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 || 70mg/mL oral suspension Logo
Chronic Lymphocytic Leukemia (Adult Patients) Previously Treated Mantle Cell Lymphoma* (Adult Patients) Waldenström's Macroglobulinemia (Adult Patients) Previously Treated Marginal Zone Lymphoma* (Adult Patients) Previously Treated Chronic Graft Versus Host Disease (Adult and Pediatric Patients Age 1 Year and Older)
*

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.

enroll in IMBRUVICA® patient support

Welcome to IMBRUVICA® By Your Side, a comprehensive, personalized support experience designed to help IMBRUVICA® patients start and stay on track with the treatment plan you prescribed.

IMBRUVICA® By Your Side provides:

Comprehensive Resources

Dedicated Ambassadors

Financial Guidance

Complete this form with the permission of your patient to enroll them in IMBRUVICA® By Your Side, so they can get the support they need throughout their treatment journey.

1

Prescriber Information

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Patient Details

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Insurance Information

4

Enrollment Complete

Prescriber Information

Office Location

Office Contact Information

For information on how Pharmacyclics and Janssen handle personal information, please visit their privacy notices at https://www.pharmacyclics.com/privacy-policy.

Patient Details

Please enter the following information to successfully enroll your patient in IMBRUVICA® By Your Side. Be advised that the form MUST be filled out properly, so that your patient has the best experience in the program.

All fields are required unless otherwise noted

Contact Information

Caregiver Information

Be sure to ask your patient to provide any information about their caregiver, so we can send their caregiver information to help them stay on track. I authorize the IMBRUVICA® By Your Side patient support program to contact and communicate with the individual listed here.

For information on how Pharmacyclics and Janssen handle personal information, please visit their privacy notices at https://www.pharmacyclics.com/privacy-policy.

Insurance Information

IMBRUVICA® By Your Side patient support offers financial guidance for enrolled patients, including a copay card for eligible patients with commercial insurance.

Type of Insurance

With IMBRUVICA® By Your Side, your patient with commercial insurance may be eligible for the IMBRUVICA® Copay Card. Once your patient is successfully enrolled, they will immediately receive the copay card and a call within one business day from their dedicated By Your Side Ambassador.

Please enter patient’s Rx insurance information

†This includes Medicare Part D, Medicare Advantage Plan, Medicaid, TRICARE, or any other federal or state healthcare plan, including pharmaceutical assistance programs

IMBRUVICA® By Your Side Ambassadors can connect your patients with Insurance Specialists who will work with them to review financial support options and confirm their out-of-pocket costs for IMBRUVICA® patients.

IMBRUVICA® By Your Side Ambassadors can connect your patients with Insurance Specialists who will review financial support options and confirm their out-of-pocket costs for IMBRUVICA®.

IMBRUVICA® By Your Side Ambassadors can help your patients learn about potential resources to help them with affording IMBRUVICA®

*Privately purchased insurance or insurance made available through an employer.

Prescriber Certification

Benefits Verification

Benefits verifications are performed by the IMBRUVICA® By Your Side Program as a part of all program enrollments. If you would like to have a benefits verification performed on behalf of your patient and receive a copy of the results, please select the check box below and provide the insurance information requested.

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IMPORTANT INFORMATION: By submitting this form you are referring the above patient to PCYC’s patient support program to determine eligibility and receive support related to a PCYC product. Please share this information with your patient. (1) IMBRUVICA® By Your Side is a Pharmacyclics, LLC, (“PCYC”) and Janssen Biotech, Inc. sponsored program that provides personalized patient support (“By Your Side”). (2) PCYC, its affiliates, collaborators and agents (“PCYC”) will use your personal information, including your health information, collected through your enrollment and participation in “By Your Side” to: (1) provide you with support and communications for your prescribed product; and (2) perform research and analytics.

For more information about PCYC’s Privacy Policy practices or how to opt-out, visit https://www.pharmacyclics.com/privacy-policy.

