IMBRUVICA® is available as a single tablet, taken once daily IMBRUVICA® is available as a single tablet, taken once daily 

IMBRUVICA®—the once-daily oral medication—is available in a single-tablet formulation1

The same active ingredient is available as one tablet at multiple dose strengths.1 No matter what dose your patient requires, they will take just one tablet a day.1

The tablet comes in a blister pack with daily tracking. Patients will receive a 4-week supply with a reminder to refill printed on the package.1

Single-tablet FAQs

One tablet, multiple strengths

IMBRUVICA® One Pill Strength Options
New IMBRUVICA® (ibrutinib) Dosing

Single-tablet dosing

IMBRUVICA® (ibrutinib) one pill packaging
IMBRUVICA® Example New Dosing Formulation

Dose modification guidelines for adverse reactions1:

Interrupt IMBRUVICA® therapy for any Grade 3 or greater non-hematological toxicities, Grade 3 or greater neutropenia with infection or fever, or Grade 4 hematological toxicities. Once the symptoms of the toxicity have resolved to Grade 1 or baseline (recovery), IMBRUVICA® therapy may be reinitiated at the starting dose. If the toxicity reoccurs, reduce dose by 140 mg per day. A second reduction of dose by 140 mg may be considered as needed. If these toxicities persist or recur following two dose reductions, discontinue IMBRUVICA®.

For more information on dosing considerations, including use with CYP3A inhibitors and/or inducers, and in patients with hepatic impairment, please see the full Prescribing Information.

If a patient requires a dose modification, they will need a new prescription for that specific dose.

YOU&i™ Dose Exchange Program

The YOU&i™ Dose Exchange Program

There may be times when you need to reduce your patient’s dose because they have experienced an adverse reaction or are taking certain concomitant medications. The YOU&i™ Dose Exchange Program is available to facilitate this dose reduction if you decide to adjust your patient’s dose before they have finished their current pack of IMBRUVICA®.

  • Your patient who requires a dose reduction can exchange their unused tablets for the same number of tablets at their new dose strength

  • Your patient can receive their new dose before returning their unused tablets

  • As a safety-based returns program, the tablets at the new dose strength will be provided at no additional cost to the patient

How it works:

IMBRUVICA® Dose Exchange Prescription & Enrollment Form

Download a Dose Exchange Prescription and Enrollment Form to prescribe a new dose strength. Submit the completed form with prescriber’s signature to the YOU&i™ Support Program

YOU&I™ Support Program will call within 24 Hours

The YOU&i™ Support Program will contact your patient within 24 hours of receiving the completed form to confirm eligibility and arrange rapid shipment of the new dose

YOU&i™ Dose Exchange Program pharmacy

The YOU&i™ Dose Exchange Program pharmacy will send the new dose strength and prepaid return envelope via rapid transport directly to your patient

Return Unused Pills

Your patient will then return the unused tablets remaining from their previous prescription in the prepaid envelope provided. The tablets can be returned either by mail or pick up can be arranged by the Dose Exchange Program if preferred

  • The YOU&i™ Support Program staff can answer any questions you or your patient may have about this program

  • Your patient may participate in the Dose Exchange Program even if they are not enrolled in the YOU&i™ Support Program

Dosing FAQs Download Enrollment Form

Setting patients up for a successful start on tablets

The IMBRUVICA® blister pack was designed to help patients take their medicine as prescribed.

The package is organized by week, with daily labels to help keep track. Each tablet in the pack is identical. Patients should start on Day 1. The pack also lets patients see when they need to refill, at a glance. There is even a reminder to refill printed on the package.

Sample Image of the IMBRUVICA® 420-mg Blister Pack Sample Image of the IMBRUVICA® 420-mg Blister Pack

Sample image of the 420-mg blister pack.

How to open the package—a step-by-step demo

Watch a video demonstrating how to open the package, step by step.

Frequently asked questions about the IMBRUVICA® single-tablet formulation

Frequently Asked Questions

Single-tablet formulation

Why did the makers of IMBRUVICA® decide to introduce the single-tablet formulation?

The makers of IMBRUVICA® developed the single-tablet formulation to reduce the number of pills your patients have to take each day and designed packaging with daily tracking to help patients take their medication as prescribed.

Why is the packaging for single tablet a blister pack and not a bottle?

