Active Ingredient: Acalabrutinib
Acalabrutinib is indicated for the treatment of adult patients with small lymphocytic lymphoma (SLL).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 100 milligrams acalabrutinib, 2 times daily.
The recommended dose of acalabrutinib is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity.
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 dose modifications of Acalabrutinib for Grade 3 or greater adverse reactions are provided in the following table.
Recommended Dose Modifications for Adverse Reactions:
| Event | Adverse Reaction Occurrence | Dose Modification (Starting dose = 100 mg approximately every 12 hours) |
|---|---|---|
| Grade 3 or greater non-hematologic toxicities, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia or Grade 4 neutropenia lasting longer than 7 days | First and Second | Interrupt acalabrutinib. Once toxicity has resolved to Grade 1 or baseline level, acalabrutinib may be resumed at 100 mg approximately every 12 hours. |
| Third | Interrupt acalabrutinib. Once toxicity has resolved to Grade 1 or baseline level, acalabrutinib may be resumed at a reduced frequency of 100 mg once daily. | |
| Fourth | Discontinue acalabrutinib. |
Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Refer to the obinutuzumab prescribing information for management of obinutuzumab toxicities.
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