API- Acalabrutinib

Packaging- Capsules

Strength-100 mg

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Acalabrutinib is a kinase inhibitor used for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received at least one therapy.

Dosage and Side Effects

The recommended dose of Acalabrutinib is 100 mg taken orally approximately every twelve hours until the disease is progressive or unacceptable toxicity occurs. Patients should swallow the acalabrutinib capsules whole with water. It is advisable not to open, break or chew the capsules. The dosage of Acalabrutinib may be taken with or without food. If a dose is missed by more than 3 hours, it should be skipped and the next scheduled dose should be taken at its regularly scheduled time. Extra capsules of acalabrutinib should not be taken in order to make up for a missed dose.

The most commonly reported side effects due to Acalabrutinib may include: neutropenia, anemia, thrombocytopenia, headache, diarrhea, fatigue, myalgia, and bruising.

Warning and Precautions

  • Severe hemorrhagic events, including fatal events, have emerged. The acalabrutinib 100 mg capsule may further increase the probability of hemorrhage in patients taking antiplatelet or anticoagulant therapies and patients should be assessed for signs of bleeding.
  • Severe infections (viral, bacterial or fungal), including fatal events and opportunistic infections have emerged. Assess patients for signs/symptoms of infection and treat them as medically appropriate.
  • Second primary malignancies, including non-skin carcinomas, have been observed in patients with hematologic malignancies treated with acalabrutinib 100 mg monotherapy. Protection from sun exposure is required.
  • Patients with hematologic malignancies treated with acalabrutinib monotherapy, atrial fibrillation and atrial flutter of any grade observed. Assess for atrial flutter and atrial fibrillation and manage as appropriate.
  • Periodic blood tests are needed to check blood counts during treatment with acalabrutinib. It is advisable to counsel patients to report any signs of dizziness, palpitations, shortness of breath, lightheadedness, fainting, and chest discomfort.


What is Acalabrutinib?

Acalabrutinib is a chemotherapy and an anticancer drug formulated to treat adults with mantle cell lymphoma (a type of non-Hodgkin lymphoma). This oral therapy is prescribed after the failure of other existing treatments.

What dosage strengths Acalabrutinib is supplied?

Acalabrutinib is supplied in the form of capsules as 100 mg dosage strength. 

How is Acalabrutinib taken?

Acalabrutinib comes as a capsule to be taken orally. It is typically taken with or without meals every 12 hours (twice daily) for as long as a health specialist prescribed.

What type of medicine is Acalabrutinib?

Acalabrutinib specifically is a type of medicine known as kinase inhibitor.