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Cabometyx Dosage

Medically reviewed by Drugs.com. Last updated on Sep 30, 2021.

Generic name: cabozantinib s-malate 60mg
Dosage form: tablet

Important Dosage Information

  • Stop treatment with CABOMETYX at least 3 weeks prior to scheduled surgery, including dental surgery [see Warnings and Precautions (5.1, 5.10, 5.11)].
  • Do not substitute CABOMETYX tablets with cabozantinib capsules.

Recommended Dosage for Renal Cell Carcinoma

The recommended dosage of CABOMETYX as a single agent is 60 mg once daily until disease progression or unacceptable toxicity administered as recommended [see Dosage and Administration (2.9)].

The recommended dosage of CABOMETYX in combination with nivolumab is provided in the following table:

Table 1. Recommended Dosage of CABOMETYX in Combination with Nivolumab
Recommended Dosage Duration of Therapy
CABOMETYX 40 mg once daily without food until disease progression or unacceptable toxicity
Nivolumab 240 mg every 2 weeks (30-minute intravenous infusion) or 480 mg every 4 weeks (30- minute intravenous infusion) until disease progression or unacceptable toxicity for up to 2 years

Recommended Dosage for Hepatocellular Carcinoma

The recommended dosage of CABOMETYX as a single agent is 60 mg once daily until disease progression or unacceptable toxicity administered as recommended [see Dosage and Administration (2.9)].

Recommended Dosage for Differentiated Thyroid Cancer

The recommended dosage of CABOMETYX as a single agent for adult and pediatric patients 12 years of age and older with BSA greater than or equal to 1.2 m2 is 60 mg once daily until disease progression or unacceptable toxicity administered as recommended [see Dosage and Administration (2.9), Clinical Pharmacology (12.3)].

The recommended dosage of CABOMETYX as a single agent in pediatric patients 12 years of age and older with BSA less than 1.2 m2 is 40 mg once daily until disease progression or unacceptable toxicity administered as recommended [see [see Dosage and Administration (2.9), Clinical Pharmacology (12.3)].

Dosage Modifications for Adverse Reactions

Withhold CABOMETYX for:

  • Intolerable Grade 2 adverse reactions
  • Grade 3 or 4 adverse reactions
  • Osteonecrosis of the jaw

Upon resolution/improvement (i.e., return to baseline or resolution to Grade 1) of an adverse reaction, reduce the dose as follows:

Table 2. Recommended Dosage Reductions for CABOMETYX for Adverse Reactions
Recommended Dosage First Dosage Reduction To Second Dosage Reduction To
*
If previously receiving lowest dose, resume at same dose. If lowest dose not tolerated, discontinue CABOMETYX.
CABOMETYX 60 mg daily in adult and pediatric patients with BSA greater than or equal to 1.2 m2 40 mg daily 20 mg daily*
CABOMETYX 40 mg daily in pediatric patients with BSA less than 1.2 m2 20 mg daily 20 mg every other day*
CABOMETYX 40 mg daily in combination with nivolumab 20 mg daily 20 mg every other day*
Table 3. Recommended Dosage Modifications for CABOMETYX Adverse Reactions
Adverse Reaction Severity* CABOMETYX Dosage Modification
*
Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0)
Hemorrhage [see Warnings and Precautions (5.1)] Grade 3 or 4
  • Permanently discontinue CABOMETYX
Perforations and Fistulas [see Warnings and Precautions (5.2)] Any grade gastrointestinal perforation or

Grade 4 fistula
  • Permanently discontinue CABOMETYX
Thrombotic Events [see Warnings and Precautions (5.3)] Any grade acute myocardial infarction or

