Safinamide (Xadago) is a type B monoamine oxidase (MAO-B) inhibitor. Used as an adjunctive therapeutic agent to levodopa/carbidopa, it is indicated for the treatment of "off" episodes in patients with Parkinson's disease (PD).

What Are the Side Effects of Safinamide (Xadago)?

Neurological Reactions

Dyskinesia (21% in the 50mg group, 18% in the 100mg group).

Headache (14%).

Gastrointestinal Reactions

Nausea (6% in the 100mg group).

Dyspepsia (2% in the 100mg group).

Other Common Reactions

Falls (6% in the 100mg group).

Insomnia (4% in the 100mg group).

Orthostatic hypotension (2% in the 100mg group).

Severe Side Effects of Safinamide (Xadago) That Require Vigilance

Hypertension

May cause hypertension or exacerbate existing hypertension.

Incidence of hypertension in clinical studies: 7% (50mg group), 5% (100mg group).

Regular blood pressure monitoring is required; adjust antihypertensive medications if necessary.

Serotonin Syndrome

May occur when used concomitantly with MAO inhibitors, antidepressants, or opioid drugs.

Symptoms include changes in mental status, autonomic disturbances, neuromuscular symptoms, etc.

Concomitant use with certain drugs is contraindicated.

Sudden Sleep Onset During Daily Activities

Sudden sleep onset without obvious warning may occur.

If daytime sleepiness occurs or the patient falls asleep during activities requiring full attention (such as driving), consideration should be given to discontinuing the drug.

Exacerbation of Dyskinesia

May cause or exacerbate existing dyskinesia.

Consider reducing the dose of levodopa to relieve symptoms.

Hallucinations/Psychiatric Behavioral Abnormalities

May cause hallucinations or psychiatric symptoms.

Patients with a history of severe psychiatric disorders should use the drug with caution.

Impulse Control Disorders

Uncontrollable behaviors such as intense gambling, shopping, and sexual urges may occur.

It is necessary to regularly ask patients whether such symptoms appear.

Precautions for Safinamide (Xadago) Administration

Medication for Special Populations

Pregnant women: Animal studies have shown that it may cause harm to the fetus; use only if the potential benefit outweighs the risk.

Lactating women: Should not breastfeed.

Patients with hepatic impairment: The maximum dose for patients with moderate hepatic impairment is 50mg per day; the drug is contraindicated in patients with severe hepatic impairment.

Elderly patients: No dose adjustment is required.

Administration Precautions

The initial dose is 50mg once daily; it can be increased to 100mg once daily after 2 weeks.

Tablets should be swallowed whole and must not be split, crushed, or chewed.

Can be taken with or without food.

If a dose is missed, take the next dose at the normal time on the following day.