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LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information

Indication
LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their
growth, including length, thickness, and darkness.
The following information can help your office prepare for questions eyelash hypotrichosis patients may have about LATISSE®.

Click on a question to view the answer.
Q: How is LATISSE® solution different from other eyelash growth products?
A:
Over-the-counter products condition eyelashes. Only LATISSE® has been approved by the FDA as a prescription treatment to grow eyelashes in people with inadequate or not enough eyelashes.
Q: What does FDA approved mean?
A:
The US Food and Drug Administration (FDA) is the federal governmental agency charged with protecting the health and welfare of the US public by regulating prescription products. FDA regulations are extremely stringent, and when a drug is FDA approved, that means its efficacy and safety have been scientifically studied in valid clinical trials. FDA approval also requires the sponsoring pharmaceutical company to record all adverse events reported after the drug is approved.

LATISSE® received its FDA approval in December 2008.
Q. How can lashes change over time?
A:
Initial data from a group of women diagnosed with eyelash hypotrichosis in the LATISSE® clinical studies suggest that eyelashes may change over time.1,2 These are the trends that were suggested1,2:
  • Length decreased with increasing age (based on assessment of 607 women)
  • Fullness decreased with increasing age (based on assessment of 468 women)
  • Darkness decreased with increasing age (based on assessment of 568 women)
Q: What is hypotrichosis of the eyelashes?
A:
Hypotrichosis is another name for having inadequate or not enough eyelashes.
Q. Does LATISSE® really work?
A:
In a clinical study of 278 participants, 78% of LATISSE® users (107/137) experienced a significant increase in overall eyelash prominence (including elements of length, fullness, and darkness) at week 16, versus 18% for the vehicle (26/141).3-5,* Lashes were3,4:
  • 25% longer (2% for vehicle*)
  • 106% fuller (12% for vehicle*)
  • 18% darker (3% for vehicle*)
*Vehicle is the same solution as LATISSE® without the active ingredient.
Q: How does it work?
A:
LATISSE® is believed to prolong the anagen (active growth) phase.3 The exact way it works is unknown.3
Q: How do patients apply the product?
A:
Patients should be informed that LATISSE® should be applied every night using only the accompanying sterile applicators. They should start by ensuring their face is clean, all makeup is removed, and their contact lenses are removed (if applicable). Then carefully place one drop of LATISSE® solution on the disposable sterile applicator and brush cautiously along the skin of the upper eyelid margin at the base of the eyelashes. If any LATISSE® solution gets into the eye, it is not expected to cause harm. The eye should not be rinsed. Patients should be informed not to apply to the lower eyelash line. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material.
Q: How should patients handle the bottle and applicators?
A:
Patients should be instructed that the LATISSE® bottle must be maintained intact and to avoid allowing the tip of the bottle or applicator to contact surrounding structures, fingers, or any other unintended surface in order to avoid contamination of the bottle or applicator by common bacteria known to cause ocular infections. Patients should also be instructed to only use the applicator supplied with the product once and then discard it, since reuse could result in using a contaminated applicator. Serious infections may result from using contaminated solutions or applicators.
Q: Who should not use LATISSE® solution?
A:
Patients should not use LATISSE® solution if they are allergic to one of its ingredients.
Q: Whom should patients tell if they’re using LATISSE®?
A:
Patients should tell their physician they are using LATISSE® especially if they have a history of eye pressure problems. They should also tell anyone conducting an eye pressure screening that they are using LATISSE® solution.
Q: Are there any special warnings associated with LATISSE® use?
A:
LATISSE® solution is intended for use on the skin of the upper eyelid margin at the base of the eyelashes. DO NOT APPLY to the lower lid. If patients are using LUMIGAN® (bimatoprost ophthalmic solution) or other products in the same class used for elevated intraocular pressure (IOP), or if they have a history of abnormal IOP, they should only use LATISSE® under the close supervision of their physician.

LATISSE® use may cause darkening of the eyelid skin, which may be reversible. LATISSE® use may also cause increased brown pigmentation of the colored part of the eye, which is likely to be permanent.

