Injectables

BOTOX® Cosmetic is the first and only FDA-approved product to temporarily improve both moderate to severe frown lines between the brows and crow’s feet lines around the sides of the eyes in adults.

BOTOX® Cosmetic is the first and only FDA-approved product to temporarily improve both moderate to severe frown lines between the brows and crow’s feet lines around the sides of the eyes in adults.

BOTOX® Cosmetic targets one of the underlying causes of frown lines and crow’s feet—the repeated muscle contractions from frowning and squinting over the years. Your doctor will inject these muscles with BOTOX® Cosmetic to temporarily reduce muscle activity. You’ll begin to notice a visible smoothing of these lines.

To temporarily improve moderate to severe crow’s feet, your doctor will inject BOTOX® Cosmetic into the muscle surrounding the sides of your eyes—called the orbicularis oculi.

For temporary improvement of moderate to severe frown lines, BOTOX® Cosmetic is injected into 2 muscles—the corrugator and procerus muscles.

Treatment with BOTOX® Cosmetic takes approximately 10 minutes and requires minimal downtime or recovery—it’s often called a lunchtime procedure.

Think 2 treatments, 1 visit. Ask your doctor aboutreceiving BOTOX® Cosmetic for moderate to severe frown lines and crow’s feet at the same time.

BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Indications

BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:

– moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity

– moderate to severe lateral canthal lines associated with orbicularis oculi activity

– moderate to severe forehead lines associated with frontalis activity

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 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), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead 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.

Increased Risk of Clinically Significant Effects with 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 and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

ADVERSE REACTIONS

The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for glabellar lines was eyelid ptosis (3%).

The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).

The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%) and eyelid ptosis (2%).

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

There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.

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BOTOX & FILLERS: PRE-TREATMENT INSTRUCTIONS

• Do not consume alcoholic beverages at least 24 hours prior to treatment (alcohol may thin the blood and increase the risk of bruising).

• Avoid anti-inflammatory/blood thinning medications, if possible, for a period of two weeks before treatment. Medications and supplements, Ibuprofen, Motrin, Advil, Aleve and other NSAIDs have a blood thinning effect and can increase the risk of bruising and swelling after injections.

• Schedule your Dermal Filler and Botox appointment at least 2 weeks prior to a special event which you may be attending, such as a wedding or a vacation. Results from Botox injections will take approximately 4 to 7 days to appear. Also bruising and swelling may be apparent at that time period.

• Discontinue Retin-A 2 days before and 2 days after treatment.

• Reschedule your appointment at least 24 hours in advance if you have a rash, cold sore or blemish on the area to be treated.

• Be sure to have a good breakfast, including food and drink before your procedure. This will decrease the chances of lightheadedness during your treatment.

• You are not a candidate for injectables if you are pregnant or breastfeeding.

BOTOX: POST-TREATMENT INSTRUCTIONS

• Do not manipulate the treated area for 3 hours following treatment.

• Do not receive facial/laser treatments or microdermabrasion after Botox injections for at least 10 days. Ask Dr. Reidy if you are not sure about the time frame for certain services.

• Avoid consuming alcohol for 8 hours after treatment.

• Do not lie down for 4 hours after your Botox treatment. This will prevent the Botox from tracking into the orbit of your eye and causing drooping eyelid.

• It can take approximately 4 to 7 days for results to be seen. If the desired result is not seen after 2 weeks of your treatment you may need additional Botox. You are charged for the amount of product used. Therefore, you will be charged for any product used during any touch-up or subsequent appointments.

• Do not perform activities involving straining, heavy lifting or vigorous exercise for 6 hours after treatment. This will keep the Botox in the injected area and not elsewhere.

FILLERS: POST-TREATMENT INSTRUCTIONS

• Avoid significant movement or massage of the treated area, unless instructed to do so by Dr. Reidy.

• Avoid strenuous exercise for 24 hours.

• Avoid extensive sun or heat for 72 hours.

• Avoid consuming alcohol for 8 hours after treatment.

• If you have swelling you may apply a cool compress for 15 minutes each hour. You may use the ice pack we provide as much as is comfortable for the first 1-2 hours after treatment.

• Use Tylenol for discomfort.

• Try to sleep face up and slightly elevated if you experience swelling.

The JUVÉDERM® range of fillers can correct age-related loss in the cheeks, lips, lip lines, and other facial wrinkles and folds in individuals over the age of 21.

JUVÉDERM® is the world's #1 selling dermal filler collection, and with good reason! JUVÉDERM® is FDA-Approved, so you can rest assured that it is safe. Using JUVÉDERM® offers:

• Instant results
• Nonsurgical treatments
• Natural-looking, long-lasting results
• In-office procedures

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 these products are 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.

• Do not consume alcoholic beverages at least 24 hours prior to treatment (alcohol may thin the blood and increase the risk of bruising).
• Avoid anti-inflammatory/blood thinning medications, if possible, for a period of two weeks before treatment. Medications and supplements, Ibuprofen, Motrin, Advil, Aleve and other NSAIDs have a blood thinning effect and can increase the risk of bruising and swelling after injections.
• Schedule your Dermal Filler and Botox appointment at least 2 weeks prior to a special event which you may be attending, such as a wedding or a vacation. Results from Botox injections will take approximately 4 to 7 days to appear. Also bruising and swelling may be apparent at that time period.
• Discontinue Retin-A 2 days before and 2 days after treatment.
• Reschedule your appointment at least 24 hours in advance if you have a rash, cold sore or blemish on the area to be treated.
• Be sure to have a good breakfast, including food and drink before your procedure. This will decrease the chances of lightheadedness during your treatment.
• You are not a candidate for injectables if you are pregnant or breastfeeding.

• Do not manipulate the treated area for 3 hours following treatment.
• Do not receive facial/laser treatments or microdermabrasion after Botox injections for at least 10 days. Ask Dr. Reidy if you are not sure about the time frame for certain services.
• Avoid consuming alcohol for 8 hours after treatment.
• Do not lie down for 4 hours after your Botox treatment. This will prevent the Botox from tracking into the orbit of your eye and causing drooping eyelid.
• It can take approximately 4 to 7 days for results to be seen. If the desired result is not seen after 2 weeks of your treatment you may need additional Botox. You are charged for the amount of product used. Therefore, you will be charged for any product used during any touch-up or subsequent appointments.
• Do not perform activities involving straining, heavy lifting or vigorous exercise for 6 hours after treatment. This will keep the Botox in the injected area and not elsewhere.

• Avoid significant movement or massage of the treated area, unless instructed to do so by Dr. Reidy.
• Avoid strenuous exercise for 24 hours.
• Avoid extensive sun or heat for 72 hours.
• Avoid consuming alcohol for 8 hours after treatment.
• If you have swelling you may apply a cool compress for 15 minutes each hour. You may use the ice pack we provide as much as is comfortable for the first 1-2 hours after treatment.
• Use Tylenol for discomfort.
• Try to sleep face up and slightly elevated if you experience swelling.