This is a combination product containing 2 medications: foslevodopa and foscarbidopa. It is used to treat severe movement problems caused by Parkinson's disease, that are not controlled by other combinations of medications.

In the body, foslevodopa is changed into the active medication levodopa and foscarbidopa is changed into the active medication carbidopa.

Levodopa helps to control the symptoms of Parkinson's disease by correcting the chemical imbalance in the brain that causes symptoms. Levodopa can be used alone, but adding carbidopa lowers the amount of levodopa that is required and may reduce some of the side effects that are associated with levodopa, such as nausea and vomiting.

Although levodopa helps relieve symptoms of Parkinson's disease, it does not slow down the progression of the disease.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

This medication is given as a continuous subcutaneous (under the skin) infusion, using a special pump. This pump is programmed to give a continuous, specific dose of medication through infusion sites in the abdomen. By keeping the amount of medication in the body at a constant level, the “on-off” effect may be reduced.

The starting dose is determined by your doctor, based on the amount of levodopa-containing medication that you are using.

Foscarbidopa - foslevodopa is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and setting up the infusion for your first infusion (or first few infusions). Do not attempt to set up the infusion of this medication on your own until you completely understand how to inject a dose.

The infusion may be given through a particular site in the abdomen for up to 3 days. After no longer than every 3 days, the infusion site should be moved at least 2.5 cm (1 inch) and a new infusion started. Avoid reusing an infusion site for at least 12 days. This will help to minimize changes to the skin and infection.

To prepare this medication for infusion, the medication in the vial needs to be drawn up into a syringe. The vials are intended for single use only. Any medication remaining in the vial must be safely discarded. Do not save it for another dose. Inspect the vial and syringe for any discolouration or particles in the solution. Use the medication only if the solution is clear and particle-free.

Any medication remaining in the syringe after it has been used for 24 hours should also be safely discarded and a new syringe prepared.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. Avoid stopping the infusion for more than one hour as this can allow symptoms of movement difficulties to occur. If the infusion has been stopped for more than an hour, a new infusion set and different infusion site should be used.

Store this medication in the refrigerator, protect it from light and moisture, and keep it out of the reach of children. After the medication is removed from the refrigerator, it should sit at room temperature away from direct sunlight for 30 minutes. The vial may be stored at room temperature for a maximum of 28 days. If it has not been used within 28 days, safely discard the medication. Do not return it to the refrigerator once it has been stored at room temperature for any length of time.

Each mL of sterile solution for subcutaneous infusion contains 240 mg of foslevodopa and 12 mg of foscarbidopa. Nonmedicinal ingredients: hydrochloric acid, sodium hydroxide, and sterile water for injection.

Do not take this medication if you:

• are allergic to foslevodopa, foscarbidopa, levodopa, carbidopa, or any ingredients of the medication
• cannot take sympathomimetic amines (e.g., epinephrine, norepinephrine)
• have active heart disease, circulatory disease affecting the brain, blood related diseases, endocrine disease, liver disease, lung disease, or kidney disease
• have narrow-angle glaucoma
• have suspicious undiagnosed skin lesions or a history of melanoma
• have used an MAO inhibitor (e.g., phenelzine, tranylcypromine) within the past 2 weeks (MAO inhibitors should not be used within 2 weeks after taking foscarbidopa - foslevodopa)
• have other medical conditions where this medication may not be appropriate or cause worsening of the condition (e.g., pheochromocytoma, overactive thyroid, Cushing's syndrome)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• diarrhea
• dizziness
• dry mouth
• falls
• nausea
• spinning sensation

