WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE Perforations and fistulas: Gastrointestinal perforations occurred in 3% and fistula formation in 1% of COMETRIQ®-treated patients. Discontinue COMETRIQ for perforation or for fistula formation [See Warnings and Precautions (5.1)]. 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 [See Warnings and Precautions (5.2)]. WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE See full prescribing information for complete boxed warning. Perforations and Fistulas: Gastrointestinal perforations occurred in 3% and fistula formation in 1% of COMETRIQ-treated patients. Discontinue COMETRIQ in patients with perforation or fistula. (5.1) 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. (5.2)
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warnings and cautions
5 WARNINGS AND PRECAUTIONS Thrombotic Events: Discontinue COMETRIQ for myocardial infarction, cerebral infarction, or other serious arterial thromboembolic events. (5.3) Wound Complications: Withhold COMETRIQ for dehiscence or complications requiring medical intervention. (5.4) Hypertension: Monitor blood pressure regularly. Discontinue COMETRIQ for hypertensive crisis. (5.5) Osteonecrosis of the jaw: Discontinue COMETRIQ. (5.6). Palmar-plantar erythrodysesthesia syndrome (PPES): Interrupt COMETRIQ, decrease dose. (5.7) Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. (5.8) Reversible posterior leukoencephalopathy syndrome (RPLS): Discontinue COMETRIQ. (5.9) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.10, 8.1, 8.3)
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the label: Perforations and Fistula [see Boxed Warning, Warnings and Precautions (5.1)] Hemorrhage [see Boxed Warning, Warnings and Precautions (5.2)] Thromboembolic Events [see Warnings and Precautions (5.3)] Wound Complications [see Warnings and Precautions (5.4)] Hypertension [see Warnings and Precautions (5.5)] Osteonecrosis of the Jaw [see Warnings and Precautions (5.6)] Palmar-plantar erythrodysesthesia syndrome [see Warnings and Precautions (5.7)] Proteinuria [see Warnings and Precautions (5.8)] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.9)] The most commonly reported adverse drug reactions (≥ 25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (≥ 25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Exelixis, Inc. at 1-855-500-3935 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.