Description

Selective Serotonin Reuptake Inhibitors: Monitor patients for serotonin syndrome Sympathomimetic Medications: Monitor patients for hypertension Tyramine: Risk of severe hypertension Substrates of Breast Cancer Resistance Protein (BCRP): Potential increase in plasma concentration of BCRP substrate

Most common adverse reactions of Safinamide’s are dyskinesia, fall, nausea, and insomnia.

Pregnancy Category C. There are no adequate and well-controlled studies of XADAGO in pregnant women. In animals, developmental toxicity, including teratogenic effects, was observed when safinamide was administered during pregnancy at clinically relevant doses. Skin discoloration, presumed to be caused by hyperbilirubinemia resulting from hepatobiliary toxicity, was observed in rat pups indirectly exposed to safinamide through the milk during the lactation period. It is not known whether this drug is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from safinamide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

May cause or exacerbate hypertension May cause serotonin syndrome when used with MAO inhibitors, antidepressants, or opioid drugs May cause falling asleep during activities of daily living May cause or exacerbate dyskinesia; consider levodopa dose reduction May cause hallucinations and psychotic behavior May cause problems with impulse control/compulsive behaviors May cause withdrawal-emergent hyperpyrexia and confusion

There is no human experience with Safinamide overdose. If an important overdose occurs, Safinamide treatment should be discontinued and supportive treatment should be administered as clinically indicated along with dietary restriction of tyramine for several weeks.

Antiparkinson drugs

Do not store above 30°C. Keep away from light and out of the reach of children.