Informational only — Not medical advice. Always consult a licensed healthcare provider.

Community data Updated 23 hours ago

Indications

Safinamide Mesylate is a monoamine oxidase type B (MAO-B) inhibitor. Doctors use it as an add-on treatment alongside levodopa/carbidopa for people with Parkinson's disease who experience "off" episodes. It has not been shown to work when used alone, so it is not a treatment for Parkinson's disease on its own.

⚠️ Always consult a registered physician before taking any medicine.

Pharmacology

Nobody knows exactly how Safinamide Mesylate works in Parkinson's disease. What is known is that it inhibits monoamine oxidase B (MAO-B). By blocking the breakdown of dopamine, this inhibition is thought to raise dopamine levels and so increase dopaminergic activity in the brain.

Pregnancy & Breastfeeding

Safinamide Mesylate (XADAGO) is Pregnancy Category C. There are no adequate and well-controlled studies of XADAGO in pregnant women. In animals, developmental toxicity, including teratogenic effects, was seen when safinamide was given during pregnancy at clinically relevant doses.

Rat pups that were exposed to safinamide indirectly, through the milk during the lactation period, showed skin discoloration. This was presumed to be caused by hyperbilirubinemia resulting from hepatobiliary toxicity.

It is not known whether the drug is present in human milk. Many drugs are excreted in human milk, and safinamide could cause serious adverse reactions in nursing infants. So a decision should be made whether to stop nursing or to stop the drug, taking into account how important the drug is to the mother.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Dosage Reference

⚠️ Reference ranges from official sources only. Consult your doctor for personalized dosing.

Adults: Usual Initial Dosage The recommended starting dosage of Safinamide tablet is 50 mg taken by mouth once daily, at the same time each day. If you miss a dose, take the next one at the same time the next day. Maintenance Dosage After 2 weeks, the dose may be raised to 100 mg once daily, depending on the person's need and how well they tolerate it. Before stopping Safinamide 100 mg, the dose should be tapered by reducing it to 50 mg for one week. Use in Children Safety and effectiveness of Safinamide in infants and children have not been established. Geriatric Use Older patients showed no overall differences in safety or effectiveness compared with younger patients. Hepatic Impairment Safinamide plasma concentrations are increased in patients with hepatic impairment.