Transcript
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[logo] VYALEV foscarbidopa/foslevodopa
Injection for subcutaneous use 12 mg/240 mg per mL
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USE
VYALEV is a prescription medicine used for treatment of advanced Parkinson’s disease in adults. VYALEV contains two medicines, foscarbidopa and foslevodopa.
SAFETY CONSIDERATIONS
Don't take VYALEV if you've taken a nonselective MAO inhibitor in the last 2 weeks.
Please continue watching for additional Safety Information.
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 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. ASK YOUR DOCTOR ABOUT THE RIGHT VYALEV DOSE FOR YOU. 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: VYALEV was studied against oral immediate-release carbidopa/levoddopa pills. At week 12, patients taking VYALEV achieved 2.72 hours more "On" time vs 0.97 hours more "On" time for those taking levodopa pills, a difference of 1.75 hours.
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 time to be you.
Text on screen: MORE TIME TO BE YOU™
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More "On" time is possible with VYALEV, a 24-hour, continuous levodopa-based therapy—morning, day, and night.
Delivered under the skin through a wearable pump. No surgery required.
SAFETY CONSIDERATIONS
Don't take VYALEV if you’ve taken a nonselective MAO inhibitor in the last 2 weeks.
Sleepiness or suddenly falling asleep can happen up to a year after starting. Don’t drive or use machinery until effects are known.
Serious side effects are hallucinations; compulsive urges like gambling, eating, shopping, or increased sex drive; fever and confusion after stopping; infusion site reactions or infections; uncontrolled movements; and vitamin B6 deficiency which may cause seizures, confusion, neuropathy, or swollen lips or tongue. May also cause heart attack, heart problems, or glaucoma.
Tell your doctor about high blood pressure, fast or irregular heartbeat, chest pain, seizures, or signs of infection like site pain or fever during use.
Please see additional Important Safety Information on this webpage.
US-VYAL-260380