It is possible for hair growth to occur in other areas of the skin that LATISSE® frequently touches. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material to reduce the chance of this happening. It is also possible for a difference in eyelash length, thickness, fullness, pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur between eyes. These differences, should they occur, will usually go away if the patient stops using LATISSE® solution.
Q: What are the most frequently reported adverse events in the clinical study?
A.
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.
Q: Is there potential for iris darkening?
A:
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.
Q. Is there potential for eyelid skin darkening?
A:
Skin hyperpigmentation (or skin darkening) is a less common side effect that typically occurs close to where the solution is applied. The eyelid skin may look a little darker due to an increase of melanin in the skin. This is expected to reverse after several weeks to months if the patient stops using the product.
Q: What if patients stop using LATISSE®?
A:
Patients’ lashes are expected to return to their previous appearance over several weeks to months.
Q: Where is LATISSE® available?
A:
LATISSE® solution is available by prescription only and is distributed by Allergan to doctors’ offices and retail pharmacies.
Q: Why do contact lenses need to be removed before applying?
A:
It’s recommended that patients remove their contact lenses because LATISSE® solution contains benzalkonium chloride (BAK), and this may be absorbed by soft contact lenses. Contacts may be reinserted 15 minutes following LATISSE® administration.
Q: Can patients continue to use mascara while using LATISSE®?
A:
Yes, patients can use mascara in addition to LATISSE® solution.
Q: How soon can patients expect results?
A:
It’s important for patients to remember that LATISSE® solution works gradually. While they may start seeing longer lashes after 4 weeks, they must use LATISSE® every day for 16 weeks for full results. They should not reduce or stop daily application of LATISSE® solution when they first notice results. After 16 weeks, they should talk to their doctor about ongoing use. Individual results may vary.
Q: Can patients use cotton swabs or other cosmetic brushes to apply LATISSE®?
A:
No, LATISSE® should only be used with its FDA-approved sterile applicators, designed to help patients apply the product properly.
Q: What if LATISSE® gets in a patient’s eye?
A:
It is not expected to cause harm. Patients don’t need to rinse their eye. Reinforce the proper application instructions.
Q: How much does LATISSE® cost?
A:
For most patients, the daily cost of LATISSE® solution is about the same as their morning coffee. Make sure to talk to patients about special offers or promotional discounts. Membership in Brilliant Distinctions® can also provide savings. With the Brilliant Distinctions® Consumer Loyalty Program, patients can earn points on all eligible LATISSE® purchases and redeem those points on more LATISSE® or other Allergan aesthetics products such as BOTOX® Cosmetic (onabotulinumtoxinA) or JUVÉDERM® XC, if they are appropriate patients.



To learn more, see the Patient Counseling Information section of the LATISSE® Prescribing Information.

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. 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: eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred.

Please see LATISSE® full Prescribing Information.


BOTOX® Cosmetic (onabotulinumtoxinA) IMPORTANT INFORMATION

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 BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.



JUVÉDERM® Ultra XC, JUVÉDERM® XC, and JUVÉDERM VOLUMA® XC Important Information

Indications
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® XC injectable gels (JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC) 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 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.

IMPORTANT SAFETY INFORMATION
Do not inject into blood vessels, as introduction into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Rare, but serious, adverse events associated with intravascular injection of soft-tissue fillers in the face have been reported, including 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 changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. These products should only be used by healthcare professionals with appropriate experience and knowledge about facial anatomy and product use. Healthcare professionals should discuss the potential risks and signs of potential complications with their patients prior to treatment. Do not use in patients with a history of anaphylaxis, presence of multiple severe allergies, or allergies to gram‐positive bacterial proteins or the lidocaine in these products. The safety for use during pregnancy, in breastfeeding females, and in patients with scarring and pigmentation disorders has not been studied. The safety for use of JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC in patients under 18 years, and of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years, has not been established. Use with caution in patients on immunosuppressive therapy. Dermal filler implantation carries the risk of infection, and standard precautions should be taken.

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

To report an adverse reaction with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.

For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.

JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLUMA® XC injectable gels are available by prescription only.


