IFINWIL

What it is

Ifinwil contains 192 mg eflornithine (as hydrochloride) . It is supplied as a white to off-white, round, biconvex tablet . Eflornithine is an irreversible inhibitor of the enzyme ornithine decarboxylase (ODC), the first and rate-limiting enzyme in the biosynthesis of polyamines .

Approved indications

— High-risk neuroblastoma in adults and paediatric patients who have responded to prior multiagent, multimodality therapy .

Dosing overview

The recommended dose of Ifinwil depends on body surface area (BSA). For BSA greater than 1.5 m², the dose is 768 mg (four tablets) orally twice a day; for BSA 0.75 to 1.5 m², 576 mg (three tablets) orally twice a day; for BSA 0.5 to less than 0.75 m², 384 mg (two tablets) orally twice a day; and for BSA 0.25 to less than 0.5 m², 192 mg (one tablet) orally twice a day . Treatment should continue for 2 years, or until recurrence of disease or unacceptable toxicity occurs . The appropriate dose should be recalculated every 3 months as BSA changes during treatment . Ifinwil tablets are taken orally, with or without food, and can be swallowed whole, chewed or crushed .

Key safety warnings

Ifinwil can cause myelosuppression. Grade 3 or 4 neutropenia occurred in 4.2% of patients, Grade 3 or 4 thrombocytopenia occurred in 1.4% of patients, and Grade 3 anaemia occurred in 3.3% of patients . Blood counts including neutrophil count, platelet count, and haemoglobin level should be monitored prior to administration of Ifinwil and periodically during treatment . Ifinwil can cause hepatotoxicity. Grade 3 or 4 events of increased alanine aminotransferase (ALT) occurred in 11% of patients and Grade 3 or 4 events of increased aspartate aminotransferase (AST) occurred in 6% of patients . Liver function tests (ALT, AST, and total bilirubin) should be performed prior to the start of Ifinwil, every month for the first six months of treatment, then once every 3 months or as clinically indicated . Ifinwil can cause hearing loss. New or worsening hearing loss occurred in 13% of patients who received Ifinwil; hearing loss worsened from baseline to Grade 3 or 4 in 12% of patients . An audiogram should be performed prior to initiation of therapy and at 6-month intervals, or as clinically indicated, to monitor for potential hearing loss .

Contraindications

Ifinwil is contraindicated in patients with hypersensitivity to eflornithine or to any of the excipients .

PBS listing

Ifinwil tablets 192 mg are listed on the PBS with 4 items, authority required restriction, at an ex-manufacturer price of A$11540.80 .

Regulatory history

Ifinwil eflornithine 192 mg tablets were first registered on the ARTG on 11 April 2025 . This medicinal product is subject to additional monitoring in Australia due to approval of an extension of indications . The PBAC recommended listing in March 2025 for post-maintenance treatment to prevent relapse in patients with high-risk neuroblastoma who are in remission after receiving multiagent, multimodality therapy .