Injectables – XEOMIN®

XEOMIN® (incobotulinumtoxinA) is a prescription medication used to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) in adults. XEOMIN® contains botulinum toxin type A, a protein purified from the bacterium Clostridium botulinum.

When you squint or frown, the muscles between your brows contract, causing the skin to furrow and fold. Over time, as your skin ages and loses some of its elasticity, these repeated contractions can cause persistent frown lines. Botulinum toxin type A – the active ingredient in XEOMIN® – acts on nerve endings in muscles to prevent muscle fibers from contracting. By reducing these contractions, XEOMIN® can temporarily reduce the lines on your forehead between your brows.

XEOMIN® was proven effective in two randomized, double-blind, multicenter, placebo-controlled clinical trials of 547 healthy, adult patients. The average age of patients in the study was 46 years. Patients received 20 Units of XEOMIN® and were classified as responders if they had a 2-grade improvement on a 4-point scale as assessed by the physician and patient. Using these criteria, treatment success was higher with XEOMIN® than placebo on Day 30 in both studies (60% and 48% vs. 0% for placebo in both studies). Based on these trials, XEOMIN® received FDA approval for aesthetic use in 2011.

If you are an adult with moderate to severe glabellar lines, XEOMIN® may be right for you. Talk to your doctor to discuss the benefits and risks of treatment.

Do not take XEOMIN® if you are allergic to botulinum toxin or any of the other ingredients in XEOMIN®. You should also not take XEOMIN® if you have had an allergic reaction to any other botulinum toxin product or have a skin infection at the planned injection site.

Before receiving treatment with XEOMIN® you should tell your doctor about all of your medical conditions, including whether you have a disease that affects your muscles and nerves, have allergies to any botulinum toxin product, or have experienced any side effect from any other botulinum toxin in the past.

In addition, tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you have received any other botulinum toxin product in the last four months or in the past. Be sure your doctor knows exactly which product(s) you received and when you received them.

During treatment, which usually takes about 10-20 minutes, your doctor will inject XEOMIN® into the muscles in your forehead that cause frown lines between your brows. No anesthesia is required; however, your physician may use a topical anesthetic or cold pack to reduce any discomfort.

In clinical trials, some patients observed visible smoothing as early as 3-4 days after injection. The median first onset of effect was less than a week. The maximum effect typically occurs at 30 days. The typical duration of effect is up to 3 months, but may last significantly longer or shorter in individual patients.

XEOMIN® may cause serious side effects, including allergic reactions. Symptoms of an allergic reaction to XEOMIN® may include: itching, rash, redness, swelling, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or seek medical help right away if you have wheezing, experience other asthma symptoms, or if you become dizzy or faint.

In clinical trials of XEOMIN® for the treatment of frown lines between the brows, headache was the most common side effect.

XEOMIN® may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking XEOMIN® . If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Tell your doctor if you have any side effect that bothers you or that does not subside. These are not all of the possible side effects of XEOMIN®. For more information, see the Important Safety Information on the back cover, Medication Guide and Full Prescribing Information, or ask your doctor.