JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLUMA® XC Important Information
JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
JUVÉDERM® XC injectable gels (JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC) are for injection into areas of facial tissue where moderate to severe facial wrinkles and folds occur to temporarily add volume to the skin, especially around the nose and mouth.
JUVÉDERM VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThese products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to gram-positive bacterial proteins or lidocaine contained in these products.
ADVERSE EVENTSThe most commonly reported side effects for JUVÉDERM® XC injectable gels were temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® Ultra XC or JUVÉDERM® Ultra Plus XC, they were mild or moderate in severity, with a duration of 14 days or less; and for JUVÉDERM VOLUMA® XC, they were predominantly moderate in severity, with a duration of 2 to 4 weeks.
To report an adverse reaction with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.
For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.
JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLUMA® XC injectable gels are available by prescription only.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Lateral Canthal Lines
BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
CONTRAINDICATIONSBOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin EffectPlease refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines) have been reported.
Serious Adverse Reactions With Unapproved UseSerious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
Hypersensitivity ReactionsSerious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
Cardiovascular SystemThere have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Pre-existing Neuromuscular DisordersIndividuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).
Dysphagia and Breathing DifficultiesTreatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
Pre-existing Conditions at the Injection SiteCaution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Human Albumin and Transmission of Viral DiseasesThis product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
ADVERSE REACTIONSThe most frequently reported adverse event following injection of BOTOX® Cosmetic for glabellar lines was eyelid ptosis (3%).
The most frequently reported adverse event following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).
DRUG INTERACTIONSCo-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.
USE IN SPECIFIC POPULATIONSBOTOX® Cosmetic is not recommended for use in children or pregnant women. It is not known whether BOTOX® Cosmetic is excreted in human milk. Caution should be exercised when BOTOX® Cosmetic is administered to a nursing woman.
Natrelle® Breast Implants Important Information
INDICATIONSNatrelle® Breast Implants are indicated for women for the following:
Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.IMPORTANT SAFETY INFORMATION
WARNINGSAVOID DAMAGE DURING SURGERY
Do not do the following: place drugs or substances inside saline-filled implants other than sterile saline for injection, inject through the implant shell, contact the implant with disposable, capacitor-type cautery devices, alter the implants, repair or insert a damaged prosthesis, immerse the implant in povidone-iodine (rinse the breast pocket thoroughly if povidone-iodine is used), reuse or resterilize any product that has been previously implanted, place more than one implant per breast pocket, use the periumbilical approach to place the implant or use microwave diathermy in patients with breast implants.
PRECAUTIONSSafety and effectiveness have not been established in patients with the following: autoimmune diseases, a compromised immune system, planned radiation therapy to the breast or planned chemotherapy following breast implant placement, conditions/medications that interfere with wound healing and blood clotting, reduced blood supply to breast tissue or a clinical diagnosis of depression, other mental health disorders, body dysmorphic disorder or eating disorders. These disorders should be resolved or stabilized prior to surgery.
ADVERSE EVENTSKey adverse events are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture Baker Grade III/IV. Other adverse events that may occur include: asymmetry, nipple/breast/skin sensation changes, scarring or wrinkling/rippling.
For more information see the full Directions for Use at www.allergan.com/labeling/usa.htm or call the Allergan Product Support line at 1-800-433-8871.
To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.
Natrelle® Breast Implants are available by prescription only.
The information on this site is intended for US medical professionals only. The information on this site is not intended as a substitute for professional medical training.
1. Data on file, Allergan, Inc.; Worldwide Dermal Facial Filler Market Overview, Q4 2013. 2. JUVÉDERM VOLUMA® XC Directions for Use, 2014.