), vomiting (27%), dyspnea (27%), and urinary tract infections (23%).
The most common (≥5%) grade 3-4 lab abnormalities include: lymphopenia (27%), increased blood creatine phosphokinase (27%), hyponatremia (18%), hypokalemia (12%), increased blood creatinine (9%), increased AST (9%), hypocalcemia (9%), leukopenia (9%), and anemia (8%).
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.