INDICATIONS
Acaluxen is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
DOSAGE AND ADMINISTRATION
Recommended Dosage
The recommended dose of Acaluxen is 100 mg taken orally approximately every twelve hours until disease progression or unacceptable toxicity.
Advise patients to swallow capsule whole with water. Advise patients not to open, break or chew the capsules. Acaluxen may be taken with or without food. If a dose of Acaluxen is missed by more than 3 hours, it should be skipped and the next dose should be taken at its regularly scheduled time. Extra capsules of Acaluxen should not be taken to make up for a missed dose.
Dose Modifications
Recommended Dose Modifications for Adverse Reactions: Dosage of Acalabrutinib can be reduced up to 100 mg daily for the toxicity has resolved to Grade 1 or baseline level. If the adverse reaction occurrence more than four times Acalabrutinib can be Discontinue.
