Here are some important things to know about VYALEV, a treatment for motor fluctuations in adults with advanced Parkinson’s disease.
About VYALEV
What is VYALEV?
VYALEV is a prescription medication used to treat motor fluctuations in adults with advanced Parkinson's disease.
How does VYALEV work?
The VYALEV pump is programmed by your doctor to deliver a customized dose to meet your individual treatment needs. The portable pump provides continuous, 24-hour delivery of levodopa-based therapy. See how VYALEV works.
When will VYALEV be available?
VYALEV is FDA approved. Your doctor can help you with exact availability and timing based on your health coverage, or you can call us at 1-866-489-2538 to discuss.
Can I take other Parkinson’s medications with VYALEV?
VYALEV replaces all levodopa-containing medications and COMT inhibitors. You can take other Parkinson’s disease medications with VYALEV. Keep a supply of oral immediate-release carbidopa/levodopa tablets with you in case you are unable to use VYALEV infusion.
COMT=catechol-O-methyltransferase.
Can I wear the VYALEV pump while sleeping?
VYALEV is approved for continuous 24-hour use. When sleeping with the pump, it is suggested to position it so the tubing will not get pulled or kinked, and in a way that’s comfortable to suit your regular sleeping position. Explore the variety of carrying cases available to keep the pump close to your body.
If the cannula becomes loose or detached from the body, you will need to replace the entire infusion set, including the tubing and the cannula. Please see Pump Instructions for Use for further details. Keep a supply of oral immediate-release carbidopa/levodopa tablets with you in case you are unable to use VYALEV infusion.
The VYALEV pump
How do I use and wear my pump?
The VYALEV system delivers medication through a nonsurgical and wearable pump.
The VYALEV pump is available with a range of carrying cases, so you can wear it in a way that works for you. Depending on your preference, you can wear the pump under or over your clothing.
Once the pump is attached and turned on, it will begin continuously delivering VYALEV to your body.
What is the size of the pump?
Weight: 10.0 oz (285 gm)
Height: 6.7 in (17.02 cm)
Width: 3.0 in (7.62 cm)
Depth: 1.3 in (3.30 cm)
The pump is designed to be worn throughout the day and night.
Is the pump removable?
Yes, and the VYALEV pump should always be temporarily disconnected while you are engaging in any activity that could result in liquid getting onto or into the pump, such as bathing, showering, or swimming. See the Pump Instructions for Use for more details.
How to administer VYALEV
Can I administer VYALEV at home?
Yes. The VYALEV pump delivers levodopa-based treatment through a subcutaneous (under-the-skin) continuous infusion using a cannula that is attached to your skin by you or your care partner. You should rotate the infusion site every 3 days or more frequently as needed.
How do I learn to administer VYALEV?
A qualified healthcare provider will train you and make sure you are comfortable with the steps of the 5 Ps (Plan, Prepare, Prime, Place, and Pump) before you start VYALEV.
What are the steps to taking VYALEV?
The 5 Ps (Plan, Prepare, Prime, Place, and Pump) will help prepare you to administer VYALEV.
- Plan it out by cleaning your hands and workspace and gathering and checking your supplies.
- Prepare the syringe by adding the medication into it, then inserting it into the pump.
- Prime the tubing by filling it with medication.
- Place the cannula on clean skin and connect the tubing.
- Pump the medication by starting the pump.
You can see this in more detail by clicking here.
About VYALEV Complete
What is a Patient Support Program?
A Patient Support Program is typically offered by a medication’s manufacturer. It offers resources and dedicated team members to help you throughout your treatment. VYALEV’s Patient Support Program is called VYALEV Complete.
What is VYALEV Complete?
VYALEV Complete is a Patient Support Program that is available at no cost to you. It provides people on VYALEV and their care partners with one-on-one guidance every step of the way with a Nurse Ambassador.* Your Ambassador will help prepare you to use the VYALEV delivery system and give you resources to help you move forward. They’ll also help you navigate insurance options and look for ways for you to save. If challenges pop up, your VYALEV Complete dedicated support will be there to help you get back on track.
Can care partners enroll in VYALEV Complete?
Yes. When a loved one starts a new treatment, it affects their care partner, too. Once a patient is enrolled, VYALEV Complete can enroll their care partners. VYALEV Complete can answer your treatment-related questions along the way. You’ll also have access to one-on-one support from a dedicated Nurse Ambassador.*
What is a Nurse Ambassador?*
A Nurse Ambassador is the go-to for VYALEV support and resources for those prescribed VYALEV and their care partners. Once you’re enrolled, you’ll have the same Ambassador helping you start and stay on track with your treatment. They’ll meet with you in the comfort of your own home when you need them. You can also call or video chat with them.
They’ll also:
- Discuss your insurance coverage and out-of-pocket costs
- Prepare you for the start of your infusion at your doctor’s office
- Practice with you until you are prepared to administer your treatment at home
Is VYALEV covered by Medicare, Medicare Advantage, Medicare Supplemental, or commercial plans?
AbbVie is committed to working toward 100% coverage.
As with all new treatments, establishing full coverage with health plans (including government plans such as Medicare) takes time and cannot begin until the FDA approves the product. We anticipate VYALEV to be available on Medicare and other plans (including supplemental plans and Medicare Advantage) in the second half of 2025. This means that patients aged 64 or older are advised to wait a little longer until coverage details are determined. Patients aged 63 or younger may be able to access VYALEV sooner.
If I'm interested in VYALEV as a treatment choice, what should I do?
Patients aged 63 or younger without government insurance: If you and your doctor decide VYALEV could be right for you, they can prescribe it now, and then AbbVie (the manufacturer of VYALEV) will assist both you and your doctor’s office in working toward establishing a path to coverage.
Patients aged 64 or older: You can discuss the potential benefits of VYALEV with your doctor at your next appointment. AbbVie is committed to working toward 100% coverage, and your doctor will update you as Medicare coverage is established. You can also check on the status by visiting VYALEV.com or signing up to receive updates here.
If I'm older than 63, could VYALEV still be a treatment option for me?
VYALEV does not have an age cap. It may be suitable for patients who experience at least 2.5 hours of “Off” time per day and have noticed that they are taking more levodopa pills, more often, over time. If you meet these criteria, talk to your doctor to see if VYALEV could be right for you.
Specialty Pharmacy
What is a Specialty Pharmacy?†
A Specialty Pharmacy is a type of pharmacy that handles medications that may have special requirements for storage and handling. Specialty Pharmacies ship the medication and supplies directly to your home.
How will I get my medication, refills, and equipment?
All medication, refills, and medical equipment will be mailed to you. Your Specialty Pharmacy will call ahead of time to schedule your shipments and refills.
*Nurse Ambassadors are provided by AbbVie and do not work under the direction of your healthcare professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.
†A Specialty Pharmacy is a type of pharmacy that handles medication for conditions like advanced Parkinson’s. These medications often need special storage and processing.
