{"id":59182,"date":"2024-02-28T05:45:17","date_gmt":"2024-02-28T05:45:17","guid":{"rendered":"https:\/\/medsname.com\/xafinact\/"},"modified":"2026-05-01T10:49:15","modified_gmt":"2026-05-01T10:49:15","slug":"xafinact","status":"publish","type":"product","link":"https:\/\/medsbase.com\/el\/xafinact\/","title":{"rendered":"Xafinact"},"content":{"rendered":"

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⚡ Quick Answer<\/h3>\n

Xafinact<\/strong> \u03b5\u03af\u03bd\u03b1\u03b9 \u03b1\u03c0\u03cc \u03c4\u03bf\u03c5 \u03c3\u03c4\u03cc\u03bc\u03b1\u03c4\u03bf\u03c2 safinamide<\/strong> (50 mg or 100 mg) tablet \u2014 a selective monoamine oxidase type B (MAO-B) inhibitor<\/strong> \u03c7\u03c1\u03b7\u03c3\u03b9\u03bc\u03bf\u03c0\u03bf\u03b9\u03b5\u03af\u03c4\u03b1\u03b9 \u03b3\u03b9\u03b1 \u03c4\u03b7 \u03b8\u03b5\u03c1\u03b1\u03c0\u03b5\u03af\u03b1 Parkinson disease<\/strong>. By blocking MAO-B in the brain, it slows the breakdown of dopamine and helps lengthen the time levodopa keeps working between doses (reduces “off” time). Safinamide adds a unique glutamate-modulating effect<\/strong> on top of MAO-B inhibition — it blocks voltage-dependent sodium channels and reduces stimulated glutamate release in the basal ganglia. Licensed only as adjunct to levodopa<\/strong>, not as monotherapy. Common side effects: insomnia, headache, dyskinesia, dry mouth, postural hypotension. \u03a3\u03b7\u03bc\u03b1\u03bd\u03c4\u03b9\u03ba\u03cc:<\/strong> avoid combination with most antidepressants (SSRIs, SNRIs, TCAs), opioids such as pethidine and tramadol, and dextromethorphan — risk of serotonin syndrome<\/em>.<\/p>\n<\/div>\n

\n\u0391\u03c5\u03c4\u03cc \u03c0\u03bf\u03c5 \u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03b5\u03c4\u03b5 \u03bc\u03b5 \u03c4\u03b7\u03bd MedsBase:<\/strong> \u03a0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03b9\u03b7\u03bc\u03ad\u03bd\u03bf\u03c2 \u03ba\u03b1\u03c4\u03b1\u03c3\u03ba\u03b5\u03c5\u03b1\u03c3\u03c4\u03ae\u03c2 WHO-GMP \u00b7 \u0394\u03b9\u03b1\u03ba\u03c1\u03b9\u03c4\u03b9\u03ba\u03ae \u03c3\u03c5\u03c3\u03ba\u03b5\u03c5\u03b1\u03c3\u03af\u03b1 \u00b7 \u03a0\u03b1\u03b3\u03ba\u03cc\u03c3\u03bc\u03b9\u03b1 \u03b1\u03c0\u03bf\u03c3\u03c4\u03bf\u03bb\u03ae \u00b7 1,400+ \u03b5\u03c0\u03b1\u03bb\u03b7\u03b8\u03b5\u03c5\u03bc\u03ad\u03bd\u03b5\u03c2 \u03ba\u03c1\u03b9\u03c4\u03b9\u03ba\u03ad\u03c2 \u03c0\u03b5\u03bb\u03b1\u03c4\u03ce\u03bd<\/a>\n<\/div>\n

\ud83d\udce6 \u039a\u03ac\u03b8\u03b5 \u03c0\u03b1\u03c1\u03b1\u03b3\u03b3\u03b5\u03bb\u03af\u03b1 \u03ba\u03b1\u03bb\u03cd\u03c0\u03c4\u03b5\u03c4\u03b1\u03b9 \u03b1\u03c0\u03cc \u03c4\u03b7\u03bd \u03a0\u03bf\u03bb\u03b9\u03c4\u03b9\u03ba\u03ae \u0395\u03b3\u03b3\u03cd\u03b7\u03c3\u03b7\u03c2 \u0395\u03c0\u03b1\u03bd\u03b1\u03c0\u03bf\u03c3\u03c4\u03bf\u03bb\u03ae\u03c2<\/strong><\/a> \u2014 \u03b5\u03ac\u03bd \u03c4\u03bf \u03b4\u03ad\u03bc\u03b1 \u03c3\u03b1\u03c2 \u03b4\u03b5\u03bd \u03c6\u03c4\u03ac\u03c3\u03b5\u03b9 \u03b5\u03bd\u03c4\u03cc\u03c2 20 \u03b5\u03c1\u03b3\u03ac\u03c3\u03b9\u03bc\u03c9\u03bd \u03b7\u03bc\u03b5\u03c1\u03ce\u03bd, \u03c4\u03bf \u03b5\u03c0\u03b1\u03bd\u03b1\u03c0\u03bf\u03c3\u03c4\u03ad\u03bb\u03bb\u03bf\u03c5\u03bc\u03b5.<\/p>\n

