Butinib

Ibrutinib INN

Composition: Each capsule contains Ibrutinib INN 140 mg.

Indications: Mantle Cell Lymphoma: Butinib is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Butinib is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p Deletion: Butinib is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p
deletion. Waldenström’s Macroglobulinemia: Butinib is indicated for the treatment of adult patients with Waldenström's macroglobulinemia (WM). Marginal Zone Lymphoma: Butinib is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.

Dosage and Administration: Mantle Cell Lymphoma and Marginal Zone Lymphoma: The recommended dose of Butinib for MCL and MZL is 560 mg orally once daily until disease
progression or unacceptable toxicity. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenström’s Macroglobulinemia: The recommended dose of Butinib for
CLL/SLL and WM as a single agent, in combination with Rituximab for WM, or in combination with Bendamustine and Rituximab for CLL/SLL is 420 mg orally once daily until disease progression or unacceptable toxicity. When madministering Butinib in combination with Rituximab, it should be administered prior to Rituximab when given on the same day.
Chronic Graft versus Host Disease: The recommended dose of Butinib for cGVHD is 420 mg orally once daily until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity. When a patient no longer requires therapy for the treatment of cGVHD, Butinib should be discontinued considering the medical assessment of the individual patient. Or, as directed by the registered physicians.

Use in Pregnancy and Lactation: There are no available data on Butinib use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. If Butinib is used during pregnancy or if the patient becomes pregnant while taking Butinib, the patient should be apprised of the potential hazard to the fetus. Lactation: There is no information regarding the presence of Ibrutinib or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

Packing: Each box contains 30 capsules in a blister pack.

Prescribing Description

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