Ibruxen (Ibrutinib) Capsules

Indicated for the treatment of adult patients with:

• 🔹 Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL): Including patients with 17p deletion.
• 🔹 Mantle Cell Lymphoma (MCL): For patients who have received at least one prior therapy.
• 🔹 Waldenström's Macroglobulinemia (WM): Indicated as a single agent or in combination with rituximab.
• 🔹 Marginal Zone Lymphoma (MZL): Relapsed or refractory cases.

Packaging: 140 mg capsules.

⚠️ ADMINISTRATION PROTOCOL:

• For CLL/SLL & Waldenström's: 420 mg (3 capsules) orally once daily.
• For Mantle Cell Lymphoma (MCL): 560 mg (4 capsules) orally once daily.
• Administration: Swallow capsules whole with water. Do not open, break, or chew.
• Missed Dose: If a dose is missed, it can be taken as soon as possible on the same day. Do not take extra capsules to make up for a missed dose.
• 🚫 Interaction: Avoid grapefruit and Seville oranges completely.

• Hypersensitivity to Ibrutinib.
• Pregnancy and breastfeeding (risk of fetal harm).
• Severe hepatic impairment (Child-Pugh Class C).
• Concomitant use with strong CYP3A inducers (e.g., St. John's Wort).

Common and serious adverse reactions include:

• 🩸 Cardiovascular/Hematic: Hemorrhage (bruising, bleeding), atrial fibrillation/flutter, hypertension.
• 📉 Infections: Pneumonia, upper respiratory tract infections.
• 🌀 Gastrointestinal: Diarrhea, nausea, stomatitis.
• ⚠️ Pre-surgery: Therapy should be withheld for at least 3 to 7 days pre- and post-surgery depending on the type of surgery and the risk of bleeding.