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Xafinact

✅ Manages Parkinson’s symptoms
✅ Reduces tremors and stiffness
✅ Improves motor function
✅ Enhances quality of life
✅ Increases dopamine levels

Xafinact contains Safinamide.

Medisch beoordeeld door Morgan Ellis — Apotheekonderzoeker · 8 jaar ervaring  · Laatst beoordeeld: mei 2026

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⚡ Quick Answer

Xafinact is een oraal safinamide (50 mg or 100 mg) tablet — a selective monoamine oxidase type B (MAO-B) inhibitor gebruikt voor de behandeling van Parkinson disease. 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 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, not as monotherapy. Common side effects: insomnia, headache, dyskinesia, dry mouth, postural hypotension. Belangrijk: avoid combination with most antidepressants (SSRIs, SNRIs, TCAs), opioids such as pethidine and tramadol, and dextromethorphan — risk of serotoninesyndroom.

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What Is Xafinact?

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

Safinamide is the newest MAO-B inhibitor (approved by the EMA in 2015 and FDA in 2017). Its dual mechanism — reversible MAO-B inhibition plus 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, never as monotherapy.

How Does Xafinact (safinamide) Work?

Safinamide works through two parallel mechanisms. The dopaminergic action — reversible, highly selective MAO-B inhibition — raises brain dopamine levels and lengthens the effect of each levodopa dose. The non-dopaminergic action — 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. The combination explains why safinamide reduces dyskinesia where most other dopaminergic agents would worsen it.

Comparing the MAO-B Inhibitors

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:

KenmerkSelegilineRasagilineSafinamide
Typical dose5–10 mg/day0.5–1 mg/day50–100 mg/day
Active metabolitesAmphetamine + methamphetamineAminoindan (non-amphetamine)No active stimulant metabolite
Glutamate effectNeeNeeYes — sodium-channel/glutamate-release modulation
IndicatieMonotherapy or adjunctMonotherapy or adjunctAdjunct only — for fluctuating PD on levodopa
Insomnia riskHigher (amphetamine metabolites)LowLow

Who Is Xafinact For?

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 niet 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.

Dosing and Administration

The standard regimen is 50 mg once daily for 2 weeks as a starting dose, then increased to 100 mg eenmaal daags 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.

FaseDosering
Weeks 1–250 mg once daily, morning
Maintenance (if 50 mg insufficient)100 mg eenmaal daags
Ernstige leverfunctiestoornisVermijden
⚠ Tyramine and the “cheese effect” At standard MAO-B-selective doses, dietary tyramine restriction is generally niet 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.

Veelvoorkomende bijwerkingen

Dyskinesia (a paradoxical early effect — safinamide initially amplifies levodopa effect, so dyskinesia can increase in the first weeks before settling), nausea, insomnia, postural hypotension, fall risk. Less common: visual hallucinations, anxiety, weight loss. Retinal toxicity 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.

⚠ Serotonin syndrome — dangerous interactions Combining a MAO-B inhibitor with serotonergic drugs can cause serotoninesyndroom: agitation, sweating, tremor, hyperreflexia, fever, diarrhoea, in severe cases seizures and death. Avoid: 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: 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.

Drug and Food Interactions

  • Antidepressants — SSRIs, SNRIs, TCAs: avoid. If a serotonergic antidepressant is essential, mirtazapine or bupropion are sometimes used cautiously under specialist supervision.
  • Opioids — pethidine, tramadol, methadone: contraindicated. Morphine, codeine, oxycodone are safer alternatives if analgesia is required.
  • Sympathomimetics — pseudoephedrine, phenylephrine, ephedrine: risk of hypertensive crisis. Avoid OTC decongestants.
  • Other MAO inhibitors — phenelzine, tranylcypromine, isocarboxazid, linezolid, methylene blue: contraindicated.
  • CYP1A2 inducers/inhibitors — safinamide is metabolised mainly by non-CYP pathways (amidase enzymes); few clinically important interactions.
  • Levodopa — intentional combination: start at the lower MAO-B dose and watch for dyskinesia (a sign that levodopa effect has been amplified). Levodopa dose may need a 10–30% reduction.

