IMPORTANT SAFETY INFORMATION
What is the most important safety information I should know about VYALEV® (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.
Withdrawal-emergent fever (hyperpyrexia) and confusion. Tell your healthcare provider if you have fever, confusion, or severe muscle stiffness after stopping 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.
Vitamin B6 deficiency and seizures. Tell your healthcare provider if you experience seizures. Carbidopa/levodopa therapies, including VYALEV, may decrease vitamin B6 levels, and severe vitamin B6 deficiency can lead to seizures. Other symptoms of vitamin B6 deficiency include depression, confusion, cracked or swollen lips or tongue, rash, low red blood cell count, and/or numbness, tingling, or weakness in the extremities.
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.
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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