EnglishIBRUTINIB Ibrutinib Imbruvica 140mg
[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 "ibr 140 mg" in black ink.
[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 × 120 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 are 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 are 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 sealed.
[Packaging] 140 mg × 120 capsules/box.
[Shelf Life] 36 months.
Product Specifications
Product Name: Original Research Drug: Johnson & Johnson Ibrutinib (IBRUTINIB) 140 mg × 120 Capsules (Ibrutinib Imbruvica 140 mg)
Common Name: Ibrutinib
Composition: Ibrutinib
Dosage Form: White, opaque capsules
Specification: 140 mg × 120 capsules
Manufacturer: Johnson & Johnson Pharmaceutical
Indicated for: (1) Mantle Cell Lymphoma (MCL) in patients who have received at least one prior therapy.
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
(2) Chronic Lymphocytic Leukemia (CLL) in patients who have received at least one prior therapy.
(3) Chronic Lymphocytic Leukemia with 17p deletion.
Dosage and Administration: MCL: 560 mg orally once daily (four 140 mg capsules once daily).
CLL and WM: 420 mg orally once daily (three 140 mg capsules once daily).
Swallow the capsules whole with a glass of water. Do not open, break, or chew the capsules.