Vyalev
Vyalev (foscarbidopa / foslevodopa) is used to treat movement problems in adults with advanced Parkinson's disease (PD). It's given as a continuous infusion under the skin of the stomach using the Vyafuser pump. This anti-Parkinson medication helps raise and keep dopamine levels high in the brain. Side effects can include hallucinations and uncontrolled movements. It can also cause skin reactions where the medication is infused.
What is Vyalev (foscarbidopa / foslevodopa)?
What is Vyalev (foscarbidopa / foslevodopa) used for?
- Advanced Parkinson’s disease (PD)
How Vyalev (foscarbidopa / foslevodopa) works
Vyalev contains two medications: foscarbidopa and foslevodopa. In the body, they turn into carbidopa and levodopa, which work together to raise dopamine levels in the brain. This helps relieve symptoms of Parkinson's disease (PD).
- Levodopa is a dopamine replacement. It travels to the brain, where it's converted into dopamine. By restoring dopamine levels in the brain, levodopa helps relieve PD symptoms.
- Carbidopa is a dopa decarboxylase inhibitor. Dopa decarboxylase is a protein that breaks down levodopa before it can reach the brain. Blocking this protein lets more levodopa reach the brain and turn into dopamine. This means more levodopa and dopamine stay in the brain longer. This helps improve PD symptoms.
Drug facts
Side effects of Vyalev (foscarbidopa / foslevodopa)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Reaction at the infusion or catheter site (62%)
- Infection at the infusion or catheter site (28%)
- Hallucination (12%)
- Uncontrolled movements (11%)
- "On and off" phenomenon (8%)
Less Common Side Effects
- Balance problems
- Constipation
- Swelling in the arms or legs
- Agitation
- Trouble sleeping
- Mood problems (e.g., delusions, paranoia)
- Shortness of breath
Vyalev (foscarbidopa / foslevodopa) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Infection at the infusion site: redness, swelling, pain, fever
- Falling asleep suddenly or feeling very sleepy
- Hallucinations: seeing things that aren't there, hearing sounds that aren't real, feeling unreal sensations
- Abnormal thinking or behavior: confusion; trouble sleeping; paranoia; delusions; aggression; agitation; strong urges to gamble, shop, or eat
- Heart problems: chest pain that spreads to the arm, neck, or jaw; cold sweat; irregular heartbeat; dizziness
- Withdrawal symptoms after stopping or lowering the dose suddenly: very high fevers, sweating, confusion, irregular heartbeat, muscle stiffness, changes in blood pressure
The following Vyalev (foscarbidopa / foslevodopa) 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
- Falling asleep during daily activities
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
- New or worsening uncontrolled and repetitive movements of the face, mouth, or upper body
- Painful swelling, warmth, or redness of the skin, blisters or sores at the infusion site
- Skin infection—skin redness, swelling, warmth, or pain at the injection site
- Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
- 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):
- Constipation
- Irritability
- Swelling of the ankles, hands, or feet
Pros and cons of Vyalev (foscarbidopa / foslevodopa)
Pros
- First continuous, non-surgical treatment option for people with advanced PD
- Can help control symptoms for 24 hours
- No need to time doses around food
Cons
- Can cause irritation at the injection site
- Requires training on how to use the Vyafuser pump to take the medication
- Not approved for people with early stages of Parkinson's disease
Pharmacist tips for Vyalev (foscarbidopa / foslevodopa)
- Vyalev (foscarbidopa / foslevodopa) is infused continuously over 24 hours using the Vyafuser pump. The Vyfuser pump comes separately from the medication. Be sure you have all the supplies you need for the infusion.
- Before using Vyalev (foscarbidopa / foslevodopa), your healthcare team will teach you or your caregiver how to use the medication with the Vyafuser pump. Carefully read the instructions for use for Vyalev and the Vyafuser pump. Call your prescriber or your care team if you have any questions.
- How to store Vyalev (foscarbidopa / foslevodopa): Store the medication vials in the refrigerator in the original carton. Don't let the medication freeze, though. If needed, you can keep the vials at room temperature up to 86ºF for up to 28 days. But once it's reached room temperature, don't put it back in the fridge. If you take a vial out of the fridge, write the date down on the carton so you know when to throw it away.
