If you have advanced Parkinson’s disease (PD), you may hear about a treatment option called Vyalev (foscarbidopa/foslevodopa). It was approved by the FDA in 2024. It is also known by the brand name Produodopa in other countries.
Parkinson’s disease is a condition that affects your brain’s ability to make dopamine, a chemical messenger involved in body movement. Managing PD often starts with taking oral medicines that help replace or mimic dopamine, such as levodopa. These medicines can work well in the early stages to manage symptoms.
As PD advances, many people begin to notice “wearing off,” when symptoms such as tremor, stiffness, or slow walking return before the next dose of medicine. Shifts between “ON” and “OFF” periods can be abrupt and may become hard to predict.
Infusion therapies, such as Vyalev, were developed to help reduce these fluctuations. A wearable pump delivers Vyalev continuously through a tube placed under the skin. This gives your body a steadier supply of medicine and may replace the need to take multiple pills throughout the day for PD.
Keep reading for answers to common questions about using Vyalev for Parkinson’s disease.
How Does Vyalev Work, and Is It Right for My Parkinson’s Disease?
Vyalev is FDA-approved to treat movement (motor) fluctuations in adults with advanced Parkinson’s disease (PD). It works by helping replace the brain chemical dopamine.
Vyalev contains two medicines, foslevodopa and foscarbidopa, which get converted to levodopa and carbidopa once they enter your body.
- Levodopa turns into dopamine in the brain and helps control your body movements.
- Carbidopa stops your body from breaking down levodopa too quickly, allowing more levodopa to reach the brain.
To decide if Vyalev is a good option for you, your health care provider will consider factors such as your overall health, current medicines, how well your symptoms are managed, and if you can learn to use the infusion system at home.
You may be a good candidate for Vyalev if your oral PD medicines still help but you have OFF times — when your movements are not well controlled between doses. Vyalev is designed for people who respond to levodopa. If you do not respond to levodopa at all, Vyalev is not a good option for you.
Vyalev is not recommended if you are unable to use the infusion system on your own or with help from a caregiver. You will receive training before you start, and you must be comfortable managing the pump every day. Your health care provider can guide you through the benefits, risks, and practical steps involved in infusion treatment to help decide if Vyalev is right for you.
How Was Vyalev Studied for Parkinson’s Disease?
Before we get into the details of how Vyalev was studied for Parkinson’s disease (PD), we’ll review some of the terms used in the research:
- ON time is when symptoms of PD (such as tremor or stiffness) are well controlled by your medicine. During ON time, you have an easier time moving around.
- OFF time is when your PD symptoms are poorly managed. OFF times may happen as your PD medicine wears off or can be unpredictable.
- Motor fluctuations refer to when you alternate between ON and OFF time throughout the day. These shifts can be sudden.
- Dyskinesia refers to extra movements that you cannot control, such as fidgeting or head bobbing. Dyskinesia is a common side effect of levodopa. It may happen during ON time, even when your PD symptoms are well controlled, and can be either:
- Non-troublesome — mild and does not interfere with daily activities, or
- Troublesome — painful, disabling, or may increase your risk of falling and injuries
Ideally, effective PD treatment helps you have more ON time, less OFF time, and less troublesome dyskinesia. Now, we’ll look at how the effectiveness of Vyalev was studied.
The effect of Vyalev for PD was studied in a 12-week clinical trial. To join the study, adults needed to have PD with uncontrolled motor fluctuations despite taking at least 400 milligrams of levodopa per day. They also needed to average at least 2.5 hours per day in OFF time over three days in a row.
People could not join the study if they had unstable medical problems, allergies to ingredients in study medicines, or received certain PD treatments in the past (deep brain stimulation, carbidopa/levodopa intestinal gel, or any other continuous infusion for PD).
Before the study treatment began, researchers collected basic information about the 141 people in the study:
- The average age was 66 years, with 70% men and 30% women.
- On average, people had been living with PD for nearly nine years.
- Most (93%) people were White, 3% were Black or African American, 2% were Asian, 1% were American Indian or Alaska Native, and 1% were Native Hawaiian or Pacific Islander.
- Most people (70%) were taking at least one other type of PD medicine in addition to levodopa. The average daily dosage of levodopa was 1,000 milligrams.
- The average person’s day included around nine hours of good ON time without troublesome dyskinesia, six hours OFF time, and under one hour ON time with troublesome dyskinesia.
All people in the study attended a training session to learn how to use the infusion system. People were randomly assigned to one of two groups. One group received Vyalev as a continuous subcutaneous infusion along with placebo capsules. The other group received a placebo infusion and took immediate-release (IR) carbidopa/levodopa encapsulated tablets. The placebos were designed to look real but did not contain any medicine. Neither the participants nor the researchers knew which treatment anyone was getting.
For the next 12 weeks, participants had weekly checkup visits. They also used diaries to keep track of ON/OFF times and were asked to record their symptoms every 30 minutes while awake.
What Are the Main Benefits of Vyalev Based on Studies?
