"The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers.
Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has retu"...
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-Advise pregnant women of potential fetal B-cell depletion [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: 1/27/2016
This monograph has been modified to include the generic and brand name in many instances.
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