- Before using each Vyalev (foscarbidopa / foslevodopa) vial: Take it out of the refrigerator and let it reach room temperature for 30 minutes. If it isn't at room temperature when you use it, you might not get the correct amount of medication. Don't warm it up any other way, like microwaving or running under hot water.
- Where to infuse Vyalev (foscarbidopa / foslevodopa): Infuse the medication under the skin on the stomach, 2 inches away from your belly button. At least every 3 days, move the infusion site 1 inch from areas you've used within the last 12 days. This helps your skin heal. Don't infuse into tender, red, bruised, or hard skin.
- How to fill the syringe with Vyalev (foscarbidopa / foslevodopa) and place it into the Vyafuser pump: Your care team will show you how to draw the medication up from the vial into the syringe to fill your pump. Don't use the medication if it's been in the syringe for more than 24 hours. Follow your care team's steps to connect the infusion tubing to the syringe and place the syringe into the pump.
- When to change your Vyalev (foscarbidopa / foslevodopa) infusion set tubing: Talk to your prescriber about how often to change your infusion set tubing. It can stay in place for up to 3 days when you infuse the medication continuously.
- Stopping the Vyalev (foscarbidopa / foslevodopa) infusion for a short amount of time: You can stop the infusion for a short amount of time, like when you take a shower. But if you stop it for more than 1 hour, you'll need to use a new infusion set (the cannula and tubing) when you start it again. Also choose a different spot on your stomach for the infusion.
- If you need to stop the Vyalev (foscarbidopa / foslevodopa) infusion for more than 3 hours: If you stop the infusion for more than 3 hours, you might need a loading dose to help control your symptoms. Ask your prescriber what to do, whether you need a loading dose, and how much medication to take.
- Keep a back-up supply of carbidopa-levodopa pills: Make sure to have some extra carbidopa-levodopa pills like Sinemet that you can take by mouth. This is helpful in case the Vyafuser pump stops working or if you take the pills for loading doses. Ask your prescriber how to take the pills if needed.
- Don't drive or do anything that needs your full attention until you know how Vyalev (foscarbidopa / foslevodopa) affects you. This medication can make you sleepy and might even make you fall asleep suddenly.
- Keep an eye on the infusion sites you use for Vyalev (foscarbidopa / foslevodopa). Watch for skin redness, swelling, tenderness, soreness, bruising, bleeding, or rash. Also be aware of any fevers or chills. These could be signs of a reaction or infection at the infusion site. If this happens, call your care team so they can help you.
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Risks and warnings for Vyalev (foscarbidopa / foslevodopa)
Vyalev (foscarbidopa / foslevodopa) 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.
Sleepiness or falling asleep during activities
- Risk factors: History of drowsiness | History of sleep problems | Taking sedatives or medications that make you drowsy
Vyalev (foscarbidopa / foslevodopa) can sometimes make you fall asleep suddenly, even if you didn't feel tired beforehand. This can happen while eating, talking, or even driving, which can be very dangerous.
Because of this risk, avoid driving or doing anything that requires your focus until you know how Vyalev (foscarbidopa / foslevodopa) affects you. This is extra important if you often feel sleepy or have ever fallen asleep suddenly before. Also avoid taking medications that make you sleepy since they can make this worse.
Let your prescriber know if you feel very sleepy during the daytime while taking Vyalev (foscarbidopa / foslevodopa). Also tell them if you fall asleep in the middle of activities that require your full attention.
Hallucinations and changes in behavior and thoughts
- Risk factors: History of certain mental health conditions
Vyalev (foscarbidopa / foslevodopa) can raise the risk of hallucinations. They might come with confusion, trouble sleeping, or a lot of dreaming. These symptoms often happen shortly after starting the medication, and they might go away after your dose is lowered. Tell your care team if you or your loved ones notice you're hallucinating while you're taking Vyalev (foscarbidopa / foslevodopa).
Vyalev (foscarbidopa / foslevodopa) can also raise the risk of psychosis (abnormal thinking and behavior). This can include paranoia, delusions, aggression, agitation, and confusion. Call your care team if you notice these changes while taking this medication.
