IMBRUVICA® for Previously Treated Adult cGVHDIMBRUVICA® for Previously Treated Adult cGVHD

IMBRUVICA® (ibrutinib)
for Previously Treated
Adult cGVHD

IMBRUVICA® Is an Oral, Once-Daily cGVHD Medication That May Help When Other Systemic Therapies Have Failed 

IMBRUVICA® is the first FDA-approved therapy for adult chronic graft versus host disease (cGVHD) patients who have already been treated with other systemic therapies

Patients who aren’t getting results with steroid therapy have another option1

  • In a trial of previously treated patients, 2 out of 3 patients (28 of 42 patients enrolled in the study) had a response with IMBRUVICA®, which means they showed improvement1
  • Almost half of patients (20 of 42) in the trial had a response to IMBRUVICA® that lasted for at least 20 weeks

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

 

The most common side effects in the adult cGVHD clinical trial were1:

  • Tiredness
  • Muscle spasms
  • Bruising
  • Nausea
  • Diarrhea
  • Bleeding (Hemorhage)
  • Low platelet counts
  • Low red blood cell count
  • Mouth sores (stomatitis)
  • Pneumonia

In the adult cGVHD clinical trial, nearly 1 in 4 patients stopped taking IMBRUVICA® because of side effects.1

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

Reference: 1IMBRUVICA® (ibrutinib) Prescribing Information.

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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).