February 14, 2016
Recommended Topic Related To:


"The U.S. Food and Drug Administration today approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.

MCL is a rare form of non-Hodgkin lymphoma and represents about 6 "...




Advise patients to seek immediate medical attention for any of the following:

  • Signs and symptoms of infusion reactions including dizziness, nausea, chills, fever, vomiting, diarrhea, breathing problems, or chest pain [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
  • Symptoms of tumor lysis syndrome such as nausea, vomiting, diarrhea, and lethargy [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
  • Signs of infections including fever and cough [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
  • Symptoms of hepatitis including worsening fatigue or yellow discoloration of skin or eyes [see WARNINGS AND PRECAUTIONS].
  • New or changes in neurological symptoms such as confusion, dizziness or loss of balance, difficulty talking or walking, or vision problems [see WARNINGS AND PRECAUTIONS].

Advise patients of the need for:

Advise pregnant women of potential fetal B-cell depletion [see Use In Specific Populations].

Last reviewed on RxList: 10/26/2015
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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