Label Changes for:
Arranon (nelarabine) injection
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
- the risk of rhabdomyolysis and increased blood creatine phosphokinase (CPK) added
WARNING and PRECAUTIONS
- Administration of live vaccines to immunocompromised patients should be avoided.
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.
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.