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New FDA Approval for IMBRUVICA®

On behalf of Pharmacyclics LLC, an AbbVie Company, we wanted to share that today we received US FDA approval for IMBRUVICA® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. With this approval, IMBRUVICA® becomes the first and only therapy specifically approved for adult patients in this disease state. 

   

For your reference, click here  to read our company press release and click here to access the complete, updated Prescribing Information. 

 

Important safety highlights include the following:  

 

Warnings and Precautions

  • Hemorrhage: Monitor for bleeding and manage.
  • Infections: Monitor patients for fever and infections, evaluate promptly, and treat. 
  • Cytopenias: Check complete blood counts monthly.
  • Atrial Fibrillation: Monitor for atrial fibrillation and manage.
  • Hypertension: Monitor blood pressure and treat.
  • Second Primary Malignancies: Other malignancies have occurred in patients, including skin cancers, and other carcinomas.
  • Tumor Lysis Syndrome (TLS): Assess baseline risk and take precautions. Monitor and treat for TLS.
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise women of the potential risk to a fetus and to avoid pregnancy while taking the drug and for 1 month after cessation of therapy. Advise men to avoid fathering a child during the same time period.

 

Adverse Reactions

The most common adverse reactions (≥20%) in patients with cGVHD were fatigue, bruising, diarrhea, thrombocytopenia, muscle spasms, stomatitis, nausea, hemorrhage, anemia, and pneumonia.

 

For additional safety information, please see the full Prescribing Information here