Iwilfin

To reduce the risk of relapse in pediatric patients with high-risk neuroblastoma who have had at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

Pediatric: 384-1024 mg/m2 orally twice daily, based on BSA. 28-day cycles.

Tablets: 192 mg

None listed in the prescribing information.

• Myelosuppression: Monitor CBCs at baseline and regularly.
• Hearing Loss: Perform audiometric testing at baseline and during treatment.
• Hepatotoxicity: Monitor LFTs.
• Embryo-Fetal Toxicity: Can cause fetal harm.

Otitis Media (44%), Diarrhea (38%), Cough (34%), Vomiting (32%), Pyrexia (30%), Upper Respiratory Infection (28%), Hearing Loss (12%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

No formal drug interaction studies conducted.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Eflornithine (DFMO) irreversibly inhibits ornithine decarboxylase (ODC), a key enzyme in polyamine biosynthesis. Polyamines are essential for cell growth and proliferation in neuroblastoma. Inhibition of polyamine synthesis reduces tumor cell proliferation and maintenance.

Tmax: 3-4 hours. Protein binding: minimal. Elimination: primarily renal (>80% unchanged). Half-life: ~3.5 hours.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• ANBL1232 — Eflornithine + isotretinoin vs isotretinoin in high-risk neuroblastoma maintenance. Phase II, n=393.
  🔬 NCT02395666 ↗

Consult the prescribing information for complete indication details and associated tumor types.