Skip to content

Safinamide

    Brands

    DEA Class;  Rx

    Common Brand Names; Xadago

    • Antiparkins Agents, Adjunct; 
    • Antiparkinson Agents, MAO Type B Inhibitors

    Selective and reversible inhibitor of monoamine oxidase (MAO) Type B
    Used as an adjunct to levodopa; carbidopa therapy to treat “off” episodes in adults with Parkinson’s disease
    Although MAO-B selectivity of the drug is high, patients should be instructed to avoid certain foods that contain very high amounts (i.e., more than 150 mg) of tyramine due to the potential for a tyramine reaction such as severe hypertension

    Indicated for adjunctive treatment to levodopa-carbidopa therapy in patients with Parkinson’s disease experiencing ‘off’ episodes.

    History of hypersensitivity to safinamide; reactions include swelling of the tongue and oral mucosa, and dyspnea

    Severe hepatic impairment (Child-Pugh C: 10-15)

    Coadministration with other monoamine oxidase inhibitors (MAOIs) or drugs that are potent inhibitors of MAO (eg, linezolid); combination may result in increased blood pressure, including hypertensive crisis

    Coadministration with opioids (eg, meperidine and its derivatives, methadone, tramadol); serotonin-norepinephrine reuptake inhibitors (SNRIs); tricyclic, tetracyclic, or triazolopyridine antidepressants; cyclobenzaprine; methylphenidate, amphetamine, and their derivatives; or St John’s wort; combination could result in life-threatening serotonin syndrome

    Coadministration with dextromethorphan; combination of MAOIs and dextromethorphan has been reported to cause episodes of psychosis or abnormal behavior

    • Dyskinesia (17-21%)
    • Hypertension (5-7%)
    • ALT or AST increased to >ULN (5-7%)
    • Fall (4-6%)
    • Nausea (3-6%)
    • Insomnia (1-4%)
    • Orthostatic hypotension (2%)
    • Anxiety (2%)
    • Cough (2%)
    • Dyspepsia (2%)
    • Swelling of tongue and gingiva
    • Dyspnea
    • Rash
    • Hypersensitivity
    • Headache

    May cause or exacerbate hypertension; monitor patients for new onset hypertension or hypertension not adequately controlled after initiating therapy; medication adjustment may be necessary if blood pressure elevation is sustained

    May cause serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs (see Contraindications)

    May cause falling asleep during activities of daily living

    May cause or exacerbate dyskinesia; consider levodopa dose reduction to mitigate dyskinesia

    May cause hallucinations and psychotic behavior; consider dosage reduction or stopping medication if patient develops hallucinations or psychotic-like behaviors while on therapy

    May cause problems with impulse control/compulsive behaviors; consider dose reduction or stopping medication if a patient develops compulsive behavior while on therapy

    May cause withdrawal-emergent hyperpyrexia and confusion

    Retinal degeneration and loss of photoreceptor cells observed in animal studies (albino and pigmented rats); periodically monitor patients for visual changes in patients with a history of retinal/macular degeneration, uveitis, inherited retinal conditions, family history of hereditary retinal disease, albinism, retinitis pigmentosa, or any active retinopathy

    There are no adequate and well-controlled studies of safinamide in pregnant women

    Unknown if distributed in human breast milk

    Adults

    100 mg/day PO.

    Geriatric

    100 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Not indicated.

    Safinamide

    afinamide

    tablet

    • 50mg
    • 100mg