Jeuveau®

Jeuveau® (prabotulinumtoxinA-xvfs) is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).

What exactly is Jeuveau® (prabotulinumtoxinA-xvfs)?

You know those pesky little wrinkles between your eyebrows that won’t go away? Well, they're called glabellar lines, also referred to as "frown lines" or "elevens." Jeuveau® is a prescription injectable treatment that works to temporarily improve the appearance of moderate to severe frown lines in adults.

How does Jeuveau® work?

When injected, Jeuveau® temporarily prevents your nerves from telling your facial muscles to flex. The result? In clinical trials, Jeuveau® was shown to temporarily improve the appearance of moderate to severe frown lines.

What are the results with Jeuveau®?

In clinical trials, Jeuveau® was shown to temporarily improve the appearance of moderate to severe frown lines. In US studies, 68% and 70% of Jeuveau® patients had a 2-grade or better physician and patient-rated improvement in frown lines at Day 30. But that's not all. In a study conducted in Europe and Canada, 54% of patients had visible results as early as 2 days after treatment.* And at 5 months after treatment, 38% of patients had visible results with Jeuveau® **

* 54% of patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.

** 38% of patients had a ≥1-grade improvement in frown lines at 5 months based on physician assessment compared to 8% for placebo (secondary endpoint). In US studies, almost 5% of patients had a ≥2-grade improvement in frown lines at 5 months based on both patient and physician assessments compared to 0% for placebo (secondary endpoint). Results after day 30 or based on a 1-grade improvement may not be clinically meaningful.

What’s it like before & after treatment?

If it’s your first time getting a treatment, you may be a little nervous and that’s okay! Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may be associated with the injection.

For specific instructions on what to do before and after your treatment, please follow the instructions as given to you by your doctor or healthcare provider.

What are the possible side effects of Jeuveau®?

No serious or drug-related adverse events were observed in the Jeuveau® studies.

Jeuveau® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of Jeuveau®:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.

  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

Jeuveau® can cause other serious side effects including:

  • Allergic reactions such as itching, rash, red itchy welts, wheezing, trouble breathing, asthma symptoms, or dizziness or feeling faint. Tell your healthcare provider or get emergency medical help right away if you develop wheezing or trouble breathing, or if you feel dizzy or faint.

  • Heart problems. Irregular heartbeat and heart attack that have caused death, have happened in some people who received botulinum toxin products.

  • Eye problems such as dry eye, reduced blinking, and corneal problems. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.

The most common side effects of Jeuveau® include headache, eyelid drooping, upper respiratory infection, and increased white blood cell count.

These are not all the possible side effects of Jeuveau®. Call your doctor for medical advice about side effects. You may report side effects to FDA at www.fda.gov/medwatch or 1-800-FDA-1088.