Safinamide (Xadago) is a selective monoamine oxidase type B (MAO-B) inhibitor, used as an adjunctive medication for the treatment of Parkinson's disease. It was first approved for marketing by the U.S. FDA in 2017. This product must be used in combination with levodopa/carbidopa to treat the "off" episodes in patients with Parkinson's disease.
Indications for Safinamide (Xadago)
Adjunctive Treatment of Parkinson's Disease
The core indication of Safinamide (Xadago) is to serve as an adjunct to levodopa/carbidopa, for patients with Parkinson's disease (PD) who are experiencing "off" episodes.
The so-called "off" episodes refer to the phase of worsening motor function in Parkinson's disease patients when the effect of drug treatment diminishes.
Clinical studies have confirmed that safinamide can significantly increase the patients' "on" time (periods with well-controlled symptoms) while reducing the "off" time.
Dosage Form, Strength and Composition of Safinamide (Xadago)
Dosage Form and Strength
50 mg tablets: Orange-copper colored with a metallic luster, round and biconcave, imprinted with "50" on one side, and approximately 7 mm in diameter.
100 mg tablets: Orange-copper colored with a metallic luster, round and biconcave, imprinted with "100" on one side, and approximately 9 mm in diameter.
Composition
Each safinamide tablet contains the active ingredient safinamide mesylate, whose chemical name is (S)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methyl]aminopropanamide methanesulfonate (1:1).
Its molecular formula is C₁₇H₁₉FN₂O₂•CH₄O₃S, with a molecular weight of 398.45.
Inactive ingredients include: microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol 6000, iron oxide red, potassium aluminum silicate, and titanium dioxide.
Storage Method for Safinamide (Xadago)
Storage Conditions
Safinamide tablets should be stored at 25°C (77°F), with a permitted brief fluctuation range between 15°C and 30°C (59°F and 86°F).
The original packaging must be kept tightly sealed to protect from moisture and direct sunlight.
Precautions
The medication should always be stored in the original packaging bottle until it is taken out for administration.
Do not use pill boxes or pill organizers for storage.
Keep the medication out of the reach of children.
Avoid storage in humid environments such as bathrooms.
Expired or no longer needed medications should be properly disposed of in accordance with local regulations.