Natrelle® Breast Implants Important Information

INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
Breast augmentation for women at least 22 years old for silicone-filled implants.
Breast augmentation for women at least 18 years old for saline-filled implants.
Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

Breast reconstruction. 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 a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, and women who are currently pregnant or nursing.

WARNINGS
AVOID DAMAGE DURING SURGERY
Avoid excessive force, minimize handling of the implant and use care when using surgical instruments near the breast implant. Do not treat capsular contracture by closed capsulotomy or forceful external compression. Use care in subsequent breast procedures to avoid damage to the implant.

Do not do the following: place drugs or substances inside saline-filled implants other than sterile saline for injection, inject through the implant shell, contact the implant with disposable, capacitor-type cautery devices, alter the implants, repair or insert a damaged prosthesis, immerse the implant in povidone-iodine (rinse the breast pocket thoroughly if povidone-iodine is used), reuse or resterilize any product that has been previously implanted, place more than one implant per breast pocket, use the periumbilical approach to place the implant or use microwave diathermy in patients with breast implants.

PRECAUTIONS
Safety and effectiveness have not been established in patients with the following: autoimmune diseases, a compromised immune system, planned radiation therapy to the breast or planned chemotherapy following breast implant placement, conditions/medications that interfere with wound healing and blood clotting, reduced blood supply to breast tissue or a clinical diagnosis of depression, other mental health disorders, body dysmorphic disorder or eating disorders. These disorders should be resolved or stabilized prior to surgery.

ADVERSE EVENTS
Key adverse events are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture Baker Grade III/IV. Other adverse events that may occur include: asymmetry, nipple/breast/skin sensation changes, scarring or wrinkling/rippling.

For more information see the full Directions for Use at http://www.allergan.com/products/key-products/product-prescribing/labeling/natrelle_usa or call the Allergan Product Support line at 1-800-433-8871.

To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.

Natrelle® Breast Implants are available by prescription only.

IMPORTANT SAFETY INFORMATION
EXPAND SAFETY INFORMATION

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. 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: eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred.

Please see LATISSE® full Prescribing Information.

BOTOX® Cosmetic (onabotulinumtoxinA) IMPORTANT INFORMATION

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 BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.


JUVÉDERM® Ultra XC, JUVÉDERM® XC, and JUVÉDERM VOLUMA® XC Important Information

Indications
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® XC injectable gels (JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC) 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 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.

IMPORTANT SAFETY INFORMATION
Do not inject into blood vessels, as introduction into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Rare, but serious, adverse events associated with intravascular injection of soft-tissue fillers in the face have been reported, including 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 changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. These products should only be used by healthcare professionals with appropriate experience and knowledge about facial anatomy and product use. Healthcare professionals should discuss the potential risks and signs of potential complications with their patients prior to treatment. Do not use in patients with a history of anaphylaxis, presence of multiple severe allergies, or allergies to gram‐positive bacterial proteins or the lidocaine in these products. The safety for use during pregnancy, in breastfeeding females, and in patients with scarring and pigmentation disorders has not been studied. The safety for use of JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC in patients under 18 years, and of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years, has not been established. Use with caution in patients on immunosuppressive therapy. Dermal filler implantation carries the risk of infection, and standard precautions should be taken.

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

To report an adverse reaction with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.

For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.

JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLUMA® XC injectable gels are available by prescription only.


Natrelle® Breast Implants Important Information

INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
Breast augmentation for women at least 22 years old for silicone-filled implants.
Breast augmentation for women at least 18 years old for saline-filled implants.
Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

Breast reconstruction. 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 a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, and women who are currently pregnant or nursing.

WARNINGS
AVOID DAMAGE DURING SURGERY
Avoid excessive force, minimize handling of the implant and use care when using surgical instruments near the breast implant. Do not treat capsular contracture by closed capsulotomy or forceful external compression. Use care in subsequent breast procedures to avoid damage to the implant.

