SAFINAMIDE

Background and Date of Approval

Safinamide received its initial approval for medical use from the U.S. Food and Drug Administration (FDA) on March 21, 2017.

Uses

Safinamide is primarily used as an adjunct medication for Parkinson's disease management. It helps control symptoms like tremors and movement difficulties by increasing dopamine levels in the brain.

How is it administered?

Safinamide is administered orally, meaning you take it by mouth and is available as 50 and 100mg tablet. The recommended dosage may be adjusted by a healthcare professional as needed.

Side Effects

Common side effects of Safinamide may include symptoms like nausea, insomnia, dizziness, headache, and uncontrolled movements. Serious side effects, although less common includes allergic reactions, which might present as rashes, itching, swelling, or even difficulties in breathing. Additionally, it may rarely lead to hallucinations or psychiatric symptoms, serotonin syndrome, or alterations in liver function.

Warnings

Safinamide may cause an increase in blood pressure. Some individuals may experience hallucinations, confusion, or changes in mood or behavior while taking this medication.

Precautions

Regular monitoring of blood pressure is recommended, especially at the start of Safinamide or with any dosage adjustments. Promptly inform your healthcare provider if any unusual mental health changes occur.

Word of Advice

Inform your doctor about all medications, supplements, and herbal products you are taking to prevent potential drug interactions. Use caution when combining Safinamide with other medications that increase serotonin levels, as this may result in serotonin syndrome. Monitor for symptoms including confusion, hallucinations, elevated heart rate, and elevated blood pressure. Blood pressure should be checked regularly, particularly when starting treatment or following any dose changes. Notify your doctor if you experience any unusual changes in your mental health.

References

U.S FDA (Food and Drug Safety Administration), [ Last Revised 21st March 2017], [Accessed on 29th Dec 2023], https://www.fda.gov/news-events/press-announcements/fda-approves-drug-treat-parkinsons-disease Baker DE, Kim AP. Formulary Drug Review: Safinamide. Hosp Pharm.[Published on 2017 September] [Accessed on 29th Dec 2023]

Frequently Asked Questions

Can Safinamide be used alone to treat Parkinson's?

Safinamide is often used in combination with other Parkinson's medications, especially levodopa/carbidopa, to enhance their effects and manage motor fluctuations.

What are the common side effects of Safinamide?

Common side effects of Safinamide may include nausea, insomnia, dizziness, headaches, and uncontrolled movements.

What should I do if I miss a dose of Safinamide?

If you miss a dose, take it as soon as you remember. However, if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

Can Safinamide be stopped suddenly?

It is important not to stop taking Safinamide abruptly without consulting your healthcare provider. They can provide guidance on tapering off the medication if necessary.

Are there specific dietary restrictions while taking Safinamide?

Safinamide doesn't typically have specific dietary restrictions. However, it's advisable to discuss dietary considerations with your doctor, especially concerning tyramine-rich foods if taking other MAO inhibitors.

How often should I have check-ups while on Safinamide?

The frequency of check-ups varies based on individual needs and response to the Safinamide. Your doctor will determine the appropriate schedule for monitoring your condition while taking Safinamide.

Available Brands 7

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS