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Iwilfin Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs—100
Manufacturer
Generic Availability
NO
Mechanism of Action
Eflornithine is an irreversible inhibitor of the enzyme ornithine decarboxylase (ODC), the first and rate-limiting enzyme in the biosynthesis of polyamines and a transcriptional target of MYCN. Inhibition of polyamine synthesis by eflornithine restored the balance of the LIN28/Let-7 metabolic pathway, which is involved in regulation of cancer stem cells and glycolytic metabolism, by decreasing expression of the oncogenic drivers MYCN and LIN28B in MYCN-amplified neuroblastoma. In vitro, eflornithine induced senescence and suppressed neurosphere formation in MYCN-amplified and MYCN non-amplified neuroblastoma cells, indicating a cytostatic effect. Treatment with eflornithine prevented or delayed tumor formation in mice injected with limiting dilutions of MYCN-amplified neuroblastoma cells.
Iwilfin Indications
Indications
To reduce the risk of relapse in patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
Iwilfin Dosage and Administration
Adults and Children
Individualize. Dose based on BSA; should recalculate every 3 months during therapy. Swallow whole; if unable to swallow, tabs can be chewed, or crushed then mixed with 2 tablespoons of soft food or liquid. BSA (0.25–<0.5m2): 192mg twice daily; (0.5–<0.75m2): 384mg twice daily; (0.75–1.5m2): 576mg twice daily; (>1.5m2): 768mg twice daily. Continue for 2 years or until recurrence of disease or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Iwilfin Contraindications
Not Applicable
Iwilfin Boxed Warnings
Not Applicable
Iwilfin Warnings/Precautions
Warnings/Precautions
Myelosuppression. Hepatotoxicity. Hearing loss. Perform CBCs (including neutrophils, platelets, hemoglobin) prior to and periodically during treatment. Obtain LFTs (ALT, AST, total bilirubin) prior to initiation, monthly for the first 6 months, then once every 3 months or as clinically indicated. Perform audiogram prior to initiation and at 6 month intervals, or as clinically indicated. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Iwilfin Pharmacokinetics
Absorption
Peak plasma concentration: achieved at Tmax 3.5 hours post-dose.
Distribution
Volume of distribution: 24.3 L.
Elimination
Half-life: 3.5 hours. Clearance: 5.3 L/h.
Iwilfin Interactions
Not Applicable
Iwilfin Adverse Reactions
Adverse Reactions
Hearing loss, otitis media, pyrexia, pneumonia, diarrhea, cough, lab abnormalities (increased ALT, increased AST, decreased neutrophils, decreased hemoglobin); skin infection.
Iwilfin Clinical Trials
See Literature
Iwilfin Note
Not Applicable
Iwilfin Patient Counseling
See Literature
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