"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 contact a healthcare professional for any of the following:
- Signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within 24 hours of infusion [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS]
- Symptoms of hepatitis including worsening fatigue or yellow discoloration of skin or eyes [see WARNINGS AND PRECAUTIONS]
- New neurological symptoms such as confusion, dizziness or loss of balance, difficulty talking or walking, or vision problems [see WARNINGS AND PRECAUTIONS]
- Bleeding, easy bruising, petechiae, pallor, worsening weakness, or fatigue [see WARNINGS AND PRECAUTIONS]
- Signs of infections including fever and cough [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS]
- Pregnancy or nursing [see Use In Specific Populations]
Advise patients of the need for:
- Monitoring and possible need for treatment if they have a history of hepatitis B infection (based on the blood test) [see WARNINGS AND PRECAUTIONS].
- Periodic monitoring for blood counts [see WARNINGS AND PRECAUTIONS]
- Avoiding vaccination with live viral vaccines [see WARNINGS AND PRECAUTIONS]
Last reviewed on RxList: 4/30/2014
This monograph has been modified to include the generic and brand name in many instances.
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