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

How to Use Safinamide (Xadago)

Administration Method

Safinamide is available as oral tablets. It is recommended to take it at the same time every day, either with food or on an empty stomach.

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

Dosage Regimen

Initial dose: 50 mg once daily.

Dose adjustment: After two weeks, the dose may be increased to 100 mg once daily based on individual needs and tolerability.

Maximum dose: The daily dose should not exceed 100 mg. Higher doses do not provide additional benefits but will increase the risk of adverse reactions.

Management of Missed Dose

If a dose is missed, take the next dose at the same time on the following day. Do not double the dose to make up for the missed one.

Dosage Adjustment of Safinamide (Xadago)

Patients with Hepatic Impairment

Moderate hepatic impairment (Child-Pugh Class B: 7-9 points): The maximum recommended dose is 50 mg once daily.

Severe hepatic impairment (Child-Pugh Class C: 10-15 points): Use of this drug is contraindicated.

Management of worsening hepatic function: If a patient's hepatic function deteriorates from moderate to severe impairment, safinamide should be discontinued immediately.

Discontinuation Regimen

When it is necessary to discontinue the 100 mg dose, the dose should first be reduced to 50 mg once daily, maintained for one week, and then completely discontinued to avoid withdrawal-induced hyperpyrexia and confusion.

Safinamide (Xadago) Use in Special Populations

Elderly Patients

Clinical studies have shown that the pharmacokinetics of safinamide in elderly patients (≥65 years old) are similar to those in younger patients, so no dose adjustment is required.

However, some elderly patients may be more sensitive to the drug, requiring close monitoring.

Pregnant Women

Animal studies have shown that safinamide may cause fetal malformations. During pregnancy, this drug should be considered only if the expected benefit to the mother outweighs the potential risk to the fetus.

Patients who become pregnant while using this drug should inform their doctor immediately.

Lactating Women

Animal experiments have shown that safinamide can be excreted in breast milk and may cause skin discoloration in nursing pups.

Lactating women should not use this drug; if treatment is necessary, breastfeeding should be discontinued.

Pediatric Patients

The efficacy of safinamide in adolescent patients aged 13-17 years has been established, and they can use the same dose as adults.

The efficacy of safinamide in children under 13 years old has not been established, and its use in this population is not recommended.

Patients with Renal Impairment

Patients with renal impairment of all degrees, including end-stage renal disease, do not require dose adjustment.

Hemodialysis does not affect the drug clearance rate, and no supplementary dose is needed after dialysis.