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Cabozantinib tablets

CABOMETYX® is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

For more information about CABOMETYX, visit www.cabometyx.com.

Please see Important Safety Information for CABOMETYX, including Warnings and Precautions for hemorrhage, gastrointestinal perforations and fistulas, thrombotic events, hypertension and hypertensive crisis, diarrhea, palmar-plantar erythrodysesthesia, reversible posterior leukoencephalopathy syndrome, and embryofetal toxicity, by clicking here, and full Prescribing Information.

Cabozantinib 80 mg and 20 mg capsules

COMETRIQ® is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). For more information about COMETRIQ, visit www.cometriq.com.

Important Safety Information

Warning: Perforations and Fistulas, and Hemorrhage

Perforations and Fistulas: Gastrointestinal perforations occurred in 3% and fistula formulation in 1% of COMETRIQ®-treated patients. Discontinue COMETRIQ® in patients with perforation or fistula.

Hemorrhage: Severe, sometimes fatal, hemorrhage including hemoptysis and gastrointestinal hemorrhage occurred in 3% of COMETRIQ®-treated patients. Monitor patients for signs and symptoms of bleeding. Do not administer COMETRIQ® to patients with severe hemorrhage.

Please see additional Important Safety Information here , and full Prescribing Information here.

Cobimetinib tablets

COTELLIC® (cobimetinib) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
For more information about COTELLIC, click here.

Important Safety Information

Warnings and Precautions

Review the Full Prescribing Information for vemurafenib for information on the serious risks of vemurafenib.

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

Use in Specific Populations: Lactation

Do not breastfeed while taking COTELLIC and for 2 weeks after the final dose.

Drug Interactions

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 are 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.

Medical Information

Adverse Events or Product Quality Complaints

If you want to report an adverse event related to use of CABOMETYX or COMETRIQ, or if you have a CABOMETYX or COMETRIQ product quality complaint,
please call 1-855-500-3935 (EXEL).

This page is intended for U.S. residents only.

  • Ipsen has an exclusive license to commercialize cabozantinib outside of the United States and Japan. Please visit www.ipsen.com for more information when available.
  • Takeda has an exclusive license to commercialize cabozantinib in Japan. Please visit www.takeda.com for more information when available.