Pronunciation: vye-uh-lev
Generic name: ​​foscarbidopa and foslevodopa
Dosage form: infusion 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL
Drug class: Dopaminergic antiparkinsonism agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 29, 2024.

What is Vyalev?

Vyalev is a 24-hour infusion treatment for advanced Parkinson’s disease to help control symptoms, increase the “on” time, and decrease the “off” time.  Vyalev is given under the skin using a wearable pump (Vyafuser) and works all day and night.  Vyalev works by increasing the level of dopamine in the brain, which helps Parkinson’s disease symptoms that are caused by low levels of dopamine. Vyalev contains foscarbidopa and foslevodopa which increases brain dopamine levels.

Vyalev FDA approval was granted on October 20, 2024, and is ​​indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. FDA approval was based on positive results from the Phase 3 M15-736 clinical trial. Vyalev infusions extended the “on” time - periods without troublesome dyskinesia - by an additional 1.75 hours compared to the group using oral immediate-release levodopa-carbidopa. Specifically, Vyalev provided 2.72 hours of “on” time, while oral levodopa-carbidopa offered only 0.97 hours. Additionally, Vyalev significantly reduced “off” time, improving symptoms of Parkinson’s disease.

Vyalev is also called Produodopa in other countries, and the pump is called Vyafuser.

What is Parkinson’s disease?

Parkinson’s disease is a disorder of the nervous system that affects movement and causes symptoms including tremors, slow movement, rigid muscles, stiffness, balance problems, speech problems, and other symptoms such as depression, anxiety, memory and thinking issues. Parkinson’s disease is caused by a loss of nerves in a part of the brain called substantia nigra, and these nerves make the chemical messenger called dopamine. The lack of dopamine causes irregular brain activity and results in movement symptoms and other issues of Parkinson’s disease. 

How does it work? 

Vyalev is thought to work by increasing the amount of dopamine in the brain. Vyalev mechanism of action (MOA) is a prodrug combination of foscarbidopa and foslevodopa, which are converted in the body to carbidopa and levodopa. Levodopa works in the brain, where it is then converted to dopamine, and carbidopa stops the levodopa from being broken down, which means there is more levodopa available to be turned into dopamine. Levodopa and carbidopa working together results in an increase in dopamine in the brain, which is thought to improve tremors, body stiffness, and other symptoms of Parkinson's disease. 

Vyalev side effects  

Common side effects

Common Vyalev side effects are infusion site reactions with pain (26%), skin redness (27%), infection (19%) and swelling (12%). Other common side effects include hallucinations and involuntary muscle movements (dyskinesia). These common side effects occurred in at least 10% of patients in clinical trials and were greater than oral carbidopa-levodopa group.

Serious Vyalev side effects

Serious Vyalev side effects include hallucinations, compulsive urges, reactions or infections at the infusion site, heart problems, worsening glaucoma, and withdrawal-emergent fever (hyperpyrexia) and confusion. 

Hallucinations:  Hallucinations are seeing things that are not there, hearing sounds, or feeling sensations that are not real. This is a common and sometimes serious side effect of Vyalev. Tell your healthcare provider if you have hallucinations.  

Unusual urges. Some people taking certain medicines to treat Parkinson’s disease, including Vyalev, have reported problems with gambling, compulsive eating, compulsive shopping, and increased sex drive. If you or your family members notice you have unusual urges or behaviors, talk to your healthcare provider.  

Infusion site reactions and infections. This is a common and sometimes serious side effect. Some people using Vyalev have had reactions and infections at the infusion site. Remove your cannula and call your healthcare provider if you have any of the following symptoms of an infection:

• local spreading of redness 
• pain, swelling, or warmth in the site area
• change in color when pressing on the area
• fever.

To prevent infection, clean your infusion site as trained to (aseptic technique) and change your infusion site at least every 3 days using a new infusion site that is at least 1 inch from a site you used in the last 12 days.  

Withdrawal-emergent fever (hyperpyrexia) and confusion. Call your healthcare provider if you have any of the following symptoms after stopping Vyalev treatment

• fever
• confusion
• severe muscle stiffness  

Sudden uncontrolled movements (dyskinesia). This is a common and sometimes serious side effect. If you have new sudden uncontrolled movement, or your they get worse, tell your healthcare provider. This may be a sign that your dose of your Parkinson’s disease mediciations need to be adjusted. 

Heart attack or other heart problems. Tell your healthcare provider if you have had increased blood pressure, a fast or irregular heartbeat or chest pain.  

Worsening of the increased pressure in your eye (glaucoma). The pressure in your eyes should be checked after starting this medicine. 

Also, see the warnings section.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Warning 

Vymay may cause sleepiness and falling asleep during activities of daily living, this may require discussion with your healthcare provider. 

Also, see the side effects section.

Who should not take Vyalev?

You should not take Vyalev with a nonselective monoamine oxidase (MAO) inhibitor medicine or have taken a nonselective MAO inhibitor within the last 14 days. Ask your healthcare provider or pharmacist if you are not sure if you take an MAO inhibitor. 

Before taking this medicine

Before using this medicine, tell your healthcare provider about all your medical conditions or if you

• feel drowsy, sleepy, or have fallen asleep suddenly during the day.  
• have hallucinations or have been seeing things that are not there, hearing sounds or feeling sensations that are not real 
• have or have had unusual urges or compulsions such as compulsive eating, compulsive shopping, gambling and increased sex drive. 
• have dyskinesia - trouble controlling your muscles.  
• have glaucoma or eye problems that cause increased pressure in your eye.
• drink alcohol, as alcohol can increase the chance that this medicine will make you feel sleepy or fall asleep when you should be awake. 
• have or have had heart problems, an abnormal heart rate or have had a heart attack in the past.
• have or have had high blood pressure (hypertension).  

