Latisse^® (bimatoprost ophthalmic solution) 0.03%

Indication

LATISSE^® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness.

Important Safety Information

Warnings and Precautions: In patients using LUMIGAN^® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of LATISSE^® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN^® for IOP reduction should only use LATISSE^® after consulting with their physician and should be monitored for changes to their intraocular pressure.

Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation, which is likely to be permanent.

Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes.

There is the potential for hair growth to occur in areas where LATISSE^® solution comes in repeated contact with skin surfaces. Apply LATISSE^® only to the skin of the upper eyelid margin at the base of the eyelashes.

LATISSE^® solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated.

LATISSE^® contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.

Adverse Reactions: The most frequently reported adverse events were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and erythema of the eyelid. These events occurred in less than 4% of patients.

Postmarketing Experience: The following reactions have been identified during postmarketing use of LATISSE^® in clinical practice: burning sensation (eyelid), erythema periorbital, eye swelling, eyelid irritation, eyelid edema, eyelid pruritus, iris hyperpigmentation, lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), rash (including macular, erythematous, and pruritic limited to the eyelids and periorbital region), skin discoloration (periorbital), and vision blurred.

Use in Specific Populations: Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.

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BOTOX^® Cosmetic (onabotulinumtoxinA) Important Information

Indication
BOTOX^® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in patients 18 to 65 years of age.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

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.

Human Albumin
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.

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.

Drug Interactions
Co-administration of BOTOX^® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like nondepolarizing blockers, lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases, succinylcholine chloride) should only be performed with caution as the effect of the toxin may be potentiated.

The effect of administering different botulinum neurotoxin serotypes 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.

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.

Please see Botox^® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.

Important Natrelle® Safety Information

The Natrelle^® Silicone and Saline Breast Implants are indicated for females for breast augmentation and breast reconstruction. Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a breast augmentation surgery. 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 severe breast abnormality, as well as revision surgery to correct or improve the result of a breast reconstruction surgery.

For breast augmentation, Natrelle^® Silicone-Filled Breast Implants are indicated for women at least 22 years old and Natrelle^® Saline-Filled Breast Implants are indicated for women at least 18 years old.

Natrelle^® implants are not for women with active infection, existing cancer or pre-cancer of the breast who have not received adequate treatment for those conditions, and women who are currently pregnant or nursing. Complications may include, reoperation, deflation or rupture, capsular contracture, implant malposition, and asymmetry. For full safety information, please visit http://www.natrelle.com or call Allergan Product Support at 1-800-433-8871. Natrelle^® Silicone and Saline Breast Implants are available by prescription only.