IMBRUVICA® (Ibrutinib) 420, 280, 140 mg tablets | 140, 70 mg capsule Logo
IMBRUVICA® (Ibrutinib) 420, 280, 140 mg tablets | 140, 70 mg capsule || 70mg/mL oral suspension Logo
Chronic Lymphocytic Leukemia (Adult Patients) Waldenström's Macroglobulinemia (Adult Patients) Previously Treated Chronic Graft Versus Host Disease (Adult and Pediatric Patients Age 1 Year and Older)

IMBRUVICA® VOUCHER PROGRAM

FREE TRIAL OFFER† FOR ELIGIBLE NEW PATIENTS INITIATING THERAPY

IMBRUVICA® FREE UP TO 1-MONTH SUPPLY

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 up to 1-month free 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.

Visit IMBRUVICA® By Your Side patient support

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

FREE UP TO 1-MONTH TRIAL OFFER FOR NEW IMBRUVICA® PATIENTS

Eligible* patients will receive up to a one month† free supply of IMBRUVICA®

*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 up to a 1-Month† supply

†Up to 1-month supply of IMBRUVICA®
capsules, tablets, or oral suspension

BIN: 610524 PCN: Loyalty GRP: IMB57962
ID:

Free Trial Off er for eligible‡ commercial, Medicare, Medicaid, or cash patients.

This voucher is valid once per patient for up to a 1-month§ trial of IMBRUVICA®.

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

30-day supply: 140 mg capsules

Up to 1-month supply: 1 bottle/108 mL; oral suspension

‡Limits, terms and conditions apply.
§Capsules, tablets, and oral suspension

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.

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 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 up to a month supply of IMBRUVICA®. 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.

logo logo

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 2022 © Janssen Biotech, Inc. 2022 08/22 PRC-09679

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 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 up to a month's† 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 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 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 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

Are you a healthcare professional?

You are leaving the patient and caregiver site and entering the US Healthcare professional site. The information contained in this site is intended for US Healthcare professionals only. Click “OK” below if you are a healthcare professional.
 

OK