- Bladder, kidney, and other urologic cancers
- Colorectal and other GI cancers
- Pancreatic, thyroid, and other endocrine cancers
Bladder, kidney, and other urologic cancers:
Indications for: CABOMETYX
As a single agent for advanced renal cell carcinoma (RCC). In combination with nivolumab for first-line treatment of advanced RCC.
Adult Dosage:
Swallow whole. Take at least 1hr before or 2hrs after food. As a single agent: 60mg once daily. In combination with nivolumab: 40mg once daily. Continue 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 (Child-Pugh B): reduce starting dose by 20mg. Dose modifications for adverse reactions: see full labeling.
Children Dosage:
Not established.
CABOMETYX Warnings/Precautions:
Not substitutable with cabozantinib caps. Permanently discontinue if the following occurs: GI perforation, GI fistula (Grade 4), severe hemorrhage (Grade 3/4), acute MI, serious thromboembolic events that require medical intervention, hypertensive crisis or severe hypertension despite optimal medical management, nephrotic syndrome, reversible posterior leukoencephalopathy syndrome; with nivolumab: if AST or AST >10×ULN or >3×ULN with total bilirubin ≥2×ULN. Withhold for intolerable Grade 2 reactions, Grade 3/4 reactions, or osteonecrosis of the jaw; with nivolumab: for ALT or AST >3×ULN but ≤10×ULN with total bilirubin <2×ULN. 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. Higher risk of hepatotoxicity (with nivolumab); monitor liver enzymes prior to initiation and more frequently during treatment; withhold (consider corticosteroid therapy) and resume at reduced dose based on severity. Risk of adrenal insufficiency (with nivolumab); withhold therapy based on severity. 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. Impaired wound healing: withhold for ≥3 weeks prior to elective surgery (including dental); do not give for ≥2 weeks after major surgery and until adequate healing. Monitor for thyroid dysfunction prior to initiation and during therapy; perform thyroid function tests and manage as clinically indicated. Monitor blood calcium levels during therapy; withhold and resume at reduced dose upon recovery or permanently discontinue based on severity. Severe hepatic impairment (Child-Pugh C): avoid. Severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).
CABOMETYX Classification:
Kinase inhibitor.
CABOMETYX 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 Adult dose.
Adverse Reactions:
Diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation; also with nivolumab: hepatotoxicity, stomatitis, rash, hypothyroidism, musculoskeletal pain, dysgeusia, abdominal pain, cough, upper RTI.
Generic Drug Availability:
NO
How Supplied:
Tabs—30
Colorectal and other GI cancers:
Indications for: CABOMETYX
Hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.
Adult Dosage:
Swallow whole. Take at least 1hr before or 2hrs after food. As a single agent: 60mg once daily. In combination with nivolumab: 40mg once daily. Continue 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 (Child-Pugh B): reduce starting dose by 20mg. Dose modifications for adverse reactions: see full labeling.
Children Dosage:
Not established.
CABOMETYX Warnings/Precautions:
Not substitutable with cabozantinib caps. Permanently discontinue if the following occurs: GI perforation, GI fistula (Grade 4), severe hemorrhage (Grade 3/4), acute MI, serious thromboembolic events that require medical intervention, hypertensive crisis or severe hypertension despite optimal medical management, nephrotic syndrome, reversible posterior leukoencephalopathy syndrome; with nivolumab: if AST or AST >10×ULN or >3×ULN with total bilirubin ≥2×ULN. Withhold for intolerable Grade 2 reactions, Grade 3/4 reactions, or osteonecrosis of the jaw; with nivolumab: for ALT or AST >3×ULN but ≤10×ULN with total bilirubin <2×ULN. 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. Higher risk of hepatotoxicity (with nivolumab); monitor liver enzymes prior to initiation and more frequently during treatment; withhold (consider corticosteroid therapy) and resume at reduced dose based on severity. Risk of adrenal insufficiency (with nivolumab); withhold therapy based on severity. 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. Impaired wound healing: withhold for ≥3 weeks prior to elective surgery (including dental); do not give for ≥2 weeks after major surgery and until adequate healing. Monitor for thyroid dysfunction prior to initiation and during therapy; perform thyroid function tests and manage as clinically indicated. Monitor blood calcium levels during therapy; withhold and resume at reduced dose upon recovery or permanently discontinue based on severity. Severe hepatic impairment (Child-Pugh C): avoid. Severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).
CABOMETYX Classification:
Kinase inhibitor.
CABOMETYX 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 Adult dose.
Adverse Reactions:
Diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation; also with nivolumab: hepatotoxicity, stomatitis, rash, hypothyroidism, musculoskeletal pain, dysgeusia, abdominal pain, cough, upper RTI.
Generic Drug Availability:
NO
How Supplied:
Tabs—30
Pancreatic, thyroid, and other endocrine cancers:
Indications for: CABOMETYX
As a single agent for patients with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.
Adult Dosage:
Swallow whole. Take at least 1hr before or 2hrs after food. ≥12yrs (BSA ≥1.2m2): 60mg once daily; (BSA <1.2m2): 40mg once daily. Continue 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 (Child-Pugh B): reduce starting dose by 20mg. Dose modifications for adverse reactions: see full labeling.
Children Dosage:
<12yrs: not established.
CABOMETYX Warnings/Precautions:
Not substitutable with cabozantinib caps. Permanently discontinue if the following occurs: GI perforation, GI fistula (Grade 4), severe hemorrhage (Grade 3/4), acute MI, serious thromboembolic events that require medical intervention, hypertensive crisis or severe hypertension despite optimal medical management, nephrotic syndrome, reversible posterior leukoencephalopathy syndrome; with nivolumab: if AST or AST >10×ULN or >3×ULN with total bilirubin ≥2×ULN. Withhold for intolerable Grade 2 reactions, Grade 3/4 reactions, or osteonecrosis of the jaw; with nivolumab: for ALT or AST >3×ULN but ≤10×ULN with total bilirubin <2×ULN. 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. Higher risk of hepatotoxicity (with nivolumab); monitor liver enzymes prior to initiation and more frequently during treatment; withhold (consider corticosteroid therapy) and resume at reduced dose based on severity. Risk of adrenal insufficiency (with nivolumab); withhold therapy based on severity. 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. Impaired wound healing: withhold for ≥3 weeks prior to elective surgery (including dental); do not give for ≥2 weeks after major surgery and until adequate healing. Monitor for thyroid dysfunction prior to initiation and during therapy; perform thyroid function tests and manage as clinically indicated. Monitor blood calcium levels during therapy; withhold and resume at reduced dose upon recovery or permanently discontinue based on severity. Severe hepatic impairment (Child-Pugh C): avoid. Severe renal impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).
CABOMETYX Classification:
Kinase inhibitor.
CABOMETYX 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 Adult dose.
Adverse Reactions:
Diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation; also with nivolumab: hepatotoxicity, stomatitis, rash, hypothyroidism, musculoskeletal pain, dysgeusia, abdominal pain, cough, upper RTI.
Generic Drug Availability:
NO
How Supplied:
Tabs—30