Do not do the following: place drugs or substances inside saline-filled implants other than sterile saline for injection, inject through the implant shell, contact the implant with disposable, capacitor-type cautery devices, alter the implants, repair or insert a damaged prosthesis, immerse the implant in povidone-iodine (rinse the breast pocket thoroughly if povidone-iodine is used), reuse or resterilize any product that has been previously implanted, place more than one implant per breast pocket, use the periumbilical approach to place the implant or use microwave diathermy in patients with breast implants.

PRECAUTIONS
Safety and effectiveness have not been established in patients with the following: autoimmune diseases, a compromised immune system, planned radiation therapy to the breast or planned chemotherapy following breast implant placement, conditions/medications that interfere with wound healing and blood clotting, reduced blood supply to breast tissue or a clinical diagnosis of depression, other mental health disorders, body dysmorphic disorder or eating disorders. These disorders should be resolved or stabilized prior to surgery.

ADVERSE EVENTS
Key adverse events are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture Baker Grade III/IV. Other adverse events that may occur include: asymmetry, nipple/breast/skin sensation changes, scarring or wrinkling/rippling.

For more information see the full Directions for Use at http://www.allergan.com/products/key-products/product-prescribing/labeling/natrelle_usa or call the Allergan Product Support line at 1-800-433-8871.

To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.

Natrelle® Breast Implants are available by prescription only.

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. 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: eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred.

Please see LATISSE® full Prescribing Information.


BOTOX® Cosmetic (onabotulinumtoxinA) IMPORTANT INFORMATION

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 BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.



JUVÉDERM® Ultra XC, JUVÉDERM® XC, and JUVÉDERM VOLUMA® XC Important Information

Indications
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® XC injectable gels (JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC) 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 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.

IMPORTANT SAFETY INFORMATION
Do not inject into blood vessels, as introduction into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Rare, but serious, adverse events associated with intravascular injection of soft-tissue fillers in the face have been reported, including 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 changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. These products should only be used by healthcare professionals with appropriate experience and knowledge about facial anatomy and product use. Healthcare professionals should discuss the potential risks and signs of potential complications with their patients prior to treatment. Do not use in patients with a history of anaphylaxis, presence of multiple severe allergies, or allergies to gram‐positive bacterial proteins or the lidocaine in these products. The safety for use during pregnancy, in breastfeeding females, and in patients with scarring and pigmentation disorders has not been studied. The safety for use of JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC in patients under 18 years, and of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years, has not been established. Use with caution in patients on immunosuppressive therapy. Dermal filler implantation carries the risk of infection, and standard precautions should be taken.

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

To report an adverse reaction with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.

For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.

JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLUMA® XC injectable gels are available by prescription only.


Natrelle® Breast Implants Important Information

INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
Breast augmentation for women at least 22 years old for silicone-filled implants.
Breast augmentation for women at least 18 years old for saline-filled implants.
Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

Breast reconstruction. 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 a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, and women who are currently pregnant or nursing.

WARNINGS
AVOID DAMAGE DURING SURGERY
Avoid excessive force, minimize handling of the implant and use care when using surgical instruments near the breast implant. Do not treat capsular contracture by closed capsulotomy or forceful external compression. Use care in subsequent breast procedures to avoid damage to the implant.

Do not do the following: place drugs or substances inside saline-filled implants other than sterile saline for injection, inject through the implant shell, contact the implant with disposable, capacitor-type cautery devices, alter the implants, repair or insert a damaged prosthesis, immerse the implant in povidone-iodine (rinse the breast pocket thoroughly if povidone-iodine is used), reuse or resterilize any product that has been previously implanted, place more than one implant per breast pocket, use the periumbilical approach to place the implant or use microwave diathermy in patients with breast implants.

PRECAUTIONS
Safety and effectiveness have not been established in patients with the following: autoimmune diseases, a compromised immune system, planned radiation therapy to the breast or planned chemotherapy following breast implant placement, conditions/medications that interfere with wound healing and blood clotting, reduced blood supply to breast tissue or a clinical diagnosis of depression, other mental health disorders, body dysmorphic disorder or eating disorders. These disorders should be resolved or stabilized prior to surgery.