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant as is not known if this medicine can harm your unborn baby.  

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you take Vyalev. 

How should I use Vyalev?

Vyalev is given as a continuous infusion under the skin over 24 hours using a Vyafuser pump.  It can be stopped for brief periods of time, such as when taking a shower or a short medical procedure. The Vyalev pump is small, about the size of two stacked cell phones, and has a range of carrying case options. Your prescribed Vyalev dose will be programmed into your pump by a healthcare provider and should only be changed by your healthcare provider.

You will need to change your infusion set (tubing and cannula) and rotate to a different infusion site if you stop the infusion for longer than 1 hour.  If your infusion has been stopped for less than 1 hour you will not need a new infusion set (tubing and cannula), and you will not need to rotate to a different infusion site.  If your infusions have been stopped for longer than 3 hours, consider also giving yourself a loading dose to quickly get your symptoms back under control.  Have oral carbidopa and levodopa available in case your treatment with infusion treatment is stopped for 1 hour or longer. 

Do not stop using Vyalev infusion unless you are told to do so by your healthcare provider.  Talk with your healthcare provider about what to do in case you are unable to use the infusion.  Always keep a supply of backup oral Parkinson’s disease medicines that contain levodopa and carbidopa with you at all times. 

Use the infusion exactly as your healthcare provider tells you to use it.  Only use this medication by yourself after you have been trained in the right way to use it. Ask your healthcare provider if you have any questions.  

Dosing information

Base Continuous Vyalev Dosage and Hourly Infusion Rate 

The continuous infusion rate is based on total levodopa dosage (TLD). The hourly base continuous infusion rate (mL/hr) = [(TLD x 1.3) / 240] / [number of hours the patient is typically awake (e.g., 16 hours)]. See detailed dosage page for directions.

Maximum Vyalev Dosage

The maximum recommended daily dosage is 3,525 mg of the foslevodopa component (equivalent to approximately 2,500 mg levodopa). 

Preparation and Administration Instructions

Preparation 

Use an aseptic technique.  

Use sterile, single-patient-use infusion components (syringe, infusion set, and vial adapter) qualified for use with the pump to infuse Vyalev. 

Do not dilute.  Do not mix Vyalev with other products.  

The medication vials are for single dose only. 

The entire contents of a vial should be transferred into a syringe for administration. Do not withdraw a partial portion of the vial contents.  

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.

Patients should be trained on the proper use of this infusion before starting treatment. 

Vyalev should be administered subcutaneously, preferably in the abdomen, avoiding the area with a 2-inch radius from the navel. Rotate the infusion site and use a new infusion set at least every 3 days.  

Select new infusion sites at least 1 inch from sites used within the previous 12 days.  Do not infuse into areas where the site is tender, bruised, red, or hard to the touch.

Infusion Flow Rates  Adjustment

Infusion rates may be adjusted in increments of 0.01 mL/hr (which is equivalent to approximately 1.7 mg of levodopa/hour). 

What happens if I miss a dose?

​​Interruption of Therapy

Prescribing a backup of oral carbidopa and levodopa products is recommended in the event that delivery of Vyalev infusion is interrupted, which may result in underdosing. Sudden discontinuation or rapid dose reduction of the infusion without administration of alternative dopaminergic therapy, should be generally avoided. Following interruptions of more than 1 hour, a new infusion set (tubing and cannula) should be used and rotated to a different infusion site. If the infusion has been interrupted for longer than 3 hours, the patient may also self-administer a loading dose, if enabled by their healthcare professional.

Vyalev Support Program

Vyalev Complete is a support program that is available at no cost to patients using Vyalev and their caregivers. Vyalev Complete may help you find a way to save money on your medication, and it has one-on-one support, resources and videos, and a 24-hour, 7-day week hotline available for any queries.

For Vyalev Complete Support Program, call 1-8666-489-2538.

What other drugs will affect Vyalev 

Other drugs may interact with Vyalev and cause serious side effects. Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Selective MAO-B inhibitors: May cause orthostatic hypotension. 

Antihypertensive drugs: May cause symptomatic postural hypotension. Dosage adjustment of the antihypertensive drug may be needed. 

Dopamine D2 receptor antagonists and isoniazid may reduce the effectiveness of Vyalev.

Not all possible drug interactions are listed here.

Storage

• Keep the vials in the outer carton to protect the vials from breaking.  
• Store in the refrigerator between 36°F to 46°F (2°C to 8°C).  
• If Vyalev is stored in the refrigerator, take one vial out of the carton and out of the refrigerator 30 minutes before use. Use the Vyalev at room temperature or you may not get the right amount of the medicine. 
• Vyalev may be stored at room temperature up to a maximum of 86°F (30°C) for a single period of up to 28 days.  After it has been stored at room temperature, do not return the medicine to the refrigerator.  If stored at room temperature, throw away (dispose of) if not used within 28 days. 
• Record the date when it is first removed from the refrigerator in the space provided on the carton.  
• Do not freeze.  Do not shake.  

Ingredients

Active ingredients: foscarbidopa and foslevodopa 

Inactive ingredients: Sterile water for injection. Sodium hydroxide and hydrochloric acid may be used to adjust the pH to 7.4.

Vyalev Manufacturer

Vyalev manufacturer AbbVie Inc. North Chicago, IL 60064 U.S.A. 

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer