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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 ≤ 65 years of age.
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 at lower doses.
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.
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.
Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal outcomes have been reported in patients who had received BOTOX® injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus and stomach. Safety and effectiveness have not been established for indications pertaining to these injection sites. Some patients had pre-existing dysphagia or significant debility. Pneumothorax associated with injection procedure has been reported following the administration of BOTOX® near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.
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.
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.
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.
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.
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); and when used in patients who have 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.
The most frequently reported adverse events following injection of BOTOX® Cosmetic include blepharoptosis
and nausea.
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. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.
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.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.
BOTOX® Cosmetic is not recommended for use in children or pregnant women.
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
Indication
LATISSE® 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. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients.
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.
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.
Please click here for full Prescribing Information.
JUVÉDERM® 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).
Side effects are usually mild to moderate, lasting 7 days or less, and include temporary injection-site reactions such as redness, pain, firmness, swelling, and bumps.
JUVÉDERM® is not for people with severe allergies.
To report a problem with JUVÉDERM®, please call Allergan Product Surveillance at 1-800-624-4261.
For more information, please see the About Safety page at www.juvederm.com or call the Allergan Product Support line at 1-800-433-8871.
JUVÉDERM® injectable gel is available by prescription only.
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/safety_information or call Allergan Product Support at 1-800-433-8871. Natrelle® Silicone and Saline Breast Implants are available by prescription only.
BOTOX® Cosmetic (onabotulinumotoxinA) 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 ≤ 65 years of age.1
BOTOX® Cosmetic was approved by the FDA 10 years ago and approximately 11 million treatments have been performed during that time.2
Please see Important Safety Information below.
- BOTOX® Cosmetic Prescribing Information, November, 2012.
- Data on file, Allergan, Inc.; Safety Analysis, March 25, 2009. Based on treatment sessions 2002-2008.
JUVÉDERM® XC injectable gel is the first and only FDA-approved HA filler that lasts up to 1 year with optimal correction at initial treatment.1 Innovative HYLACROSS™ technology makes JUVÉDERM® XC the first smooth-consistency gel that flows easily and consistently. Patients can expect smooth, natural-looking results with the improved comfort they want, when compared to non-lidocaine JUVÉDERM® XC formulations.2,3
Click here for JUVEDERM®XC Important Safety Information.
Click here to learn more.
- Pinsky MA, Thomas JA, Murphy DK, Walker PS; for JUVÉDERM® vs ZYPLAST® Nasolabial Fold Study Group. JUVÉDERM® injectable gel: A multicenter, double-blind, randomized study of safety and effectiveness. Aesthetic Surg J. 2008;28(1):17-23.
- Data on file. Allergan, Inc.
- Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of JUVÉDERM® injectable gel with and without lidocaine. J Cosmet Dermatol. 2009;8(3):205-210.
LATISSE® (bimatoprost ophthalmic solution) 0.03%
Click here for LATISSE® Important Safety Information.
Get it all from Natrelle® for your patients. Tested, trusted, and technologically advanced, Natrelle® gives your reconstruction and augmentation patients the look and the options they want from breast implant surgery—while providing you with the necessary product and educational resources and offers to help you with your patients. Please see Important Safety Information below. For more information,
VIVITÉ® (nonprescription) skin care is a nonprescription product and is physician dispensed.
Allergan Academy® provides education in aesthetic and reconstructive breast surgery for plastic surgeons. The mission of ALLERGAN ACADEMY is to educate plastic surgeons through a unique forum that reinforces product knowledge, encourage practice innovation, and allows for the exchange of new ideas. To find out more or register for an upcoming event, enter below.
The Allergan BrandBox is your tool kit to create educational materials and resources for your practice. Explore a library of assets that includes logos, before-and-after photos, office materials, and more. Available on each brand website or click below to access.