Indications for XADAGO:
As adjunct to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.
Initially 50mg once daily (at same time of day); may increase to 100mg once daily after 2 weeks as tolerated. Moderate hepatic impairment (Child-Pugh B): max 50mg once daily. Taper gradually upon discontinuation.
Severe hepatic impairment (Child-Pugh C). Concomitant other MAOIs including linezolid, opioids (eg, meperidine, methadone, propoxyphene, tramadol), SNRIs, tricyclic, tetracyclic, or triazolopyridine antidepressants, cyclobenzaprine, methylphenidate, amphetamine and their derivatives, St. John's wort, dextromethorphan.
Monitor for new onset or uncontrolled hypertension. Avoid tyramine-rich (>150mg) foods (see full labeling). Dyskinesia: reduce daily dose of levodopa or dopaminergic agent. Consider reducing dose or discontinuing therapy if hallucinations, psychotic disorders, urges/compulsive behaviors develop. Consider discontinuing if excessive daytime sleepiness or if sudden onset of sleep occurs. History of retinal/macular degeneration, uveitis, inherited retinal conditions, family history of hereditary retinal disease, albinism, retinitis pigmentosa, active retinopathy; monitor periodically for visual changes. Discontinue if severe hepatic impairment develops. Pregnancy. Nursing mothers.
See Contraindications. Allow at least 14 days after discontinuing safinamide before starting MAOIs, opioids, serotonergics. Possible hypertensive crisis with excess dietary tyramine (see full labeling). Monitor for hypertension and reaction to dietary tyramine if concomitant with isoniazid. Concomitant SSRIs: use lowest effective dose and monitor for serotonin syndrome. Monitor for hypertension if concomitant with sympathomimetics (eg, nasal, oral, ophthalmic, decongestants or cold remedies). May be antagonized by dopamine antagonists (eg, antipsychotics, metoclopramide).
Dyskinesia, fall, nausea, insomnia; serotonin syndrome, withdrawal-emergent hyperpyrexia and confusion, retinal pathology.
Generic Drug Availability: