safinamide methansulfonate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
safinamide methansulfonate: clinical details
Prescribing considerations
- Confirm the licensed fluctuating, mid- to late-stage Parkinson’s context and established levodopa therapy.
- Reconcile MAO inhibitors, opioid analgesics, antidepressants, sympathomimetics and non-prescription cough or cold products before initiation.
- Assess hepatic and retinal history and discuss effective contraception where relevant.
- Experience in people older than 75 years is limited; paediatric safety and efficacy have not been established.
- Moderate hepatic impairment increases exposure and requires caution; progression to severe impairment requires discontinuation.
Contraindications and cautions
- Hypersensitivity to safinamide or an excipient
- Concomitant treatment with another MAO inhibitor
- Concomitant treatment with pethidine
- Severe hepatic impairment
- Albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy
Monitoring
- Review dyskinesia and other potentiated levodopa effects after treatment changes.
- Monitor for postural hypotension, falls, somnolence and driving impairment.
- Ask patients and carers about hallucinations, compulsive or impulsive behaviour and other neuropsychiatric changes.
- Review new visual symptoms and avoid use where retinal history confers increased risk.
- Monitor clinically for serotonergic or blood-pressure toxicity when potentially interacting treatment cannot be avoided.
Clinical pharmacology
Safinamide is a highly selective, reversible MAO-B inhibitor that increases extracellular striatal dopamine. It also inhibits voltage-gated sodium channels in a state-dependent manner and modulates stimulated glutamate release. Oral bioavailability is high; it undergoes extensive metabolism to inactive metabolites, with elimination mainly through urine.
Formulation and product differences
- The selected product is an orange-to-copper, round, biconcave film-coated tablet with strength-specific embossing.
- Xadago tablets are available in two distinguishable tablet sizes and are supplied in blister packs.
- The selected formulation has no special storage requirements.
safinamide methansulfonate preparations and strengths
Tablet
Route: Oral
Strengths: 50 mg, 100 mg
safinamide methansulfonate interactions
A full medicines review is important, including prescribed, non-prescription and herbal products.
Other monoamine oxidase inhibitors
Concomitant use is contraindicated because loss of MAO-B selectivity may cause a hypertensive crisis.
Pethidine
Concomitant use is contraindicated because serious reactions have occurred with MAO inhibitors.
SSRIs, SNRIs and tricyclic or tetracyclic antidepressants
Serious serotonergic reactions are possible; specialist review is advised, with fluoxetine or fluvoxamine generally avoided.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.