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IMBRUVICA® (Ibrutinib) 560, 420, 280, 140 mg tablets | 140, 70 mg capsule Logo
IMBRUVICA® (Ibrutinib) 560, 420, 280, 140 mg tablets | 140, 70 mg capsule Logo
Chronic Lymphocytic Leukimia Previously Treated Mantle Cell Lymphoma* Waldenstrom's Macroglobulinemia Previously Treated Marginal Zone Lymphoma* Previously Treated Chronic Graft Versus Host Disease
*

The MCL and MZL indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.

IMBRUVICA® BY YOUR SIDE PATIENT SUPPORT PROGRAM 

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IMBRUVICA® By Your Side is a patient support program designed specifically to support IMBRUVICA® patients throughout their treatment journey.

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IMBRUVICA® By Your Side offers patients:

Comprehensive resources individually selected for your patients

Financial guidance for commercially, federally, or uninsured patients

Dedicated IMBRUVICA® By Your Side Nurse Ambassadors† to provide one-on-one guidance

Enroll IMBRUVICA® patients in IMBRUVICA® By Your Side- so they can get the support they need, when they need it.

To learn more about IMBRUVICA® By Your Side patient support, call 1-888-YourSide(1-888-968-7743) Monday-Friday,8:00 AM-8:00 PM ET

Enroll Patients Faster

Enrolling patients in the IMBRUVICA® By Your Side patient support program is easier than ever.

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Step 1: Enroll

You can enroll your patients directly online or by fax.

Online:

  • Click the button below to complete the form online with your patient’s consent (no patient or physician signature is required).
  • If your patient is eligible for the IMBRUVICA® Copay Card, it will be immediately available upon successful enrollment.
Click here for Online Enrollment Form >

-OR-

Fax:
  • Click the button below to download the form and Prescribing Information.

  • Complete the form with your patient’s consent.

  • Print it out and fax to 1-800-752-5896

Download Enrollment Form and Prescription Information
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Step 2: Inform

Let your patient know that once enrolled, they will receive:

  • A call within one business day from their dedicated By Your Side Ambassador
  • A welcome email
  • Educational materials selected just for them

Help Patients Afford Treatment

Learn more about financial support for your patients with and without insurance. By Your Side Ambassadors connect your patients with Insurance Specialists to learn about access to IMBRUVICA® (ibrutinib), find affordability support options, and sign up for information and resources to support them along their treatment journey. Those with commercial insurance may be able to pay as little as $0 per prescription‡ of IMBRUVICA®.

For patients with federally funded Medicare, Medicaid, or commercial insurance, financial assistance may be available from independent charitable organizations. Contact information for such independent charitable organizations is available upon request. Independent charitable organizations have their own rules for eligibility. We have no control over these independent charitable organizations.

Additional Resources

Download List of Speciality Pharmacies & Distributors
Dose Exchange Program Information

*IMBRUVICA® By Your Side patient support program is not intended to provide medical advice, replace prescribed treatment plans, or provide treatment or case management services. Patients are advised to always talk to their healthcare provider and treatment team about any medical decisions and concerns they may have.
†By Your Side Ambassadors are provided by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie Company, and do not provide medical advice or work under the direction of the prescribing healthcare professional (HCP). They are trained to direct patients to speak with their HCP about any treatment-related questions, including further referrals.
‡Eligible patients may pay as little as $0 per prescription of IMBRUVICA®. Rules and maximum limits apply. Patients currently using the IMBRUVICA® Copay Card are not eligible for retroactive billing or reimbursement of previous copays. The IMBRUVICA® Copay Card is available to patients with commercial prescription coverage for IMBRUVICA® who meet eligibility criteria. The IMBRUVICA® Copay Card cannot be used by patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs, including Medicare Part D, Medicare Advantage Plan, Medicaid, Medigap, VA, DOD, and TRICARE, or where prohibited by law or the patient’s health insurance provider. The IMBRUVICA® Copay program may be updated or discontinued at any time without notice.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Hemorrhage: Fatal bleeding events have occurred in patients who received IMBRUVICA®. Major hemorrhage (≥ Grade 3, serious, or any central nervous system events; e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) occurred in 4% of patients, with fatalities occurring in 0.4% of 2,838 patients who received IMBRUVICA® in 27 clinical trials. Bleeding events of any grade including bruising and petechiae occurred in 39%, and excluding bruising and petechiae occurred in 23% of patients who received IMBRUVICA®, respectively.

The mechanism for the bleeding events is not well understood.

