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
IMBRUVICA(ibrutinib)tablets, for oral use
Initial U.S. Approval: 2013
RECENT MAJOR CHANGES
Indications and Usage (1.6) 08/2017
Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5) 02/2018
Warnings and Precautions (5) 12/2017
INDICATIONS AND USAGE
IMBRUVICA is a kinase inhibitor indicated for the treatment of adult patients with:
Mantle cell lymphoma (MCL) who have received at least one prior therapy (1.1).
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.2).
Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.3).
Waldenström's macroglobulinemia (WM) (1.4).
Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy (1.5).
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.6).
DOSAGE AND ADMINISTRATION
MCL and MZL: 560 mg taken orally once daily (2.2).
CLL/SLL, WM, and cGVHD: 420 mg taken orally once daily (2.2).
Dose should be taken orally with a glass of water. Do not open, break, or chew the capsules. Do not cut, crush, or chew the tablets (2.1).
DOSAGE FORMS AND STRENGTHS
Capsules: 70 mg and 140 mg (3)
Tablets: 140 mg, 280 mg, 420 mg, and 560 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hemorrhage: Monitor for bleeding and manage (5.1).
Infections: Monitor patients for fever and infections, eva luate promptly, and treat (5.2).
Cytopenias: Check complete blood counts monthly (5.3).
Cardiac arrhythmias: Monitor for symptoms of arrhythmias and manage (5.4).
Hypertension: Monitor blood pressure and treat (5.5).
Second Primary Malignancies: Other malignancies have occurred in patients, including skin cancers, and other carcinomas (5.6).
Tumor Lysis Syndrome (TLS): Assess baseline risk and take precautions. Monitor and treat for TLS (5.7).
Embryo-Fetal Toxicity: Can cause fetal harm. Advise women of the potential risk to a fetus and to avoid pregnancy while taking the drug and for 1 month after cessation of therapy. Advise men to avoid fathering a child during the same time period (5.8, 8.3).
ADVERSE REACTIONS
The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia, thrombocytopenia, diarrhea, anemia, musculoskeletal pain, rash, nausea, bruising, fatigue, hemorrhage, and pyrexia (6).
The most common adverse reactions (≥20%) in patients with cGVHD were fatigue, bruising, diarrhea, thrombocytopenia, muscle spasms, stomatitis, nausea, hemorrhage, anemia, and pneumonia (6).
To report SUSPECTED ADVERSE REACTIONS, contact Pharmacyclics at 1-877-877-3536 or FDA at 1-800-F