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

The Benefits of Balance

You’ve always been able to look younger than your age, trimming a few years off here and there with your stylish clothes, your radiant smile, and even your vibrant personality. All the while, the effects of aging have been trying to catch up to you, working to form small wrinkles and stubborn etched-in lines on specific areas of your face.

Maybe you’ve noticed a few stubborn lines above your lips that used to be hidden by makeup, or you’ve caught your reflection and seen some small wrinkles starting to develop around your mouth. Although these changes are natural, it doesn’t mean you have to live with them.

Fortunately, there may be an ideal option that can help you take those wrinkles all the way to smooth.

BELOTERO BALANCE® injectable gel is a prescription injection that is used to temporarily smooth out and fill in moderate-to-severe nasolabial folds as well as other moderate-to-severe etched-in lines and wrinkles around your lips and mouth.1

It Works Within Your Skin 

One of the most important factors in choosing a filler treatment is understanding how it works. Over time, our skin begins to lose naturally occurring components such as collagen, elastin, and hyaluronic acid (HA), leaving skin more prone to develop etched-in lines and wrinkles.1-3

BELOTERO BALANCE® is a hyaluronic acid (HA) injectable filler that completely integrates into the skin tissue.2,3 While some fillers are designed to rebuild facial volume and structure, BELOTERO BALANCE specifically treats moderate-to-severe etched-in lines and wrinkles such as vertical lip lines above and around the lips.4

Safe and effective

After just one treatment of BELOTERO BALANCE®, you may see a noticeable difference in your appearance. BELOTERO BALANCE creates an elegant finishing touch to your injectable treatment regimen, filling small gaps beneath your skin’s surface and improving the appearance of moderate-to-severe etched-in lines and wrinkles.1,2

BELOTERO BALANCE is injected into the skin during a simple, quick appointment that can be performed around your schedule. The treatment requires little to no downtime, so you are able to continue with the rest of your day.3 As with all injectable procedures, your licensed healthcare provider has options to help manage your comfort during treatment.

FREQUENTLY ASKED QUESTIONS

+ What is BELOTERO BALANCE®?

BELOTERO BALANCE is an injectable filler that is used to smooth moderate-to-severe etched-in lines and wrinkles on your face.1 Upon injection, it quickly and evenly integrates into your skin.2,3

+ Is this like a botulinum toxin treatment?

No, BELOTERO BALANCE acts in a totally different way. It fills in areas within the skin to reduce the depth of wrinkles, lines, and folds. The skin remains mobile and flexible, with a natural look, feel, and movement.

+ What is the difference between BELOTERO BALANCE and other fillers?

BELOTERO BALANCE is a hyaluronic acid injectable filler designed to integrate into facial skin tissue. The unique manufacturing process for BELOTERO BALANCE yields a soft and cohesive gel that, once injected, instantly fills the skin to help smooth moderate-to-severe etched-in lines and wrinkles.4,5 While the product is versatile enough to handle moderate nasolabial folds (smile lines around the mouth), it may be an ideal option for treating delicate areas such as etched-in smile lines and vertical lip lines (thin lines that appear above and around the lips).5

+ How soon can I expect results?

Immediately upon treatment, BELOTERO BALANCE helps smooth etched-in lines and wrinkles, such as vertical lip lines above and around your lips.5

+ How long does it last?

Individual results may vary, but BELOTERO BALANCE may last about 6 months or more.5 Some factors that affect how long it lasts are the amount of product used and the area it is injected into. In areas that experience a lot of movement due to eating, talking, and smiling, the product may not last as long as other less active areas.

+ How much do I need?

Just as wrinkles and folds vary from face to face, so does the amount of BELOTERO BALANCE needed per treatment.1 It’s very individual—it depends on the amount of correction desired, the number of areas to be treated, and other factors. Your healthcare provider can better estimate once you have a consultation about your individual needs.

+ How much does it cost?

While each BELOTERO BALANCE healthcare provider determines price in his/her own way, BELOTERO BALANCE is comparably priced to other fillers.

+ Does it hurt?

As with all injectable treatments, there can be discomfort associated with the procedure.1 If you have concerns, discuss them with your healthcare provider, because there are effective ways to manage this during treatment.

+ What is BELOTERO BALANCE made of?

