STATE-OF-THE-ART MANUFACTURING PROCESS.
Xeomin® is made through a unique precision manufacturing process called XTRACT Technology™, that uses two filtration steps to isolate the therapeutic component of the molecule and removes the complexing/unnecessary proteins that don’t play an active role in treatment. Xeomin® is a double filtered neurotoxin. Head-to-head studies evaluating the relative risk of immunogenicity due to the presence or absence of complexing/unnecessary proteins have not been performed.
Frown lines form when facial expressions are made as the muscle under the skin contracts. Over time, as your skin ages, these repeated expressions cause lasting frown lines. Neurotoxins, such as Xeomin®, are prescription medications that block the release of chemicals that cause these muscle contractions so frown lines are softened.
WHAT IS XEOMIN®
Xeomin® (incobotulinumtoxinA) is a medication injected into muscles and used to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines), forehead, and around the eyes (crows feet) in adults. Xeomin® contains botulinum toxin type A, a protein purified from the bacterium Clostridium botulinum.
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.
FREQUENTLY ASKED QUESTIONS
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.
During treatment, which usually takes about 10-20 minutes, your provider 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.
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 the possible side effects of Xeomin®. For more information, see accompanying Full Prescribing Information including Medication Guide, or ask your doctor.