Safinamide: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
Safinamide: clinical details
Prescribing considerations
- Confirm use as an add-on to stable levodopa in an adult with mid- to late-stage idiopathic Parkinson’s disease and motor fluctuations.
- Review hepatic function, ophthalmic history and interacting medicines before initiation.
- Safinamide may amplify levodopa-related adverse effects, particularly existing dyskinesia.
- Experience in people older than 75 years is limited; safety and efficacy are not established in children or adolescents.
Contraindications and cautions
- Hypersensitivity to safinamide or an excipient.
- Concurrent treatment with another MAO inhibitor.
- Concurrent treatment with pethidine.
- Severe hepatic impairment.
- Albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy.
Monitoring
- Review motor response and emerging or worsening dyskinesia.
- Assess dizziness, postural symptoms, somnolence, falls, hallucinations and impulse-control behaviours.
- Monitor for serotonergic or hypertensive symptoms with potentially interacting medicines.
- Reassess worsening hepatic impairment; severe impairment requires discontinuation.
- Consider ophthalmic assessment for symptoms or relevant retinal risk factors.
Clinical pharmacology
Safinamide is a highly selective, reversible MAO-B inhibitor with additional sodium-channel inhibition and modulation of stimulated glutamate release. It is extensively metabolised. Exposure rises substantially in moderate hepatic impairment, while renal impairment does not materially alter exposure.
Formulation and product differences
- Both selected products are orange-to-copper film-coated tablets, but their markings, excipients, packaging and storage instructions differ.
- The selected Celix formulation contains sodium stearyl fumarate and ascorbic acid and has no special storage requirement.
- The selected Amarox formulation uses magnesium stearate without ascorbic acid and has a storage-temperature restriction in its product information.
Safinamide preparations and strengths
Tablet
Route: Oral
Strengths: 50 mg, 100 mg
Safinamide interactions
Check prescribed, pharmacy and over-the-counter medicines before combining them with safinamide.
Other monoamine oxidase inhibitors, including moclobemide
Contraindicated because excessive MAO inhibition can cause a hypertensive crisis. Switching requires prescriber management.
Pethidine
Contraindicated because serious reactions can occur with MAO inhibitors.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.