BELOTERO BALANCE is made of a substance called hyaluronic acid (HA)1, a natural component of skin. HA binds to water, making it an ideal product for correcting wrinkles and folds, as it binds with the skin’s own water.6 The HA in BELOTERO BALANCE is specially formulated in a proprietary process to create a uniquely smooth and cohesive gel.5 This injectable gel blends into the natural structure of your skin, gently filling etched-in lines and wrinkles and creating a smooth, natural look and feel.2,3

+ How is the treatment performed?

BELOTERO BALANCE is injected into the skin in a simple, quick treatment performed by a licensed healthcare provider using a fine-gauge needle. You can either sit or recline during treatment and the aftercare is minimal.

+ Is it safe?

BELOTERO BALANCE is FDA approved and clinically proven safe and effective.1 Hyaluronic acid products for wrinkle correction have been available for a long time and used in thousands of treatments.

+ Are there any side effects?

BELOTERO BALANCE is FDA approved and has undergone testing in a clinical study to demonstrate its safety. Hyaluronic acid products for wrinkle correction have been available for a long time and used in thousands of treatments.

Just like any injection, you may experience mild irritation, swelling, itching, redness, bruising, or tenderness at the injection site. These side effects typically resolve on their own. If any of these side effects persist for more than 7 days, contact your healthcare provider immediately.1

+ How long is the recovery time?

There is very little to no downtime associated with a BELOTERO BALANCE treatment. In fact, most patients return to their normal, daily activities right after their visit. Every patient is unique, so be sure to discuss your plans during a consultation with your healthcare provider.

 
 

What is BELOTERO BALANCE®?
BELOTERO BALANCE is a prescription injection that is approved to temporarily smooth out and fill in moderate to- severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth).

IMPORTANT SAFETY INFORMATION FOR BELOTERO BALANCE

Who should not use BELOTERO BALANCE?
BELOTERO BALANCE should not be used in patients with a history of or presence of multiple or severe allergies, including those with a history of anaphylaxis. BELOTERO BALANCE should not be used in patients with allergies to gram-positive bacterial proteins.

What is the most important information I should know about BELOTERO BALANCE?
Introduction of BELOTERO BALANCE into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.

As with all events that involve an injection through the skin, there is a risk of infection. Laser treatments or chemical peels or any other treatments that affect the skin can increase the risk of infection. Do not use BELOTERO BALANCE if you have a skin inflammation or a skin infection. Do not use until the infection is healed.

Patients getting BELOTERO BALANCE may have an injection site reaction. These reactions can include inflammation and usually last less than seven days.

For approximately 24 hours after treatment, avoid:

  • strenuous activity

  • extensive sun or heat exposure

  • aspirin or non-steroidal anti-inflammatory drugs

  • alcoholic beverages

Exposure to any of the above can cause temporary redness, swelling, and/or itching at the injection site.

It is not known how BELOTERO BALANCE will work in areas of the face other than the smile lines. It is not known how BELOTERO BALANCE will work in women who are pregnant or breastfeeding or people who are less than 21 years of age.

What should I tell my doctor before injections with BELOTERO BALANCE?

Tell your doctor if you are taking medicines that affect blood clotting, like aspirin, an NSAID or warfarin.  These medicines may put you at an increased risk of bruising or bleeding at the treatment site. Tell your doctor if you have a skin reaction like cold sores, cysts, pimples, rashes, hives, or an infection. Treatment with BELOTERO BALANCE should be delayed until the reaction goes away. Tell your doctor if you are taking medicines that affect your immune system.

What are the most common adverse events seen with BELOTERO BALANCE?

The most common adverse events seen in clinical studies with BELOTERO BALANCE were swelling, bruising, redness, hardening of the skin, pain, altered color, or itching. Other side effects that have occurred in clinical studies of 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 often resolved within 7 days.

Information on adverse events from post-market surveillance of BELOTORO BALANCE are included in the Package Insert (PI) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to BELOTERO BALANCE.    Please see the PI and PIG available on www.belotero.com for a complete list of these events. 

Important: For full safety information and Instructions for Use, please visit www.belotero.com or call MyMerz Solutions at 1-844-469-6379.

Rx only

Reference: 1. BELOTERO BALANCE® [Instructions for Use]. EM00494. Merz North America, Inc.; 2016.