CABOZANTINIB

Other

Brand names: COMETRIQ

Oral

Mechanism of Action

12.1 Mechanism of Action In vitro biochemical and/or cellular assays have shown that cabozantinib inhibits the tyrosine kinase activity of RET, MET, VEGFR-1, -2 and -3, KIT, TRKB, FLT-3, AXL, ROS1, TYRO3, MER, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.

Indications

1 INDICATIONS AND USAGE COMETRIQ is indicated for the treatment of patients with progressive

metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive

metastatic medullary thyroid cancer (MTC). ( 1 )

Contraindications

• 4 CONTRAINDICATIONS None None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Perforations and Fistulas: Monitor for symptoms
2 ) Thrombotic Events: Discontinue COMETRIQ for myocardial infarction or serious arterial or venous thromboembolic events
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception
1 Perforations and Fistulas Gastrointestinal (GI) perforations and fistulas, including fatal cases, were reported in 3% and 1% of COMETRIQ-treated patients (N=214), respectively

Known Side Effects

9 documented side effects by frequency

Diarrhea

>10%

Fatigue

>10%

Nausea

1-10%

Decreased Appetite

1-10%

High Blood Pressure

1-10%

Weight Loss

1-10%

Constipation

0.1-1%

Vomiting

0.1-1%

Weakness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral