Chronic lymphocytic leukaemia

Active Ingredient: Acalabrutinib

Indication for Acalabrutinib

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

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:

100 mg twice daily

For:

Dosage regimens

Oral, 100 milligrams acalabrutinib, 2 times daily.

Detailed description

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.

Dose adjustments

Recommended dose modifications of acalabrutinib for Grade ≥ 3 adverse reactions are provided in the following table.

Recommended dose adjustments for adverse reactions*:

Adverse reactionAdverse
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.

Missed dose

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.

Dosage considerations

It should be taken at approximately the same time each day, with or without food.

Active ingredient

Acalabrutinib

Acalabrutinib is a small-molecule inhibitor of BTK (Bruton’s tyrosine kinase). Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. In nonclinical studies, acalabrutinib inhibited BTK-mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and tumor growth in mouse xenograft models.

Read more about Acalabrutinib

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