Botox and Filler Treatments

Legal Information

IMPORTANT INFORMATION ABOUT BOTOX® Cosmetic

Indications

Glabellar Lines

BOTOX® Cosmetic (onabotulinumtoxinA) for injection is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator
and/or procerus muscle activity in adult patients. 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

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and upper limb spasticity and at lower doses.

CONTRAINDICATIONS

BOTOX® 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 Effect

Please 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 Use

Serious 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 Reactions

Serious 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 System

There 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 Disorders

Individuals 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 Difficulties

Treatment 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 Site

Caution 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 Diseases

This 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 REACTIONS

The 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 INTERACTIONS
Co-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 POPULATIONS

BOTOX® 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. [Please see accompanying full Prescribing Information including Boxed Warning and Medication Guide.]


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 in adults over the age of 21.

JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus 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 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® 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 VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids 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, 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

In order to minimize the risk of potential complications, these products should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy.

Healthcare professionals are encouraged to discuss the potential risks of soft-tissue injections with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.

The safety and effectiveness for the treatment of anatomic regions other than the mid-face with JUVÉDERM VOLUMA® XC; facial wrinkles and folds with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLLURE™ XC; and the lips and perioral area with JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC have not been established in controlled clinical studies.

As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials.

The safety for use during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied.

The safety for use of JUVÉDERM VOLUMA® XC in patients under 35 or over 65 years, JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC in patients under 18 years, and JUVÉDERM VOLLURE™ XC and JUVÉDERM VOLBELLA® XC in patients under 22 years has not been established.

Use with caution in patients on immunosuppressive therapy.

Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites.

If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or if the product is administered before the skin has healed completely, there is a possible risk of an inflammatory reaction at the treatment site.

Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events.

The safety of JUVÉDERM VOLUMA® XC injectable gel for use in patients with very thin skin in the mid-face has not been established.

Patients may experience late onset nodules with use of dermal fillers, including JUVÉDERM VOLUMA® XC.

Patients may experience late onset adverse events with use of dermal fillers.

ADVERSE EVENTS

The most commonly reported side effects for JUVÉDERM® injectable gels were injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM VOLBELLA® XC, dryness was also reported. For JUVÉDERM VOLUMA® XC, side effects were predominantly moderate in severity, with duration of 2 to 4 weeks; for JUVÉDERM® Ultra XC , JUVÉDERM® Ultra Plus XC, or JUVÉDERM VOLLURE™ XC, they were mostly mild or moderate in severity, with duration of 14 days or less; and for JUVÉDERM VOLBELLA® XC, they were predominantly mild or moderate, with duration of 30 days or less.

To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan at 1-800-433-8871. Please visit JuvedermDFU.com for more information.

Products in the JUVÉDERM® Collection are available by prescription only.