Registration complete!

Thank you for enrolling your patient in IMBRUVICA® By Your Side! Make sure to DOWNLOAD and PRINT or EMAIL the IMBRUVICA® By Your Side patient information to give to your patient before leaving your office.

To Request a Benefit Verification: Call: 1-888-YourSide (1-888-968-7743). Choose option 2 for Healthcare Professional. Then select option 1 to speak to an Access Specialist.

What to expect next:

Remind your patient to expect a call from an Ambassador within one business day (call may come from any area code, including a toll free number).

Ambassadors provide important educational resources, answer questions and help navigate the prescription process and identify ways patients may be able to save on IMBRUVICA®.

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IMBRUVICA® Copay Card

Your patient has qualified for the copay card.

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RxBIN: 610524 RxGRP: IMB57962 RxPCN: Loyalty ISSUER: 80840 ID: XXXXXXXXXX

Eligibility: Available to patients with commercial insurance coverage for IMBRUVICA® (ibrutinib) who meet eligibility criteria. This copay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law. Offer subject to change or termination without notice. Restrictions, including monthly maximums, may apply. This is not health insurance. For full Terms and Conditions, visit https://www.imbruvica.com/imbruvica-by-your-side or call 1-888-YourSide (1-888-968-7743) for additional information. To learn about Pharmacyclics’ privacy practices and your privacy choices, visit https://www.pharmacyclics.com/privacy-policy

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For help submitting your request, please call 1-888-YourSide (1-888-968-7743), Monday-Friday, 8AM-8PM ET.

RxBIN: 610524 RxGRP: IMB57962 RxPCN: Loyalty ISSUER: 80840 ID: XXXXXXXXXX

*Eligibility: Available to patients with commercial insurance coverage for IMBRUVICA® (ibrutinib) who meet eligibility criteria.
This copay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law. Offer subject to change or termination without notice. Restrictions, including monthly maximums, may apply. This is not health insurance. For full Terms and Conditions, visit https://www.imbruvica.com/imbruvica-by-your-side or call 1-888-YourSide (1-888-968-7743) for additional information. To learn about Pharmacyclics’ privacy practices and your privacy choices, visit https://www.pharmacyclics.com/privacy-policy.

 

IMBRUVICA® Copay Full Terms and Conditions

Terms and Conditions apply. This benefit covers IMBRUVICA® (ibrutinib). Eligibility: Available to patients with commercial insurance coverage for IMBRUVICA® who meet eligibility criteria. Copay assistance program is not available to patients receiving reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the IMBRUVICA® Copay Card and patient must call IMBRUVICA® at 1-855-332-6210 to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the IMBRUVICA® Copay Card program from any third-party payers. Offer subject to change or discontinuation without notice. Restrictions, including monthly maximums, may apply. Subject to all other terms and conditions, the maximum annual benefit that may be available solely for the patient’s benefit under the copay assistance program is $24,600 per calendar year. The actual application and use of the benefit available under the copay assistance program may vary on a monthly, quarterly, and/or annual basis depending on each individual patient’s plan of insurance and other prescription drug costs. This assistance offer is not health insurance. By redeeming this card, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer. To learn about Pharmacyclics’ privacy practices and your privacy choices, visit https://www.pharmacyclics.com/privacy-policy.

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 4.2% 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.

Cardiac Arrhythmias, Cardiac Failure, and Sudden Death: Fatal and serious cardiac arrhythmias and cardiac failure have occurred with IMBRUVICA®. Deaths due to cardiac causes or sudden deaths occurred in 1% of 4,896 patients who received IMBRUVICA® in clinical trials, including in patients who received IMBRUVICA® in unapproved monotherapy or combination regimens. These adverse reactions occurred in patients with and without preexisting hypertension or cardiac comorbidities. Patients with cardiac comorbidities may be at greater risk of these events.

