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Uses

What is Vyalev used for?

Vyalev (foscarbidopa/foslevodopa) is commonly used to treat certain people with Parkinson’s disease, a condition that affects the part of your brain that controls your movements. 

Vyalev may also be used for other conditions as determined by your healthcare provider.

How does Vyalev work (mechanism of action)?

In people with Parkinson's disease, the brain does not have enough of a chemical called dopamine, which helps control movement. This makes it hard for people to move their bodies the way they want to.

Vyalev contains two medicines, foscarbidopa and foslevodopa. When these medicines enter your body, they turn into carbidopa and levodopa. Carbidopa and levodopa are medicines that work together to help people with Parkinson's disease.

Levodopa is a medicine that turns into dopamine in the brain. When levodopa is used by itself, it gets broken down too quickly, before it can reach the brain. Carbidopa works to block the breakdown of levodopa so that more dopamine can get to the brain. This helps people with Parkinson's disease move more easily.

How is Vyalev supplied (dosage forms)?

Brands and other names

  • Vyalev

Dosage forms and strengths

  • 120 mg/2,400 mg per 10 mL (12 mg/240 mg per mL) for subcutaneous injection

How should I store Vyalev?

Vyalev should be refrigerated, between 36 F to 46 F (2 C to 8 C). It may be stored at room temperature up to 86 F (30 C) for up to 28 days. Once Vyalev is stored at room temperature, it should not be placed back in the refrigerator. If Vyalev is stored at room temperature and is not used within 28 days, it should be thrown away. Keep the vials in the original carton. Do not freeze or shake Vyalev.

Side Effects

What are the most common side effects of Vyalev?

The most common side effects of Vyalev are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Reaction or infection near the infusion site (see below)
  • Hallucinations (see below)
  • Uncontrollable, involuntary movements (see below)

There may be other side effects of Vyalev that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Vyalev?

While less common, the most serious side effects of Vyalev are described below, along with what to do if they happen.

Severe Allergic Reactions. Vyalev may cause allergic reactions, which can be serious. Stop using Vyalev and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Sleepiness. Vyalev can make you sleepy, sometimes very suddenly and without warning signs (also called a "sleep attack"). Do not drive or do other activities that require alertness or coordination until you know how Vyalev affects you. Tell your healthcare provider if you feel sleepy or drowsy while using Vyalev.

Hallucinations or Psychotic-like Behaviors. Vyalev may cause hallucinations or psychotic-like behaviors. Talk to your healthcare provider right away if you or someone you know notices that you have any of the following symptoms.

  • Hearing, seeing, smelling, tasting, or otherwise perceiving things that others do not
  • Delusional thoughts, such as false beliefs that you are being controlled
  • Disorganized thoughts, such as jumping between topics or having a hard time focusing
  • Sudden decline in self-care, such as personal hygiene or academic/work performance
  • Aggressive behavior

Unusual or Compulsive Behaviors. Vyalev can cause some people to have strong unusual and uncontrolled urges (compulsions), including gambling, sex, shopping, or eating. Talk to your healthcare provider right away if you or someone you know notices that you have new or worsening strong urges or behaviors.

Reaction or Infection Near the Infusion Site. Vyalev may cause reactions or an infection at or near the infusion site. If you notice any pain, itching, swelling, or redness of the skin, contact your healthcare provider immediately. They may direct you to change infusion sites.

Uncontrollable, Involuntary Movements (Dyskinesias). Vyalev may cause involuntary movement problems, including shakiness, stiffness, or jerkiness. Call your healthcare provider right away if you develop any unusual or uncontrolled movements or if they get worse.

Warnings & Precautions

Who should not use Vyalev?

Allergies to Ingredients. People who are allergic to any of the following should not use Vyalev.

  • Foscarbidopa
  • Foslevodopa
  • Vyalev
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Vyalev.

Drug Interactions. Vyalev should not be used while you are using or if you have recently used certain other medicines. Before using Vyalev, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about Vyalev before using it?

Do not use Vyalev unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Do not share Vyalev with other people, even if they have the same condition as you. It may harm them.

Keep Vyalev out of the reach of children.

This medicine is given using a pump device. Make sure that you or a caregiver understands how to properly prepare and use the device. If you have any questions, talk to your healthcare provider.

Rotate the site of infusion and use a new infusion set at least every three days. The new infusion site should be at least one inch away from a site used within the last 12 days. Avoid areas within two inches from your belly button (navel). Avoid areas that are red, bruised, tender, or hard to the touch.

Vyalev may be stopped briefly as needed, such as when you are taking a shower. See the Overdose/Missed Dose section for more information on what to do if the infusion is interrupted for more than one hour.

Do not stop using Vyalev without talking to your healthcare provider. Stopping too quickly may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms.

  • High fever
  • Muscle stiffness or rigidity, where it is hard to move
  • Changes in your breathing or heart rate
  • Increased sweating
  • Confusion

Vyalev may cause you to feel sleepy, especially if you already have conditions that can make you drowsy. Do not drive or do other activities that require alertness or coordination until you know how Vyalev affects you.

What should I tell my healthcare provider before using Vyalev?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Vyalev is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Mental health or behavior problems, including hallucinations or any psychotic disorder (such as schizophrenia or delusional disorder)
  • Sleep problems
  • Any other movement disorders
  • Eye problems, such as glaucoma
  • Heart problems, such as a prior heart attack, heart disease, or an abnormal heart rhythm
  • High blood pressure
  • Unusual urges, such as gambling, binge eating, compulsive shopping, or increased sex drive

Pregnancy. It is not known if or how Vyalev could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.

Breastfeeding. Foslevodopa, one of the medicines in Vyalev, turns into levodopa inside your body. Levodopa passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Vyalev while breastfeeding.

How can I get more information about Vyalev?

For more information about Vyalev, you can visit the manufacturer’s website at www.vyalev.com or call them at 866-489-2538.

Interactions

Does Vyalev interact with foods or drinks?

There are no known interactions between Vyalev and foods or drinks.

It is unknown if drinking alcohol will affect Vyalev. However, the risk of drowsiness, sleepiness, and/or dizziness may be increased if you drink alcohol while using Vyalev. 

Does Vyalev interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Vyalev.

  • A nonselective monoamine oxidase inhibitor (MAOI) within the past 2 weeks, such as phenelzine (Nardil), tranylcypromine (Parnate), or isocarboxazid (Marplan), which is a medicine usually used for depression
  • A selective monoamine oxidase B (MAO-B) inhibitor, such as rasagiline or selegiline, which is a medicine usually used for depression or Parkinson’s disease
  • A medicine for high blood pressure
  • An antipsychotic, such as haloperidol, chlorpromazine, thioridazine, fluphenazine, or risperidone, which is a medicine for certain mental health conditions
  • Metoclopramide (Reglan and others), which is a medicine for certain stomach problems
  • Papaverine, which is a medicine used for various blood flow problems, including chest pain
  • Isoniazid, which is a medicine used to treat an infection called tuberculosis
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, and medicines for anxiety
  • Any medicine that contains carbidopa or levodopa

This may not be a complete list of medicines that can interact with Vyalev. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Vyalev?

If you or someone else has used too much Vyalev, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Vyalev?

Vyalev is infused continuously under the skin. If the infusion is interrupted for more than one hour, change the tubing and cannula and use a different infusion site prior to restarting. If the infusion is interrupted for more than three hours, ask your healthcare provider what to do.

Your healthcare provider may prescribe backup medicine for you to take in case the infusion is interrupted or the pump device stops working. Keep the backup medicine with you at all times and take it as instructed by your healthcare provider when needed.