August 24, 2016
Recommended Topic Related To:


"The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).


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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:

Last reviewed on RxList: 3/7/2016
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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