July 27, 2016
Recommended Topic Related To:

Cometriq

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Cometriq




Indications
Dosage
How Supplied

INDICATIONS

COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).

DOSAGE AND ADMINISTRATION

Recommended Dose

Do NOT substitute COMETRIQ capsules with cabozantinib tablets.

The recommended daily dose of COMETRIQ is 140 mg (one 80-mg and three 20-mg capsules). Do not administer COMETRIQ with food. Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking COMETRIQ. Continue treatment until disease progression or unacceptable toxicity occurs.

Swallow COMETRIQ capsules whole. Do not open COMETRIQ capsules.

Do not take a missed dose within 12 hours of the next dose.

Do not ingest foods (e.g., grapefruit, grapefruit juice) or nutritional supplements that are known to inhibit cytochrome P450 while taking COMETRIQ.

In Patients with Hepatic Impairment: The recommended starting dose of COMETRIQ for patients with mild to moderate hepatic impairment is 80 mg [see Use in Specific Populations, CLINICAL PHARMACOLOGY].

Dosage Modifications

For Adverse Reactions

Withhold COMETRIQ for NCI CTCAE Grade 4 hematologic adverse reactions, Grade 3 or greater non-hematologic adverse reactions or intolerable Grade 2 adverse reactions.

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

  • If previously receiving 140 mg daily dose, resume treatment at 100 mg daily (one 80-mg and one 20-mg capsule)
  • If previously receiving 100 mg daily dose, resume treatment at 60 mg daily (three 20-mg capsules)
  • If previously receiving 60 mg daily dose, resume at 60 mg if tolerated, otherwise, discontinue COMETRIQ

Permanently discontinue COMETRIQ for any of the following:

In Patients Concurrently Taking A Strong CYP3A4 Inhibitor

Reduce the daily COMETRIQ dose by 40 mg (for example, from 140 mg to 100 mg daily or from 100 mg to 60 mg daily). Resume the dose that was used prior to initiating the CYP3A4 inhibitor 2 to 3 days after discontinuation of the strong inhibitor [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].

In Patients Concurrently Taking A Strong CYP3A4 Inducer

Increase the daily COMETRIQ dose by 40 mg (for example, from 140 mg to 180 mg daily or from 100 mg to 140 mg daily) as tolerated. Resume the dose that was used prior to initiating the CYP3A4 inducer 2 to 3 days after discontinuation of the strong inducer. The daily dose of COMETRIQ should not exceed 180 mg [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

COMETRIQ 20-mg gelatin capsules are grey with “XL184 20mg” printed in black on the body of the capsule.

COMETRIQ 80-mg gelatin capsules are Swedish orange with “XL184 80mg” printed in black on the body of the capsule.

Storage And Handling

COMETRIQ 20 mg capsules are supplied as hard gelatin capsules with grey cap and grey body, printed with “XL184 20mg” in black ink and containing cabozantinib (S)-malate salt equivalent to 20 mg cabozantinib.

COMETRIQ 80 mg capsules are supplied as hard gelatin capsules with Swedish orange cap and Swedish orange body, printed with “XL184 80mg” in black ink and containing cabozantinib (S)malate salt equivalent to 80 mg cabozantinib.

COMETRIQ capsules are supplied as follows:

Cartons

140 mg daily-dose carton NDC#42388-011-14

Containing four 140 mg daily-dose blister cards (each blister card contains seven 80-mg and twenty-one 20-mg capsules)

100 mg daily-dose carton NDC#42388-012-14

Containing four 100 mg daily-dose blister cards (each blister card contains seven 80-mg and seven 20-mg capsules)

60 mg daily-dose carton NDC#42388-013-14

Containing four 60 mg daily-dose blister cards (each blister card contains twenty-one 20-mg capsules)

Store COMETRIQ at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Manufactured for Exelixis, Inc. South San Francisco, CA 94080. Revised: May 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/6/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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