Safety

Gazyva (obinutuzumab) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

September 2015

Summary View

WARNINGS AND PRECAUTIONS

Tumor Lysis Syndrome
  • Tumor Lysis Syndrome (TLS), including fatal cases, has been reported in patients receiving Gazyva. Patients with high tumor burden, high circulating lymphocyte count (> 25 x 109/L) or renal impairment are at greater risk for TLS and should receive appropriate tumor lysis prophylaxis with anti-hyperuricemics (e.g., allopurinol or rasburicase) and hydration prior to the infusion of Gazyva. During the initial days of Gazyva treatment, monitor the laboratory parameters of patients considered at risk for TLS. For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.
Use in Specific Populations
  • *updated to conform with the Pregnancy and Lactation Labeling Rule (PLLR).

 

December 2014

Summary View

WARNINGS AND PRECAUTIONS

Infections
  • …Fatal infections have been reported with GAZYVA….
Neutropenia

*Change in percentage

  • caused Grade 3 or 4 neutropenia in 33% of patients
Thrombocytopenia

*Change in percentage

  • GAZYVA in combination with chlorambucil caused Grade 3 or 4 thrombocytopenia in 10% of patients in the trial. In 4% of patients, ... 

 

June 2014

Summary View

WARNINGS AND PRECAUTIONS
Thrombocytopenia

  • Monitor all patients frequently for thrombocytopenia and hemorrhagic events, especially during the first cycle. In patients with Grade 3 or 4 thrombocytopenia, monitor platelet counts more frequently until resolution and consider subsequent dose delays of Gazyva and chlorambucil or dose reductions of chlorambucil. Transfusion of blood products (i.e., platelet transfusion) may be necessary. Consider withholding concomitant medications which may increase bleeding risk (platelet inhibitors, anticoagulants), especially during the first cycle.
     

 

Page Last Updated: 10/09/2015
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