"The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
CLL is a rare blood and bone marrow disease"...
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:
- Periodic monitoring of blood counts [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
- Avoid vaccinations with live viral vaccines [see WARNINGS AND PRECAUTIONS].
- Patients with a history of hepatitis B infection (based on the blood test) should be monitored and sometimes treated for their hepatitis [see WARNINGS AND PRECAUTIONS].
- Advise pregnant women of potential fetal B-cell depletion [see Use In Specific Populations].
Last reviewed on RxList: 3/7/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Gazyva Information
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