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FREQUENTLY ASKED QUESTIONS


WHAT IS XEOMIN®?
  • XEOMIN® (incobotulinumtoxinA) is a prescription medication injected into muscles and 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.
HOW DOES XEOMIN® WORK?
  • When you squint or frown, the muscles between your eyebrows 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 between your eyebrows.
IS XEOMIN® PROVEN?
  • 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 use in glabellar lines in 2011.
HOW DO I KNOW IF XEOMIN® IS RIGHT FOR ME?
  • 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.
WHAT SHOULD I TELL MY DOCTOR BEFORE TREATMENT?
  • 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 your medical history and 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.
WHAT CAN I EXPECT DURING TREATMENT?
  • 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 eyebrows. No anesthesia is required; however, your physician may use a topical anesthetic or cold pack to reduce any discomfort.
WHEN CAN I EXPECT TO SEE RESULTS?
  • You may begin to see visible smoothing as early as 3-4 days after injection. The median first onset of effect was less than a week. The maximum effect occurred at 30 days. The typical duration of effect was up to 3 months in clinical trials but may last significantly longer or shorter in individual patients.
WHAT ARE THE MOST COMMON SIDE EFFECTS OF XEOMIN®?
  • 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 eyebrows, 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 accompanying Important Safety Information, Medication Guide, and Full Prescribing Information, or ask your doctor.
ARE YOU CONCERNED ABOUT LOOKING PLASTIC OR OVERDONE?
  • Looking plastic or overdone is a common concern among individuals considering an in-office treatment for moderate to severe frown lines.* Talk to your licensed, trained, healthcare professional. There are steps you can take to make you feel more comfortable. First, have a detailed discussion with your provider. You want to talk through every concern you have, until you feel comfortable. Your provider, who is experienced in facial anatomy, can determine the right options for you. For example, the most widely used procedure for moderate to severe frown lines is neurotoxin injections, a class of prescription medication that has been shown to be effective in many studies. Finally, ask for an FDA-approved product, such as XEOMIN®. Individual results may vary.
    *Data on File.

XEOMIN® IMPORTANT CONSUMER SAFETY INFORMATION

Read the Medication Guide before you start receiving XEOMIN® (Zeo-min) and each time XEOMIN® is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more:

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

Warnings

XEOMIN® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to week) after treatment with XEOMIN®:

These problems could make it unsafe for you to drive a car or do other dangerous activities.

Do not use XEOMIN® if you are allergic to XEOMIN® or any of the ingredients in XEOMIN® (see the end of this Guide for a list of ingredients in XEOMIN®, had an allergic reaction to any other botulinum toxin products such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC), or abobotulinumtoxinA (DISPORT®) or have a skin infection at the planned injection site.

Ask a doctor before use if you

Tell your doctor about all of your medical conditions and all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using XEOMIN® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received XEOMIN® in the past.

Especially tell your doctor if you

Ask your doctor if you are not sure if your medicine is one that is listed above.

Possible Side Effects

XEOMIN® can cause serious side effects that can be life threatening. See "Warnings."

Headache was the most common side effect of XEOMIN® for treatment of glabellar lines. Other possible side effects include:

XEOMIN® may cause other 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 get medical help right away if you get wheezing or asthma symptoms, or if you get dizzy or faint.

These are not all the possible side effects of XEOMIN®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Directions

General information about the safe and effective use of XEOMIN®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XEOMIN® for a condition for which it was not prescribed. Do not give XEOMIN® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about XEOMIN® that is written for health professionals.

Active Ingredient: incobotulinumtoxinA

Inactive Ingredients: human albumin and sucrose

Please see accompanying XEOMIN® full Prescribing Information and Medication Guide.