Acalabrutinib

INDICATIONS AND USAGE

LuciAcal is a kinase inhibitor 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.

• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

DOSAGE AND ADMINISTRATION

• Recommended dose is 100 mg orally approximately every 12 hours; swallow whole with water and withor without food.
• Advise patients not to break, open, or chew capsules.
• Manage toxicities using treatment interruption, dose reduction, or discontinuation.

DAvoid LuciAcal in patients with severe hepatic impairment.

DOSAGE FORMS AND STRENGTHS

Capsules: 100 mgx60 capsules