\u0393\u03b9\u03b1\u03c4\u03af \u03bd\u03b1 \u03c0\u03b1\u03c1\u03b1\u03b3\u03b3\u03b5\u03af\u03bb\u03b5\u03c4\u03b5 \u03b1\u03c0\u03cc \u03c4\u03b7 MedsBase<\/h3>\n

\u03a4\u03b1 \u03b3\u03b5\u03bd\u03cc\u03c3\u03b7\u03bc\u03b1 \u03c6\u03ac\u03c1\u03bc\u03b1\u03ba\u03ac \u03bc\u03b1\u03c2 \u03c0\u03c1\u03bf\u03ad\u03c1\u03c7\u03bf\u03bd\u03c4\u03b1\u03b9 \u03b1\u03c0\u03cc \u03ba\u03b1\u03c4\u03b1\u03c3\u03ba\u03b5\u03c5\u03b1\u03c3\u03c4\u03ad\u03c2 \u03c0\u03bf\u03c5 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03b9\u03bf\u03cd\u03bd\u03c4\u03b1\u03b9 \u03b1\u03c0\u03cc \u03c4\u03b7\u03bd WHO-GMP \u03ba\u03b1\u03b9 \u03b1\u03c0\u03bf\u03c3\u03c4\u03ad\u03bb\u03bb\u03bf\u03bd\u03c4\u03b1\u03b9 \u03c0\u03b1\u03b3\u03ba\u03bf\u03c3\u03bc\u03af\u03c9\u03c2 \u03c3\u03b5 \u03b4\u03b9\u03b1\u03ba\u03c1\u03b9\u03c4\u03b9\u03ba\u03ae, \u03b1\u03c0\u03bb\u03ae \u03c3\u03c5\u03c3\u03ba\u03b5\u03c5\u03b1\u03c3\u03af\u03b1 \u2014 \u03c7\u03c9\u03c1\u03af\u03c2 \u03cc\u03bd\u03bf\u03bc\u03b1 \u03c6\u03b1\u03c1\u03bc\u03ac\u03ba\u03bf\u03c5 \u03c3\u03c4\u03bf \u03b5\u03be\u03c9\u03c4\u03b5\u03c1\u03b9\u03ba\u03cc \u03c4\u03bf\u03c5 \u03b4\u03ad\u03bc\u03b1\u03c4\u03bf\u03c2. \u039f\u03b9 \u03c0\u03bb\u03b7\u03c1\u03c9\u03bc\u03ad\u03c2 \u03bc\u03b5 \u03ba\u03ac\u03c1\u03c4\u03b1 \u03b4\u03c1\u03bf\u03bc\u03bf\u03bb\u03bf\u03b3\u03bf\u03cd\u03bd\u03c4\u03b1\u03b9 \u03bc\u03ad\u03c3\u03c9 \u03c1\u03c5\u03b8\u03bc\u03b9\u03c3\u03bc\u03ad\u03bd\u03bf\u03c5 \u03b5\u03c0\u03b5\u03be\u03b5\u03c1\u03b3\u03b1\u03c3\u03c4\u03ae (\u03bf\u03b9 \u03c0\u03b5\u03c1\u03b9\u03b3\u03c1\u03b1\u03c6\u03ad\u03c2 \u03b5\u03ba\u03ba\u03b1\u03b8\u03ac\u03c1\u03b9\u03c3\u03b7\u03c2 \u03c0\u03b5\u03c1\u03b9\u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03bf\u03c5\u03bd \u03c1\u03c5\u03b8\u03bc\u03b9\u03c3\u03bc\u03ad\u03bd\u03bf \u03b5\u03c0\u03b5\u03be\u03b5\u03c1\u03b3\u03b1\u03c3\u03c4\u03ae \u03c0\u03bb\u03b7\u03c1\u03c9\u03bc\u03ce\u03bd \u03bc\u03b5 \u03ba\u03ac\u03c1\u03c4\u03b1 \u2014 \u03c0\u03bf\u03c4\u03ad \u201cMedsBase\u201d \u03ae \u03bf\u03c0\u03bf\u03b9\u03bf\u03b4\u03ae\u03c0\u03bf\u03c4\u03b5 \u03cc\u03bd\u03bf\u03bc\u03b1 \u03c6\u03b1\u03c1\u03bc\u03ac\u03ba\u03bf\u03c5). \u0393\u03af\u03bd\u03bf\u03bd\u03c4\u03b1\u03b9 \u03b4\u03b5\u03ba\u03c4\u03ad\u03c2 \u03ba\u03b1\u03b9 \u03c0\u03bb\u03b7\u03c1\u03c9\u03bc\u03ad\u03c2 \u03bc\u03b5 \u03ba\u03c1\u03c5\u03c0\u03c4\u03bf\u03bd\u03bf\u03bc\u03af\u03c3\u03bc\u03b1\u03c4\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03c1\u03b1\u03c0\u03b5\u03b6\u03b9\u03ba\u03ae \u03bc\u03b5\u03c4\u03b1\u03c6\u03bf\u03c1\u03ac SEPA. \u039a\u03ac\u03b8\u03b5 \u03c0\u03b1\u03c1\u03b1\u03b3\u03b3\u03b5\u03bb\u03af\u03b1 \u03ba\u03b1\u03bb\u03cd\u03c0\u03c4\u03b5\u03c4\u03b1\u03b9 \u03b1\u03c0\u03cc \u03c4\u03b7\u03bd \u03a0\u03bf\u03bb\u03b9\u03c4\u03b9\u03ba\u03ae \u0395\u03c0\u03b1\u03bd\u03b1\u03c0\u03bf\u03c3\u03c4\u03bf\u03bb\u03ae\u03c2 \u0395\u03be\u03b1\u03c3\u03c6\u03b1\u03bb\u03af\u03c3\u03b5\u03ce\u03c2 \u03bc\u03b1\u03c2.<\/p>\n

