Vyalev is a prescription medicine used for adults with advanced Parkinson’s disease who have motor fluctuations. Motor fluctuations are changes between periods when symptoms are better controlled and periods when symptoms return or worsen.
Vyalev contains foslevodopa and foscarbidopa. These are prodrugs, which means they are changed in the body into levodopa and carbidopa, two medicines commonly used to manage Parkinson’s symptoms.
This medicine is given as a continuous infusion under the skin. It is designed to provide steady levodopa-based treatment, which may help reduce “off” time and increase “on” time without troublesome dyskinesia in some people with advanced Parkinson’s disease.
Indications for use
Vyalev is FDA-approved for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
It may be considered when Parkinson’s symptoms are not well controlled throughout the day with oral medicines. It is used to help provide a more continuous supply of levodopa-based treatment, especially in people who have changes between “on” and “off” periods.
Clinical studies have shown that foslevodopa/foscarbidopa can improve “on” time without troublesome dyskinesia and reduce “off” time compared with oral levodopa/carbidopa in people with advanced Parkinson’s disease and motor fluctuations.
How to take it
Vyalev is not taken by mouth. It is given as a continuous subcutaneous infusion, which means the medicine is delivered under the skin through an infusion system.
The dose is individualized by a healthcare provider. Dose planning may consider the person’s current levodopa needs, symptom control, side effects, and whether the infusion is used during waking hours or over 24 hours.
The maximum recommended daily dose described in dosing resources is 3525 mg of foslevodopa, which is about equal to 2500 mg of levodopa.
Infusion schedule
Vyalev may be given as a continuous infusion during waking hours or as a 24-hour infusion, depending on the treatment plan. A healthcare provider adjusts the infusion settings to help control symptoms while reducing side effects.
How it is administered
Vyalev is delivered with a pump and infusion supplies. The medicine is placed under the skin, and the infusion site needs to be managed carefully to lower the risk of skin reactions.
Infusion sites may need to be rotated as instructed by a healthcare provider. Pump handling, infusion setup, site care, and troubleshooting should be reviewed with a trained healthcare professional before treatment begins.
Possible side effects
Vyalev can cause side effects, and some may be related to the medicine itself while others may be related to the infusion site or pump system.
Possible side effects include:
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Infusion-site reactions, such as redness, pain, swelling, nodules, or irritation where the medicine is delivered
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Dyskinesia, which means involuntary movements
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Falls
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Hallucinations
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Other neuropsychiatric symptoms, such as confusion or changes in thinking or behavior
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Sleepiness or other levodopa-related effects
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Nausea or other digestive symptoms
Long-term studies and extension data have reported a generally consistent safety profile over time, with infusion-site reactions, falls, and hallucinations among the safety outcomes monitored.
Contraindications for use
Vyalev should not be used in people who have a contraindication listed in the official prescribing information. This may include people who should not use foslevodopa, foscarbidopa, levodopa/carbidopa, or any component of the medicine.
Because Vyalev is related to levodopa/carbidopa treatment, a healthcare provider should review current medicines, medical history, psychiatric symptoms, fall risk, and skin or infusion-site concerns before starting treatment.
People using Vyalev also need medical guidance if side effects develop, if Parkinson’s symptoms suddenly worsen, or if the pump or infusion site is not working properly.