belotero

BELOTERO

What is BELOTERO BALANCE®?

BELOTERO BALANCE is a prescription injection that is approved to temporarily smooth and fill moderate to severe nasolabial folds (the folds or wrinkles that run from the side of the nose to the corner of the mouth).

Important Safety Information on BELOTERO BALANCE

Who should not use BELOTERO BALANCE

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

What is the most important information I should know about BELOTERO BALANCE?

Introducing BELOTERO BALANCE into the vascular system can lead to embolization, vessel occlusion, ischemia or infarction. Use extreme caution when injecting soft tissue fillers, e.g., inject the product slowly and apply as little pressure as possible. Rare but serious adverse events associated with intravascular injection of soft tissue fillers into the face have been reported and include temporary or permanent visual impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Stop the injection immediately if a patient experiences any of the following symptoms, including vision changes, signs of stroke, skin blanching, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate specialist health care practitioner for intravascular injection.

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

Patients receiving BELOTERO BALANCE may have a reaction at the injection site. These reactions may include inflammation and usually last less than seven days.

For about 24 hours after treatment, avoid:

• strenuous activity
• prolonged exposure to sun or heat
• aspirin or nonsteroidal anti-inflammatory drugs
• alcoholic beverages.

Exposure to any of these substances may 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 smile lines. It is not known how BELOTERO BALANCE will work in pregnant or breastfeeding women, or in people under the age of 21.

What should I tell my doctor before BELOTERO BALANCE injections?

Inform your doctor if you are taking any medications that affect blood clotting, such as aspirin, an NSAID, or warfarin.  These medications may increase the risk of hematoma or bleeding at the treatment site. Tell your doctor if you have a skin reaction such as cold sores, cysts, pimples, rash, hives or infection. Treatment with BELOTERO BALANCE should be delayed until the reaction goes away. Tell your doctor if you are taking any medications that affect your immune system.

What are the most common side effects seen with BELOTERO BALANCE?

The most common side effects observed in clinical studies with BELOTERO BALANCE were swelling, bruising, redness, skin hardening, pain, color change, or itching. Other side effects that occurred in clinical studies with BELOTERO BALANCE were headache, swelling on the side of the nose, moderate cold sore, numbness of the lips and dryness of the lips. Side effects were often mild to moderate and often resolved within 7 days.

Adverse event information from postmarketing surveillance of BELOTORO BALANCE is included in the package insert (PI) and patient information guide (PIG) based on an assessment of severity and potential causal relationship with BELOTERO BALANCE.   

Please see the package insert and PIG available at www.belotero.com for a complete list of these events.