general
Approved by the US FDA in March 2017, safinamide is a monoamine oxidase type B (MAO-B) inhibitor prescribed as an adjunctive treatment alongside the levodopa and carbidopa combination for Parkinson’s disease patients encountering ‘off’ episodes.
- Generic Name : Safinamide
- Pronunciation : sa-FIN-a-mide
- Trade Names/Brand Name : Xadago
prescription
Safinamide is recommended as an additional treatment, combined with the levodopa and carbidopa regimen, for managing idiopathic Parkinson’s disease during ‘off’ episodes—instances marked by a loss of muscle control and the onset of muscle stiffness, especially when the effectiveness of levodopa is diminished.
risk factors
- Allergy to safinamide or its excipients
- Presence of eye disorders such as uveitis and retinitis pigmentosa, with heightened susceptibility observed in patients with albinism
- Severe diabetic neuropathy
- Severe liver impairment
- Pregnancy and breastfeeding
- History of hallucination or other major psychotic disorders
- Simultaneous use with the following medications:
– Monoamine oxidase inhibitor drugs
– Antidepressants
– Opioid drugs
– Dextromethorphan (may lead to psychosis when combined with safinamide)
– Herbal supplements containing St. John’s wort
side effects
- Gastrointestinal: Nausea, vomiting, diarrhea, stomach discomfort
- Central Nervous System: Confusion, hallucination, agitation, seizures, dizziness, excessive drowsiness, abnormal movements, compulsive behaviors
- Cardiovascular: Abnormalities in heartbeat, orthostatic hypotension
- Eye: Blurred vision, retinal damage
- Musculoskeletal: Twitching, poor coordination, or repetitive uncontrolled movements of lips, tongue, arms, or legs
- Others: Fever, sweating, allergic reaction
dosage
The recommended adult dose as an adjunctive treatment for Parkinson’s disease is as follows:
- The initial dose of safinamide is 50mg once a day.
- The dose can be increased after two weeks to a maximum of 100mg once daily based on the patient’s needs and tolerance to the escalated dose.
The daily dose should not exceed 100 mg due to the potential for adverse reactions. However, if the 100mg dose is being discontinued, it should be reduced to 50mg one week prior to stopping safinamide.
For individuals with moderate liver damage, the maximum adult dose is 50mg once a day. Discontinuation is advised if the patient progresses to severe liver disease.
how to take
- Safinamide is available in tablet form to be taken orally, either with or without food, once daily.
- It should be swallowed with an ample amount of water, typically around the same time each day.
warning
- Patients should be made aware that safinamide has the potential to increase blood pressure even at the recommended dose.
- Foods containing tyramine, such as aged, smoked, or fermented meats, cheese, pickled foods, and eggs, should be avoided, as they may elevate blood pressure in patients taking the recommended dose of safinamide.
- Due to the risk of drowsiness, patients on safinamide should refrain from driving, operating heavy machinery, or working at heights.
- Patients should promptly report to their physician if they experience compulsive behaviors, such as the urge to gamble, spend more money, engage in binge eating, or experience increased sexual urges. In such cases, either dose reduction or discontinuation of the therapy is advised.
- Safinamide therapy may induce or worsen uncontrolled involuntary muscle movements (dyskinesia); therefore, the dose should be adjusted based on the patient’s response to the drug.
- Sudden withdrawal or rapid dose reduction is not recommended, as it may lead to increased temperature, altered consciousness, and muscle rigidity.