SUPER/VO:
Before you administer VYALEV, you should be shown how to do it correctly by a healthcare provider.
This demonstration is intended to help you become familiar with the VYALEV delivery system and be used as a supplemental resource as you make infusing VYALEV part of your routine. Before you start VYALEV for the first time, and also each time you get a refill, please use the Medication Guide and the Instructions for Use materials that came with your drug vials, pump and other supplies from your Specialty Pharmacy. Use VYALEV exactly as your healthcare provider tells you to use it.
SUPER/VO:
USE
VYALEV is a prescription medicine used for treatment of advanced Parkinson's disease in adults. VYALEV contains two medicines, foscarbidopa and foslevodopa.
SUPER:
Please see Important Safety Information included in this video. Please see Instructions For Use, and full Prescribing Information, along with Medication Guide, which was provided with your pump.
SUPER:
Getting Started
JANE:
Hi, I’m Jane. You and your doctor have decided that VYALEV is right for you. I’m here to give you a quick overview of what to expect and help you move forward.
JANE:
At the end of the video, you should have a better understanding of how the VYALEV Delivery System works and how VYALEV Complete can support you throughout your treatment.
SUPER:
- The VYALEV Delivery System
- VYALEV Complete support
JANE:
Hi, Sam. Hi, Sally.
SAM:
Hi.
JANE:
I’m going to show you all of the parts of the VYALEV Delivery System. But before I can touch any of the supplies…
(VO) JANE:
I need to wash my hands with soap and water for at least 20 seconds and then dry them with a new paper towel.
(VO) JANE:
I also need to clean my workspace so all the supplies stay as clean as possible, too.
(VO) JANE:
The VYALEV Delivery System uses a pump to deliver a continuous subcutaneous infusion.
SUPER:
The VYALEV Delivery System
JANE:
Subcutaneous means that it delivers the medication just under the skin. Continuous infusion means the pump is designed to deliver medication 24 hours a day, 7 days a week.
SUPER:
Subcutaneous = medication is delivered under your skin
(VO) JANE:
There is the medication, a vial adapter, a syringe, an infusion set which includes the cannula and tubing, the pump, the pump’s battery, and the battery charger.
SUPER:
Medication Vial, Vial Adapter, Syringe, Infusion Set, Pump, Pump Battery, Battery Charger
JANE:
All of these will arrive from your Specialty Pharmacy straight to your home.
SUPER:
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.
(VO) JANE:
Let me explain how these pieces work together. The medication comes in a vial.
(VO) JANE:
The medication solution gets into the syringe through the vial adapter. The infusion set has…
SUPER:
The medication gets to the syringe through the vial adapter
Please read the Instructions for Use of VYALEV that you received from the Specialty Pharmacy for details on how to fill the syringe with medication.
(VO) JANE:
…two pieces inside.
(VO) JANE:
First is the tubing. That’s how the medication gets to you.
SUPER:
Medication moves through the tubing
(VO) JANE:
Then there is the insertion device that is used to place a cannula onto the body that the tubing can attach to.
SUPER:
Cannula insertion device places the cannula on your body
(VO) JANE:
For this video, we removed the cannula from the insertion device to show you that it’s a tiny, flexible tube. It’s inserted about a quarter of an inch into the skin of the belly. One end of the tubing will attach to it.
SUPER:
Don’t touch the tip
This is for demonstration
(VO) JANE:
The other end of the tubing connects to the tip of the syringe. After it’s connected, the filled syringe is placed inside the pump.
SUPER:
The tubing is attached to the syringe and placed in the pump
(VO) JANE:
It sticks out here. See?
(VO) JANE:
Once the cannula is inserted, the tubing can be connected. One end of the tubing has a site connector that clicks into the cannula…
SUPER:
Tubing connects the syringe to the cannula
(VO) JANE:
…so the medication is delivered by the pump, which pushes the medication from the syringe through the tubing and into the cannula and under the skin.
SUPER:
Medication flows continuously
(VO) JANE:
Once the delivery system is connected, you can put it in your carrying case and adjust the strap so it fits. Make sure it’s comfortable!
JANE:
Now let’s talk about the support available to you throughout your treatment. This video is just an overview to help you prepare for next steps. You’ll have ongoing support through VYALEV Complete...
SUPER:
Your VYALEV Complete dedicated support
Nurse Ambassadors are provided by AbbVie and do not work under the direction of your health care professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.
JANE:
...including your own dedicated Nurse Ambassador who’s eager to be there for you.
SUPER:
Your own Nurse Ambassador
Nurse Ambassadors are provided by AbbVie and do not work under the direction of your health care professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.
(VO) JANE:
They’ll provide you with 1-on-1 support throughout your treatment, from helping you organize your supplies to helping you prepare for delivery system training at your doctor’s office.
