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Please read full Important Safety Information for Xeomin®, for upper facial lines, including Distant Spread of Toxin Effect Boxed Warning at bottom of page.
XEOMIN® (incobotulinumtoxinA) 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:
- Talk to your health care provider or pharmacist.
- Visit www.xeominaesthetic.com to obtain the Full Prescribing Information and Medication Guide.
- Call 1-866-862-1211
Uses: XEOMIN is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe upper facial lines (frown lines, forehead lines, and crow’s feet) in adults for a short period of time (temporary). Please see additional Important Safety Information below and Full Prescribing Information and Medication Guide at XeominAesthetic.com.
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 weeks) after treatment with XEOMIN:
- Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.
- People 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, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People 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, trouble swallowing.
These symptoms can happen hours to weeks after you receive an injection of 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 (DYSPORT®) or have a skin infection at the planned injection site.
Before receiving XEOMIN, tell your doctor about all of your medical conditions, including 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.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN.
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:
- have received any other botulinum toxin product in the last four 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.
Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
Possible Side Effects
XEOMIN can cause serious side effects that can be life threatening 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. See “Warnings.”
The most common side effect of XEOMIN in people with upper facial lines include:
- injection site bruising.
These are not all the possible side effects of XEOMIN. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
General information about the safe and effective use of XEOMIN
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.
Active Ingredient: botulinum toxin type A.
Inactive Ingredients: human albumin and sucrose.
What are RADIESSE® and RADIESSE® (+)?
RADIESSE® and RADIESSE® (+) are dermal fillers that are used for smoothing moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of your nose to the corner of your mouth).
RADIESSE® is also used for correcting volume loss in the back of the hands and, when diluted with saline to smooth away wrinkles such as those in the décolleté in patients 22 years of age and older. RADIESSE® (+) is also used for improving moderate to severe loss of jawline contour in adults over 21 years old.
RADIESSE® and RADIESSE® (+) IMPORTANT SAFETY INFORMATION
Who should not use RADIESSE® or RADIESSE® (+)?
You should not use RADIESSE® or RADIESSE® (+) if you have an allergy to any component of the product, if you have a history of severe allergies, if you have a bleeding disorder. You should not use RADIESSE® (+) if you have an allergy to lidocaine or medicines like it.
What is the most important information I should know about RADIESSE® and RADIESSE® (+)?
One of the risks with using these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
As with all procedures that involve an injection through the skin, there is a risk of infection.
Do not use RADIESSE® or RADIESSE® (+) if you have a skin infection until it has healed.
It is not known if RADIESSE® or RADIESSE® (+) is safe or effective in the lips, or in the area around the eyes, or if you are pregnant or breastfeeding.
It is not known if RADIESSE® or RADIESSE® (+) is safe or effective beyond 3 years in the face, 1 year in the hand, and 84 weeks in the décolleté.
Injection of RADIESSE® (+) into the jawline may temporarily alter jaw function.
The safety of RADIESSE® in the décolleté in patients under 22 years of age has not been established.
The microspheres in RADIESSE® and RADIESSE® (+) can be seen in X-rays and CT scans. It is very important that you tell your health care provider that you have had RADIESSE® or RADIESSE® (+) dermal filler. A clinical study found no evidence of RADIESSE® injected in the décolleté being visible on mammograms or breast ultrasounds, but you should still inform your doctor and radiologist that you have received RADIESSE® in the treated area so they can interpret your imaging appropriately.
If you have a history of herpes, you may experience a herpes breakout after receiving RADIESSE® or RADIESSE® (+).
Injection in the back of the hand may result in temporary difficulty performing activities. RADIESSE® may cause nodules, bumps or lumps in the back of the hand and can last up to 1 year.
You should minimize strenuous activity and avoid extensive sun or heat exposure for about 24 hours after treatment and until any swelling or redness has resolved.
What should I tell my doctor before using RADIESSE® or RADIESSE® (+)?
Tell your health care provider if you are taking blood thinners or medicines that can interfere with the clotting of blood, such as aspirin or warfarin. These medicines might make it more likely that you will experience bruising or bleeding at the injection site. Tell your health care provider if you have any diseases, injuries or disabilities of the hand, if you have a history forming large, raised scars or if you have had any other skin treatments such as skin peels.
What are the most common adverse events with RADIESSE® or RADIESSE® (+)?
The most common adverse events seen in clinical studies of RADIESSE® used in the hands include bruising, redness, swelling, pain, itching, nodules or bumps/lumps, difficulty performing activities, loss of sensation and other local side effects. The most common adverse events seen in clinical studies of RADIESSE® or RADIESSE® (+) used in the face include bruising, redness, swelling, pain, itching, difficulty chewing, and other local side effects.