Because this medication can worsen psychosis, you shouldn't take Vyalev (foscarbidopa / foslevodopa) if you have certain mental health conditions. Also, some mental health medications, like haloperidol (Haldol), can make Parkinson's symptoms worse. They could also make Vyalev (foscarbidopa / foslevodopa) work less well. Let your prescriber know about any mental health problems you have.
Difficulty controlling impulsive behavior
Vyalev (foscarbidopa / foslevodopa) can sometimes make people act more impulsively. Some examples include having strong sexual or gambling urges, having urges to spend a lot of money, and binge eating. These behaviors can be hard to control.
Tell your care team if you or someone close to you notices you start having these urges while you're taking Vyalev (foscarbidopa / foslevodopa). In particular, tell them if the urges start to have a negative impact on your life. Your prescriber will also ask you about these behaviors during follow-up visits, since you might not notice them yourself.
Infusion site reactions and infections
Vyalev (foscarbidopa / foslevodopa) can cause skin reactions and infections where the pump tubing gets inserted into your stomach area. The area can become red, sore, swollen, bruised, or itchy. There could also be a rash or some bleeding. If this happens, tell your care team so they can give you tips on how to relieve and manage these reactions.
The most common infection at the infusion site is cellulitis (a skin infection). Watch for discolored skin, swelling, tenderness, chills, or a fever. Ask your care team about other signs of infection so you know when to call them. If you get an infection, your care team might have you change where the infusion site is. They could also tell you to stop Vyalev (foscarbidopa / foslevodopa) and take a carbidopa-levodopa pill instead until the infection clears up.
High fevers and confusion when lowering the dose or stopping too suddenly
Although rare, stopping Vyalev (foscarbidopa / foslevodopa) or lowering the dose too quickly can cause withdrawal symptoms. They can look similar to symptoms of neuroleptic malignant syndrome (NMS). These symptoms can include very high fever, confusion, an irregular heartbeat, muscle stiffness, and changes in blood pressure.
Don't stop taking Vyalev (foscarbidopa / foslevodopa) or lower your dose without talking to your prescriber first. They can tell you how to do this in a safe way. Usually, this involves slowly lowering the dose.
Uncontrolled movements
Vyalev (foscarbidopa / foslevodopa) can cause or make uncontrolled movements (dyskinesias) worse. Tell your prescriber if you notice movements you can't control. They might need to lower the dose of your medication.
Heart attack and abnormal heart rhythm
In studies, some people taking carbidopa-levodopa medications like Vyalev had a heart attack or an abnormal heart rhythm (arrhythmia). Tell your prescriber if you've ever had a heart attack or irregular heartbeat before starting this medication.
Get medical help right away if you notice signs of these heart problems while taking Vyalev (foscarbidopa / foslevodopa). Watch for chest pain that spreads to your neck, jaw, or arm. Also look out for a fast or irregular heartbeat, trouble breathing, or dizziness.
Higher pressure in the eyes in people with glaucoma
Vyalev (foscarbidopa / foslevodopa) might raise the pressure in the eyes in people with glaucoma. Tell your eye specialist that you're taking this medication. Make sure to go to your eye appointments so they can check your eye pressure regularly.
Vyalev (foscarbidopa / foslevodopa) dosage
Typical dosage for Vyalev (foscarbidopa / foslevodopa)
Vyalev (foscarbidopa / foslevodopa) is given as a continuous injection under the skin of your stomach. It's given using the Vyafuser pump.
Your prescriber will calculate how much medication you need each day based on your symptoms. The dose is based on the foslevodopa component of Vyalev. The maximum daily dose of foslevodopa is 3,525 mg (about 2,500 mg of levodopa).
They will also help set the infusion rate, which is how fast you'll receive the medication during the day. This depends on your dose and how many hours you're usually awake.
Your prescriber might decide that you need extra doses throughout the day. They'll tell you when to take them and how much to use, if needed. The pump can only give one extra dose per hour.
Vyalev (foscarbidopa / foslevodopa) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Vyalev (foscarbidopa / foslevodopa) will not be safe for you to take.
- Currently taking a non-selective monoamine oxidase inhibitor (MAOI)
- Have taken a non-selective MAOI within 2 weeks of taking Vyalev (foscarbidopa / foslevodopa)
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