"The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses"...
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: 10/26/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Gazyva Information
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.
Find out what women really need.