Veelgestelde vragen

Can I take Xafinact instead of levodopa?

No — unlike selegiline and rasagiline, safinamide is licensed only as an adjunct to levodopa. It has not been studied as monotherapy and would be unlikely to provide adequate symptom control alone.

How quickly will I feel an effect?

MAO-B inhibitors work gradually. Most patients notice a smoother “on” period and reduced “off” time within 2–4 weeks. The full benefit on motor fluctuations is usually clear by 4–8 weeks.

Will I have to follow a low-tyramine diet?

At normal prescribed doses (selegiline ≤ 10 mg/day, rasagiline 1 mg/day, safinamide ≤ 100 mg/day), no special diet is required. Above those doses, MAO-B selectivity is lost and tyramine restriction becomes important.

Does Xafinact slow down Parkinson disease itself?

A neuroprotective or disease-modifying effect of MAO-B inhibitors has been studied (e.g. the DATATOP and ADAGIO trials with selegiline and rasagiline). Results are suggestive but not definitive. The drugs are prescribed primarily for symptom control, not as guaranteed disease-modifying therapy.

Wat als ik een dosis vergeet?

Neem de vergeten dosis zo snel mogelijk in that day. If it is already evening or close to bedtime, skip it — selegiline and rasagiline can both cause insomnia, and a late dose can disrupt sleep. Never double-dose. Resume normal schedule the next day.

Can I drink alcohol with Xafinact?

Moderate alcohol is not strictly forbidden, but heavy drinking and red-wine binges can interact with residual MAO inhibition and increase blood-pressure variability. Many Parkinson patients also have postural hypotension on dopaminergic therapy — alcohol worsens this. Limit to 1 standard drink occasionally.

Can I drive while taking Xafinact?

Most patients tolerate Xafinact without driving impairment. However, dopaminergic therapy as a whole can cause sudden-onset sleep (sleep attacks), particularly when Xafinact is added to a dopamine agonist or levodopa. Until you know how you respond, avoid driving long distances or operating heavy machinery.

Is Xafinact safe in older adults?

Yes — safinamide is widely used in elderly Parkinson patients. Watch for postural hypotension (rise from sitting slowly), confusion, hallucinations, and impulse-control changes. Lower starting doses may be appropriate.

Can Xafinact be stopped abruptly?

No. Sudden withdrawal of any dopaminergic agent in a Parkinson patient can precipitate a neuroleptic-malignant-like syndrome with rigidity, fever and altered consciousness. If discontinuation is needed, taper over 1–2 weeks under medical supervision.

Will Xafinact cause weight loss or weight gain?

Neither markedly. Some patients on selegiline lose a small amount of weight (the amphetamine-like metabolites can suppress appetite slightly). Rasagiline and safinamide are weight-neutral.

How does MedsBase ship Xafinact?

Worldwide shipping in discreet packaging from a WHO-GMP certified manufacturer. Tablets are shipped in original sealed blister packs. Track your order from your MedsBase account.

Opslag

Store at room temperature (15–30°C / 59–86°F), protected from heat, moisture and direct light. Keep in the original container with the lid tightly closed. Keep out of reach of children. Do not use beyond the expiry date printed on the packaging.

Medische Disclaimer

This information is provided for educational purposes only and is not a substitute for the advice of a qualified clinician. Parkinson disease and parkinsonian syndromes require individualised neurology care. Discuss all medications, supplements and pre-existing conditions with your doctor before starting, changing or stopping treatment. Do not abruptly discontinue dopaminergic therapy — sudden withdrawal can precipitate a neuroleptic malignant-like syndrome.

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50 mg, 100 mg

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30 Tabletten, 60 Tabletten, 90 Tabletten, 180 Tabletten

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