BELOTERO BALANCE® (+)
Important Safety Information
Indications
BELOTERO BALANCE® (+) Injectable Implant is FDA-approved for injection into the mid-to-deep dermis for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds and for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21.
Contraindications
BELOTERO BALANCE® (+) should not be used in patients with bleeding disorders or in patients with severe allergies manifested by a history of anaphylaxis, or with a history or presence of multiple severe allergies. BELOTERO BALANCE® (+) should not be used in patients with a history of hypersensitivity to lidocaine or anesthetics of the amide type. BELOTERO BALANCE® (+) contains trace amounts of gram-positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material.
Warnings
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 (skin eruptions such as cold sores, cysts, pimples, rashes, or hives) or infection in or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
Precautions
In order to minimize the risks of potential complications, BELOTERO BALANCE® (+) should only be used by health care professionals who have appropriate training experience, and who are knowledgeable about the anatomy at and around the site of injection. Health care professionals are encouraged to discuss all potential risks of soft tissue infection with their patients prior to treatment and ensure that patients are aware of the signs and symptoms of potential complications. As with all skin-injection procedures, there is a risk of infection with BELOTERO BALANCE® (+). BELOTERO BALANCE® (+) should be used with caution in patients on immunosuppressive therapy. The use of BELOTERO BALANCE® (+) in patients with a history of previous herpetic eruption may be associated with reactivation of the herpes. Based on clinical trials, patients should be limited to a 6.0 mL of BELOTERO BALANCE® (+) per year. The safety of injecting greater amounts has not been established. The long-term safety and effectiveness of BELOTERO BALANCE® (+) beyond 96 weeks have not been investigated. The safety and effectiveness of BELOTERO BALANCE® (+) during pregnancy or breastfeeding, or in patients under 21 years have not been established. The safety of BELOTERO BALANCE® (+) in patients with known susceptibility to recurrent sore throat or Osler Rendu endocarditis has not been studied. No studies of BELOTERO BALANCE® (+) Injectable Implant with drugs or other substances or implants have been conducted. Patients using medications that prolong bleeding, such as aspirin, non-steroidal anti-inflammatory drugs, or warfarin, may experience increased bruising and bleeding at the injection site. Exposure of the treated area to excessive sun, UV lamp exposure, and extreme cold weather should be minimized until any initial swelling and redness have resolved and puncture sites have healed. Laser treatment, chemical peeling, or any other procedure based on active dermal response performed after treatment with BELOTERO BALANCE® (+) may increase the risk of an inflammatory reaction at the injection site.
Adverse Events
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 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 often resolved within 7 days.
Cases of delayed-onset inflammation have been reported to occur at the dermal filler 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.
Information on adverse events from post-market surveillance of BELOTERO BALANCE® (+) are included in the Instructions for Use (IFU) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to the products. Please see the IFU 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 or email AxUS-adverse.events@merz.com. For complete Safety Information, please visit www.belotero.com.
Rx only
References: 1. Sundaram H, et al. Plast Reconstr Surg. 2015;136(5 Suppl):149S-163S. 2. Micheels P, et al. Dermatol Surg. 2012;38(7 Pt 2):1162-1169. 3. Tran C, et al. Dermatology. 2014;228(1):47-54. 4. Borrell M, et al. J Cosmet Laser Ther. 2011;13(1):21-27. 5. Micheels P, et al. J Cosmet Dermatol. 2019;18(1):36-44. 6. Lorenc ZP, et al. Plast Reconstr Surg. 2013;132(4 Suppl 2):33S-40S. 7. Belotero Balance (+) [Instructions for Use]. IN00201-01. Merz North America, Inc; 2023. 8. Merz Aesthetics. Published September 26, 2023. Accessed October 18, 2023. https://us.merzaesthetics.com/news/merz-aesthetics-continues-to-fuel-confidence-by-expanding-belotero-balance-filler-treatment-areas/ 9. Sundaram H, et al. Dermatol Surg. 2010;36 Suppl 3:1859-1865. 10. Sundaram H, et al. Plast Reconstr Surg. 2015;136(4):678-686. 11. Sundaram H, et al. Poster presented at: American Academy of Dermatology 74th Annual Meeting; March 4-8, 2016; Washington, DC. Abstract 3940. 12. Sundaram H, et al. Poster presented at: 23rd World Congress of Dermatology; June 8-13, 2015; Vancouver, Canada. 13. Prasetyo AD, et al. Clin Cosmet Investig Dermatol. 2016;9:257-280. 14. Hermitte L, Benoit O, inventors; Anteis SA, assignee. European patent WO/2005/085329. September 15, 2005. 15. Narins RS, et al. Dermatol Surg. 2010;36(s1):730-740.
