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IMBRUVICA® for WM

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IMBRUVICA® Can Be Used in Combination With Rituximab1

In a clinical trial of 150 previously untreated and previously treated patients with WM who received IMBRUVICA® with rituximab:

  • Adults with WM who took IMBRUVICA® + rituximab were 75% less likely to have their disease worsen or die compared to those taking rituximab alone. At an overall follow-up of 63 months, 29% of patients treated with IMBRUVICA® in combination with rituximab therapy experienced disease progression or death compared to 67% of patients treated with rituximab monotherapy
  • Adding IMBRUVICA® to rituximab more than doubled response rates compared to rituximab alone (76% response rate for IMBRUVICA® + rituximab vs 31% for rituximab)

IMBRUVICA® is the first FDA-approved therapy for WM

In a clinical trial of 63 previously treated WM patients who received IMBRUVICA® alone

  • 62% (39 patients) had a response to IMBRUVICA®, which means that their doctor observed fewer signs of the disease as seen through blood tests, X-rays, CT scans, and/or bone marrow tests
  • The median amount of time to respond to IMBRUVICA® treatment was 1.2 months

IMBRUVICA® will not work for every patient. Individual results may vary.

What should I know about IMBRUVICA® side effects?

IMBRUVICA® may cause serious side effects, including1:

  • Bleeding problems (hemorrhage)
  • Infections
  • Heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter), heart failure and death
  • High blood pressure (hypertension)
  • Decrease in blood cell counts
  • Second primary cancers
  • Tumor lysis syndrome (TLS)*

*TLS is a disorder caused by the breakdown products of cancer cells, which can lead to kidney failure and other abnormalities.
 

The most common side effects in the WM clinical study during which IMBRUVICA® was administered in combination with rituximab were1:

  • Bruising
  • Joint pain
  • Muscle and bone pain
  • Rash
  • Bleeding
  • Nausea
  • Diarrhea
  • Hypertension

In the WM clinical study for IMBRUVICA® administered in combination with rituximab, 5% of patients stopped taking IMBRUVICA® therapy because of side effects.2

The most common side effects during ibrutinib single agent therapy study in previously treated patients were1:

  • Low white blood cell count
  • Low blood platelet count
  • Diarrhea
  • Bruising
  • Bleeding
  • Low red blood cell count
  • Nausea
  • Rash
  • Muscle and bone pain

In the WM clinical trials ibrutinib single therapy, 6% of patients stopped taking IMBRUVICA® due to side effects and 11% of patients had their dosage reduced due to side effects.3

This is not a complete list of side effects. Others may occur. Tell your doctor if you think you are experiencing side effects.

References: 1. IMBRUVICA® (ibrutinib) Prescribing Information 2. Dimopoulos MA, Tedeschi A, Trotman J, et al. Phase 3 trial of ibrutinib plus rituximab in Waldenström’s macroglobulinemia. N Engl J Med. 2018;378(25):2399-2410. 3. Data on file. Pharmacyclics LLC.

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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).

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