Safety Information

Botox® Cosmetic

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, blurred vision, 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 underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia 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

The recommended dosage and frequency of administration for BOTOX® Cosmetic should not be exceeded. Risks resulting from administration at higher dosages are
not known.

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 or 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) have been reported.

Hypersensitivity Reactions

Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, 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.

Pre-existing Neuromuscular Disorders

Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic.

Precautions

Caution should be used when BOTOX® Cosmetic treatment is used in patients who have an inflammatory skin problem at the injection site, marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the inability to substantially lessen glabellar lines by physically spreading them apart.

Information for Patients

Patients should be counseled that if loss of strength, muscle weakness, or impaired vision occur, they should avoid driving a car or engaging in other potentially hazardous activities.

Pregnancy

Administration of BOTOX® Cosmetic is not recommended during pregnancy. There are no adequate and well-controlled studies of BOTOX® Cosmetic in pregnant women.

Nursing Mothers

It is not known whether BOTOX® Cosmetic is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BOTOX® Cosmetic is administered to a nursing woman.

Adverse Reactions

General

The most serious adverse events reported after treatment with botulinum toxin include spontaneous reports of death, sometimes associated with anaphylaxis, dysphagia, pneumonia, and/or other significant debility. There have also been reports 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. The most frequently reported adverse events following injection of BOTOX® Cosmetic include blepharoptosis and nausea.

Overdosage

Excessive doses of BOTOX® Cosmetic may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where
excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis. In the event of suspected or actual overdosage, please contact your local or state health department to process a request for antitoxin through the Centers for Disease Control and Prevention (CDC). If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100.

Juvederm®

Safety Considerations

With any cosmetic treatment, safety is the first concern. As always, it’s important to consult with your doctor before deciding on a wrinkle treatment. Because JUVÉDERM® injectable gel is a non-surgical, in-office treatment, most patients experience minimal recovery and downtime.

JUVÉDERM® and JUVÉDERM® XC Side Effects

JUVÉDERM® XC injectable gel is generally well tolerated. Most side effects are mild to moderate in nature and their duration is short lasting (7 days or less). The most common side effects include, but are not limited to, temporary injection site reactions such as redness, pain/tenderness, firmness, swelling, lumps/bumps, bruising, itching, and discoloration. As with all skin injection procedures, there is a risk of infection.

Hyaluronic acid fillers are generally biocompatible, which means allergy skin testing is not required prior to treatment.

Allergies

If you’re considering treatment with JUVÉDERM® injectable gel, your healthcare professional should ask about your medical history to determine if you are an appropriate candidate for treatment. JUVÉDERM® injectable gel for facial wrinkles and folds should not be used in patients who have:

Severe allergies marked by a history of anaphylaxis or history or presence of multiple severe allergies

A history of allergies to gram-positive bacterial proteins

JUVÉDERM® should not be used in patients with a history of allergies to lidocaine.

Other Considerations

In addition, you and your healthcare professional should discuss the following important treatment considerations in order to help avoid unsatisfactory results and complications when using JUVÉDERM® injectable gel:

Patients who are using substances that can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may experience increased bruising or bleeding at the injection site. You should inform your healthcare professional before treatment if you are using these types of substances.

If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with JUVÉDERM® injectable gel, there is a possible risk of an inflammatory reaction at the treatment site.

JUVÉDERM® injectable gel should be used with caution in patients on immunosuppressive therapy, or therapy used to decrease the body’s immune response, as there may be an increased risk of infection.

The safety of JUVÉDERM® injectable gel for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established.

The safety of JUVÉDERM® injectable gel hyaluronic acid dermal filler in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied.

Your healthcare professional should also warn you that the safety and effectiveness of JUVÉDERM® injectable gel for the treatment of areas other than facial lines and facial folds (such as lips) have not been established in controlled clinical studies.

Persons of Color

JUVÉDERM® is the first FDA approved hyaluronic acid dermal filler with demonstrated safety and effectiveness in persons of color.

Other Treatments

Other treatments for dermal soft tissue augmentation include bovine-based collagen and other hyaluronic acid-based dermal fillers. Aside from these treatments, additional options for the correction of facial folds and wrinkles do exist, including facial creams, chemical peels, and laser skin surface treatments, and may be discussed with your healthcare professional.

Latisse® Solution

If you are using, or have used, prescription products for any eye pressure problems, only use LATISSE® under close doctor care. Although not seen in LATISSE® clinical studies, may cause increased brown pigmentation of the colored part of the eye which is likely permanent. Eyelid skin darkening may occur which may be reversible. Only apply at the base of the upper eyelashes. DO NOT APPLY to the lower eyelid. Hair growth may occur in other skin areas that LATISSE® solution frequently touches. If you develop or experience any eye problems or have eye surgery, consult your doctor immediately about continued use of LATISSE®. The most common side effects after using LATISSE® solution are itchy eyes and/or eye redness. If discontinued, lashes will gradually return to their previous appearance.