Grade 3 or greater ventricular tachyarrhythmias were reported in 0.2%, Grade 3 or greater atrial fibrillation and atrial flutter were reported in 3.7%, and Grade 3 or greater cardiac failure was reported in 1.3% of 4,896 patients who received IMBRUVICA® in clinical trials, including in patients who received IMBRUVICA® in unapproved monotherapy or combination regimens. These events have occurred particularly in patients with cardiac risk factors including hypertension and diabetes mellitus, a previous history of cardiac arrhythmias, and in patients with acute infections.

Evaluate cardiac history and function at baseline, and monitor patients for cardiac arrhythmias and cardiac function. Obtain further evaluation (e.g., ECG, echocardiogram) as indicated for patients who develop symptoms of arrhythmia (e.g., palpitations, lightheadedness, syncope, chest pain), new onset dyspnea, or other cardiovascular concerns. Manage cardiac arrhythmias and cardiac failure appropriately, follow dose modification guidelines, and consider the risks and benefits of continued IMBRUVICA® treatment.

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®, initiate or adjust anti-hypertensive medication throughout treatment with IMBRUVICA® as appropriate, and follow dosage modification guidelines for Grade 3 or higher hypertension.

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 2.8%, based on laboratory measurements. Monitor complete blood counts monthly.

Second Primary Malignancies: Other malignancies (10%), including non-skin carcinomas (3.9%), 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 adult 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 adult 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 adult 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 adult or pediatric patients with cGVHD were fatigue (57%), anemia (49%)*, bruising (40%), diarrhea (36%), thrombocytopenia (33%)*, musculoskeletal pain (30%), pyrexia (30%), muscle spasms (29%), stomatitis (29%), hemorrhage (26%), nausea (26%), abdominal pain (23%), pneumonia (23%), and headache (21%).

The most common Grade 3 or higher adverse reactions (≥5%) reported in adult or pediatric patients with cGVHD were pneumonia (14%), anemia (13%)*, fatigue (12%), pyrexia (11%), diarrhea (10%), neutropenia (10%)*, sepsis (10%), osteonecrosis (9%), stomatitis (9%), hypokalemia (7%), headache (5%), and musculoskeletal pain (5%).

Discontinuation of IMBRUVICA® treatment due to an adverse reaction occurred in 24% of adult patients and 23% of pediatric patients. Adverse reactions leading to dose reduction occurred in 26% of adult patients and 19% of pediatric 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

Pediatric Use: The safety and effectiveness of IMBRUVICA® have not been established for the treatment of cGVHD after failure of one or more lines of therapy in pediatric patients less than 1 year of age. The safety and effectiveness of IMBRUVICA® in pediatric patients have not been established in MCL, CLL/SLL, CLL/SLL with 17p deletion, WM, MZL or in patients with mature B-cell non-Hodgkin lymphoma.

In the randomized population from a study that included 35 patients (26 pediatric patients age 5 to less than 17 years) with previously treated mature B-cell non-Hodgkin lymphoma, major hemorrhage and discontinuation of chemoimmunotherapy due to adverse reactions occurred more frequently in the ibrutinib plus chemoimmunotherapy arm compared to the chemoimmunotherapy alone arm.

Hepatic Impairment:

Adult Patients with B-cell Malignancies: 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®.

Patients with cGVHD: Avoid use of IMBRUVICA® in patients with total bilirubin level > 3x upper limit of normal (ULN) (unless of non-hepatic origin or due to Gilbert’s syndrome). Reduce recommended dose when administering IMBRUVICA® to patients with total bilirubin level > 1.5 to 3x ULN (unless of non-hepatic origin or due to Gilbert’s syndrome).

Please see full Prescribing Information.

 

INDICATIONS

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.
    • 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).
  • Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).
  • Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
  • Adult patients with Waldenström's macroglobulinemia (WM).
  • Adult patients with 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).
  • Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

IMPORTANT SAFETY INFORMATION

INDICATIONS

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