Please click for full Prescribing Information and Patient Information for DANYELZA including BOXED WARNING on serious infusion-related reactions and neurotoxicity.
INDICATION
DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partiaI response, minor response, or stable disease to prior therapy.
This indication is approved under accelerated approval based on overalI response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
SELECTED IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY
Serious Infusion-Related Reactions
- DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Infusion reactions of any Grade occurred in 94-100% of patients. Severe infusion reactions occurred in 32-68% and serious infusion reactions occurred in 4-18% of patients in DANYELZA clinical studies.
- Premedicate prior to each DANYELZA infusion as recommended and monitor patients for at least 2 hours following completion of each infusion. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity.
Neurotoxicity
- DANYELZA can cause severe neurotoxicity, including severe neuropathic pain,transverse myelitis and reversible posterior leukoencephalopathy syndrome (RPLS). Pain of any Grade occurred in 94-100% of patients in DANYELZA clinical studies.
- Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity.