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 FDA-approved product labeling 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 frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary).

It is not known if XEOMIN is safe and effective in children under 18 years of age.

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:

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HOW IT WORKS

How RADIESSE® Dermal Filler Smooths Skin Wrinkles & Folds

RADIESSE is a wrinkle filler used to plump the skin. RADIESSE is injected through a small needle and placed under the skin. Immediately, this filler works to add volume under the skin and over time, the benefits of RADIESSE continue by stimulating your body’s own natural collagen. The natural results have been shown to last a year or more in many patients, making the treatment results both immediate and long lasting.

Mechanism of Action

RADIESSE is comprised of Calcium Hydroxylapatite (CaHA) microspheres suspended in an aqueous gel carrier.1

Once injected, it provides immediate volume and correction but continues to work by stimulating the body to produce its own natural collagen.1

Over time, the gel is absorbed and the body metabolizes the CaHA microspheres leaving behind only your own natural collagen.1

Why choose RADIESSE?

RADIESSE immediately replenishes lost volume and stimulates the production of your own natural collagen with results that can last a year or more in many patients.1-3

  • Over time, the gel is absorbed and the body metabolizes the CaHA microspheres leaving behind only your own natural collagen.1

  • RADIESSE is clinically proven to last a year or more in many patients2,3

  • RADIESSE provides results with high patient satisfaction2,4

  • RADIESSE is FDA approved to mix with lidocaine, an anesthetic, to significantly reduce injection-related pain

RADIESSE is a viable option to help provide a long-lasting natural look while immediately smoothing wrinkles.

Find a provider in your area and ask how it gets better with RADIESSE.

 
 

+ What are RADIESSE®, RADIESSE® (+), and BELOTERO BALANCE®?

RADIESSE, RADIESSE (+), and BELOTERO BALANCE are dermal fillers that are FDA-approved to smooth 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 to correct volume loss in the back of the hands.

BELOTERO BALANCE, RADIESSE, and RADIESSE (+) Important Safety Information

+ Who should not use RADIESSE, RADIESSE (+), or BELOTERO BALANCE?

You should not use RADIESSE, RADIESSE (+), or BELOTERO BALANCE if you have a history of severe allergies or anaphylaxis, or if you are pregnant or breastfeeding.

You should not use RADIESSE or RADIESSE (+) if you have an allergy to any part of the product, or if you have a bleeding disorder.

You should not use RADIESSE (+) if you have an allergy to lidocaine or medicines like it.

You should not use BELOTERO BALANCE if you have an allergy to gram-positive bacterial proteins.

+ What is the most important information I should know about RADIESSE, RADIESSE (+), and BELOTERO BALANCE?

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.

The safety and effectiveness of RADIESSE, RADIESSE (+), or BELOTERO BALANCE in parts of the face other than facial wrinkles and folds has not been established.

Do not use RADIESSE, RADIESSE (+), or BELOTERO BALANCE if you have a skin infection or inflammation until it has healed.

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.

If you have a history of herpes, you may experience a herpes breakout after treatment.

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, RADIESSE (+), or BELOTERO BALANCE?

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 of forming large, raised scars, or if you have had any other skin treatments such as skin peels.

Before treatment with BELOTERO BALANCE, tell your doctor if you have frequent sore throats, or if you are on any immunosuppressive therapy.

+ What are the most common adverse events with RADIESSE, RADIESSE (+), or BELOTERO BALANCE?

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, and other local side effects.

The most common adverse events seen in clinical studies with BELOTERO BALANCE were swelling, bruising, redness, hardening of the skin, pain, altered color, and itching. Other adverse events that have occurred with BELOTERO BALANCE include headache, swelling of the side of the nose, moderate cold sore, lip numbness, and lip dryness. Side effects were often mild to moderate and usually resolved within 7 days.

These are not all of the possible side effects with RADIESSE, RADIESSE (+), or BELOTERO BALANCE. Merz collects information about adverse events seen with these products post-approval. These events are included in the RADIESSE, RADIESSE (+), and BELOTERO BALANCE Patient Information Guide based on an assessment of seriousness and potential causal relationship to the products. Please see the Patient Information Guides available at www.Radiesse.com and www.belotero.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 www.Radiesse.com, www.Belotero.com, or call MyMerz Solutions at 1-844-469-6379

RADIESSE, RADIESSE (+), and BELOTERO BALANCE are available by prescription only.


References:

1Berlin AL, Hussain M, Goldberg DJ. Calcium hydroxylapatite filler for facial rejuvenation: a histologic and immunohistochemical analysis. Dermatol Surg. 2008;34(suppl 1):S64-S67.

2Moers-Carpi M, Vogt S, Santos BM, et al. A multicenter, randomized trial comparing calcium hydroxylapatite to two hyaluronic acids for treatment of nasolabial folds. Dermatol Surg. 2007;33(suppl 2):S144-S151.

3Bass LS, Smith S, Busso M, McClaren M. Calcium hydroxylate (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results. Aesthetic Surg J. 2010;30(2):235-238.

4Moers-Carpi M, Tufet JO. Calcium hydroxylapatite versus nonanimal stabilized hyaluronic acid for the correction of nasolabial folds: a 12-month, multicenter, prospective, randomized, controlled split-face trial. Dermatol Surg. 2008;34(2):210-215.



Manufactured by Merz North America, Inc. Copyright © 2018 Merz North America, Inc. All rights reserved. MERZ AESTHETICS and the Merz Aesthetics logo are trademarks of Merz Pharma GmbH & Co. KGaA. RADIESSE and IT JUST GETS BETTER are registered trademarks of Merz North America, Inc. All other trademarks are the property of their respective owners.