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal thinking – holding false beliefs that cannot be changed by fact
• agitation
• anxiety
• blood pressure changes (increase and decrease)
• blurred or double vision
• compulsive behaviour (e.g., gambling, spending, increased sexual urges)
• confusion
• decreased sensation
• dizziness or lightheadedness when rising from a lying or sitting position
• fast, irregular, or pounding heartbeat
• hallucinations (e.g., seeing or hearing things that are not there)
• hand tremor (increased)
• mood or mental changes
• on-off phenomenon (e.g., changes to movement control)
• pain in the hands, ankles, feet, legs, or arms
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of infusion site reactions (e.g., redness, warmth, swelling, pain, itchiness, infection, bruising)
• signs of nerve damage (e.g., decreased ability to sense vibration, sharp shooting pain, numbness, tightness, tingling, burning, or sensory loss)
• skin changes (e.g., sores, warts, or bumps that do not heal)
• sudden onset of sleep
• swelling of the feet, ankles, legs, hands, and arms
• symptoms of "freezing phenomenon" – inability to move feet, or feeling that feet are frozen or stuck to the ground
• symptoms of glaucoma (e.g., eye pain, increased eye pressure, eye redness, headache, blurred vision, nausea, vomiting)
• symptoms of osteoarthritis (e.g., joint pain and stiffness, balance problems, muscle weakness, swelling around a joint, decreased range of motion, clicking or popping when a joint is bent)
• unusual and uncontrolled movements of the body, including face

Stop taking the medication and seek immediate medical attention if any of the following occur:

• difficulty breathing
• signs of neuroleptic malignant syndrome (e.g., confusion, reduced consciousness, high fever, or muscle stiffness)
• thoughts of self-harm or suicide

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Behaviour and mood changes: This medication has been known to cause mood swings, changes in behaviour, and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may notice compulsive behaviour, such as gambling, increased sexual activity, or inappropriate spending. Foscarbidopa - foslevodopa has been associated with hallucinations and confusion. If you experience these side effects, contact your doctor.

Bleeding: Levodopa - carbidopa may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Blood pressure and heart: Some people using foscarbidopa - foslevodopa experience sudden blood pressure drops when getting up from a sitting or lying position. These blood pressure drops could lead to dizziness, lightheadedness, and falls. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor.

Blood pressure changes can cause symptoms of heart conditions worse. If you have heart disease (e.g., history of heart attack, arrhythmia), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Depression: This medication has been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Drowsiness/dizziness: Foscarbidopa - foslevodopa may cause drowsiness, dizziness, or affect mental abilities necessary to drive or operate machinery. Some people taking this medication have reported suddenly falling asleep while driving, or doing other routine daily activities. Avoid activities that that require alertness until you know how this medication affects you.

Glaucoma: This medication may cause symptoms of glaucoma to get worse by increasing the pressure inside the eye. If you have chronic wide-angle glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: Foscarbidopa - foslevodopa has been reported to reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people who have contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Infusion site reactions: Swelling, redness, pain, and changes in the skin are commonly reported by people using this medication. There is a risk of developing an infection at the injection site, which can become serious if not treated as soon as possible. When you are preparing the pump and injection site for a new infusion, make sure to use the techniques your health care provider has shown you to keep the skin from becoming infected. Report any discomfort or change in the appearance of the injection site to your doctor as soon as possible.

Kidney problems: Foscarbidopa – foslevodopa contains phosphorus, an element that is removed from the body by the kidneys. If you have decreased kidney function, in particular, end-stage renal disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Melanoma: People with Parkinson's disease may be at increased risk of developing melanoma (a type of skin cancer). It is not known if this increased risk is due to Parkinson's disease or to the medications used to treat Parkinson's disease. Your doctor will monitor you for skin cancer while you are taking this medication. Talk to your doctor if you have any concerns.

Neuroleptic malignant syndrome (NMS): Very rarely, foscarbidopa - foslevodopa has been reported to cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). This may happen if this medication is stopped suddenly. If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Seizures: If you have seizures or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Sudden onset of sleep: There are reports of people who take levodopa - carbidopa combinations falling asleep with no warning or drowsiness. If you have a sleep disorder, discuss this with your doctor. If you experience drowsiness while taking this medication, avoid driving or using machinery.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Levodopa passes into breast milk. It is not known whether carbidopa passes into breast milk. If you are breast-feeding and taking foscarbidopa - foslevodopa, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children and adolescents.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.