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Important Safety Information
Indication:
RADIESSE® injectable implant is FDA-approved for hand augmentation to correct volume loss in the dorsum of the hands.
RADIESSE IMPORTANT SAFETY INFORMATION:
Contraindications:
RADIESSE injectable implant is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders.
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 RADIESSE 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.
Do not overcorrect (overfill) a contour deficiency with RADIESSE because the depression should gradually improve within several weeks as the treatment effect of RADIESSE occurs. The safety and effectiveness for use in the lips has not been established.
Special care should be taken to avoid injection into veins or tendons in the hand. Injection into tendons may weaken tendons and cause tendon rupture. Injection into veins may cause embolization or thrombosis.
Injection into the hand may cause adverse events that last for more than 14 days. Injection in the dorsum of the hand may result in temporary difficulty performing activities (48% of study patients reported this adverse event). Fitzpatrick Skin Types IV-VI may have an increased risk in difficulty performing activities (68% of Fitzpatrick Skin Types IV-VI reported this event). RADIESSE may cause nodules, bumps or lumps in the dorsum of the hand (12% reported this event) and can last up to 1 year.
Injection into patients with very severe loss of fatty tissue with marked visibility of veins and tendons has not been studied. The safety and effectiveness in this patient population has not been established.
Volumes over 3 cc of RADIESSE per hand in a treatment session have not been studied. Increased bruising is associated with higher volume injection. Retreatment with RADIESSE of volumes greater than approximately 1.6cc per hand in a treatment session can result in increased adverse events (redness, pain, swelling, and difficulty performing activities).
Precautions:
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.
RADIESSE contains calcium hydroxylapatite (CaHA) particles that are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography. Safety of RADIESSE injectable implant beyond 3 years in the face and 1 year in the hand has not been investigated in clinical trials.
As with all transcutaneous procedures, RADIESSE injectable implant injection carries a risk of infection.
Use of RADIESSE in the dorsum of the hand in patients with diseases, injuries or disabilities of the hand has not been studied. Care should be used in treating patients with autoimmune disease affecting the hand, hand implants, Dupuytren’s contracture, history of hand tumor, vascular malformations, Raynaud’s disease and patients at risk for tendon rupture.
Use of RADIESSE in the dorsum of the hand may result in significant swelling of the dorsum of the hand. Patients should be instructed to remove jewelry (rings) before treatment and until swelling has resolved to avoid compromise of finger circulation. The effects of RADIESSE injection on hand function is uncertain.
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 inform their physician if they are using such medications. Interactions between RADIESSE with drugs or other substances or implants have not been evaluated.
Safety of RADIESSE for use during pregnancy, in breastfeeding has not been established. Safety of RADIESSE injected into the dorsum of the hand in patients under 26 years old and over 79 years old has not been studied. The safety of RADIESSE in patients with increased susceptibility to keloid formation and hypertrophic scarring has not been studied. The safety of RADIESSE injectable implant with concomitant dermal therapies such as epilation, UV irradiation, or laser, mechanical or chemical peeling procedures has not been evaluated in controlled clinical trials.
Patients with a history of previous herpetic eruption may experience reactivation of the herpes.
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.
Adverse Events:
Serious adverse events that have been seen with RADIESSE regardless of indication include necrosis, allergic reaction, edema and infection. Common adverse events with RADIESSE when injected into the dorsum of the hand include bruising, redness, swelling, pain, itching, nodule or bumps/ lumps, difficulty performing activities, loss of sensation and other local side effects. To report a problem with RADIESSE, please call Customer Service at 1-866-862-1211.
For complete Safety Information please refer to the Instructions for Use
RADIESSE® and BELOTERO BALANCE®
Indication
RADIESSE® Injectable Implant is FDA-approved for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. 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.
Important Safety Information for RADIESSE® and BELOTERO BALANCE®
Contraindications
RADIESSE® and 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.
