Safety

Oxaliplatin (Oxaliplatin) for Injection

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

April 2016

Summary View

WARNINGS AND PRECAUTIONS

Severe Neutropenia
  • Grade 3 or 4 neutropenia occurred in 41 to 44% of patients with colorectal cancer treated with oxaliplatin in combination with 5-flurouracil (5-FU) and leucovorin compared to 5% with 5-FU plus leucovorin alone. Sepsis, neutropenic sepsis and septic shock have been reported in patients treated with oxaliplatin, including fatal outcomes.
  • Delay oxaliplatin until neutrophils are = 1.5 x 109/L. Withhold oxaliplatin for sepsis or septic shock. Dose reduce oxaliplatin after recovery from Grade 4 neutropenia or febrile neutropenia.
Cardiovascular Toxicity
  • QT prolongation and ventricular arrhythmias including fatal Torsade de Pointes have been reported in postmarketing experiences following oxaliplatin administration. ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating oxaliplatin and monitor these electrolytes periodically during therapy. Avoid oxaliplatin in patients with congenital long QT syndrome.
Rhabdomyolysis
  • Rhabdomyolysis, including fatal cases, has been reported in patients treated with oxaliplatin. Discontinue oxaliplatin if any signs or symptoms of rhabdomyolysis occur.

ADVERSE REACTIONS

Post Marketing Experience
  • … QT prolongation, septic shock, and rhabdomyolysis…

 

August 2012

Summary View 

WARNINGS AND PRECAUTIONS

Allergic Reactions
  • These reactions are usually managed with standard epinephrine, corticosteroid, antihistamine therapy, and require discontinuation of therapy. Rechallenge is contraindicated in these patients…
Neurologic Toxicity
  • Reversible Posterior Leukoencephalopathy Syndrome: Reversible Posterior Leukoencephalopathy Syndrome (RPLS, also known as PRES, Posterior Reversible Encephalopathy Syndrome) has been observed in clinical trials (< 0.1%) and postmarketing experience…

 

Page Last Updated: 05/13/2016
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