Xadago (Onstryv – Safinamide)

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Xadago (Safinamide) - Canada Product Information

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IMPORTANCE NOTICE: In Canada, Xadago is marketed as Onstryv.

What is Xadago?

Xadago (safinamide) is an oral medication used as an add-on therapy for patients with Parkinson’s disease who are already taking levodopa. It is specifically designed to help reduce “off” episodes—times when the effects of levodopa wear off and Parkinson’s symptoms, such as stiffness, tremors, and movement difficulties, return. Xadago works by inhibiting an enzyme called monoamine oxidase-B (MAO-B), which increases dopamine levels in the brain and improves movement control.

How does Xadago work?

Xadago is a selective MAO-B inhibitor, which means it helps block the breakdown of dopamine in the brain. Dopamine is a chemical that helps regulate movement, and Parkinson's disease occurs when the brain's dopamine levels drop. By increasing dopamine levels, Xadago enhances the effects of levodopa and provides more consistent symptom control.

Who can use Xadago?

Xadago is prescribed for adults with Parkinson's disease who experience "off" episodes while taking a stable dose of levodopa, either alone or in combination with other medications used to treat Parkinson’s. Xadago is not meant to be used as a standalone treatment for Parkinson's disease, and it must be used alongside levodopa.

How to take Xadago

• Xadago is available in 50 mg and 100 mg tablets.
• Typically, treatment begins with 50 mg once daily, taken orally. After two weeks, your doctor may increase the dose to 100 mg daily depending on your response to the treatment.
• Take Xadago at the same time every day, with or without food.
• Do not double your dose if you forget to take it. Simply take the next dose at the usual time.

Missed dose: If you miss a dose, take your next dose at the usual time the following day. Do not take two doses to make up for a missed dose.

What to avoid while taking Xadago

• Certain foods: While dietary tyramine restriction is usually not necessary, it’s advisable to avoid consuming foods that are extremely high in tyramine, such as aged cheeses, which could cause high blood pressure.
• Other medications: Do not take Xadago with certain other medications like MAO inhibitors, opioid painkillers (meperidine, tramadol), antidepressants (SNRIs, tricyclics), or St. John’s wort. These can lead to severe interactions, including serotonin syndrome, which is potentially life-threatening.

Common side effects of Xadago

Most people tolerate Xadago well, but some common side effects include:

• Nausea
• Headache
• Insomnia
• Increased involuntary movements (dyskinesia)
• High blood pressure

If you experience side effects like confusion, hallucinations, or severe agitation, contact your healthcare provider immediately.

Warnings and precautions

1. Hepatic Impairment: Xadago should not be used by individuals with severe liver problems. For those with moderate liver impairment, the dose should not exceed 50 mg per day.

2. Sudden Onset of Sleep: Some patients have experienced sudden sleep episodes while taking Xadago, especially when combined with other dopaminergic medications. This can happen without warning, so be cautious when driving or operating heavy machinery.

3. Hallucinations: Safinamide may cause or worsen hallucinations and psychotic-like behaviors in some patients. If this occurs, speak with your doctor about adjusting your dose.

4. Impulse Control Disorders: Some people taking medications like Xadago may develop compulsive behaviors, such as binge eating, gambling, or hypersexuality. Let your doctor know if you experience these symptoms.

5. Drug Interactions: Be sure to tell your doctor about any other medications you are taking, including over-the-counter medicines and herbal supplements, to avoid harmful interactions.

Who should not take Xadago?

• If you are allergic to safinamide or any other ingredients in the formulation.
• If you are taking any MAO inhibitors, certain opioids, antidepressants, or decongestants.
• If you have severe liver problems (Child-Pugh C).
• If you have a history of retinal disease, including severe diabetic retinopathy or other progressive retinal conditions.

Storage

• Store Xadago at room temperature 
• Keep it in a dry place away from moisture.
• Do not refrigerate or freeze.
• Keep out of the reach of children.

Overdose

In the event of an overdose, symptoms such as hypertension, nausea, vomiting, hallucinations, and agitation may occur. Seek emergency medical help or contact your regional poison control center immediately.

For further details about how Xadago works, or if you have concerns about side effects, consult your healthcare provider. 

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Reference: Onstryv Canada product monograph

Xadago (safinamide) is taken once daily by mouth, with or without food. It is typically prescribed as an add-on to levodopa/carbidopa for patients with Parkinson's disease. The usual starting dose is 50 mg, which may be increased to 100 mg based on response and tolerance. It should be taken at the same time each day, and doses should not be doubled if missed. Avoid abrupt discontinuation without consulting a doctor.