伊布替尼英文说明书.pdf

IMBRUVICA- ibrutinib capsule
Pharmacyclics, Inc
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full
prescribing information for IMBRUVICA.
IMBRUVICA® (ibrutinib) capsules, for oral use
Initial . Approval: 2013
RECENT MAJOR CHANGES
Indications and Usage () 01/15
Dosage and Administration (, , ) 01/15
Warnings and Precautions (, ) 01/15
INDICATIONS AND USAGE
IMBRUVICA is a kinase inhibitor indicated for the treatment of patients with:
Mantle cell lymphoma (MCL) who have received at least one prior therapy ().
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this
indication may be contingent upon verification of clinical benefit in confirmatory trials.
Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy ().
Chronic lymphocytic leukemia with 17p deletion ().
Waldenström's macroglobulinemia (WM) ().
DOSAGE AND ADMINISTRATION
MCL: 560 mg taken orally once daily (four 140 mg capsules once daily) ().
CLL and WM: 420 mg taken orally once daily (three 140 mg capsules once daily) ().
Capsules should be taken orally with a glass of water. Do not open, break, or chew the capsules ().
DOSAGE FORMS AND STRENGTHS
Capsule: 140 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hemorrhage: Monitor for bleeding ().
Infections: Monitor patients for fever and infections and evaluate promptly ().
Cytopenias: plete blood counts monthly ().
Atrial Fibrillation: Monitor patients for atrial fibrillation ().
Second Primary Malignancies: Other malignancies have occurred in patients, including skin cancers, and other
carcinomas ().
Tumor Lysis Syndrome (TLS): Monitor patients at risk for TLS (. high tumor burden) ().
Embryo-Fetal Toxicity: Can cause fetal harm. A