INDICATION
IWILFIN is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
IWILFIN can cause myelosuppression. CBC and liver function tests should be performed before starting treatment and as clinically indicated for the duration of treatment. Withhold, reduce the dose, or permanently discontinue IWILFIN based on severity.
IWILFIN can cause hearing loss. Monitor hearing before and during treatment with IWILFIN. Withhold, reduce the dose, or permanently discontinue IWILFIN based on severity.
IWILFIN can cause fetal harm. Advise females of reproductive potential of the possible risk to a fetus and to use effective contraception.
Adverse Reactions
The most common (≥5%) adverse reactions are hearing loss, otitis media, pyrexia, pneumonia, and diarrhea.
The most common (≥2%) Grade 3 or 4 laboratory abnormalities are increased ALT, increased AST, decreased neutrophil count, and decreased hemoglobin.
