Foscarbidopa; Foslevodopa Injection

What is this medication?

FOSCARBIDOPA; FOSLEVODOPA (fos kar bi DOE pa; fos lee voe DOE pa) treats the symptoms of Parkinson disease. It works by increasing the amount of dopamine in your brain, a substance which helps manage body movements and coordination. This reduces the symptoms of Parkinson, such as body stiffness and tremors.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Vyalev

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Feel very sleepy during the day, fall asleep suddenly during the day
• Glaucoma
• Have had a heart attack
• Have trouble controlling your muscles
• Heart disease
• High blood pressure
• Irregular heartbeat or rhythm
• Mental health conditions
• Sleep apnea
• Taken an MAOI, such as Marplan, Nardil, or Parnate in the last 14 days
• Urges to engage in impulsive behaviors in ways that are unusual for you
• An unusual or allergic reaction to foscarbidopa, foslevodopa, carbidopa, levodopa, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is infused under the skin. You will be taught how to prepare and give it. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Talk to your care team about what to do if you are not able to use this infusion. Keep a backup supply of oral levodopa; carbidopa with you at all times.

If the infusion has been stopped for more than 1 hour, change the infusion set and rotate the infusion site.

If the infusion has been stopped for more than 3 hours, you may need to take a loading dose of this medication or oral levodopa; carbidopa to help manage your symptoms.

What may interact with this medication?

Do not take this medication with any of the following:

• MAOIs, such as Marplan, Nardil, and Parnate

This medication may also interact with the following:

• Alcohol
• Benzodiazepines, such as alprazolam, diazepam, lorazepam
• Certain antihistamines
• Certain medications for depression, such as amitriptyline or trazodone
• Certain medications for mental health conditions, such as haloperidol or risperidone
• Certain medications for seizures, such as phenobarbital or primidone
• Droperidol
• Isoniazid
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that help you fall asleep
• Medications that relax muscles
• Metoclopramide
• Opioids for pain or cough
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Rasagiline
• Selegiline
• Tetrabenazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

When taking this medication, you may fall asleep without notice. You may be doing activities, such as driving a car, talking, or eating. You may not feel drowsy before it happens. Contact your care team right away if this happens to you.

There have been reports of increased sexual urges or other strong urges, such as gambling while taking this medication. If you experience any of these while taking this medication, you should report this to your care team as soon as possible.

A severe reaction similar to neuroleptic malignant syndrome (NMS) may occur if you reduce the dose of or stop taking this medication too quickly. Symptoms of NMS include high fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion. Contact your care team right away if you think you have NMS.

What side effects may I notice from receiving this medication?

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Refrigerator (preferred): Store in the refrigerator. Do not freeze. Keep this medication in the original carton until you are ready to take it. Remove the vial from the carton 30 minutes before it is time to take it. Get rid of any unused medication after the expiration date.

Room temperature: This medication may be stored at room temperature up to 30 degrees C (86 degrees F) for up to 28 days. Keep it in the original carton until you are ready to take it. Do not return it to the refrigerator. Get rid of any used medication after 28 days.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.