Description

Product Features

Product Name	:	Butinib
Generic Name	:	Ibrutinib
Formulation	:	Capsules
Available Pack Size	:	112’s Pot
Available Strength	:	140 mg
Registrations	:	Export Only

 

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 administering 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. 

 

Side Effects

• Hemorrhage
• Infections
• Cytopenias
• Cardiac Arrhythmias
• Hypertension
• Second Primary Malignancies
• Tumor Lysis Syndrome

Contraindication: It is contraindicated in patients with known hypersensitivity to Ibrutinib or any other components of this product.

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.

 

Contraception

Females: Females of reproductive potential should be advised to avoid pregnancy while taking Butinib and for up to 1 month after ending treatment. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus. Males: Men should be advised to avoid fathering a child while receiving Butinib, and for 1 month following the last dose of Butinib.

Pediatric Use: The safety and effectiveness of Butinib in pediatric patients has not been established. Pediatric studies have not been completed.

 

Precautions

Hemorrhage: Fatal bleeding events have occurred in patients treated with Butinib. Grade 3 or higher bleeding events (intracranial hemorrhage (including subdural hematoma), gastrointestinal bleeding, hematuria, and post procedural hemorrhage) have occurred in 3% of patients, with fatalities occurring in 0.3% of 1,011 patients exposed to Butinib in clinical trials. Bleeding events of any grade, including bruising and petechiae, occurred in 44% of patients treated with Butinib. Butinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding. The benefit-risk should be considered of withholding Butinib for at least 3 to 7 days pre and postsurgery depending upon the type of surgery and the risk of bleeding.

 

Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with Butinib therapy. Grade 3 or greater infections occurred in 24% of 1,011 patients exposed to Butinib in clinical trials. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with Butinib. Prophylaxis should be considered according to standard of care in patients who are at increased risk for opportunistic infections. Patients should be monitored and evaluated for fever and infections and treated appropriately.

 

Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (23%), thrombocytopenia (8%), and anemia (3%) based on laboratory measurements occurred in patients with B-cell malignancies treated with single agent Butinib. Complete blood counts should be monitored monthly.

 

Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred with Butinib therapy. Grade 3 or greater ventricular tachyarrhythmias occurred in 0.2% of patients, and Grade 3 or greater atrial fibrillation and atrial flutter occurred in 4% of 1,011 patients exposed to Butinib inclinical trials. These events have occurred particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of cardiac arrhythmias. Periodically patients should be monitored clinically for cardiac arrhythmias.

 

Hypertension: Hypertension has occurred in 12% of 1,011 patients treated with Butinib in clinical trials with a median time to onset of 5 months (range, 0.03 to 22 months). Patients should be monitored for new onset hypertension or hypertension that is not adequately controlled after starting Butinib. Existing anti-hypertensive medications should be adjusted and/or initiated anti-hypertensive treatment as appropriate.

 

Second Primary Malignancies: Other malignancies (9%) including non-skin carcinomas (2%) have occurred in 1,011 patients treated with Butinib in clinical trials. The most frequent second primary malignancy was non-melanoma skin cancer (6%).

 

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with Butinib therapy. The baseline risk should be assessed (e.g., high tumor burden) and taken appropriate precautions, monitored patients closely and treated as appropriate.

 

Embryo-Fetal Toxicity: Butinib can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while taking Butinib and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

 

Overdose

There is no specific experience in the management of Ibrutinib overdose in patients. Patients should be closely monitored who ingest more than the recommended dosage and provided appropriate supportive treatment.

Storage: Store below 30°C in a dry place, away from sunlight. Keep out of the reach of children.

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