Transcript
Text on screen:
[logo] VYALEV foscarbidopa/foslevodopa
Injection for subcutaneous use 12 mg/240 mg per mL
Text on screen:
USE
VYALEV is a prescription medicine used for treatment of advanced Parkinson’s disease in adults. VYALEV contains two medicines, foscarbidopa and foslevodopa.
SELECT SAFETY INFORMATION
DO NOT USE VYALEV if you take or have taken a nonselective monoamine oxidase (MAO) inhibitor within the last 14 days. Ask your healthcare provider if you are not sure if you take an MAO inhibitor.
Please see Full Important Safety Information throughout, and see Full Prescribing information on WWW.VYALEV.COM.
VO: If levodopa pills are no longer working as well as they used to, it could be a sign your Parkinson’s disease has advanced and…
VO: ...VYALEV could be a treatment that’s right for you.
VO: But first, let’s talk about what could be happening with your Parkinson’s disease and your current treatment.
VO: When you’re feeling your best, it’s likely you’re in the “sweet spot” of the therapeutic window.
Text on screen: Therapeutic Window
VO: ...your levodopa levels are neither too high nor too low, and your treatment is working well. This is your “On” time.
Text on screen: Therapeutic Window
VO: However, if you’re treating your Parkinson’s with levodopa pills, you may sometimes notice a feeling of “peaks and valleys,” which are the ups and downs of your levodopa levels.
Text on screen: Therapeutic Window
VO: When there is too much levodopa in the body, you may experience troublesome dyskinesia, or involuntary movements like twisting and turning. Without enough levodopa, you have "Off" time when your medication is not working well or is no longer helping with mobility, slowness, stiffness, and tremor.
Text on screen: Therapeutic Window
VO: As Parkinson’s disease progresses, the therapeutic window narrows, and it may seem like your levodopa pills are not working as well as they used to.
Text on screen: Therapeutic Window
VO: Changes between “On” and “Off” time and the feelings of “peaks and valleys” may become more noticeable.
Text on screen: Therapeutic Window
VO: The neurons in your brain continue to lose the ability to make and store dopamine and...
VO: ...as a result, you may need to take more pills, more often, to help your body get the dopamine it needs.
VO: At the same time, as Parkinson’s disease advances, it frequently slows the stomach,
VO: causing pills to sit in your stomach longer. This delays absorption, which affects how much levodopa is in your body.
VO: So, even though you’re taking levodopa pills more frequently...
VO: ... staying within that sweet spot can become more difficult over time.
VO: Introducing VYALEV, a treatment that is delivered differently.
Text on screen: VYALEV IS A PRESCRIPTION MEDICINE USED FOR TREATMENT OF ADVANCED PARKINSON'S DISEASE IN ADULTS.
VO: to treat motor fluctuations in adults with advanced Parkinson’s disease.
VO: VYALEV is a…
VO: 24-hour, continuous delivery of levodopa-based therapy.
VO: Delivered under the skin through a wearable pump, VYALEV replaces your levodopa pills...
Text on screen: *VYALEV REPLACES LEVODOPA-CONTAINING MEDICATIONS AND COMT INHIBITORS. KEEP A SUPPLY OF ORAL IMMEDIATE-RELEASE CARBIDOPA/LEVODOPA TABLETS WITH YOU IN CASE YOU ARE UNABLE TO USE VYALEV INFUSIONS.
VO: ...and provides a continuous flow of levodopa-based medication over 24 hours—morning, day and night.
VO: And since VYALEV doesn’t pass through the stomach, what and when you eat doesn’t affect how well it works.
VO: The goal of VYALEV is to keep you in the sweet spot and provide you with more “On” time.
VO: In clinical trials, patients experienced superior “On” time versus pills.
Text on screen: VYALEV WAS STUDIED AGAINST ORAL IMMEDIATE-RELEASE CARBIDOPA/LEVODOPA PILLS.
VO: At 12 weeks, patients achieved almost 2 more hours of “On” time each day than treatment with pills alone.
Text on screen: ~2 more hours of “On” time per day.
VO: Want to learn about more "On" time and a nonsurgical, continuous treatment for advanced Parkinson's disease? Talk to your doctor to see if your next step could be VYALEV.
VO: More "On" time is possible with VYALEV.
Text on screen: Now you can _______ more
More “On” time is possible with 24-hour, levodopa-based therapy.
Text on screen:
[logo] VYALEV foscarbidopa/foslevodopa
Injection for subcutaneous use 12 mg/240 mg per mL
Text on screen:
IMPORTANT SAFETY INFORMATION AND USE
USE
VYALEV is a prescription medicine used for treatment of advanced Parkinson’s disease in adults. VYALEV contains two medicines, foscarbidopa and foslevodopa.
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.
US-Levcar-220020