Grade 2 or higher cerebral infarction or

Grade 3 or 4 arterial thromboembolic events or

Grade 4 venous thromboembolic events
  • Permanently discontinue CABOMETYX
Hypertension and Hypertensive Crisis [see Warnings and Precautions (5.4)] Grade 3
  • Withhold CABOMETYX until hypertension is adequately controlled to ≤Grade 2
  • Resume at reduced dose
  • Permanently discontinue CABOMETYX for hypertension that cannot be controlled
Grade 4
  • Permanently discontinue CABOMETYX
Diarrhea [see Warnings and Precautions (5.5)] Grade 2, Grade, or Grade 4
  • Withhold CABOMETYX until ≤Grade 1
  • Resume at reduced dose
Palmar-Plantar Erythrodysesthesia [see Warnings and Precautions (5.6)] Intolerable Grade 2 or Grade 3
  • Withhold CABOMETYX until ≤Grade 1
  • Resume at reduced dose
Proteinuria [see Warnings and Precautions (5.9)] Grade 2 or 3
  • Withhold CABOMETYX until improvement to ≤ Grade 1 proteinuria
  • Resume at a reduced dose
  • Permanently discontinue CABOMETYX for nephrotic syndrome
Osteonecrosis of the jaw (ONJ) [see Warnings and Precautions (5.10)] Any grade
  • Withhold CABOMETYX for development of ONJ until complete resolution
  • Resume at reduced dose
Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.12)] Any grade
  • Permanently discontinue CABOMETYX
Other Adverse Reactions [see Adverse Reactions (6.1)] Intolerable Grade 2,

or Grade 3,

or Grade 4
  • Withhold CABOMETYX until improvement to baseline or ≤Grade 1
  • Resume at reduced dose

The following table represents dosage modifications for the drug administered in combination that are different from those described above for CABOMETYX or in the Full Prescribing Information:

Table 4. Recommended Specific Dosage Modifications for Hepatic Adverse Reactions for Combination
*
Consider corticosteroid therapy for hepatic adverse reactions if CABOMETYX is withheld or discontinued when administered in combination with nivolumab
After recovery, rechallenge with one or both of CABOMETYX and nivolumab may be considered. If rechallenging with nivolumab with or without CABOMETYX, refer to nivolumab Prescribing Information.
CABOMETYX in combination with nivolumab ALT or AST >3 times ULN but ≤10 times ULN with concurrent total bilirubin <2 times ULN Withhold* both CABOMETYX and nivolumab until adverse reactions recover to Grades 0 or 1
ALT or AST >10 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN Permanently discontinue both CABOMETYX and nivolumab

When administering CABOMETYX in combination with nivolumab for the treatment of advanced RCC, refer to the nivolumab prescribing information.

Dosage Modifications for Coadministration with Strong CYP3A4 Inhibitors

Reduce the daily CABOMETYX dose by 20 mg (for example, from 60 mg to 40 mg daily or from 40 mg to 20 mg daily or from 20 mg daily to 20 mg every other day in pediatric patients with BSA less than 1.2 m2). Resume the dose that was used prior to initiating the strong CYP3A4 inhibitor 2 to 3 days after discontinuation of the strong inhibitor [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Dosage Modifications for Coadministration with Strong CYP3A4 Inducers

Increase the daily CABOMETYX dose by 20 mg (for example, from 60 mg to 80 mg daily or from 40 mg to 60 mg daily) as tolerated. Resume the dose that was used prior to initiating the strong CYP3A4 inducer 2 to 3 days after discontinuation of the strong inducer. Do not exceed a daily dose of 80 mg [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Dosage Modifications for Patients with Moderate and Severe Hepatic Impairment

Reduce the starting dose of CABOMETYX 60 mg daily to 40 mg daily or 40 mg daily to 20 mg daily (for pediatric patients with BSA less than 1.2 m2) in patients with moderate hepatic impairment (Child-Pugh B) [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Administration

Do not administer CABOMETYX with food. Administer at least 1 hour before or at least 2 hours after eating [see Clinical Pharmacology (12.3)].

  • Swallow CABOMETYX tablets whole. Do not crush CABOMETYX tablets.
  • Do not take a missed dose within 12 hours of the next dose.
  • Modify the CABOMETYX dose for patients taking drugs known to strongly induce or inhibit CYP3A4 and for patients with moderate hepatic impairment [see Dosage and Administration (2.6, 2.7, 2.8)].

Frequently asked questions

Further information

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