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Exelixis, Inc. Drugs
2.1 Recommended Dose
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 treatment.
2.2 Dosage Adjustments
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
COMETRIQ is not recommended for use in patients with moderate and severe hepatic impairment [see Warnings and Precautions (5.11) and Use in Specific Populations (8.6)].
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 (5.10) and Drug Interactions7.1)].
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 (5.10) and Drug Interactions (7.2)].
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.
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