XAFIMED

What it is

XAFIMED contains safinamide (as mesilate) in tablets of 50 mg or 100 mg strength. Safinamide is an α-aminoamide derivative that acts through both dopaminergic and non-dopaminergic mechanisms of action, and is a highly selective and reversible monoamine oxidase B (MAO-B) inhibitor that causes an increase in extracellular levels of dopamine in the striatum.

Approved indications

— Treatment of adult patients with fluctuating idiopathic Parkinson's disease as add-on therapy to a regimen that includes levodopa (L-Dopa).

Dosing overview

XAFIMED treatment should be started at 50 mg per day, with the dose able to be increased to 100 mg per day after two weeks on the basis of individual clinical need. XAFIMED may be taken with or without food. XAFIMED 50 mg can be discontinued without down titration, while XAFIMED 100 mg should be tapered by decreasing the dose to 50 mg for one week prior to discontinuation.

Key safety warnings

Serotonin syndrome has been reported in patients on concomitant treatment with monoamine oxidase inhibitors (including selective MAO-B inhibitors), selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, tetracyclic antidepressants, triazolopyridine antidepressants, cyclobenzaprine, opioid drugs and methylphenidate, amphetamine and their derivatives. Safinamide may potentiate the side effects of levodopa and/or other dopaminergic drugs, and pre-existing dyskinesia may be exacerbated. Somnolence and dizziness may occur during safinamide treatment, and patients treated with dopaminergic medications have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. Safinamide should not be administered to patients with ophthalmological history that would put them at increased risk for potential retinal effects, such as family history of hereditary retinal disease or history of uveitis.

Contraindications

Hypersensitivity to safinamide or to any of the tablet excipients is a contraindication. Concomitant treatment with other monoamine oxidase (MAO) inhibitors is contraindicated, with at least 7 days required between discontinuation of safinamide and initiation of treatment with another MAO inhibitor. Concomitant treatment with pethidine is contraindicated, with at least 7 days required between discontinuation of safinamide and initiation of treatment with pethidine. Severe hepatic impairment is a contraindication. Albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy are contraindications.

PBS listing

No information regarding PBS listing has been provided in the source documents.

Regulatory history

XAFIMED safinamide 50 mg and 100 mg tablets in bottle packs were first listed on the ARTG on 20 August 2025. XAFIMED safinamide 50 mg and 100 mg tablets in blister packs were first listed on the ARTG on 12 November 2025. The medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.