"The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine"...
COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).
DOSAGE AND ADMINISTRATION
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 during COMETRIQ.
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:
- development of visceral perforation or fistula formation
- severe hemorrhage
- serious arterial thromboembolic event (e.g., myocardial infarction, cerebral infarction)
- nephrotic syndrome
- malignant hypertension, hypertensive crisis, persistent uncontrolled hypertension despite optimal medical management
- osteonecrosis of the jaw
- reversible posterior leukoencephalopathy syndrome
In Patients with Hepatic Impairment
In Patients Taking CYP3A4 Inhibitors
Avoid the use of concomitant strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) in patients receiving COMETRIQ [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
For patients who require treatment with 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.
In Patients Taking Strong CYP3A4 Inducers
Avoid the chronic use of concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) if alternative therapy is available [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
Do not ingest foods or nutritional supplements (e.g., St. John's Wort (Hypericum perforatum)) that are known to induce cytochrome P450 activity.
For patients who require treatment with 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.
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:
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)
Bottle containing sixty 20-mg COMETRIQ capsules NDC#42388-014-25
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].
Distributed by Exelixis, Inc. Revised: 11/2012
Last reviewed on RxList: 12/6/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Cometriq Information
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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