Use of either anticoagulant or antiplatelet agents concomitantly with IMBRUVICA® increases the risk of major hemorrhage. Across clinical trials, 3.1% of 2,838 patients who received IMBRUVICA® without antiplatelet or anticoagulant therapy experienced major hemorrhage. The addition of antiplatelet therapy with or without anticoagulant therapy increased this percentage to 4.4%, and the addition of anticoagulant therapy with or without antiplatelet therapy increased this percentage to 6.1%. Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA®. Monitor for signs and symptoms of bleeding. 

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 (including bacterial, viral, or fungal) have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 21% of 1,476 patients who received IMBRUVICA® in clinical trials. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA®. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.

Monitor and evaluate patients for fever and infections and treat appropriately.

Cytopenias: In 645 patients with B-cell malignancies who received IMBRUVICA® as a single agent, grade 3 or 4 neutropenia occurred in 23% of patients, grade 3 or 4 thrombocytopenia in 8% and grade 3 or 4 anemia in 3%, based on laboratory measurements.

Monitor complete blood counts monthly.

Cardiac Arrhythmias and Cardiac Failure: Fatal and serious cardiac arrhythmias and cardiac failure have occurred with IMBRUVICA®. Grade 3 or greater ventricular tachyarrhythmias occurred in 0.2% of patients, Grade 3 or greater atrial fibrillation and atrial flutter occurred in 4%, and Grade 3 or greater cardiac failure occurred in 1% of 1,476 patients who received IMBRUVICA® in clinical trials. These events have occurred particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of cardiac arrhythmias.

At baseline and then periodically, monitor patients clinically for cardiac arrhythmias and cardiac failure. Obtain an ECG for patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness, syncope, chest pain) or new onset dyspnea. Manage cardiac arrhythmias and cardiac failure appropriately, and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines.

Hypertension: Hypertension occurred in 19% of 1,476 patients who received IMBRUVICA® in clinical trials. Grade 3 or greater hypertension occurred in 8% of patients. Based on data from 1,124 of these patients, the median time to onset was 5.9 months (range, 0.03 to 24 months).

Monitor blood pressure in patients treated with IMBRUVICA® and initiate or adjust anti-hypertensive medication throughout treatment with IMBRUVICA® as appropriate.

Second Primary Malignancies: Other malignancies (10%), including non-skin carcinomas (4%), occurred among the 1,476 patients who received IMBRUVICA® in clinical trials. The most frequent second primary malignancy was non-melanoma skin cancer (6%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA®. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions.  

Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA® and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (≥30%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (54.5%)*, diarrhea (43.8%), fatigue (39.1%), musculoskeletal pain (38.8%), neutropenia (38.6%)*, rash (35.8%), anemia (35.0%)*, and bruising (32.0%).

The most common Grade ≥ 3 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (20.7%)*, thrombocytopenia (13.6%)*, pneumonia (8.2%), and hypertension (8.0%).

Approximately 9% (CLL/SLL), 14% (MCL), 14% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4-10% (CLL/SLL), 9% (MCL), and 7% (WM [5%] and MZL [13%]) of patients discontinued due to adverse reactions.

cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%)*, muscle spasms (29%), stomatitis (29%), nausea (26%), hemorrhage (26%), anemia (24%)*, and pneumonia (21%).

The most common Grade 3 or higher adverse reactions (≥5%) reported in patients with cGVHD were pneumonia (14%), fatigue (12%), diarrhea (10%), neutropenia (10%)*, sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).

Twenty-four percent of patients receiving IMBRUVICA® in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.

*Treatment-emergent decreases (all grades) were based on laboratory measurements.

DRUG INTERACTIONS

CYP3A Inhibitors: Co-administration of IMBRUVICA® with strong or moderate CYP3A inhibitors may increase ibrutinib plasma concentrations. Increased ibrutinib concentrations may increase the risk of drug-related toxicity. Dose modifications of IMBRUVICA® are recommended when used concomitantly with posaconazole, voriconazole, and moderate CYP3A inhibitors. Avoid concomitant use of other strong CYP3A inhibitors. Interrupt IMBRUVICA® if strong inhibitors are used short-term (e.g., for ≤ 7 days). Avoid grapefruit and Seville oranges during IMBRUVICA® treatment, as these contain strong or moderate inhibitors of CYP3A. See dose modification guidelines in USPI sections 2.3 and 7.1.

CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA® in patients with severe hepatic impairment. In patients with mild or moderate impairment, reduce recommended IMBRUVICA® dose and monitor more frequently for adverse reactions of IMBRUVICA®.

Please see full Prescribing Information.

 

INDICATIONS

IMBRUVICA® (ibrutinib) is a kinase inhibitor indicated for the treatment of adult patients with:

  • Mantle cell lymphoma (MCL) 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 a confirmatory trial(s).
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).

  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.

  • Waldenström's macroglobulinemia (WM).
  • Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based 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 a confirmatory trial(s).
  • Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

IMPORTANT SAFETY INFORMATION

INDICATIONS

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