foscarbidopa 12 mg-foslevodopa 240 mg/mL contin. subcut infusion soln

Generic name:
Foscarbidopa/foslevodopa - injection

Brand name(s)
Vyalev

This combination medication is used to treat symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving). It is used when other treatments for Parkinson's disease are not working as well. Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Foslevodopa changes into dopamine in the brain, helping to control movement. Foscarbidopa prevents the breakdown of foslevodopa in the bloodstream so more foslevodopa can enter the brain. Foscarbidopa can also reduce some of foslevodopa's side effects such as nausea and vomiting.

Read the Medication Guide and, if available, the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using foscarbidopa/foslevodopa and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

This medication is usually given as a continuous infusion under the skin using an infusion pump as directed by your doctor. The dosage is based on your medical condition and response to treatment.

Take the medication out of the refrigerator about 30 minutes before use to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave, place it in hot water, or leave it in direct sunlight). Do not shake the medication. Before using, check this product for cloudiness or particles. If either is present, do not use the liquid. The color of the liquid may change but this does not make the medication less effective. Learn how to store and discard medical supplies safely.

Do not stop using this medication without consulting your doctor. Some conditions may become worse when this medication is suddenly stopped. Also, if you suddenly stop using this medication, you may have withdrawal symptoms (such as anxiety, depression, confusion, fever, muscle stiffness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Do not swim, bathe, or shower with the infusion pump. If you plan to be disconnected from the pump for a short period of time (less than 1 hour, for example, to shower), restart your infusion pump at the usual dose as soon as possible. If you plan to be disconnected from the pump for longer than 1 hour, ask your doctor what you should do.

Tell your doctor if your condition does not get better or if it gets worse.

Dizziness, lightheadedness, nausea, vomiting, trouble sleeping, unusual dreams, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medication may cause urine, sweat, or saliva to turn red, brown, or black. This effect is harmless, but your clothes may become stained.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people using this medication have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with this medication even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or do other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.

Tell your doctor right away if you have any serious side effects, including:

• new/worsening movements you can't control/spasms
• greatly increased eye blinking/twitching
• vision changes (such as blurred/double/decreased vision)
• eye pain
• mental/mood changes (such as confusion, agitation, hallucinations)
• easy bruising/bleeding
• unusual tiredness
• tingling/numbness/weakness of the hands/feet
• unusual strong urges (such as increased gambling, increased sexual urges)
• signs of infection (such as fever, chills)
• redness/swelling/pain/oozing around the infusion site

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Get medical help right away if you have any very serious side effects, including:

• chest pain
• fainting

Abruptly stopping or reducing the dose of this medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms:

• fever
• unusual muscle stiffness
• severe confusion
• sweating
• fast/irregular heartbeat

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to foscarbidopa or foslevodopa; or to carbidopa or levodopa; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• glaucoma
• breathing problems (such as asthma)
• heart disease (such as irregular heartbeat, heart attack)
• kidney disease
• stomach/intestinal ulcers
• mental/mood disorders (such as depression, schizophrenia)
• blood disorders
• seizures
• sleep disorder
• high blood pressure
• numbness/tingling of the hands/feet

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section.

This medication contains sodium. Ask your doctor or pharmacist for more information if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake (such as heart failure).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Foslevodopa passes into breast milk. It is unknown if foscarbidopa passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. However, certain MAO inhibitors (rasagiline, safinamide, selegiline) may be used with careful monitoring by your doctor. Ask your doctor when to start or stop taking this medication.

This medication may interfere with certain lab tests (such as urine catecholamine/glucose/ketone tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, irregular heartbeat, mental/mood changes (such as agitation).

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, heart/kidney/liver function, blood pressure) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

This drug is to be given continuously as an infusion. If your infusion is interrupted for more than 1 hour, contact your doctor or pharmacist right away.

Store in the refrigerator away from light. Do not freeze. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, do not put it back in the refrigerator and discard after 28 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.