Composition: Each capsule contains Acalabrutinib INN 100mg.
Mantle Cell Lymphoma: Acalabrutinib 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 approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Chronic
Lymphocytic Leukemia or Small Lymphocytic Lymphoma: Acalabrutinib is
indicated for the treatment of adult patients with chronic lymphocytic leukemia
(CLL) or small lymphocytic lymphoma (SLL).
Dosage and Administration:
Acalabrutinib as Monotherapy: For patients with MCL, CLL, or SLL, the
recommended dose of Acalabrutinib is 100 mg taken orally approximately every 12
hours until disease progression or unacceptable toxicity. Acalabrutinib in
Combination with Obinutuzumab: For patients with previously untreated CLL
or SLL, the recommended dose of Acalabrutinib is 100 mg taken orally
approximately every 12 hours until disease progression or unacceptable
toxicity. Start Acalabrutinib at Cycle 1 (each cycle is 28 days). Start
Obinutuzumab at Cycle 2 for a total of 6 cycles and refer to the Obinutuzumab
prescribing information for recommended dosing. Administer Acalabrutinib prior
to Obinutuzumab when given on the same day. Advise patients to swallow capsule
whole with water. Advise patients not to open, break or chew the capsules.
Acalabrutinib may be taken with or without food. If a dose of Acalabrutinib 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 Acalabrutinib should
not be taken to make up for a missed dose. Recommended Dosage for Hepatic
Impairment: Avoid administration of Acalabrutinib in patients with severe
hepatic impairment. Dose modifications are not required for patients with mild
or moderate hepatic impairment. Or, as directed by the registered physicians.
Use in Pregnancy and Lactation: Acalabrutinib
may cause fetal harm and dystocia when administered to a pregnant woman. There
are no available data in pregnant women to inform the drug-associated risk.
Pregnant women should be advised of the potential risk to a fetus.
Packing: Each container contains 60 capsules in a box.