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.
COTELLIC (cobimetinib) is a kinase inhibitor indicated:
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:
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS: Lactation
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.