XEOMIN® Treatment in New Jersey
XEOMIN® is FDA-approved for frown line treatment.
Frown lines develop when facial expressions are made as the muscle under the skin contracts. Over time, as your skin ages, these frequent expressions result in prevalent frown lines. Neurotoxins, like XEOMIN®, are prescription medications that block the release of chemicals that cause these muscle contractions, diminishing the appearance of frown lines.
Frequently Asked Questions About XEOMIN®
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 crease and fold. Over time, as your skin ages and loses some of its elasticity, these frequent contractions can cause persistent frown lines. Botulinum toxin type A–the active ingredient in XEOMIN®–interacts with nerve endings in muscles to prevent muscle fibers from contracting. By decreasing these contractions, XEOMIN® can temporarily reduce the lines between your eyebrows.
Is XEOMIN® proven effective?
XEOMIN® was proven effective in 2 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 (6 percent and 48 percent vs. 0 percent for placebo in both studies). Dependent on these trials, XEOMIN® received FDA approval for use in glabellar lines in 2011.
How do I know if XEOMIN® is the right treatment option for me?
If you are an adult who has moderate to severe glabellar lines, XEOMIN® may be right for you. Discuss the benefits and risks of treatment with your doctor. 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 XEOMIN® 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 previously experienced any side effect from any other botulinum toxin. Additionally, tell your doctor about your medical history and all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Specifically, tell your doctor if you have received any other botulinum toxin product in the last 4 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 XEOMIN® treatment?
During treatment, which usually takes approximately 10-20 minutes, your doctor will inject XEOMIN® into the muscles in your forehead that cause frown lines between your eyebrows. No Anesthesia is necessary; however, your physician may use a topical anesthetic or cold pack to reduce any discomfort.
When can I expect to see results of XEOMIN® treatment?
You may start to observe visible smoothing as early as 3-4 days after injection. The average inception 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 XEOMIN® clinical trials 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 occurs, do not drive a car, operate machinery, or engage in dangerous activities.
Tell your doctor if you experience any side effect that bothers you or that does not subside. These are not all of the possible side effects of XEOMIN®.
Are you worried 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 discuss every concern you have, until you feel comfortable. Your provider, who is experienced in facial anatomy, can determine the right options for you. For instance, 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, request 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 administered to you as there may be new information. The risk information provided here is not comprehensive. To learn more:
- Talk to your health care provider or pharmacist.
- Visit www.xeominaesthetic.com to get the FDA-approved product labeling.
- Call 1-866-862-1211.
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).
XEOMIN® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you experience any of these problems anytime (hours to a week) after treatment with XEOMIN®:
- Difficulty swallowing, speaking, or breathing. These problems can occur hours to weeks after an injection of XEOMIN® if the muscles that you use to breathe, and swallow become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN®.
- Individuals with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN®.
- Swallowing problems may last for several months. Individuals who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. Individuals who already have swallowing or breathing problems before receiving XEOMIN® have the highest risk of getting these problems.
- Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called Botulism. The symptoms of Botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, or trouble swallowing.
These problems could make it unsafe for you to drive a car or engage in 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 (DYSPORT®) or have a skin infection at the planned injection site.
Ask a doctor before use if you:
- have a disease that affects your muscles and nerves (such as Amyotrophic Lateral Sclerosis [ALS or Lou Gehrig’s Disease], Myasthenia Gravis, or Lambert-Eaton Syndrome).
- have had any side effect from any other botulinum toxin in the past.
- have a breathing problem such as Asthma or Emphysema.
- have a history of swallowing problems or inhaling food or fluid into your lungs (Aspiration).
- have bleeding problems.
- have drooping eyelids.
- have plans to have surgery.
- have had surgery on your face.
- are pregnant or plan to become pregnant. It is not known if XEOMIN® can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if XEOMIN® passes into breast milk.
- XEOMIN® is not recommended for use in children younger than 18 years of age.
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.
Specifically tell your doctor if:
- have received any other botulinum toxin product in the last 4 months.
- have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN® may be different from other botulinum toxin products that you have received.
- have recently received an antibiotic by injection.
- take muscle relaxants.
- take an allergy or cold medicine.
- take a sleep medicine.
- take a blood thinner medicine.
Ask your doctor if you are unsure if your medicine is one that is listed above.
Possible side effects of XEOMIN®
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:
- dry mouth
- discomfort or pain at the injection site
- neck pain
- muscle weakness
- eye problems, including: double vision, blurred vision, drooping eyelids, swelling of your eyelids, and dry eyes. Reduced blinking can also occur. Tell your doctor or get medical help right away if you have eye pain or irritation after treatment.
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.
- XEOMIN® is a shot (injection) that your doctor will give you.
- XEOMIN® is injected into your affected muscles.
- Your doctor may change your dose of XEOMIN® until you and your doctor find the best dose for you.
General information about the safe, 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 individuals, even if they have the same symptoms that you have. It may harm them. You can request information about XEOMIN® that is written for health professionals from your pharmacist or doctor.
Active Ingredient: incobotulinumtoxinA
Inactive Ingredients: human albumin and sucrose