Ibrutinib BUTINIB Ibrutix 140mg

[Product Name] Ibrutinib

[Specification] 140 mg × 112 Capsules

[Manufacturer] Drug International Pharma

[Indications and Usage]

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

Mantle Cell Lymphoma (MCL) who have received at least one prior therapy.

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL).

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) with 17p deletion.

Waldenström’s Macroglobulinemia (WM).

Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.

Chronic Graft-versus-Host Disease (cGVHD) after failure of one or more lines of systemic therapy.

[Dosage and Administration]

Mantle Cell Lymphoma and Marginal Zone Lymphoma: 560 mg (4 capsules of 140 mg) orally once daily.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Macroglobulinemia, and Chronic Graft-versus-Host Disease: 420 mg (3 capsules of 140 mg) orally once daily.

Take the medication at the same time each day. Swallow the capsules whole; do not open, break, or chew them. Continue treatment until disease progression or until unacceptable toxicity occurs. If a dose is missed at the scheduled time, it may be taken as soon as possible on the same day, and the patient should resume the normal schedule the following day. Do not take extra doses to make up for a missed dose.

[Warnings and Precautions]

Hemorrhage: Ibrutinib may increase the risk of bleeding in patients receiving antiplatelet or anticoagulant therapy; patients should be monitored for signs of bleeding. Based on the type of surgery and the risk of bleeding, Ibrutinib should be withheld for at least 3 to 7 days before and after surgery.

Infections: Assess patients for fever and signs of infection, and provide appropriate treatment.

Cytopenias: Monitor complete blood counts monthly.

Cardiac Arrhythmias: Clinically monitor all patients periodically for the occurrence of cardiac arrhythmias. Patients presenting with symptoms of arrhythmia, or with new-onset dyspnea, dizziness, or syncope, should undergo clinical evaluation, including an electrocardiogram (ECG) as indicated.

Hypertension: Monitor patients for new-onset hypertension or hypertension that is not adequately controlled following the initiation of treatment with this product. Adjust existing antihypertensive medications and/or initiate antihypertensive therapy as appropriate.

Secondary Malignancies: The most common secondary malignancy is non-melanoma skin cancer (2–13%).

Tumor Lysis Syndrome (TLS): Assess baseline risk factors (e.g., high tumor burden) and implement appropriate prophylactic measures. Monitor patients closely and provide appropriate treatment.

Embryo-Fetal Toxicity: May cause fetal harm. Advise women of the potential risk to the fetus and to avoid pregnancy during treatment and for 1 month after discontinuing therapy. [Adverse Reactions]

For patients with B-cell malignancies (MCL, CLL/SLL, WM, and MZL), the most common adverse reactions (≥20%) are neutropenia, thrombocytopenia, diarrhea, anemia, musculoskeletal pain, rash, nausea, bruising, fatigue, hemorrhage, and pyrexia.

For patients with cGVHD, the most common adverse reactions (≥20%) are fatigue, bruising, diarrhea, thrombocytopenia, muscle spasms, stomatitis, nausea, hemorrhage, anemia, and pneumonia.

Product Specifications

Product Name: Ibrutinib 140mg × 112 Tablets/Capsules; Ibrutinib (Imbruvica); BUTINIB; Ibrutix; CRA-032765

Common Name: Ibrutinib

Composition: Ibrutinib

Dosage Form: Capsules

Specification: 140mg × 112 Capsules

Manufacturer: Drug International Pharma

Indications: Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with:

Mantle Cell Lymphoma (MCL) who have received at least one prior therapy.

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL).

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) with 17p deletion.

Waldenström’s Macroglobulinemia (WM).

Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Chronic Graft-versus-Host Disease (cGVHD) following failure of one or more lines of systemic therapy

**Dosage and Administration:** Mantle Cell Lymphoma and Marginal Zone Lymphoma: 560 mg (four 140 mg capsules) orally once daily.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Waldenström’s Macroglobulinemia, and Chronic Graft-versus-Host Disease: 420 mg (three 140 mg capsules) orally once daily.

Take the medication at the same time each day. Swallow the capsules whole; do not open, break, or chew them. Continue treatment until disease progression or until unacceptable toxicity occurs. If a dose is missed at the scheduled time, take it as soon as possible on the same day, and resume the regular schedule the following day. Do not take extra doses to make up for a missed dose.