Active Ingredient: Acalabrutinib
Acalabrutinib as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Acalabrutinib as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 100 milligrams acalabrutinib, 2 times daily.
The recommended dose is 100 mg acalabrutinib twice daily (equivalent to a total daily dose of 200 mg). Refer to obinutuzumab prescribing information for recommended obinutuzumab dosing information.
The dose interval is approximately 12 hours.
Treatment with acalabrutinib should be continued until disease progression or unacceptable toxicity.
Recommended dose modifications of acalabrutinib for Grade ≥ 3 adverse reactions are provided in the following table.
Recommended dose adjustments for adverse reactions*:
| Adverse reaction | Adverse reaction occurrence | Dose modification (Starting dose = 100mg approximately every 12 hours) |
|---|---|---|
| Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia Or Grade 4 neutropenia lasting longer than 7 days Grade 3 or greater non- haematological toxicities | First and second | Interrupt acalabrutinib Once toxicity has resolved to Grade 1 or baseline, acalabrutinib may be resumed at 100mg approximately every 12 hours |
| Third | Interrupt acalabrutinib Once toxicity has resolved to Grade 1 or baseline, acalabrutinib may be resumed at a reduced frequency of 100mg once daily | |
| Fourth | Discontinue acalabrutinib |
* Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
If a patient misses a dose of acalabrutinib by more than 3 hours, the patient should be instructed to take the next dose at its regularly scheduled time. Double dose of acalabrutinib should not be taken to make up for a missed dose.
It should be taken at approximately the same time each day, with or without food.
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