TM Owner Zambon
Xadago 50mg Tablet
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Indications & Clinical Uses
- Xadago 50 mg contains safinamide (as safinamide mesylate), a monoamine oxidase type B (MAO-B) inhibitor that also modulates glutamate release.
- It is used as an add-on treatment to levodopa (with or without other Parkinson's medicines; in the US, levodopa/carbidopa) in adults with Parkinson's disease who experience "off" episodes, when the effect of their levodopa wears off and symptoms return.
- It does not replace levodopa and is not used on its own.
- Treatment normally starts at 50 mg once daily and may be increased to 100 mg once daily after two weeks, depending on tolerability; the tablets can be taken with or without food.
- A 100 mg tablet also exists, so check the strength on each pack.
- In the US, Xadago is distributed by MDD US Operations (a Supernus company) under licence from Newron, and Zambon owns the Xadago trademark; in Europe it is supplied by Zambon.
- The label carries no boxed warning.
- Safety in children has not been established.
Side Effects
- The most common side effects in clinical trials (100 mg versus placebo) were dyskinesia, meaning involuntary movements (17% versus 9%), falls (6%), nausea (6%) and trouble sleeping or insomnia (4%).
- Less often, people reported low blood pressure on standing, anxiety, cough and indigestion (about 2% each).
- Serious effects to report promptly include high blood pressure or a hypertensive crisis, a life-threatening reaction called serotonin syndrome (agitation, fever, sweating, muscle stiffness, fast heartbeat), falling asleep suddenly during daily activities, worsening dyskinesia, hallucinations or psychotic behaviour, and intense urges such as gambling, spending, binge eating or sexual urges.
- Stopping the medicine suddenly can cause fever, confusion and stiffness similar to neuroleptic malignant syndrome.
- There is no boxed warning on the label.
- Contact your healthcare provider promptly if any of these occur, and seek urgent help for severe headache with very high blood pressure or signs of serotonin syndrome.
Precautions & Warnings
- Do not take Xadago if you have severe liver impairment (Child-Pugh C), have ever had an allergic reaction to safinamide, or are taking a contraindicated medicine (see interactions).
- In moderate liver impairment (Child-Pugh B) the maximum dose is 50 mg once daily.
- Blood pressure should be monitored, since Xadago can cause or worsen hypertension.
- It can cause sudden sleep onset, so avoid driving or operating machinery if you feel drowsy or have had sleep episodes.
- Tell your healthcare provider about any hallucinations, psychotic symptoms or new compulsive urges; Xadago should be avoided in people with major psychotic disorders, and your dose of levodopa or Xadago may need reducing if dyskinesia or urges develop.
- Animal studies showed retinal degeneration, so tell your provider about any history of retinal problems.
- There are no adequate data in pregnant women and animal studies showed developmental toxicity, and it is unknown whether safinamide passes into breast milk, so discuss pregnancy and breastfeeding with your provider.
- Do not stop suddenly without medical advice.
Avoid Interactions
- Medicines and foods that increase risk: other MAO inhibitors and linezolid (contraindicated, with a 14-day gap between stopping one and starting the other); opioids such as meperidine, methadone, propoxyphene and tramadol (contraindicated, 14-day gap); SNRI, tricyclic, tetracyclic and triazolopyridine antidepressants (contraindicated); cyclobenzaprine, methylphenidate, amphetamine-type stimulants and St. John's wort (contraindicated); and dextromethorphan, found in many cough remedies (contraindicated, risk of psychosis or bizarre behaviour).
- SSRIs need monitoring for serotonin syndrome, and other sympathomimetics (for example decongestants) may raise blood pressure.
- Very tyramine-rich foods (more than about 150 mg of tyramine per meal, such as aged cheeses or cured meats in large amounts) can raise blood pressure, although a special diet is not normally needed at recommended doses.
- Medicines that may reduce benefit: dopamine antagonists such as antipsychotics and metoclopramide can reduce Xadago's effect and worsen Parkinson's symptoms.
- Tell your healthcare provider and pharmacist about all prescription, non-prescription and herbal medicines and supplements before starting Xadago.
References
Frequently Asked Questions
Xadago (safinamide) is an add-on treatment for adults with Parkinson's disease who have "off" episodes while taking levodopa. It helps when levodopa effects wear off and symptoms return. It is not used alone and does not replace levodopa. The 50 mg tablet is the usual starting strength.
Take Xadago (safinamide) by mouth once daily, with or without food. Treatment usually starts at 50 mg and may be raised to 100 mg after two weeks if tolerated. Keep taking your levodopa as prescribed, and do not stop Xadago suddenly without medical advice.
The most common Xadago (safinamide) side effects are involuntary movements (dyskinesia), falls, nausea and insomnia. Tell your healthcare provider promptly about high blood pressure, hallucinations, sudden sleep onset, new intense urges such as gambling, or fever with confusion. The label has no boxed warning.
Avoid MAO inhibitors, linezolid, opioids such as tramadol and methadone, SNRI and tricyclic antidepressants, stimulants, St. John's wort and dextromethorphan cough medicines with Xadago (safinamide); they are contraindicated. Very tyramine-rich foods can raise blood pressure. Tell your healthcare provider about every medicine you take.
Store Xadago (safinamide) tablets at 25°C; short excursions between 15°C and 30°C are permitted, according to the US label. Keep them in the original bottle or pack, and check the storage line on your own pack, as labelling can differ between countries.
Yes. Xadago (safinamide) can cause sleepiness and sudden sleep onset during daily activities, including while driving. Do not drive or operate machinery if you feel drowsy or have had sleep episodes. Tell your healthcare provider straight away if this happens, as your treatment may need changing.
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