Adult Dosing
Mantle cell lymphoma (MCL)
- Recommended dose: 560 mg (four 140 mg capsules) PO Daily
Note:
- Do not open, break, or chew the capsules
- Refer to package insert for dose modifications for adverse reactions and for use with CYP3A inhibitors
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- > 25mL/min: No dose adjustments
- < 25mL/min:: Dose adjustments not defined
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustments not defined
Dose Modifications for Adverse Reactions
- Interrupt therapy for any Grade 3 or greater non-hematological, Grade 3 or greater neutropenia with infection or fever, or Grade 4 hematological toxicities.
- Once the symptoms of the toxicity have resolved to Grade 1 or baseline (recovery), therapy may be reinitiated at the starting dose.
- If the toxicity reoccurs, reduce dose by one capsule (140 mg per day). A second reduction of dose by 140 mg may be considered as needed. If these toxicities persist or recur following two dose reductions, discontinue therapy.
Dose Modifications for Use with CYP3A Inhibitors
- Avoid co-administration with strong or moderate CYP3A inhibitors and consider alternative agents with less CYP3A inhibition.
- CYP3A Inhibitors: Avoid co-administration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce dose.
- CYP3A Inducers: Avoid co-administration with strong CYP3A inducers
Pregnancy Category:D
Breastfeeding: Safety unknown. As many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
