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About IMBRUVICA®

Pharmacyclics is focused on discovering, developing, and delivering therapies that address serious unmet medical needs for the betterment of patients. Our first therapy, IMBRUVICA® (ibrutinib), is the result of this single-minded focus. 

IMBRUVICA® is a prescription medicine used to treat people with:

  • Chronic lymphocytic leukemia (CLL) who have received at least one prior treatment
  • Chronic lymphocytic leukemia (CLL) with 17p deletion
  • Waldenström’s macroglobulinemia (WM)
  • Mantle cell lymphoma (MCL) who have received at least one prior treatment
    • 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

IMBRUVICA® is the first in a class of medicines called Bruton tyrosine kinase (BTK) inhibitors. In simple terms, a BTK inhibitor helps prevent B-cell activation and can lead to inhibition of the growth and survival of malignant B cells. By blocking BTK protein, IMBRUVICA® helps reduce the number of cancer cells. It can also help slow the progression of the disease.

When the US Food and Drug Administration (FDA) designates a medicine as a breakthrough therapy, that designation expedites the development and review of the medicine.*

We are proud that IMBRUVICA® is considered a breakthrough therapy. IMBRUVICA® is the only product to have received 3 oncology breakthrough designations from the FDA.

We are continuing to study IMBRUVICA® alone and in combination with other treatments for several blood cancers. IMBRUVICA® is being jointly developed and commercialized by Pharmacyclics, Inc. and Janssen Biotech, Inc.

* In 2012, the US Food and Drug Administration signed the Safety and Innovation Act (FDASIA). This act provides Breakthrough Therapy Designation for a medicine that is intended to treat a life-threatening illness or whose early clinical evidence shows significant improvement over existing therapies.

For more information, please see the full Prescribing Information or visit IMBRUVICA.com.

IMBRUVICA® is a prescription medicine used to treat people with:

  • Chronic lymphocytic leukemia (CLL) who have received at least one prior treatment
  • Chronic lymphocytic leukemia (CLL) with 17p deletion
  • Waldenström’s macroglobulinemia (WM)
  • Mantle cell lymphoma (MCL) who have received at least one prior treatment
    • For MCL, IMBRUVICA® is approved on response. Data are not yet available to show if IMBRUVICA® improves survival or symptoms

 

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage - Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients.  Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®.

The mechanism for the bleeding events is not well understood. IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections - Fatal and non-fatal infections have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 26% of patients. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICA®. Monitor patients for fever and infections and evaluate promptly.

Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 19-29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 9%) occurred in patients treated with IMBRUVICA®. Monitor complete blood counts monthly.

Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. If atrial fibrillation persists, consider the risks and benefits of IMBRUVICA® treatment and dose modification.

Second Primary Malignancies - Other malignancies (range, 5 to 14%) including non-skin carcinomas (range, 1 to 3%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 4 to 11%).

Tumor Lysis Syndrome - Tumor lysis syndrome has been reported with IMBRUVICA® therapy. Monitor patients closely and take appropriate precautions in patients at risk for tumor lysis syndrome (eg, high tumor burden).

Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA®. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

ADVERSE REACTIONS

The most common adverse reactions (≥25%) in patients with B-cell malignancies (MCL, CLL, WM) were thrombocytopenia, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, bruising, nausea, upper respiratory tract infection, and rash. Seven percent of patients receiving IMBRUVICA® discontinued treatment due to adverse events.

DRUG INTERACTIONS

CYP3A Inhibitors - Avoid co-administration with strong or moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose.

CYP3A Inducers - Avoid co-administration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA® dose

 

Please review the full Prescribing Information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

IMBRUVICA® is being jointly developed and commercialized by Pharmacyclics, Inc. and Janssen Biotech, Inc.