The blister pack was designed to support patients taking their medicine as prescribed.

Dosing

What if the patient needs to have their dose modified?

If a patient needs to have their dose modified, they will need a new prescription for that specific dose.

Dose modification guidelines for adverse reactions remain unchanged.

There may be times when you need to reduce your patient’s dose because they have experienced an adverse reaction or are taking certain concomitant medications. The YOU&i™ Dose Exchange Program is available to rapidly facilitate this dose reduction if you decide to adjust your patient’s dose before they have finished their current pack of IMBRUVICA®.

Does my patient have to be enrolled in the YOU&i™ Support Program to use the Dose Exchange Program?

No, your patient may participate in the Dose Exchange Program even if they are not enrolled in the YOU&i™ Support Program.

Where can I get more information about the Dose Exchange Program process? 

Please call the YOU&i™ Dose Exchange Program at 1-877-877-3536.

Setting patients up for success with the single-tablet formulation

Will patients have a hard time opening the blister pack?

Ask your IMBRUVICA® Representative about getting a demonstration pack so you can see for yourself.

Can patients break or chew the tablet?

No, patients should be instructed to swallow the IMBRUVICA® tablet whole, and not to cut, crush, or chew it.1

Are there any contraindications or foods to avoid?

Patients should be advised not to drink grapefruit juice, or eat grapefruit or Seville oranges (often used in marmalade), as these products may increase the amount of IMBRUVICA® in their blood.1 Patients should be asked to tell their doctor about all medicines they take, including prescription and OTC, vitamins and herbal supplements, before starting IMBRUVICA® and while on treatment.

Do patients have to wait until the first of the month to start?

No, patients can start taking IMBRUVICA® as directed, as soon as they fill their prescription. The printed days on the pack do not correspond to calendar days. Patients can also use the space provided to write in either the date, or the day of the week, to help stay on track.

Are there materials I can give my patients about the single-tablet formulation?

Yes. Talk to your IMBRUVICA® Representative about providing you with materials to share.

EHR=electronic health record, NDC=National Drug Code.

References: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2018. 2. Data on file. Pharmacyclics LLC.
 

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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (intracranial hemorrhage [including 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 and patients should be monitored for signs 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 14% to 29% of patients. 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: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 13 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 13%) based on laboratory measurements occurred in patients with B-cell malignancies treated with single agent IMBRUVICA®.

Monitor complete blood counts monthly.

Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA® therapy. Grade 3 or greater ventricular tachyarrhythmias occurred in 0 to 1% of patients, and Grade 3 or greater atrial fibrillation and atrial flutter occurred in 0 to 6% of patients. These events have occurred particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of cardiac arrhythmias.

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

Hypertension: Hypertension (range, 6 to 17%) has occurred in patients treated with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA®.

Adjust existing anti-hypertensive medications and/or initiate anti-hypertensive treatment as appropriate.

Second Primary Malignancies: Other malignancies (range, 3 to 16%) including non-skin carcinomas (range, 1 to 4%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 2 to 13%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA® therapy. 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 women to avoid becoming pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. 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. Advise men to avoid fathering a child during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (62%)*, neutropenia (61%)*, diarrhea (43%), anemia (41%)*, musculoskeletal pain (30%), bruising (30%), rash (30%), fatigue (29%), nausea (29%), hemorrhage (22%), and pyrexia (21%).

The most common Grade 3 or 4 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (39%)*, thrombocytopenia (16%)*, and pneumonia (10%).

Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9% (WM [6%] 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%)*, stomatitis (29%), muscle spasms (29%), nausea (26%), hemorrhage (26%), anemia (24%)*, and pneumonia (21%).

The most common Grade 3 or 4 adverse reactions (≥5%) reported in patients with cGVHD were fatigue (12%), diarrhea (10%), neutropenia (10%)*, pneumonia (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 and adverse reactions.

DRUG INTERACTIONS

CYP3A Inhibitors: Dose adjustment may be recommended.

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 baseline hepatic impairment. In patients with mild or moderate impairment, reduce IMBRUVICA® dose.

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.

    • Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).

  • CLL/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.

    • Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

  • Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.


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IMBRUVICA® (ibrutinib) is covered by U.S. Patents, which are listed in FDA's Orange Book (available at https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm).

© Pharmacyclics LLC 2018

© Janssen Biotech, Inc. 2018

08/18 PRC-04306