Xadago
Xadago (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor. It's used as an add-on treatment to carbidopa/levodopa medications (e.g., Sinemet, Rytary, Duopa) to ease "off" episodes in adults with Parkinson's disease (PD). Xadago (safinamide) is taken by mouth, typically once a day. The most common side effect of this medication is uncontrolled muscle movements.
What is Xadago (safinamide)?
What is Xadago (safinamide) used for?
Treatment of "off" episodes in people with Parkinson's disease (add-on medication to carbidopa/levodopa)
How Xadago (safinamide) works
Symptoms of Parkinson's disease are caused by a low level of dopamine in your brain. Xadago (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor, which means it blocks a specific type of protein called MAO-B from breaking down dopamine. This raises the levels of dopamine in your brain and helps control your PD symptoms.
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What are the side effects of Xadago (safinamide)?
Common Side Effects
- Involuntary movements (dyskinesia) (17-21%)
- Falls (4-6%)
- Nausea (3-6%)
- Trouble sleeping (1-4%)
Other Side Effects
- Drop in blood pressure when standing up from a seated or lying down position
- Anxiety
- Cough
- Stomach upset
- Headache
Serious Side Effects
- Serotonin syndrome: confusion, restlessness, hallucinations, coma, fainting, shivering, sweating, high fevers, headache, racing heart, high blood pressure, diarrhea, muscle stiffness or twitching, tremor, seizures
- Extremely high blood pressure: severe headache, nosebleed, anxiety, feeling of pulsations in the neck or head, vision changes
- Neuroleptic malignant syndrome (NMS): high fevers, confusion, muscle stiffness
- Serious allergic reactions: swelling of the tongue and gums, shortness of breath, skin rash
- Falling asleep during normal activities
- Hallucinations or psychosis
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in vision
- Falling asleep during daily activities
- Increase in blood pressure
- Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
- Mood and behavior changes—anxiety, nervousness, irritability and restlessness, confusion, hallucinations, feeling distrust or suspicion of others
- New or worsening uncontrolled and repetitive movements of the face, mouth, or upper body
- Urges to engage in impulsive behaviors such as gambling, binge eating, sexual activity, or shopping in ways that are unusual for you
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Nausea
- Trouble sleeping
Pros and cons of Xadago (safinamide)
Pros
Can help treat PD symptoms when carbidopa/levodopa starts wearing off
Can start working in as early as 2 to 4 weeks
Taken once a day
Cons
Can interact with many medications
Can't eat foods that have high tyramine levels while taking Xadago (safinamide) (e.g., aged, fermented, cured, or pickled foods)
No lower-cost generic available
Pharmacist tips for Xadago (safinamide)
Take Xadago (safinamide) once a day at the same time each day, with or without food.
Stopping Xadago (safinamide) suddenly can raise your risk for serious withdrawal effects like high fevers and confusion. Don't stop taking Xadago (safinamide) without talking to your provider so they can instruct you on how to stop the medication safely.
Don't take more Xadago (safinamide) than what's prescribed to you in a day. Doing so can raise your risk of high blood pressure. If you miss your dose, just skip it and take it on the next day at your regularly scheduled time.
Avoid eating food that is high in tyramine, such as aged cheese, cured meats, and pickled foods, while you're taking Xadago (safinamide). Eating large amounts of tyramine can raise your risk of high blood pressure.
Xadago (safinamide) can cause sleepiness and there's a chance you can fall asleep without warning during normal daily activities. It's best to avoid alcohol, which can make these side effects worse. Don't drive or do anything that requires you to focus until you know how this medication affects you.
Xadago (safinamide) can interact with many medications. Tell your provider if you're taking or plan to take any prescription or over-the-counter medications, especially antidepressants, cold medications, and pain medications. Combining these medications with Xadago (safinamide) can lead to dangerous side effects.
Frequently asked questions about Xadago (safinamide)
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What are the risks and warnings for Xadago (safinamide)?
Xadago (safinamide) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
High blood pressure
Risk factors: Eating foods that are rich in tyramine | Taking certain types of medications such as stimulants, decongestants, or medications that lower your appetite | Taking isoniazid
Xadago (safinamide) can cause or worsen high blood pressure. Xadago (safinamide) can also make you more sensitive to tyramine, a substance in your body that helps control your blood pressure. Eating food containing very high amounts (more than 150 mg) of tyramine while taking this medication can lead to dangerously high blood pressure that can require emergency medical treatment.
Because of this risk, avoid foods that contain large amounts of tyramine, such as aged cheeses, cured meats, pickled or fermented foods, and alcohol. Taking certain medications such as isoniazid, stimulant medications, decongestants, or medications that lower your appetite can also raise your risk of high blood pressure. Monitor your blood pressure at home and let your provider know if your blood pressure is consistently above normal.
