Classes
DEA Class; Rx
Common Brand Names; Xadago
- Antiparkins Agents, Adjunct;
- Antiparkinson Agents, MAO Type B Inhibitors
Description
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
Indications
Indicated for adjunctive treatment to levodopa-carbidopa therapy in patients with Parkinson’s disease experiencing ‘off’ episodes.
Contraindications
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
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
There are no adequate and well-controlled studies of safinamide in pregnant women
Unknown if distributed in human breast milk
Maximum Dosage
100 mg/day PO.
100 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
How supplied
Safinamide
afinamide
tablet
- 50mg
- 100mg