What Is Xafinact?<\/h2>\n

Xafinact is an oral tablet containing safinamide 50 mg or 100 mg<\/strong>. safinamide is a selective monoamine oxidase type B (MAO-B) inhibitor<\/strong> originally introduced as Xadago<\/strong>. Xafinact is manufactured by a WHO-GMP certified facility and is bioequivalent to the originator brand at the same strength.<\/p>\n

Safinamide is the newest MAO-B inhibitor (approved by the EMA in 2015 and FDA in 2017). Its dual mechanism — reversible MAO-B inhibition \u03c3\u03c5\u03bd<\/em> sodium-channel and glutamate modulation — was designed specifically to address levodopa-induced dyskinesia and wearing-off in fluctuating Parkinson patients. Unlike selegiline and rasagiline, it is licensed only as an adjunct to levodopa<\/strong>, never as monotherapy.<\/p>\n

How Does Xafinact (safinamide) Work?<\/h2>\n

Safinamide works through two parallel mechanisms. The dopaminergic action<\/strong> — reversible, highly selective MAO-B inhibition — raises brain dopamine levels and lengthens the effect of each levodopa dose. The non-dopaminergic action<\/strong> — voltage-dependent sodium-channel blockade and reduced stimulated glutamate release — dampens the abnormal glutamate signalling in the basal ganglia that contributes to levodopa-induced dyskinesia<\/em>. The combination explains why safinamide reduces dyskinesia where most other dopaminergic agents would worsen it.<\/p>\n

Comparing the MAO-B Inhibitors<\/h2>\n

The three MAO-B inhibitors used in Parkinson disease — selegiline, rasagiline and safinamide — share a common mechanism but differ meaningfully in metabolites, dosing and clinical positioning:<\/p>\n\n\n\n\n\n\n\n\n\n
\u03a7\u03b1\u03c1\u03b1\u03ba\u03c4\u03b7\u03c1\u03b9\u03c3\u03c4\u03b9\u03ba\u03cc<\/th>\nSelegiline<\/th>\nRasagiline<\/th>\nSafinamide<\/th>\n<\/tr>\n<\/thead>\n
Typical dose<\/td>\n5–10 mg\/day<\/td>\n0.5–1 mg\/day<\/td>\n50–100 mg\/day<\/td>\n<\/tr>\n
Active metabolites<\/td>\nAmphetamine + methamphetamine<\/td>\nAminoindan (non-amphetamine)<\/td>\nNo active stimulant metabolite<\/td>\n<\/tr>\n
Glutamate effect<\/td>\n\u038c\u03c7\u03b9<\/td>\n\u038c\u03c7\u03b9<\/td>\nYes<\/strong> — sodium-channel\/glutamate-release modulation<\/td>\n<\/tr>\n
\u0395\u03bd\u03b4\u03b5\u03af\u03be\u03b5\u03b9\u03c2<\/td>\nMonotherapy or adjunct<\/td>\nMonotherapy or adjunct<\/td>\nAdjunct only<\/strong> — for fluctuating PD on levodopa<\/td>\n<\/tr>\n
Insomnia risk<\/td>\nHigher (amphetamine metabolites)<\/td>\nLow<\/td>\nLow<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Who Is Xafinact For?<\/h2>\n

