Foscarbidopa and Foslevodopa Injection

Foscarbidopa and foslevodopa is used to treat motor fluctuations (changes in motor symptoms due to fluctuations in dopamine) in patients with Parkinson's Disease(brain disorder that causes unintended or uncontrollable movements). Foscarbidopa and foslevodopa is in a class of medications called central nervous system agents. It works by being converted to dopamine in the brain. Carbidopa is in a class of medications called decarboxylase inhibitors. It works by preventing levodopa from being broken down before it reaches the brain. This allows for a lower dose of levodopa, which causes less nausea and vomiting.

Foscarbidopa and foslevodopa comes as a solution (liquid) to inject subcutaneously (under the skin) via an infusion pump (a device that gives medication in a controlled manner). The infusion pump will give a small amount of foscarbidopa and foslevodopa every hour for either 24 hours or just during the patient's waking hours. The patient will also have the option of administering an extra dose every hour. Your doctor or nurse will show you how to use the foscarbidopa and foslevodopa delivery system and how often you need to refill the infusion system. Make sure you let your doctor or nurse know if you don't understand. Foscarbidope and foslevodopa are only to be administered with the Vyafuser pump.^® You will be provided with instructions on how to use the pump.

Make sure you inspect each vial of foscarbidopa and foslevodopa before using. The solution should be colorless to a slight yellow to light brown color (possibly with red or purple tint) and should be free of any particles. If the vial is stored in the refrigerator, it should be removed from the refrigerator and kept at room temperate (away from direct sunlight) for 30 minutes before using.

Foscarbidopa and foslevodopa preferred infusion site is the abdomen, at least two inches from the belly button area. A new infusion site and infusion set should be used every 3 days. The new infusion site should be at least 1 inch from any other site used within the last 12 days. Avoid using sites that are tender, bruised, red or hard to the touch.

Foscarbidopa and foslevodopa controls symptoms of Parkinson's Disease but does not cure it. Do not stopusing foscarbidopa and foslevodopa without talking to your doctor. If you suddenly stop receiving foscarbidopa and foslevodopa, your motor symptoms may worse. Your doctor will likely provide you with a prescription of a carbidopa and levodopa oral tablet to use in case your foscarbidopa and foslevodopa infusion needs to be interrupted for any reason.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving foscarbidopa and foslevodopa,

• tell your doctor and pharmacist if you are allergic to foscarbidopa, foslevodopa, carbidopa, levodopa, any other medications, or any of the ingredients in foscarbidopa and foslevodopa. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking foscarbidopa and foslevodopa. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: phenelzine, tranylcypromine, isocarboxazid.
• tell your doctor if you have or have ever had psychiatric disorder such as depression, anxiety, schizophrenia, bipolar disorder; addiction disorder such as gambling addiction, alcohol abuse, drug use, compulsive eating; narcolepsy; glaucoma, heart disease; or high blood pressure.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking foscarbidopa and foslevodopa, call your doctor.
• you should know that foscarbidopa and foslevodopa may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking foscarbidopa and foslevodopa. Alcohol can make the side effects from foscarbidopa and foslevodopa worse.
• you should know that foscarbidopa and foslevodopa has caused hallucinations, psychosis and impulse control disorders. Call your doctor right away if you have any of the following symptoms: seeing things that are not there, hearing sounds or feeling sensations that are not real; unusual urges such as gambling, compulsive eating, compulsive shopping and increased sex drive.

Unless your doctor tells you otherwise, continue your normal diet.

If you have had an interruption in your infusion that has lasted greater than 1 hour, resume the infusion with a new infusion site and new infusion set. If it has been greater than 3 hours, then you should contact your provider to see if you should give yourself a loading dose.

Foscarbidopa and foslevodopa may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• swelling of the arms or legs
• difficulty falling or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• redness, pain, warmth, or swelling at the infusion site
• fever, confusion, severe muscle stiffness
• uncontrolled sudden movements
• chest pain or pressure in chest, fast or irregular heartbeat, increases in blood pressure
• eye pain or pressure in eyes, blurry vision, vision loss

Foscarbidopa and foslevodopa may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep the medication vials in the container they come in to keep them from breaking. Store in the refrigerator or at room temperature for up to 28 days (but out of sunlight). If stored at room temperature, do not return to the refrigerator. Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, stop the infusion right away and seek emergency medical treatment. If uncertain if overdose has occurred, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Vyaleva^®