Safinamide

Side effects, and when to stop

The following serious adverse reactions are discussed in greater detail in other sections of labeling:

• Hypertension
• Serotonin Syndrome
• Falling Asleep During Activities of Daily Living
• Dyskinesia
• Hallucinations / Psychotic Behavior
• Impulse Control / Compulsive Behaviors
• Withdrawal-Emergent Hyperpyrexia and Confusion
• Retinal Pathology

Who should not take it

XADAGO is contraindicated in patients with:

• Concomitant use of other drugs in the monoamine oxidase inhibitor (MAOI) class or other drugs that are potent inhibitors of monoamine oxidase, including linezolid. The combination may result in increased blood pressure, including hypertensive crisis.
• Concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, propoxyphene, or tramadol); serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic, tetracyclic, or triazolopyridine antidepressants; cyclobenzaprine; methylphenidate, amphetamine, and their derivatives; or St John's wort. Concomitant use could result in life-threatening serotonin syndrome.
• Concomitant use of dextromethorphan. The combination of MAOIs and dextromethorphan has been reported to cause episodes of psychosis or abnormal behavior.
• A history of a hypersensitivity to safinamide. Reactions have included swelling of the tongue and oral mucosa, and dyspnea.
• Severe hepatic impairment (Child-Pugh C: 10-15).

Storing it

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).