These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ.
COMETRIQ ™ (cabozantinib) capsules, for oral use
Initial U.S. Approval: 2012
WARNING: PERFORATIONS AND FISTULAS, and
HEMORRHAGE
See full prescribing information for complete boxed warning.
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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)
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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)
INDICATIONS AND USAGE
COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). (1)
DOSAGE AND ADMINISTRATION
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Recommended Dose: 140 mg orally, once daily. (2.1)
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Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking COMETRIQ. (2.1)
DOSAGE FORMS AND STRENGTHS
20 mg and 80 mg capsules. (3)
WARNINGS AND PRECAUTIONS
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Thrombotic Events: Discontinue COMETRIQ for myocardial infarction, cerebral infarction, or other serious arterial thromboembolic events. (5.3)
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Wound Complications: Withhold COMETRIQ for dehiscence or complications requiring medical intervention. (5.4)
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