Fixed-dose combination
Foscarbidopa and Foslevodopa is a fixed-dose combination medicine indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). It is available as injection for subcutaneous use. MedsAcross supplies Foscarbidopa and Foslevodopa for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
VYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). VYALEV is a combination of foscarbidopa (an aromatic amino acid decarboxylation inhibitor) and foslevodopa (an aromatic amino acid) indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
Source: US FDA prescribing information
VYALEV is a prodrug combination of foscarbidopa (carbidopa-4´-monophosphate) and foslevodopa (levodopa-4´-monophosphate). Foscarbidopa and foslevodopa are converted in vivo to carbidopa and levodopa. Carbidopa When levodopa is administered orally, it is rapidly decarboxylated to dopamine in extracerebral tissues so that only a small portion of a given dose is transported unchanged to the central nervous system. Carbidopa inhibits the decarboxylation of peripheral levodopa, making more levodopa available for delivery to the brain. Levodopa Levodopa is the metabolic precursor of dopamine, does cross the blood-brain barrier, and presumably is converted to dopamine in the brain. This is thought to be the mechanism whereby levodopa treats symptoms of Parkinson's disease.
Source: US FDA prescribing information
Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. For subcutaneous administration only, preferably in the abdomen, via the VYAFUSER pump. See the Full Prescribing Information for calculation of the base continuous dosage, hourly infusion rate, optional loading dose, and extra dose. The maximum recommended daily dosage of VYALEV is 3,525 mg of foslevodopa (approximately 2,500 mg levodopa).
Source: US FDA prescribing information
VYALEV is contraindicated in patients who are currently taking a non-selective monoamine oxidase (MAO) inhibitor or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently. VYALEV is contraindicated in patients who are currently taking a nonselective monoamine oxidase (MAO) inhibitor or have recently (within 2 weeks) taken a nonselective MAO inhibitor.
Source: US FDA prescribing information
May cause falling asleep during activities of daily living. Hallucinations/Psychosis: May respond to dose reduction of VYALEV. Impulse Control Behaviors: Consider dose reductions or stopping VYALEV. Infusion Site Reactions and Infections: Monitor for infusion site infections: Following aseptic techniques while using this medication and frequent rotation of the infusion site is recommended to reduce the risk. Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion. May cause or exacerbate dyskinesia: Consider dose reduction of VYALEV.
Source: US FDA prescribing information
The following serious adverse reactions are discussed below and elsewhere in labeling: Falling Asleep During Activities of Daily Living and Somnolence Hallucinations/Psychosis Impulse Control/Compulsive Behaviors Infusion Site Reactions and Infections Withdrawal-Emergent Hyperpyrexia and Confusion Dyskinesia Vitamin B6 Deficiency and Seizures Cardiovascular Ischemic Events Glaucoma Most common adverse reactions for VYALEV (VYALEV incidence at least 10% and greater than oral carbidopa-levodopa incidence) were infusion/catheter site reactions, infusion/catheter site infections, hallucinations, and dyskinesia.
Source: US FDA prescribing information
Selective MAO-B inhibitors: May cause orthostatic hypotension. Antihypertensive drugs: May cause symptomatic postural hypotension. Dosage adjustment of the antihypertensive drug may be needed. Dopamine D2 receptor antagonists and isoniazid may reduce the effectiveness of VYALEV.
Source: US FDA prescribing information
Store VYALEV refrigerated at 2°C to 8°C (36°F to 46°F). VYALEV may be stored at room temperature up to a maximum of 30°C (86°F) for a single period of up to 28 days. Once VYALEV has been stored at room temperature, do not return the product to the refrigerator. If stored at room temperature, discard VYALEV if not used within 28 days. Do not freeze. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Foscarbidopa and Foslevodopa, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Vyalev 120 mg/2400 mg per 10 mL injectionSubcutaneous Cold chain | Foscarbidopa and Foslevodopa | AbbVie | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 16 October 2024 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Foscarbidopa and Foslevodopa and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Foscarbidopa and Foslevodopa, including Vyalev.
Yes. The US FDA first approved Foscarbidopa and Foslevodopa on 16 October 2024, according to Drugs@FDA.
At least one listed presentation of Foscarbidopa and Foslevodopa must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.