BELOTERO ® 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).
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.
Introduction of product 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.
Use of BELOTERO BALANCE® in any person with active skin inflammation or infection in or near the treatment should be deferred until the inflammatory or infectious process is controlled.
Injection site responses to BELOTERO BALANCE® have been observed, consisting mainly of short-term inflammatory symptoms starting early after treatment and with 7 days duration or less.\
In order to minimize the risk of potential complications, this product should only be used by healthcare practitioners who have appropriate training, experience and who are knowledgeable about the anatomy at and around the injection site.
In order to minimize the risks of potential complications, Healthcare practitioners should fully familiarize themselves with the product, the product educational materials and the entire package insert.
Based on clinical trials, patients should be limited to 6.0 mL of BELOTERO BALANCE® per year. The safety of injecting greater amounts has not been established.
The safety and effectiveness of BELOTERO BALANCE® in the following situations has not been established:
- Beyond 96 weeks in the face.
- In patients during pregnancy, in breastfeeding females, or in patients under 21 years of age.
- In patients with a known susceptibility to recurrent sore throat or Osler Rendu endocarditis.
- With concomitant dermal therapies such as laser, mechanical or chemical peeling procedures.
BELOTERO BALANCE® should be used with caution in patients on immunosuppressive therapy.
Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection site.
Patients should minimize strenuous activity and exposure of the treated area to extensive sun or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has resolved.
The most common local adverse events observed in clinical trials with BELOTERO BALANCE® were swelling, bruising, redness, hardening of the skin, pain, altered color or itching. Other adverse events that have occurred observed in clinical trials 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.
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.
To report a problem with BELOTERO BALANCE®, please call MyMerz Solutions at 1-844-469-6379.
For complete Safety Information please refer to the Belotero Balance Package Insert
Caution: Rx Only