How to get Produodopa: A Guide for Patients and Caregivers

October 11, 2025 •

3 min read

According to the Parkinson's Foundation, the foslevodopa-foscarbidopa formulation (Produodopa/Vyalev) is a significant advancement for patients with advanced Parkinson's disease who experience severe motor fluctuations. To understand how to get Produodopa, it's essential to recognize that this is not a standard prescription but a specialized therapy requiring coordination with a movement disorder specialist and a specialty pharmacy.

Quick Summary

Obtaining Produodopa (or Vyalev in the US) requires a formal diagnosis of advanced Parkinson's disease with severe motor fluctuations from a specialist. The process includes specialist evaluation, titration to determine the correct dose, and training to use the pump. The medication is dispensed via specialty pharmacies, with availability varying by country.

Key Points

Specialist Referral Required: Produodopa is a specialized therapy for advanced Parkinson's disease and must be prescribed by a movement disorder specialist.
Not an Over-the-Counter Medication: The medication is not available without a prescription and is dispensed through specialty pharmacies.
Continuous Pump Infusion: The therapy is administered via a small, wearable pump that delivers a continuous subcutaneous infusion of medication.
Regional Brand Names: Known as Vyalev™ in the U.S. and Canada and Produodopa® in the European Union and UK.
Eligibility and Training: Candidates must have advanced Parkinson's with severe motor fluctuations and undergo extensive training to use the pump.
Availability Varies by Country: While approved in multiple regions, availability may depend on local healthcare systems, with the US brand Vyalev recently approved.
Requires Ongoing Management: Patients and caregivers need to manage the pump, infusion site, and follow-up with their healthcare team.

Understanding Produodopa (Vyalev) Therapy

Produodopa, known as Vyalev™ in the U.S. and Canada, is a treatment for advanced Parkinson's disease that uses a continuous subcutaneous infusion pump to deliver foslevodopa and foscarbidopa. This therapy aims to provide a steady supply of medication to manage severe motor fluctuations and dyskinesia in patients not adequately controlled by other treatments. The consistent delivery helps to smooth out the "on-off" periods experienced by many patients with advanced disease.

Is This Treatment Right for You?

A healthcare provider must determine a patient's eligibility for Produodopa (Vyalev). It is licensed for individuals with advanced Parkinson's whose motor symptoms are not well-managed by existing medications. A movement disorder specialist will perform a comprehensive evaluation to confirm if this therapy is suitable.

Key Steps to Get Produodopa (Vyalev)

The process for obtaining Produodopa therapy is a multi-step journey involving close collaboration with a healthcare team. The typical steps include:

Specialist Consultation: Begin by consulting a neurologist specializing in movement disorders to assess your medical history and determine if you are a candidate.
Assessment and Titration: The specialist will calculate the appropriate dosage based on your current levodopa intake. The dose will be adjusted to optimize your "on" time and minimize "off" periods, potentially starting with a trial.
Prescription: Once the therapy is deemed suitable and the dose is set, the specialist will provide a prescription for the medication and pump.
Insurance and Coverage: Due to the high cost, insurance typically requires prior authorization. Manufacturer (AbbVie) patient support programs and expected Medicare coverage in the U.S. (late 2025) may help with costs.
Specialty Pharmacy Dispensing: The medication is obtained through a specialty pharmacy equipped to handle and dispense this complex therapy. The pharmacy delivers the medication directly to the patient.
Patient and Caregiver Training: Comprehensive training is crucial for using the Vyafuser™ pump, preparing the medication, and managing the subcutaneous infusion site to prevent complications like infection.
Ongoing Monitoring: Regular follow-up appointments with the specialist are necessary to monitor progress, manage side effects, and make dosage adjustments.

Comparison: Oral Levodopa vs. Produodopa (Vyalev) Infusion


Feature	Oral Levodopa	Produodopa (Vyalev) Infusion
Administration Method	Taken orally multiple times a day.	Continuous, 24-hour subcutaneous infusion via a portable pump.
Symptom Control	Can lead to motor fluctuations and "on-off" periods as the disease advances.	Provides more consistent symptom control.
Suitability	Standard treatment for earlier stages of Parkinson's.	For patients with advanced Parkinson's not well-controlled by oral medication.
Effect on "Off" Time	Diminished effectiveness can increase "off" time.	Clinical trials showed a significant reduction in "off" time.
Logistics	Managing multiple daily doses.	Requires training for pump use and site management; involves a wearable device.
Common Side Effects	Nausea, low blood pressure, dyskinesia.	Infusion site reactions, dyskinesia, device complications.

Country-Specific Brand Names and Availability

Brand names and availability differ by region.

United States: Marketed as VYALEV™, approved October 2024.
European Union and UK: Known as PRODUODOPA®, launched January 2024.
Canada and Japan: Also available as VYALEV™.
Access in all regions requires a specialist's prescription and may involve a specialty pharmacy.

The Role of the Vyafuser™ Pump

The Vyafuser™ pump delivers the Produodopa/Vyalev solution subcutaneously. Proper training for patients and caregivers is essential for using the pump, preparing medication, and managing the infusion site. Regular rotation of the infusion site and proper hygiene are critical to avoid complications.

Conclusion

Obtaining Produodopa (Vyalev) is a structured process beginning with a specialist's evaluation for advanced Parkinson's disease and requiring training for continuous subcutaneous infusion. It is a significant option for patients whose motor symptoms are not adequately controlled by oral medications, offering more consistent symptom management. Close collaboration with the healthcare team is vital for navigating the prescription, insurance, and specialty pharmacy processes to effectively manage the therapy.

Frequently Asked Questions

Produodopa is delivered continuously under the skin via a pump, while oral levodopa is taken as tablets multiple times per day. The continuous infusion helps reduce the 'on-off' motor fluctuations common with advanced Parkinson's disease.

Yes, the same formulation (foslevodopa-foscarbidopa) is available in the United States under the brand name Vyalev™. It was approved by the FDA in October 2024.

You must first speak with a neurologist specializing in movement disorders. They will assess if you are a suitable candidate based on your medical history and the severity of your symptoms.

Insurance coverage varies, and prior authorization is often required due to the high cost. The manufacturer, AbbVie, may also offer a patient assistance program, and Medicare coverage is expected in the U.S. in the second half of 2025.

Yes, Produodopa (Vyalev) is dispensed exclusively through specialty pharmacies. These pharmacies handle the delivery of complex, high-cost medications and can provide patient support.

You and/or your caregiver will receive comprehensive training from your healthcare team on how to use the Vyafuser™ pump, prepare the medication, and properly insert and care for the subcutaneous infusion site.

Common side effects include reactions at the infusion site (e.g., redness, swelling), dyskinesia (involuntary movements), and potential device-related issues. Your healthcare provider will discuss all potential side effects with you.