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Mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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IbrutixIMBRUVICAis a kinase inhibitor indicated for the treatment of adult patients with:

1. Mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

2. Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.2).

3. Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion

4. Waldenström’s macroglobulinemia (WM)

5. Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

6. Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy

DOSAGE AND ADMINISTRATION

1.MCL and MZL: 560 mg taken orally once daily (four 140 mg capsules once daily)

2.CLL/SLL, WM, and cGVHD: 420 mg taken orally once daily (three 140 mg capsules once daily).

Capsules should be taken orally with a glass of water. Do not open, break, or chew the capsules

Ibrutix’s brand name is IMBRUVICA®by Janssen. Ibrutix is a generic oncologic prescription medicine from Beacon, which is one of the biggest pharmaceutical company in Bangladesh.

For more Prescribing information,please check the → “FDA Prescribing Information”.

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