Acalanib

Acalabrutinib INN

Composition: Each capsule contains Acalabrutinib INN 100mg.

Indications: 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.

Prescribing Description

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