SUPER:
- 1:1 Support
- Organize your supplies
- Prepare for delivery system training
JANE:
You’ll learn step by step how to connect and use your VYALEV Delivery System and they will start your infusion.
SUPER:
- 1:1 Support
- Organize your supplies
- Prepare for delivery system training
(VO) JANE:
Afterward your Nurse Ambassador will meet with you at home to practice what you learned. They won’t move on until you feel comfortable using your delivery system.
JANE:
In addition to visiting you at home, your Nurse Ambassador can video chat...
(VO) JANE:
...or they can talk on the phone. So if you have a question, don’t hesitate to call!
JANE:
If it’s after hours or if you can’t reach your Nurse Ambassador, you can reach out to the VYALEV Complete 24/7 Hotline. It’s staffed by nurses trained on VYALEV.
SUPER:
Call the VYALEV Complete 24/7 Hotline at 1-866-489-2538
The 24/7 Hotline is staffed by nurses that are specifically trained on VYALEV and can be reached 24 hours per day, 7 days a week
The 24/7 Hotline is staffed by nurses that are specifically trained on VYALEV and can be reached 24 hours per day, 7 days a week. After business hours, you may be asked to leave a message for a return call within 30 minutes.
(VO) JANE:
VYALEV Complete supports care partners too, with tips, materials and resources.
SUPER:
Care partner support
JANE:
Thanks for watching! I’m glad you could join me as I walked through what to expect with VYALEV. And remember, VYALEV Complete is always here to help.
SUPER:
VYALEV Complete 24/7 support
SUPER/VO:
IMPORTANT SAFETY INFORMATION
What is the most important safety information I should know about VYALEVTM (foscarbidopa/foslevodopa)?
Do not take VYALEV if you currently take or have recently taken (within the last 14 days) a medication for depression called a nonselective monoamine oxidase (MAO) inhibitor. Ask your healthcare provider or pharmacist if you are not sure if you take an MAO inhibitor.
Tell your healthcare provider about all your medical conditions and the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. When used together, VYALEV and certain other medicines, including medications for high blood pressure, MAO inhibitors, antipsychotics, metoclopramide, and isoniazid, may affect each other and cause serious side effects.
VYALEV may cause other serious side effects. Talk to your healthcare provider before starting VYALEV and while on VYALEV if you have had or have any of the following:
- Falling asleep without warning during normal daily activities. VYALEV may cause you to fall asleep while you are doing daily activities, such as driving, which may result in an accident. This can happen as late as 1 year after you start VYALEV. Do not drive or operate machinery until you know how VYALEV affects you. Tell your healthcare provider if you take medicines that can make you sleepy, such as sleep medicines, antidepressants, or antipsychotics.
- Seeing, hearing, or feeling things that are not real (hallucinations). This is a common and sometimes serious side effect.
- Unusual urges. Some people taking medicines for Parkinson’s disease, including VYALEV, have reported problems, such as gambling, compulsive eating, compulsive shopping, and increased sex drive.
- Infusion Site Reactions and Infections. Some people using VYALEV have had reactions and infections at the infusion site. This is a common and sometimes serious side effect. Remove your cannula and call your healthcare provider if you have any of the following symptoms of an infection: local spreading of redness, pain, swelling, warmth, change in color when pressing area, or fever. Take oral carbidopa/levodopa tablets until you are able to resume VYALEV.
- Uncontrolled sudden movements (dyskinesia). This is a common and sometimes serious side effect. If you have new dyskinesia or your dyskinesia gets worse, tell your healthcare provider. This may be a sign that your dose of VYALEV or other Parkinson’s medicines may need to be adjusted.
- Heart attack or other heart problems. Tell your healthcare provider if you have had increased blood pressure, a fast or irregular heartbeat, or chest pain.
- Worsening of the increased pressure in your eyes (glaucoma). The pressure in your eyes should be checked after starting VYALEV.
Do not stop using VYALEV or change your dose unless you are told to do so by your healthcare provider. Tell your healthcare provider if you develop withdrawal symptoms, such as fever, confusion, or severe muscle stiffness.
These are not all the possible side effects of VYALEV. For more information, ask your healthcare provider or pharmacist.
VYALEV (foscarbidopa and foslevodopa) injection for subcutaneous use is available in a 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL) solution.
Please see the full Prescribing Information, including Medication Guide, for additional information about VYALEV. Talk to your healthcare provider if you have questions.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.
SUPER:
[AbbVie Logo]
© 2024 AbbVie. All rights reserved.
All trademarks are the property of their respective owners.
US-LEVCAR-220033 V2.0 2024
Please see Important Safety Information included in this video. Please see Instructions For Use, and full Prescribing Information, along with Medication Guide, which was provided with your pump.
