IMBRUVICA® VOUCHER PROGRAM

FREE TRIAL OFFER FOR ELIGIBLE NEW PATIENTS INITIATING THERAPY

IMBRUVICA® FREE 1-MONTH SUPPLY (28- or 30-Day)

Free Trial Offer for eligible commercial, Medicare, Medicaid or cash patients

Subject to eligibility rules; limits and restrictions apply

Just 3 easy steps to provide a free 1-month (28- or 30-day) supply of IMBRUVICA®

Pharmacy Instructions

Fom

Complete the form below and click “Submit”. Any field marked (*) is required.

Print

Print the voucher from the confirmation page and attach it to a new prescription for IMBRUVICA®.

Success

In the confirmation, please follow the instructions outlined for processing the voucher and for reimbursement.

For questions completing the form, please call 1-855-332-6211

 

*Required

Only new patients initiating therapy on IMBRUVICA® are eligible for this voucher program.

Current IMBRUVICA® patients can visit IMBRUVICA® By Your Side patient support.

Success! Print this page and attach to a new prescription for IMBRUVICA®

FREE 1-MONTH TRIAL OFFER FOR NEW IMBRUVICA® PATIENTS

Eligible* patients will receive a free 1-month supply of IMBRUVICA® tablets or capsules

*Some restrictions apply. See eligibility rules for details.

For Eligible NEW Patients Initiating Therapy

Limit one voucher per patient for the duration of the program.

This offer will be accepted only at participating pharmacies.

Program managed by McKesson on behalf of Pharmacyclics LLC and Janssen Biotech, Inc.

IMBRUVICA® Free 1-Month (28- or 30-Day) supply

One month supply consists of tablets or capsules (28 or 30 days)

BIN: 610524 PCN: Loyalty GRP: IMB57962
ID:

Free Trial Offer for eligible commercial, Medicare, Medicaid or cash patients.

This voucher is valid once per patient for a 1-month trial (28- or 30-day) of IMBRUVICA®.

28-day supply: 140 mg, 280 mg, 420 mg, 560 mg tablets or 70 mg capsules

30-day supply: 140 mg capsules

Limits, terms and conditions apply.

Patients may be offered the free trial voucher exclusively through their healthcare provider. The prescription must be filled through a participating pharmacy. There is no obligation to continue IMBRUVICA®. To continue a patient on IMBRUVICA® therapy, a prescription can be filled through a participating pharmacy. If you have questions or need a list of participating pharmacies, please call the Help Desk at 1-855-332-6211. 

FREE TRIAL OFFER FOR ELIGIBLE COMMERCIAL, MEDICARE, MEDICAID OR CASH PATIENTS.

This offer is good for eligible patients on IMBRUVICA® who are 18 years of age or older, are residents of the United States, Puerto Rico, US Virgin Islands or Guam, and have a valid prescription for IMBRUVICA® written within the last 30 days. Only patients new to IMBRUVICA® may use this voucher. These eligible patients can receive a free 28- or 30-day supply of IMBRUVICA®. Offer is limited to one per patient and is not transferable. This Free Trial Offer cannot be combined with any other savings, free trial, or similar offer for the specified prescription. This offer will be accepted only at participating pharmacies. Patients, pharmacists, and prescribers cannot seek reimbursement for the Free Trial Offer from health insurance or any third party, including state- or federally funded programs. Patients may not count the Free Trial Offer as an expense incurred for purposes of determining out-of-pocket costs for any plan, including true out-of-pocket costs (TrOOP), or for purposes of calculating the out-of-pocket threshold for Medicare Part D plans. This voucher is not valid where prohibited by law. This free trial offer is not health insurance. This free trial offer may not be sold, purchased, traded or counterfeited. Patients have no obligation to continue to use IMBRUVICA®. Pharmacyclics/Janssen reserves the right to rescind, revoke or amend this offer at any time without notice. Program terms will expire at the end of each calendar year. For questions, please call the Help Desk at 1-855-332-6211. For information on how Pharmacyclics and Janssen handle personal information, please visit their privacy notices at https://www.pharmacyclics.com/privacy-policy and https://www.janssen.com/us/privacy-policy.

