Ibrunat Ibrutinib capsules

[Drug Name]

Generic Name: Ibrutinib Capsules

Brand Name: Ibrutinib Capsules

Full Pinyin: YiLuTiNiJiaoNang

[Active Ingredient] Ibrutinib. [Description] Imbruvica consists of white, opaque 140 mg capsules marked with black ink bearing the inscription "ibr 140 mg."

[Indications/Usage] IMBRUVICA is a kinase inhibitor indicated for the treatment of patients with: (1) Mantle Cell Lymphoma (MCL) who have received at least one prior therapy; (2) Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy. These indications are based on overall response rate. Improvement in survival or disease-related symptoms has not been established.

[Specification] 140 mg × 30 capsules

[Dosage and Administration] MCL: 560 mg orally once daily (4 capsules of 140 mg once daily). CLL: 420 mg orally once daily (3 capsules of 140 mg once daily). Administer capsules orally with a glass of water. Do not open, break, or chew the capsules.

[Adverse Reactions] The most common adverse reactions (≥20%) in patients with MCL were thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, vomiting, and decreased appetite. The most common adverse reactions (≥20%) in patients with CLL were thrombocytopenia, diarrhea, bruising, neutropenia, anemia, upper respiratory tract infection, fatigue, musculoskeletal pain, rash, pyrexia, constipation, peripheral edema, arthralgia, nausea, stomatitis, sinusitis, and dizziness. Drug Interactions: CYP3A Inhibitors: Avoid co-administration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the dose of IMBRUVICA. CYP3A Inducers: Avoid co-administration with strong CYP3A inducers. Use in Specific Populations Hepatic Impairment: Avoid the use of IMBRUVICA in patients with baseline hepatic impairment.

[Contraindications] Not yet established.

[Precautions] (1) Hemorrhage: Monitor for bleeding. (2) Infections: Monitor patients for fever and signs of infection, and evaluate promptly. (3) Cytopenias: Check complete blood counts monthly. (4) Renal Toxicity: Monitor renal function and maintain hydration. (5) Second Primary Malignancies: Other malignancies, including skin cancers and other carcinomas, have occurred in patients. (6) Embryo-Fetal Toxicity: May cause fetal harm. Advise women of the potential risk to the fetus and to avoid taking the medication during pregnancy. Please read the package insert carefully and use strictly according to physician's instructions.

[Pediatric Use] Not yet established.

[Geriatric Use] Not yet established.

[Use in Pregnant and Lactating Women] Not yet established.

[Drug Interactions] Not yet established.

[Overdosage] Not yet established.

[Pharmacology and Toxicology] Not yet established.

[Pharmacokinetics] Not yet established.

[Storage] Keep tightly closed.

[Packaging] 140 mg × 30 capsules/box.

[Shelf Life] 36 months.

Product Specifications

Product Name: Ibrutinib Capsules 140 mg × 30 capsules (Gleevec, Ibrunat, Ibrutinib)

Common Name: Ibrutinib Capsules

Composition: Ibrutinib

Dosage Form: Capsules

Specification: 140 mg × 30 capsules

Manufacturer: Natco Pharma Ltd

Indications: (1) Patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. (2) Patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy. These indications are based on overall response rate. Improvement in survival or disease-related symptoms has not yet been established.

Dosage and Administration: MCL: 560 mg. Take orally once daily (4 capsules of 140 mg once daily). For CLL: Take 420 mg orally once daily (3 capsules of 140 mg once daily). Swallow the capsules with a glass of water. Do not open, break, or chew the capsules.