The main goal of the study was to measure the change in daily ON time without troublesome dyskinesia over 12 weeks. The researchers also measured the change in daily OFF time over the same period, among other changes.
Compared to people taking immediate-release carbidopa/levodopa,people treated with Vyalev gained nearly two more hours of good ON time per day and had reduced OFF time by almost two hours.*
Oral carbidopa/levodopa | Vyalev (continuous subcutaneousinfusion) | |
| ON time without troublesome dyskinesia (hours) | ||
| Starting average | 9.49 | 9.20 |
Average change from start to week 12 (raw data) | 0.85 | 3.36 |
| Change* | 0.97 | 2.72 |
| Difference* | 1.75 | |
| OFF time (hours) | ||
| Starting average | 5.91 | 6.34 |
Average change from start to week 12 (raw data) | -0.93 | -3.41 |
| Change* | -0.96 | -2.75 |
| Difference* | -1.79 | |
*These data are based on calculations that adjust for differences between groups, known as least squares (LS) means. It is another way to compare results and may give a more accurate comparison than raw data.
Overall, the study results show that Vyalev was more effective than oral carbidopa/levodopa at improving motor fluctuations in adults with advanced Parkinson’s disease. Vyalev may help increase good ON time and reduce OFF time in some people. Your results may differ from what was seen in clinical studies.
How Do I Use Vyalev?
Vyalev is given as a continuous infusion under the skin through a small pump that you wear all day and night. A health care provider will calculate your dose, program the pump, and train you (and/or a caregiver) on how to use it properly.
You will receive Vyalev and pump instructions, with step-by-step details and pictures. A video and a how-to-use guide are also available on the product website. The steps below are not complete instructions, but they provide a basic overview.
- Prepare a sterile syringe by transferring the full contents of a Vyalev vial.
- Connect the infusion set tubing to the filled syringe.
- Place the filled syringe in the pump and prime the pump as instructed.
- Choose an infusion site on your stomach (abdomen) and insert the small cannula (plastic tube) under your skin.
- Connect the infusion set tubing to the cannula.
- Start the pump so it delivers your medicine at the rate programmed by your health care provider.
A new syringe needs to be prepared every 24 hours because any unused Vyalev in the syringe must be thrown away after that time. The infusion set (the tubing and cannula) can stay in place for up to three days before it needs to be replaced and moved to a new site.
If you have questions or trouble using Vyalev, you can reach out to your health care team. Support is also available from the drugmaker by calling 866-489-2538.
Infusion site reactions (such as discomfort or swelling) and infections are common while using Vyalev. It is very important to follow every step of the instructions included with your Vyalev prescription and pump. Below are some general reminders to help reduce the chance of infusion site reactions or infections.
- Wash your hands with soap and water before handling supplies.
- Use a clean work surface.
- Do not reuse vials, syringes, vial adapters, or any other single-use supplies.
- Always wipe vial tops with an alcohol swab before attaching the adapter.
- Do not let the tip of the syringe or adapter touch any unclean surfaces. If it happens, throw it away and use a new one.
- Choose an infusion site on your stomach (abdomen) that is not tender, bruised, irritated, or hardened. It should be at least 2 inches away from your belly button. Avoid areas where clothing might cause irritation (such as the beltline) or where the body bends or the skin folds (such as while sitting).
- Clean the site with an alcohol swab, and let it dry for at least a minute.
- Rotate your infusion site at least every three days. Each new spot should be at least 1 inch away from the last site, and you should try not to reuse the same site for at least 12 days.
If you have signs of an infection, such as fever, skin redness, increased swelling, warmth, pain, oozing, or discoloration of the area, call your health care provider for instructions. They may advise you to change to a new site or remove the cannula and take a backup oral medicine until you can restart Vyalev.
What Happens if My Vyalev Infusion Is Stopped for Too Long?
If your Vyalev infusion is stopped for less than one hour (for example, while you shower), you can usually restart the pump without changing the tubing or moving to a new infusion site. You will stop the pump, disconnect the tubing, and then reconnect it when you are ready. The syringe can stay attached to the pump during this time.
If the interruption lasts longer than one hour, you will need to use a new infusion set and move to a different infusion site before restarting the pump.
If your Vyalev infusion is stopped for more than three hours, you may need a loading dose (a one-time large dose) to help manage symptoms before you restart the infusion. A loading dose may be given using Vyalev, but only if your health care provider has told you to do so and they enabled that feature when they programmed your pump. Another option in this situation is to take oral medicine as directed by your health care provider. For this reason, you should always have some oral carbidopa/levodopa medicine as backup in case your infusion is interrupted. Contact your health care provider if you are not sure how to handle any interruptions with your infusion.
Is There Any Cost Assistance Available for Vyalev?
A cost assistance program is available through the company that makes Vyalev. It may reduce the amount you pay. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured.
Visit this website from the drugmaker for more information about Vyalev costs and copay savings. You can also call 800-222-6885 to connect with a representative for financial support information and other resources.