BY USING THIS VOUCHER, YOU AND YOUR PHARMACIST UNDERSTAND AND AGREE TO COMPLY WITH THESE  ELIGIBILITY REQUIREMENTS AND TERMS OF USE.

Pharmacist Instructions:

For reimbursement, please submit this voucher as a primary claim using BIN# 610524. The information printed on the front combined with the ID# provided on the voucher should be used when submitting for reimbursement. No claim for payment can be made to ANY Third-Party Payer for product dispensed pursuant to this offer. Not valid if reproduced. For any questions regarding online processing, please call the Help Desk at 1-855-332-6211.

You are encouraged to report negative side effects to the FDA by visiting www.FDA.gov/medwatch or calling 1-800-FDA-1088.

Program managed by McKesson on behalf of Pharmacyclics LLC and Janssen Biotech. Product dispensed pursuant to program rules and federal and state laws.

© Pharmacyclics LLC 2021 © Janssen Biotech, Inc. 2021 04/21 PRC-07824

This submission cannot be processed.

 

Thank you for submitting this application for the IMBRUVICA® Voucher Program.

Based on the information submitted, there is an issue with this request. Please call the McKesson Pharmacy Help Desk at 1-855-332-6211. We are available to answer your questions Monday through Friday 8:00am-8:00pm ET, excluding holidays.

Current IMBRUVICA® patients can visit: https://imbruvica.com/imbruvica-by-your-side.

 

Pharmacy: This requires patient consent in order to opt-in

Pharmacyclics LLC and Janssen Biotech, Inc. provide personalized support programs. Pharmacyclics LLC, Janssen Biotech, Inc., its affiliates, service providers, and co-promotion partners will use the patient's personal information, including health information, collected through enrollment and participation in the programs to: 1. provide the patient with Pharmacyclics LLC and Janssen Biotech, Inc. product-related support and communications; and 2. perform research and analytics. The patient will be able to opt out of these additional communications at any time by calling 1-855-332-6210. The ability to use the IMBRUVICA® voucher is not contingent on enrollment in the manufacturer’s patient support program. For information on how Pharmacyclics and Janssen handle personal information, please visit their privacy notices at https://www.pharmacyclics.com/privacy-policy and https://www.janssen.com/us/privacy-policy.

By using this voucher, the patient and pharmacist understand and agree to comply with these eligibility requirements and terms of use: This offer is good for eligible patients on IMBRUVICA® who are 18 years of age or older, are residents of the United States, Puerto Rico, US Virgin Islands or Guam, and have a valid prescription for IMBRUVICA® written within the last 30 days. Only patients new to IMBRUVICA® may use this voucher. These eligible patients can receive a free 28- or 30-day supply of IMBRUVICA®. Offer is limited to one per patient and is not transferable. The Free Trial Offer cannot be combined with any other savings, free trial or similar offer for the specified prescription. This voucher will be accepted only at participating pharmacies. Patients, pharmacists, and prescribers cannot seek reimbursement for the Free Trial Offer from health insurance or any third party, including state-or federally funded programs. Patients may not count the Free Trial Offer as an expense incurred for purposes of determining out-of-pocket costs for any plan, including true out-of-pocket costs (TrOOP), or for purposes of calculating the out-of-pocket threshold for Medicare Part D plans. This voucher is not valid where prohibited by law. The Free Trial Offer is not health insurance. This free trial offer may not be sold, purchased, traded or counterfeited. Patients have no obligation to continue to use IMBRUVICA®. Pharmacyclics/Janssen reserves the right to rescind, revoke, or amend this offer at any time without notice. For questions, please call the Help Desk at 1-855-332-6211. For information on how Pharmacyclics and Janssen handle personal information, please visit their privacy notices at https://www.pharmacyclics.com/privacy-policy and https://www.janssen.com/us/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 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