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CABOMETYX
Bladder, kidney, and other urologic cancers
Colorectal and other GI cancers
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Drug Name:

CABOMETYX Rx

Generic Name and Formulations:
Cabozantinib 20mg, 40mg, 60mg; tabs.

Company:
Exelixis, Inc.

Therapeutic Use:

Indications for CABOMETYX:

Advanced renal cell carcinoma (RCC).

Adult:

Swallow whole. Take at least 1hr before or 2hrs after food. 60mg once daily until disease progression or unacceptable toxicity. Concomitant strong CYP3A4 inhibitors: if unavoidable, reduce daily dose by 20mg; resume dose used prior to starting inhibitor 2–3 days after discontinuation of inhibitor. Concomitant strong CYP3A4 inducers: if unavoidable, increase daily dose by 20mg (max 80mg daily); resume dose used prior to starting inducer 2–3 days after discontinuation of inducer. Moderate hepatic impairment: initially 40mg once daily. Dose modifications for adverse reactions: see full labeling.

Children:

Not established.

Warnings/Precautions:

Not substitutable with cabozantinib caps. Permanently discontinue if the following occurs: GI perforation, unmanageable fistula, severe hemorrhage (Grade 3/4), serious thromboembolic events (eg, MI, cerebral infarction), hypertensive crisis or severe hypertension despite optimal medical management, nephrotic syndrome, reversible posterior leukoencephalopathy syndrome. Withhold for intolerable Grade 2 reactions, Grade 3/4 reactions, or osteonecrosis of the jaw. Recent history of hemorrhage (including hemoptysis, hematemesis, melena): do not administer. Monitor for GI perforations/fistulas. Monitor BP regularly; withhold for hypertension inadequately controlled with medical management; resume at reduced dose when resolved. Withhold therapy if intolerable Grade 2 diarrhea, unmanageable Grade 3/4 diarrhea, or intolerable Grade 2/3 palmar-plantar erythrodysesthesia (PPE) develops until improvement to Grade 1; resume at reduced dose. Monitor urine protein regularly. Perform oral exam prior to initiation and periodically during therapy. Stop treatment at least 28 days prior to scheduled surgery (including dental); resume based on adequate wound healing. Withhold in patients with dehiscence or wound healing complications requiring intervention. Severe hepatic impairment: not recommended. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after final dose).

Pharmacological Class:

Kinase inhibitor.

Interactions:

Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, grapefruit or grapefruit juice) and strong CYP3A4 inducers (eg, rifampin, St. John's wort); if unavoidable, see Adults.

Adverse Reactions:

Diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation; lab abnormalities.

Generic Availability:

NO

How Supplied:

Tabs—30

Indications for CABOMETYX:

Hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.

Adult:

Swallow whole. Take at least 1hr before or 2hrs after food. 60mg once daily until disease progression or unacceptable toxicity. Concomitant strong CYP3A4 inhibitors: if unavoidable, reduce daily dose by 20mg; resume dose used prior to starting inhibitor 2–3 days after discontinuation of inhibitor. Concomitant strong CYP3A4 inducers: if unavoidable, increase daily dose by 20mg (max 80mg daily); resume dose used prior to starting inducer 2–3 days after discontinuation of inducer. Moderate hepatic impairment: initially 40mg once daily. Dose modifications for adverse reactions: see full labeling.

Children:

Not established.

Warnings/Precautions:

Not substitutable with cabozantinib caps. Permanently discontinue if the following occurs: GI perforation, unmanageable fistula, severe hemorrhage (Grade 3/4), serious thromboembolic events (eg, MI, cerebral infarction), hypertensive crisis or severe hypertension despite optimal medical management, nephrotic syndrome, reversible posterior leukoencephalopathy syndrome. Withhold for intolerable Grade 2 reactions, Grade 3/4 reactions, or osteonecrosis of the jaw. Recent history of hemorrhage (including hemoptysis, hematemesis, melena): do not administer. Monitor for GI perforations/fistulas. Monitor BP regularly; withhold for hypertension inadequately controlled with medical management; resume at reduced dose when resolved. Withhold therapy if intolerable Grade 2 diarrhea, unmanageable Grade 3/4 diarrhea, or intolerable Grade 2/3 palmar-plantar erythrodysesthesia (PPE) develops until improvement to Grade 1; resume at reduced dose. Monitor urine protein regularly. Perform oral exam prior to initiation and periodically during therapy. Stop treatment at least 28 days prior to scheduled surgery (including dental); resume based on adequate wound healing. Withhold in patients with dehiscence or wound healing complications requiring intervention. Severe hepatic impairment: not recommended. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after final dose).

Pharmacological Class:

Kinase inhibitor.

Interactions:

Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, grapefruit or grapefruit juice) and strong CYP3A4 inducers (eg, rifampin, St. John's wort); if unavoidable, see Adults.

Adverse Reactions:

Diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation; lab abnormalities.

Generic Availability:

NO

How Supplied:

Tabs—30

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