Serotonin syndrome
Risk factors: Combining Xadago (safinamide) with certain medications that raise serotonin levels
Taking Xadago (safinamide) with other medications that affect your serotonin levels can lead to serotonin syndrome. This is a potentially life-threatening condition caused by high levels of serotonin in your body. Symptoms include confusion, hallucinations, coma, fainting, shivering, sweating, high fevers, racing heart, high blood pressure, muscle stiffness or twitching, tremors, and seizures.
Because of this risk, Xadago (safinamide) shouldn't be taken with certain medications, including some antidepressants (e.g., MAOIs, SNRIs), opioids, cyclobenzaprine (Flexeril), methylphenidate (Ritalin), amphetamine). If you experience any of the above symptoms, stop taking Xadago (safinamide) and get emergency medical help right away. Let your healthcare provider know about all the prescription and over-the-counter medications you take before starting Xadago (safinamide).
Sleepiness or falling asleep during activities
Risk factors: History of drowsiness | History of sleep problems | Taking sedatives or medications that make you drowsy | Taking medications that raise your dopamine levels
Xadago (safinamide) and other medications that raise your dopamine levels can make you fall asleep out of nowhere, even if you don't feel sleepy. Because of this risk, avoid driving or doing things that require you to focus until you know how this medication affects you, especially if you feel sleepy normally or if you've fallen asleep suddenly in the past. Let your provider know if you feel very sleepy during the daytime or if you fall asleep during activities where you need to concentrate.
Uncontrolled movements (dyskinesia)
Risk factors: Taking levodopa for Parkinson's disease
Xadago (safinamide) might cause you to have involuntary movements, also known as dyskinesia. This is more likely to happen if you're also taking levodopa for Parkinson's disease. If this becomes bothersome, let your provider know. They might adjust the doses of your PD medications.
Hallucinations and psychotic behavior
Risk factors: History of mental health conditions
In general, people with a history of psychotic conditions shouldn't take Xadago (safinamide) because it can worsen their mental health. If you develop hallucinations, strange thoughts, or unusual behavior, let your provider know right away.
Difficulty controlling impulses
Xadago (safinamide) and other Parkinson's disease medications can cause changes in people's behavior. Some people have experienced strong sexual or gambling urges, urges to spend a lot of money, and binge eating. These medications can also make it hard to control these urges. If this becomes bothersome, let your provider know.
High fevers and confusion
Although rare, stopping Xadago (safinamide) suddenly or lowering your dose too quickly can cause symptoms similar to neuroleptic malignant syndrome (NMS). Symptoms of NMS include very high fevers, irregular pulse, sweating, muscle stiffness, confusion, and changes in blood pressure. NMS is treatable if it's recognized early. Don't stop taking Xadago (safinamide) or lower your dose without talking to your provider so they can instruct you on how to stop the medication safely.
Eye damage
Risk factors: Personal or family history of eye diseases
In animal studies, Xadago (safinamide) caused eye damage. It isn't known if this also happens in humans. Your risk might be higher if you have a personal or family history of macular degeneration, inherited eye conditions, or any retinopathy. Your provider will monitor your vision occasionally depending on your risk factors.
Xadago (safinamide) dosage forms
Typical dosing for Xadago (safinamide)
The typical starting dose is 50 mg by mouth once a day, at the same time every day. After two weeks, your provider might raise your dose to 100 mg once a day based on how you respond to the medication.
Your dose might differ if you have liver problems.
How much does Xadago (safinamide) cost?
Xadago (safinamide) contraindications
Taking medications called monoamine oxidase inhibitors (MAOIs), including linezolid (Zyvox)
Taking opioids such as meperidine (Demerol), methadone (Dolophine), propoxyphene, and tramadol (Ultram)
Taking certain antidepressants (serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic, tetracyclic, or triazolopyridine antidepressants)
Taking cyclobenzaprine (Flexeril)
Taking methylphenidate (Ritalin) or medications similar to methylphenidate
Taking amphetamine (Adderall) or medications similar to amphetamine
Taking St. John's wort
Taking dextromethorphan (Delsym)
Severe liver disease
What are alternatives to Xadago (safinamide)?
Treatment of "off" episodes in people with Parkinson's disease (add-on medication to carbidopa/levodopa)
Relief of "off" episodes in people with Parkinson's disease (PD) who are taking a carbidopa/levodopa medication
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References
Best studies we foundAmerican Parkinson Disease Association. (n.d.). Communicating about OFF episodes and dyskinesia with your doctor.
American Parkinson Disease Association. (n.d.). Parkinson’s disease and dyskinesia.
Giossi, R., et al. (2021). Overall efficacy and safety of safinamide in Parkinson’s disease: A systematic review and a meta-analysis. Clinical Drug Investigation.
MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. (2023). Xadago- safinamide mesylate tablet, film coated [package insert]. DailyMed.
Supernus Pharmaceuticals, Inc. (n.d.). What is ON and OFF time?
Supernus Pharmaceuticals, Inc. (n.d.). Why Xadago?
Thanvi, B., et al. (2007). Levodopa-induced dyskinesia in Parkinson's disease: Clinical features, pathogenesis, prevention and treatment. Postgraduate Medical Journal.
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