Acalabrutinib INN

Composition: Each capsule contains 100mg of Acalabrutinib INN.

Indications: Acalabrutinib is approved for treating adult patients with mantle cell lymphoma (MCL) who have undergone at least one prior therapy, and for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Dosage and Administration:
– Acalabrutinib Monotherapy: The recommended dose for MCL, CLL, or SLL patients is 100 mg taken orally every 12 hours until disease progression or unacceptable side effects.
– Acalabrutinib in Combination with Obinutuzumab: For previously untreated CLL or SLL patients, start Acalabrutinib at 100 mg orally every 12 hours from Cycle 1 (each cycle being 28 days), and Obinutuzumab at Cycle 2 for a total of 6 cycles. Refer to Obinutuzumab prescribing information for dosing details. Administer Acalabrutinib before Obinutuzumab if given on the same day. Swallow capsules whole with water and do not open, break, or chew them. Acalabrutinib can be taken with or without food. If a dose is missed by more than 3 hours, skip it and take the next dose as scheduled. Extra capsules should not be taken to compensate for a missed dose.
– Recommended Dosage for Hepatic Impairment: Severe hepatic impairment patients should avoid Acalabrutinib, while no dose adjustments are needed for those with mild or moderate impairment.

Use in Pregnancy and Lactation: Acalabrutinib may cause fetal harm and dystocia if used during pregnancy, but there is insufficient data to determine the associated risk. Pregnant women should be informed about potential risks to the fetus.

Packing: Each box contains 60 capsules in a container.