Xafinact is appropriate for adults with mid- or late-stage Parkinson disease on stable levodopa therapy who are experiencing motor fluctuations (end-of-dose wearing-off). It is \u03b4\u03b5\u03bd<\/strong> licensed for early monotherapy — rasagiline or selegiline are the appropriate MAO-B options for that. Patients with severe hepatic impairment, retinal disease (especially albinism, retinitis pigmentosa, retinal degeneration, severe diabetic retinopathy or uveitis) should not use safinamide.<\/p>\n

Dosing and Administration<\/h2>\n

The standard regimen is 50 mg once daily for 2 weeks<\/strong> as a starting dose, then increased to 100 mg \u03bc\u03af\u03b1 \u03c6\u03bf\u03c1\u03ac \u03c4\u03b7\u03bd \u03b7\u03bc\u03ad\u03c1\u03b1<\/strong> if tolerated. There is no benefit to higher doses; above 100 mg\/day MAO-B selectivity is lost. Take in the morning with or without food. May be combined with any standard levodopa regimen; the levodopa dose may need a small reduction (10–30%) if dyskinesia worsens.<\/p>\n\n\n\n\n\n\n\n
\u03a6\u03ac\u03c3\u03b7<\/th>\n\u0394\u03cc\u03c3\u03b7<\/th>\n<\/tr>\n<\/thead>\n
Weeks 1–2<\/td>\n50 mg once daily, morning<\/td>\n<\/tr>\n
Maintenance (if 50 mg insufficient)<\/td>\n100 mg \u03bc\u03af\u03b1 \u03c6\u03bf\u03c1\u03ac \u03c4\u03b7\u03bd \u03b7\u03bc\u03ad\u03c1\u03b1<\/td>\n<\/tr>\n
\u03a3\u03bf\u03b2\u03b1\u03c1\u03ae \u03b7\u03c0\u03b1\u03c4\u03b9\u03ba\u03ae \u03b4\u03c5\u03c3\u03bb\u03b5\u03b9\u03c4\u03bf\u03c5\u03c1\u03b3\u03af\u03b1<\/td>\n\u0391\u03c0\u03bf\u03c6\u03cd\u03b3\u03b5\u03c4\u03b5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
⚠ Tyramine and the “cheese effect”<\/strong> At standard MAO-B-selective doses, dietary tyramine restriction is generally \u03b4\u03b5\u03bd<\/em> required. However, MAO-B selectivity is dose-dependent — selegiline above 10 mg\/day, rasagiline above 1 mg\/day, and safinamide above 100 mg\/day lose selectivity and inhibit peripheral MAO-A as well. At those doses, tyramine-rich foods (aged cheeses, cured meats, broad beans, fermented soya, draught beer) can trigger a hypertensive crisis. Stay within prescribed doses to avoid this risk.<\/div>\n

\u03a3\u03c5\u03c7\u03bd\u03ad\u03c2 \u03c0\u03b1\u03c1\u03b5\u03bd\u03ad\u03c1\u03b3\u03b5\u03b9\u03b5\u03c2<\/h2>\n

Dyskinesia (a paradoxical early effect — safinamide initially amplifies levodopa effect, so dyskinesia can increase<\/em> in the first weeks before settling), nausea, insomnia, postural hypotension, fall risk. Less common: visual hallucinations, anxiety, weight loss. Retinal toxicity<\/strong> has been a concern in animal studies but has not been seen at any meaningful frequency in humans — nonetheless, eye examination before starting and periodically is recommended for patients with pre-existing retinal disease.<\/p>\n

⚠ Serotonin syndrome — dangerous interactions<\/strong> Combining a MAO-B inhibitor with serotonergic drugs can cause serotonin syndrome<\/em>: agitation, sweating, tremor, hyperreflexia, fever, diarrhoea, in severe cases seizures and death. Avoid:<\/strong> SSRIs (fluoxetine, sertraline, paroxetine, citalopram, escitalopram), SNRIs (venlafaxine, duloxetine), tricyclics (amitriptyline, imipramine), pethidine (meperidine), tramadol, dextromethorphan, methadone, St John’s wort, MDMA. Wash-out periods:<\/strong> stop fluoxetine 5 weeks before starting MAO-B inhibitor; stop other SSRIs\/SNRIs at least 2 weeks before; do not start fluoxetine within 2 weeks of stopping the MAO-B inhibitor.<\/div>\n

Drug and Food Interactions<\/h2>\n