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Cabozantinib Dosage

Applies to the following strength(s): 140 mg daily-dose ; 100 mg daily-dose ; 60 mg daily-dose ; 60 mg ; 20 mg ; 40 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Thyroid Cancer

140 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity occurs.

Comments:
-Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking this drug.
-Advise patients the capsule form of this drug cannot be substituted with the tablet form of this drug.

Use: Treatment of progressive, metastatic medullary thyroid cancer (MTC).

Usual Adult Dose for Renal Cell Carcinoma

60 mg orally once a day

Duration of therapy: Until patient no longer experiences clinical benefit or unacceptable toxicity occurs.

Comments:
-Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking this drug.
-Advise patients the tablet form of this drug cannot be substituted with the capsule form of this drug.

Use: Treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Renal Dose Adjustments

-Mild to Moderate Renal Dysfunction: No adjustment recommended.
-Severe Renal Dysfunction: Data not available.

Liver Dose Adjustments

Capsule formulation (MTC):
-Mild to Moderate Hepatic Impairment: 80 mg orally once a day.
-Severe Hepatic Impairment: Not recommended.

Tablet formulation (RCC):
-Mild to Moderate Hepatic Impairment: 40 mg orally once a day.
-Severe Hepatic Impairment: Not recommended.

Dose Adjustments

Capsule formulation (MTC):
Adverse Reactions (NCI CTCAE Grade 4 Hematologic; Grade 3 or Greater Non-Hematologic; or Intolerable Grade 2): Withhold treatment until improvement of the adverse reaction to baseline or resolution to Grade 1; then adjust the dose as follows:
-If previous dose 140 mg/day: Reduce dose to 100 mg/day.
-If previous dose 100 mg/day: Reduce dose to 60 mg/day.
-If previous dose 60 mg/day: Do not dose reduce; resume at 60 mg/day if tolerated or discontinue the drug.

Concomitant Use of Strong CYP450 3A4 Inhibitors:
-Not recommended.
-If concomitant use is necessary, reduce the dose of this drug by 40 mg (e.g., from 140 mg/day to 100 mg/day).
-Resume the dose used prior to initiation of the strong CYP450 3A4 inhibitor 2 to 3 days after discontinuation of the 3A4 inhibitor.

Concomitant Use of Strong CYP450 3A4 Inducers:
-Not recommended if alternative therapy is available.
-If concomitant use is necessary, increase the dose of this drug by 40 mg (e.g., from 140 mg/day to 180 mg/day) as tolerated.
-Resume the dose used prior to initiation of the strong CYP450 3A4 inducer 2 to 3 days after discontinuation of the 3A4 inducer.
-Maximum Dose: 180 mg/day

Tablet formulation (RCC):
Scheduled Surgery: Stop treatment at least 28 days prior to scheduled surgery, including dental surgery.

Adverse Reactions (NCI CTCAE Grade 4, Grade 3, or Intolerable Grade 2): Withhold treatment until improvement of the adverse reaction to baseline or resolution to Grade 1; then adjust the dose as follows:
-If previous dose 60 mg/day: Reduce dose to 40 mg/day.
-If previous dose 40 mg/day: Reduce dose to 20 mg/day.
-If previous dose 20 mg/day: Do not dose reduce; resume at 20 mg/day if tolerated or discontinue the drug.

Concomitant Use of Strong CYP450 3A4 Inhibitors:
-Not recommended.
-If concomitant use is necessary, reduce the dose of this drug by 20 mg (e.g., from 60 mg/day to 40 mg/day).
-Resume the dose used prior to initiation of the strong CYP450 3A4 inhibitor 2 to 3 days after discontinuation of the 3A4 inhibitor.

Concomitant Use of Strong CYP450 3A4 Inducers:
-Not recommended if alternative therapy is available.
-If concomitant use is necessary, increase the dose of this drug by 20 mg (e.g., from 60 mg/day to 80 mg/day) as tolerated.
-Resume the dose used prior to initiation of the strong CYP450 3A4 inducer 2 to 3 days after discontinuation of the 3A4 inducer.
-Maximum Dose: 80 mg/day

Permanently Discontinue Treatment (either capsule or tablet formulation):
-Development of perforation or fistula formation;
-Severe hemorrhage;
-Arterial thromboembolic event (e.g., myocardial infarction, cerebral infarction);
-Nephrotic syndrome;
-Malignant hypertension, hypertensive crisis, severe hypertension despite optimal medical management;
-Osteonecrosis of the jaw;
-Reversible posterior leukoencephalopathy syndrome.

Precautions

US BOXED WARNINGS:
-Perforations and Fistulas: Gastrointestinal (GI) perforations were reported in 3% and fistula formation in 1% of patients. Discontinue this drug if either occur.
-Hemorrhage: Severe, sometimes fatal, hemorrhage including hemoptysis and GI hemorrhage occurred in 3% of patients. Monitor for signs and symptoms of bleeding. Do not administer this drug to patients with severe hemorrhage.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration Advice:
-Do not open/break/crush/chew tablets or capsules; swallow whole with a full glass of water.
-Do not take a missed dose if it is less than 12 hours before the next dose.
-Do not ingest foods (e.g., grapefruit) or nutritional supplements (e.g., St. John's Wort) that are known to inhibit or induce CYP450 activity while taking this drug.

Storage Requirements:
-Store at 20 to 25 degrees Celsius (68 to 77 Fahrenheit).
-Keep in the original package to protect from moisture.

Monitoring:
-Cardiovascular: Blood pressure (prior to and regularly during treatment)
-Musculoskeletal: Oral exam (prior to and periodically during treatment due to ONJ risk)
-Renal: Urine protein (regularly during treatment)

Patient Advice:
-This drug may cause side effects such as dizziness that can affect your ability to perform certain activities; avoid driving and activities such as operating machinery until you know how this drug affects you.

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