Transcript
Text on screen: VYALEV is a prescription medicine used for treatment of advanced Parkinson’s disease in adults. VYALEV contains two medicines, foscarbidopa and foslevodopa.
Before using VYALEV, it is important that you receive training at your doctor's office.
Please watch Important Safety Information throughout this video, and see Full Prescribing Information including Medication Guide, which is also available at https://www.rxabbvie.com/pdf/vyalev_pi.pdf
[logo] VYALEV foscarbidopa/foslevodopa
Injection for subcutaneous use 12 mg/240 mg per mL
Janice: Before VYALEV I was constantly making sure did I, did I take the oral medication? I was taking it so many times a day. And I was having more “Off” time, and I realized it was time to try something different.
Text on screen: Janice is an actual VYALEV patient and was on prescribed therapy when she provided a testimonial. Changes in therapy status may have occurred since that time.
Text on screen: Janice & Faron’s Story
Janice: My name is Janice, and I was diagnosed with Parkinson’s in 2014 when I was 50 years old.
Faron: My name’s Faron, I’m the other half.
Janice: I used to be a kitchen manager at an elementary school, and now I…I’m home, but I have my two little furry friends that keep me busy.
Janice: I like gardening out in the backyard. We like to go camping. The main thing is we like to go motorcycle riding.
Text on screen: VYALEV (foscarbidopa/foslevodopa) may be stored at room temperature up to a maximum of 86°F (30°C) for a single period of up to 28 days. Do not return VYALEV to the refrigerator once it has been stored at room temperature.
Janice: My symptoms started with my thumb, just going constantly. My primary care sent me to a neurologist, and I was formally diagnosed with Parkinson’s.
Faron: We had some tears, we had some emotion. But she doesn’t give up.
Janice: My doctor got me on the oral carbidopa/levodopa, and it did…it did pretty well for a while. I was taking probably about 8 pills a day, at least.
Faron: It was a lot of pills…
Janice: You have to be careful because you can’t eat a lot of proteins with it. With VYALEV, I don’t have to worry about that.
Text on screen: VYALEV (foscarbidopa/foslevodopa) is delivered under the skin through a wearable pump and does not pass through the stomach. Food does not affect VYALEV exposure or absorption.
Janice: The oral meds I was taking were good, but only, only for a certain amount of time. And I was having more highs and lows—it was like a roller coaster.
Janice: I talked to my doctor and I, I knew I needed something a little more.
Faron: I think he just knew that it was time for her because it was advancing.
Text on screen: VYALEV was studied against oral immediate-release carbidopa/levodopa 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. Patients achieved -2.75 hours “Off” time with VYALEV compared to -0.96 hours for those taking oral pills.
Janice: I started VYALEV when I was 57 years old. My doctor thought I would be an excellent candidate because of the “Off” times that I was experiencing with my oral meds. It wasn’t a surgical procedure, and we just felt like this was the next step.
Text on screen: Keep a supply of oral immediate-release carbidopa/levodopa tablets with you in case you are unable to use VYALEV infusion.
Janice: VYALEV gives me more “On” time. It can be in your system constantly. They can adjust it depending on how I’m feeling. If I feel like I’m not getting enough or if I’m getting too much.
Faron: It, uh, relieved my anxiety because I knew she had the pump on all the time.
Janice: It’s my buddy.
Faron: Right!
Janice: My jet pack.
Janice: There’s different ways that you can wear it: You can wear it on a hip or you can have it going this way across your body. You know, sometimes I forget that I’m wearing it until it beeps to tell me that I need to change the battery or the, uh, medicine. It’s just, it’s not in the way.
Text on screen: Before you start VYALEV (foscarbidopa/foslevodopa) for the first time, and also each time you get a refill, please use the Medication Guide and Instructions for Use of VYALEV that came with your drug vials, pump, and supplies from your Specialty Pharmacy.
Janice: When they explained VYALEV to me, at first I thought, oh my gosh, this is a lot of steps. Once I started doing it, it didn’t seem like there was that many steps to it. I’m to a point it feels effortless to me. Probably maybe less than 10 minutes to complete my daily routine. You know, it’s like combing your hair or brushing your teeth; it’s just another step. Plucking your eyebrows, do your pump.
Text on screen: Individual patient results will vary. Talk to your doctor about whether VYALEV could be a good treatment option for you.
Janice: Parkinson’s hasn’t stopped me! It’s not defining my life. I’m kind of telling it what to do, and we work together. VYALEV has helped me. And I would encourage you to try it.
Text on screen:
[logo] VYALEV foscarbidopa/foslevodopa
Injection for subcutaneous use 12 mg/240 mg per mL
Ask your doctor if VYALEV may be right for you.
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.
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