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:
Routine Reminders
JANE:
Hi! I’m Jane. It’s good to be here with you. In this video, I’m going to share some helpful guidance about living with your VYALEV Delivery System.
JANE:
We’ll chat about a few things you’ll want to remember during your day to day—and when you’re heading out the door.
Then we’ll talk about what to do if you have questions or just need a hand.
This will help you be better prepared for these common situations as they pop up.
SUPER:
This video reviews:
- Charging your pump’s battery
- Wearing your carrying case
- Showering, bathing and swimming
- Sleeping
- Leaving the house and traveling
(VO) JANE:
Let’s start by talking about your pump.
SUPER:
How do you charge your pump’s batteries?
JANE:
It comes with 2 rechargeable batteries, but it only uses one at a time. Each battery lasts about 24 hours. Your pump will let you know when the battery is running low.
SUPER:
Refer to your Battery Charger Patient Instructions for Use.
(VO) JANE:
Choose a time to replace and recharge your battery so it’ll become part of your daily routine—like after you brush your teeth, change your syringe or get ready for bed.
SUPER:
Try to change your battery at the same time each day
(VO) JANE:
When you replace your batteries, start recharging the old one right away, so it’ll be charged when it’s time to swap them out again. The goal is to always have one battery charging while the other is in use.
SUPER:
Always have one battery charging while the other is in use
(VO) JANE:
Your charging station will let you know its status. If this light is off, that means there’s no power. If the light is solid red, that means the battery has gone bad or there is no battery connected. If the light is solid orange, that means the battery is charging. And if it’s green, then the battery is fully charged. It’s a good idea to keep your charger somewhere convenient, like near your cell phone charger.
SUPER:
Off [light icon] = battery is not charging
Red [light icon] = battery has gone bad or no battery inserted
Orange [light icon] = battery is charging (might blink red when the battery is first inserted)
Green [light icon] = battery is fully charged
(VO) JANE:
When your battery is fully charged, it’s ready to go into your pump. When you leave your house, take the extra charged battery with you. If you’re traveling for more than 24 hours, be sure to bring your battery charger as well.
SUPER:
To reduce the risk of electric shock or other harm, DON’T use battery charging components that are different from those that came with your pump or appear damaged.
(VO) JANE:
You wear your VYALEV pump on your body.
SUPER:
How do you wear your pump’s carrying case?
(VO) JANE:
This carrying case comes with a short belt, a longer belt and a shoulder strap. The case also has a removable flap that covers the pump’s buttons and can be removed entirely.
SUPER:
The carrying case includes:
- Short belt
- Longer belt
- Shoulder strap
(VO) JANE:
Depending on how you’d like to wear the case, you can either slide the belt through the back or you can attach the strap to the case with the clips.
SUPER:
Refer to your VYALEV Carrying Accessory Patient Instructions for Use.
(VO) JANE:
You can wear the carrying case around your neck...
(VO) JANE:
..across your body...
(VO) JANE:
...or on your hip. Make sure the pump isn’t too far away from your infusion site...
(VO) JANE:
...it should always be near your torso. You can talk to your Nurse Ambassador about other carrying cases that are available, as well.
SUPER:
Ask your Nurse Ambassador about other carrying cases
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:
Your pump and tubing can’t get wet. When you shower or swim...
SUPER:
Can you shower or bathe with your VYALEV Delivery System on?
(VO) JANE:
...be sure to disconnect both of them first. Your cannula can stay on your body.
SUPER:
Do NOT use or wear the delivery system while engaging in any activity that could result in liquids getting in the pump, such as bathing, showering or swimming.
JANE:
You can also watch the VYALEV Complete video called “How to Use Your VYALEV Delivery System” to see how it’s done.
SUPER:
For details, watch “How to Use Your VYALEV Delivery System”
Refer to the Patient Instructions for Use materials that came with your pump and supplies.
JANE:
And make sure to follow the instructions for reconnecting when you’re ready.
SUPER:
Refer to the Patient Instructions for Use materials that came with your pump and supplies.
(VO) JANE:
There are different ways you can sleep with your VYALEV Delivery System.
SUPER:
How do you sleep with your VYALEV Delivery System?
(VO) JANE:
You can have your pump in or out of your carrying case. Some people like sleeping with the pump next to them on the bed. Others like to put their pump on a nearby night table. Either way is fine.
(VO) JANE:
Do what’s most comfortable for you, just make sure your tubing isn’t blocked or overstretched.
SUPER:
Your pump will alert you if your tubing becomes blocked.
(VO) JANE:
When packing your bag, think about how long you’ll be out.
SUPER:
What do you need when leaving home or traveling?
(VO) JANE:
How many infusion sets, medication vials, vial adapters and syringes will you need? Don’t forget your alcohol swabs and spare fully charged battery.
SUPER:
Travel Checklist:
- Enough supplies for how long you’ll be out
- Several alcohol swabs
- Spare fully charged battery
JANE:
Keep a supply of oral carbidopa-levodopa immediate-release tablets with you in case you are unable to use your VYALEV pump.
SUPER:
Travel Checklist:
- Enough supplies for how long you’ll be out
- Several alcohol swabs
- Spare fully charged battery
- Oral carbidopa-levodopa tablets
(VO) JANE:
If you’re going to be gone for a day or more, don’t forget to bring your battery charger too.
SUPER:
Travel Checklist:
- Enough supplies for how long you’ll be out
- Several alcohol swabs
- Spare fully charged battery
- Oral carbidopa-levodopa tablets
- Charging station, if gone for more than 1 day
(VO) JANE:
Pack a to-go bag and keep it some place where you’ll remember to grab it. This way, you’ll be ready to head out whenever you need.
SUPER:
Keep a to-go bag packed so you’re always ready
VYALEV can be stored at room temperature for up to 28 days.
(VO) JANE:
If you’re traveling by plane, speak with your Nurse Ambassador for resources and tips to help you discuss your pump with security.
SUPER:
Your pump works normally in flight
Ask your Nurse Ambassador for resources and traveling tips.
(VO) JANE:
It’s really important to pack your VYALEV medication vials and supplies in your carry-on bag. Do not pack them in your checked bag.
SUPER:
Pack all supplies in a carry-on bag
(VO) JANE:
If you have questions, VYALEV Complete is happy to help.
SUPER:
Who can you go to with other questions?
(VO) JANE:
Your dedicated Nurse Ambassador will be by your side throughout your VYALEV treatment. They’ll even visit you at home. You can call them, or video chat, whenever you have questions. The more your Nurse Ambassador gets to know you, the more they can help...
SUPER:
Talk to your Nurse Ambassador
JANE:
...so don’t hesitate to give them a call. They’re looking forward to speaking with you.
(VO) JANE:
Call the VYALEV Complete 24/7 Hotline if your Nurse Ambassador is not available. You’ll be connected to nurses trained on using 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.
JANE:
And remember, you can always find more support online. Reach out whenever you need help.
SUPER:
www.VYALEV.com/VYALEVComplete
JANE:
When challenges pop up, VYALEV Complete will be there to help you stay on track. Thanks for watching. Take care.
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-220035 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.
