Xadago (safinamide)
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Xadago (safinamide)
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Xadago (safinamide) is a medication used as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.
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Xadago
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Disease Indications
Parkinson's Disease
Manufacturer
Zambon SpA
Usage
Oral
Medicine approved by
European Medical Agency (EMA)
Food and Drug Administration (FDA)
Health Canada
Therapeutic Goods Administration (TGA)
Patients helped
Over 1.2 million patients reached
More than 11,000 patients helped
100% successful deliveries to 88 countries
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Xadago (safinamide)
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What is Xadago (safinamide) for?
Xadago (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor, indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes[2].
How does Xadago (safinamide) work?
Parkinson’s disease develops when neurons (brain cells) in a particular part of the brain stop working properly and are lost over time.
These neurons produce an important chemical called dopamine. Dopamine is used by the brain to send messages across brain areas to help control movement. Eventually, the brain cannot make enough dopamine to control the movement properly. There is currently no cure for Parkinson’s Disease. Existing treatments aim to help patients manage symptoms.[4]
The active substance in Xadago - safinamide - blocks the enzyme MAO-B which breaks down dopamine, thereby helping to restore dopamine levels in the brain and improving the patient's symptoms[5].
Where has Xadago (safinamide) been approved?
Xadago (safinamide) was approved as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes by:
Food and Drug Administration (FDA), USA, March 21, 2017[1]
European Medical Agency (EMA), European Union, February 24, 2017[5]
Therapeutic Goods Administration (TGA), Australia, November 2, 2018[6]
Health Canada (as Onstryv), January 9, 2019[7]
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
Please be aware that any decision to use a prescription generic or brand name medicine should always be taken in consultation with a medical professional. The FDA has sent warning letters to drugmakers in India concerning the quality of their medicines.
How is Xadago (safinamide) taken?
The standard dosage is[2,3]
Start dose: 50 mg tablets once daily at the same time of day
After two weeks, the dose may be increased to 100 mg once daily, based on individual's need and tolerability
Warning: Do not exceed 50 mg once daily in patients with moderate hepatic impairment; this medicine is contraindicated in patients with severe hepatic impairment.
Complete information about Xadago (safinamide) dosage and administration can be found in the official prescribing information listed in our references section[2,3].
Note: Please consult with your treating doctor for personalised dosing.
Are there any known side effects of Xadago (safinamide)?
Common side effects
The most common side effects listed in the prescribing information include[2,3]
insomnia
dyskinesia (difficulty controlling movement)
somnolence
dizziness
nausea.
Serious side effects
Safinamide must not be used in patients with severe liver problems, in patients treated with pethidine or other MAO inhibiting medicines[2,3]
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information[2,3]
References
1. FDA approves drug to treat Parkinson’s disease
FDA, March 2017
2. Summary of Product Characteristics [FDA]: Xadago (safinamide) [PDF]
US WorldMeds, LLC, March 2017
3. Summary of Product Characteristics [EMA]: Xadago (safinamide) [PDF]
Zambon SpA, April 2017
4. Parkinson's
Parkinsons UK, cited May 2017
5. Human Medicines: Xadago (safinamide)
6. Summary of Product Characteristics [TGA]: Xadago (safinamide) [PDF]
Zambon SpA, November 2018
7. Summary of Product Characteristics [Health Canada]: Onstryv (safinamide) [PDF]
Valeo Pharma, January 2019