Allergan Aesthetics to Present Data from Its Leading Aesthetic Portfolio at the 2022 American Society for Dermatologic Surgery Meeting

IMPORTANT SAFETY INFORMATION & APPROVED USES

JUVÉDERM^® Collection of Fillers Important Information

INDICATIONS

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 and for augmentation of the chin region to improve the chin profile in adults over the age of 21.

JUVÉDERM^® VOLUX™ XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.

JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.

JUVÉDERM^® VOLBELLA^® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.

JUVÉDERM^® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

JUVÉDERM^® Ultra XC injectable gel is also indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

These 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.

WARNINGS

• Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary.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: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
• Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled

PRECAUTIONS

• To minimize the risk of potential complications, these products should only be used by healthcare professionals who are knowledgeable about the anatomy and the product(s) for use in indicated area(s), and who have appropriate training in facial anatomy, vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
• The potential risks of soft issue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
• The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each product have not been established in controlled clinical studies
• The safety for use of these products in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
• The safety for use during pregnancy and in breastfeeding females has not been established
• The safety for use of JUVÉDERM^® VOLUMA^® XC has been established in patients between 35 and 65 years of age for cheek augmentation and in patients between 22 and 80 years of age for chin augmentation
• The safety for use of JUVÉDERM^® Ultra Plus XC and JUVÉDERM^® Ultra XC in patients under 18 years, and the safety for use of JUVÉDERM^® VOLUX™ XC, JUVÉDERM® VOLLURE^® XC, and JUVÉDERM^® VOLBELLA^® XC in patients under 22 years, has not been established
• Dermal filler implantation carries a risk of infection. Follow standard precautions
• Dermal fillers should be used with caution in patients on immunosuppressive therapy
• Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
• Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
• If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
• The safety for use of JUVÉDERM^® VOLUMA^® XC injectable gel in patients with very thin skin in the mid-face has not been established
• The safety for use of JUVÉDERM^® VOLUMA^® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
• JUVÉDERM^® VOLUMA^® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
• The effect of JUVÉDERM^® VOLUMA^® XC injection into the chin on facial hair growth has not been studied
• Patients may experience late-onset adverse events with injectable gel implants, and late-onset nodules with use of JUVÉDERM^® VOLUMA^® XC
• Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM^® injectable gel per 60 kg (132 lb) body mass per year. The safety of injecting greater amounts has not been established
• Injection of more than 9 mL of JUVÉDERM^® VOLUX™ XC for improvement of jawline definition has not been studied

ADVERSE EVENTS

The most common reported side effects for JUVÉDERM^® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM^® VOLBELLA^® XC, dryness was also reported. The majority were mild or moderate in severity.

To report an adverse reaction with any product in the JUVÉDERM^® Collection, please call Allergan^® Product Support at 1-877-345-5372. Please visit JuvedermDFU.com for more information.

Products in the JUVÉDERM^® Collection are available only by a licensed physician or properly licensed practitioner.

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA^® XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM^® VOLUX™ XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM^® VOLLURE^® XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM^® VOLBELLA^® XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus-xc_dfu.pdf for JUVÉDERM^® Ultra Plus XC

Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM^® Ultra XC

Indications
CoolSculpting^® Elite is FDA-cleared for the treatment of visible fat bulges in the thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm in patients with a Body Mass Index (BMI) of ≤ 30, and in submental and submandibular areas in patients with a BMI of ≤ 46.2. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments.

Important Safety Information
CoolSculpting^® Elite is contraindicated in patients with cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.

Ask your patient about any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.

During the procedure patients may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment.

Rare side effects may also occur. Paradoxical hyperplasia (visibly enlarged tissue volume in the treated area) may develop 2 to 5 months after treatment, will not resolve on its own, and may require surgical intervention for correction.

As with any medical procedure, a consultation should be done by a licensed healthcare professional to determine if the patient is a candidate for treatment. For a complete list of Contraindications, Warnings, Precautions, and Potential Side Effects, consult the CoolSculpting^® Elite System User Manual. Treatment applications that deviate from the guidelines are not recommended.

CoolTone^® Uses
The CoolTone^® device is FDA-cleared for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone^® is also FDA-cleared for strengthening, toning, and firming of buttocks and thighs.

CoolTone® Important Safety Information
The CoolTone^® procedure is not for everyone. You should not have the CoolTone^® treatment in areas with metal, electrical, or electronic implants/devices like cardiac pacemakers, implanted hearing devices, implanted defibrillators, implanted neurostimulators, drug pumps, or hearing aids.

Tell your doctor if you have any medical conditions as CoolTone^® should not be used over a menstruating uterus, over areas of the skin that lack normal sensation, in patients with fever, malignant tumor, hemorrhagic conditions, epilepsy, recent surgical procedure, pulmonary insufficiency, or pregnancy.

CoolTone^® should be used with caution in patients with Graves' disease (an autoimmune disorder that causes overactive thyroid), active bleeding disorders, or seizure disorders.

Women who are close to menstruation may find that it comes sooner, or cramping is increased or intensified with CoolTone^® treatments, therefore, it is recommended to not undergo treatment during this time of the month.

CoolTone^® should not be used in the heart or head areas, areas of new bone growth, over the carotid sinus nerves, or over the neck or mouth. CoolTone^® should not be applied over swollen, infected, inflamed areas or skin eruptions. Caution should be used for patients with suspected or diagnosed heart problems.

Common side effects may include, but may not be limited to, muscular pain, temporary muscle spasm, temporary joint or tendon pain, and redness at or near the treatment site.

Ask your Healthcare Provider if CoolTone^® is right for you.

Please see full Important Safety Information for additional information at coolsculpting.com/cooltone.

Patient results may vary.

RESONIC™ Important Safety Information
RESONIC™ (Rapid Acoustic Pulse™ device) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The RESONIC device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to 1 year of observation. The most common side effects may include mild to moderate temporary redness of the treatment site, mild pain, heat, and pinpoint redness. Your results and experience may vary, so it is important to talk to your healthcare provider about whether RESONIC is right for you. For full safety information, please visit www.RESONIC.com/ISI.

DiamondGlow^® Uses
The DiamondGlow^® device is a general dermabrasion device that gently removes the top layer of skin and delivers topical cosmetic serums onto the skin.

DiamondGlow^® Important Safety Information
The DiamondGlow^® treatment is not for everyone. You should not have a DiamondGlow^® treatment if you have compromised skin quality. Tell your provider if you are pregnant or lactating, or if you have medical condition, including allergies, and if you are using topical medications on the area to be treated.

Typical side effects include a scratchy, stinging sensation during the treatment and temporary tightness, redness or slight swelling after the treatment. Rare serious side effects may also occur and include severe skin irritation and allergic reactions.

SkinMedica^® Pro-Infusion Serums Disclaimer
SkinMedica^® Pro-Infusion Serums are intended to meet the FDA's definition of a cosmetic product, an article applies to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These products are not intended to be drugs that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA.

About Allergan Aesthetics
Allergan Aesthetics, an AbbVie company, develops, manufactures, and markets a portfolio of leading aesthetics brands and products.  Their aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more.  Their goal is to consistently provide customers worldwide with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. www.AllerganAesthetics.com

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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SOURCE AbbVie