Delayed-onset inflammation near the site of injection is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.
These are not all of the possible side effects with RADIESSE® or RADIESSE® (+). Merz collects information about adverse events seen with RADIESSE® and RADIESSE® (+) outside of clinical studies. These events are included in the RADIESSE® and RADIESSE® (+) Patient Information Guide based on an assessment of seriousness and potential causal relationship to RADIESSE® or RADIESSE® (+). Please see the Patient Information Guide available at radiesse.com for a list of these events. Tell your health care provider about any side effects that bother you or do not go away.
Important: For full safety information, please visit radiesse.com or call MyMerz Solutions at 1-844-469-6379
RADIESSE® and RADIESSE® (+) are available by prescription only.
What are BELOTERO BALANCE® (+) and BELOTERO® VOLUME (+)?
BELOTERO BALANCE® (+) is a hyaluronic acid dermal filler used for smoothing moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of your nose to the corner of your mouth) and also used to add volume beneath the eyes to improve the hollow, sunken appearance of the infraorbital area in adults over the age of 21.
BELOTERO® VOLUME (+) is a hyaluronic acid dermal filler used to restore volume in the midface and correct midface contour deficiencies, including adding fullness to the cheeks, in adults 22 years of age or older.
BELOTERO BALANCE® (+) and BELOTERO® VOLUME (+) IMPORTANT SAFETY INFORMATION
Who should not use these products?
You should not use BELOTERO BALANCE® (+) or BELOTERO® VOLUME (+), if you have severe allergies with a history of anaphylaxis or multiple severe allergies, or an allergic reaction to any product component, including small amounts of protein from bacteria. You should not use BELOTERO BALANCE® (+) or BELOTERO® VOLUME (+) if you are allergic to lidocaine or similar anesthetics. If you easily develop large scars or keloids, you should not use these products.
What is the most important information I should know about these products?
One of the risks with using these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
Because of this risk, your doctor may check your vision before and after treatment with any of these products and should know in advance which eye specialist to contact if you were to experience an eye-related complication.
Do not use these products if you have a skin infection, cold sore, pimple, cyst, or rash at the treatment site until it has healed.
It is not known if these products are safe or effective if you are pregnant or breastfeeding, or if you are under 21 years old (for treatment of the infraorbital hollow with BELOTERO BALANCE® (+)) or under 22 years old (for midface treatment with BELOTERO® VOLUME (+)).
It is also not known if BELOTERO BALANCE® (+) is safe or effective beyond 96 weeks.
If you have a history of cold sores, you may experience a breakout after treatment.
What should I tell my doctor before treatment?
Tell your health care provider if you are taking blood thinners or medicines that can interfere with clotting, such as aspirin or warfarin, as these may increase your risk of bruising or bleeding at the injection site. Tell your doctor if you are taking medicines that decrease your body’s natural defenses (immunosuppressants), as this may increase your risk of infection. Tell your doctor about any past skin treatments, such as laser treatment or chemical peels.
What are the most common side effects?
The most common side effects seen in clinical studies include swelling, bruising, redness, pain or tenderness, firmness, itching, and lumps or bumps at the injection site. Most of these side effects are temporary and resolve within 1 to 4 weeks, though in some people they may last longer. In studies of the infraorbital hollow and of the lips, bruising and visible lumps were reported somewhat more often than in studies of the nasolabial folds or midface.
Delayed-onset inflammation near the site of injection is a known side effect of dermal fillers. Cases have been reported to occur following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, this inflammation responds to treatment or resolves on its own.
These are not all of the possible side effects with these products. Merz collects information about side effects seen with these products outside of clinical studies. These events are included in the Patient Information Guide based on an assessment of seriousness and potential causal relationship to the product. Please see the Patient Information Guide available at www.belotero.com for a list of these events. Tell your health care provider about any side effect that bothers you or does not go away.
Important: For full safety information, please visit www.belotero.com or call MyMerz Solutions at 1-844-469-6379.
BELOTERO BALANCE® (+) and BELOTERO® VOLUME (+) are available by prescription only.
The Ulthera® System is U.S. FDA-cleared to lift the eyebrow, the skin on the neck and under the chin, as well as to improve lines and wrinkles on the décolleté, and to improve the appearance of skin laxity on the abdomen, anterior arms, posterior arms and knees.
Reported adverse events from post marketing surveillance are available in the Instructions for Use (IFU). The most common side effects reported in clinical trials were redness, swelling, pain and transient nerve effects. Talk to your practitioner for additional safety information and possible side effects or find out more at Ultherapy.com/IFU
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