Active Ingredient: Acalabrutinib
Acalabrutinib in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 100 milligrams acalabrutinib, 2 times daily.
The recommended dose of acalabrutinib in monotherapy or in combination with other medicinal products is 100 mg acalabrutinib twice daily (equivalent to a total daily dose of 200 mg).
Acalabrutinib dose interval is approximately 12 hours.
Treatment with acalabrutinib in combination with venetoclax without obinutuzumab, should continue until disease progression, unacceptable toxicity or completion of 14 cycles of treatment (each cycle is 28 days).
Acalabrutinib should be administered on Day 1 of Cycle 1 for a total of 14 cycles. Venetoclax should be administered on Day 1 of Cycle 3 for a total of 12 cycles, starting at 20 mg and increasing weekly to 50 mg, 100 mg, 200 mg and finally 400 mg.
If acalabrutinib is given in combination with venetoclax and obinutuzumab, obinutuzumab should be administered at 100 mg on Day 1 of Cycle 2, followed by 900 mg which may be administered on Day 1 or 2. Administer obinutuzumab at 1 000 mg on Day 8 and 15 of Cycle 2, followed by 1 000 mg on Day 1 of Cycles 3 to 7. Obinutuzumab is administered for a total of 6 cycles.
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.
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