Label Changes for:

Arranon (nelarabine) injection

February 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2009 and February 2012

 

February 2012

 

ADVERSE REACTIONS

Postmarketing Experience
  • the risk of rhabdomyolysis and increased blood creatine phosphokinase (CPK) added

 

December 2009

 

WARNING and PRECAUTIONS

Vaccinations
  • Administration of live vaccines to immunocompromised patients should be avoided.

 

ADVERSE REACTIONS

Clinical Trials Experience
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • Adults:...103 adult patients treated with the recommended dose and schedule in 2 studies: an adult T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LBL) study...
  • Pediatrics:...84 pediatric patients treated with the recommended dose and schedule in a T-cell acute lymphoblastic leukemia (T150 ALL)/T-cell lymphoblastic lymphoma (T-LBL) treatment study.
Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Arranon. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Infections and Infestations: Fatal opportunistic infections.
  • Metabolism and Nutrition Disorders: Tumor lysis syndrome.
  • Nervous System Disorders: Demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.

 

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