RADIESSE® should not be used in patients with a history of hypersensitivity to any of the components; and patients with bleeding disorders.
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 RADIESSE® or 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.
Do not overcorrect (overfill) a contour deficiency with RADIESSE® Injectable Implant because the depression should gradually improve within several weeks as the treatment effect of RADIESSE® occurs. The safety and effectiveness of RADIESSE® use in the lips, periorbital area, in patients under 18, or in patients with a susceptibility to keloid formation and hypertrophic scarring has not been established.
Precautions
In order to minimize the risks of potential complications, RADIESSE® and 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.
The calcium hydroxyapatite (CaHA) particles of RADIESSE® Injectable Implant are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography. Patients need to be informed of the radiopaque nature of RADIESSE® Injectable Implant, so that they can inform their primary care health professionals as well as radiologists. In a radiographic study of 58 patients, there was no indication of RADIESSE® Injectable Implant potentially masking abnormal tissues or being interpreted as tumors in CT Scans.
Safety of RADIESSE® Injectable Implant beyond 3 years has not been investigated in clinical trials. The long-term safety and effectiveness of BELOTERO BALANCE® beyond 96 weeks have not been investigated.
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.
As with all skin-injection procedures, there is a risk of infection with RADIESSE® and BELOTERO BALANCE®.
The safety and effectiveness of RADIESSE® and BELOTERO BALANCE® during pregnancy or breastfeeding, for the treatment of dermal contour defects other than nasolabial folds, such as use in the lips, or in patients under 21 years have not been established.
The use of RADIESSE® in patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
The safety of BELOTERO BALANCE® in patients with known susceptibility to recurrent sore throat or Osler Rendu endocarditis has not been studied.
BELOTERO BALANCE® should be used with caution in patients on immunosuppressive therapy.
No studies of RADIESSE® Injectable Implant with drugs or other substances or implants have been conducted.
Laser treatment, chemical peeling, or any other procedure based on active dermal response performed after treatment with RADIESSE® or BELOTERO BALANCE® may increase the risk of an inflammatory reaction at the injection site.
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.
Adverse Events
The most common local adverse events seen 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.
Serious adverse events that have been seen with RADIESSE® include necrosis, allergic reaction, edema and infection. Common adverse events with RADIESSE® are generally mild in nature and short in duration and include bruising, redness, swelling, pain, itching and other local side effects.
To report a problem with RADIESSE® or BELOTERO BALANCE®, please call Merz Aesthetics Customer Service at 1-866-862-1211.
For complete Safety Information, please visit www.radiesse.com and www.belotero.com
Rx Only
References: 1. Lorenc ZP, Fagien S, Flynn TC, Waldorf HA. Review of key Belotero Balance safety and efficacy trials. Plast Reconstr Surg. 2013;132(4 suppl 2):33S-40S. 2. Moers-Carpi M, Vogt S, Santos B, Planas J, Vallve SR, Howell DJ. A multicenter, randomized trial comparing calcium hydroxylapatite (RADIESSE®) to two hyaluronic acids (Juvéderm® and Perlane®) for treatment of nasolabial folds. Dermatol Surg. 2007;33:S144-S151. 3. RADIESSE [instructions for use for the dorsom of the hands]. Franksville,WI: Merz North America, Inc; 2015. 4. BELOTERO BALANCE [instructions for use]. Greensboro, NC: Merz North America, Inc.; 2012. 5. RADIESSE [instructions for use]. Franksville, WI: Merz North America, Inc.; 2013.
Copyright© 2015 Merz North America Inc. All rights reserved. MERZ AESTHETICS and the MERZ AESTHETICS logo are trademarks of Merz Pharma GmbH & Co. KGaA. BELOTERO and BELOTERO BALANCE are registered trademarks of Merz Pharma GmbH & Co. KGaA. RADIESSE is a registered trademark of Merz North America, Inc. EM01533-00
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