ADVERSE EVENTS
Key adverse events are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture Baker Grade III/IV. Other adverse events that may occur include: asymmetry, nipple/breast/skin sensation changes, scarring or wrinkling/rippling.

For more information see the full Directions for Use at http://www.allergan.com/products/key-products/product-prescribing/labeling/natrelle_usa or call the Allergan Product Support line at 1-800-433-8871.

To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.

Natrelle® Breast Implants are available by prescription only.

IMPORTANT SAFETY INFORMATION
EXPAND SAFETY INFORMATION

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. 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: eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred.

Please see LATISSE® full Prescribing Information.

BOTOX® Cosmetic (onabotulinumtoxinA) IMPORTANT INFORMATION

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 BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.


JUVÉDERM® Ultra XC, JUVÉDERM® XC, and JUVÉDERM VOLUMA® XC Important Information

Indications
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® XC injectable gels (JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC) 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 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.

IMPORTANT SAFETY INFORMATION
Do not inject into blood vessels, as introduction into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Rare, but serious, adverse events associated with intravascular injection of soft-tissue fillers in the face have been reported, including 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 changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. These products should only be used by healthcare professionals with appropriate experience and knowledge about facial anatomy and product use. Healthcare professionals should discuss the potential risks and signs of potential complications with their patients prior to treatment. Do not use in patients with a history of anaphylaxis, presence of multiple severe allergies, or allergies to gram‐positive bacterial proteins or the lidocaine in these products. The safety for use during pregnancy, in breastfeeding females, and in patients with scarring and pigmentation disorders has not been studied. The safety for use of JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC in patients under 18 years, and of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years, has not been established. Use with caution in patients on immunosuppressive therapy. Dermal filler implantation carries the risk of infection, and standard precautions should be taken.

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

To report an adverse reaction with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.

For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.

JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLUMA® XC injectable gels are available by prescription only.


Natrelle® Breast Implants Important Information

INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
Breast augmentation for women at least 22 years old for silicone-filled implants.
Breast augmentation for women at least 18 years old for saline-filled implants.
Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

Breast reconstruction. 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 a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, and women who are currently pregnant or nursing.

WARNINGS
AVOID DAMAGE DURING SURGERY
Avoid excessive force, minimize handling of the implant and use care when using surgical instruments near the breast implant. Do not treat capsular contracture by closed capsulotomy or forceful external compression. Use care in subsequent breast procedures to avoid damage to the implant.

Do not do the following: place drugs or substances inside saline-filled implants other than sterile saline for injection, inject through the implant shell, contact the implant with disposable, capacitor-type cautery devices, alter the implants, repair or insert a damaged prosthesis, immerse the implant in povidone-iodine (rinse the breast pocket thoroughly if povidone-iodine is used), reuse or resterilize any product that has been previously implanted, place more than one implant per breast pocket, use the periumbilical approach to place the implant or use microwave diathermy in patients with breast implants.

PRECAUTIONS
Safety and effectiveness have not been established in patients with the following: autoimmune diseases, a compromised immune system, planned radiation therapy to the breast or planned chemotherapy following breast implant placement, conditions/medications that interfere with wound healing and blood clotting, reduced blood supply to breast tissue or a clinical diagnosis of depression, other mental health disorders, body dysmorphic disorder or eating disorders. These disorders should be resolved or stabilized prior to surgery.

ADVERSE EVENTS
Key adverse events are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture Baker Grade III/IV. Other adverse events that may occur include: asymmetry, nipple/breast/skin sensation changes, scarring or wrinkling/rippling.

For more information see the full Directions for Use at http://www.allergan.com/products/key-products/product-prescribing/labeling/natrelle_usa or call the Allergan Product Support line at 1-800-433-8871.

To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.

Natrelle® Breast Implants are available by prescription only.

References
  1. Data on file, Allergan, Inc., 2008; Studies No. 192024-032, -038, -051: Digital Image Analysis at Baseline.
  2. Data on file, Allergan, Inc., 2011; Pooled Baseline Analyses Memo.
  3. LATISSE® Prescribing Information, September 2014.
  4. Data on file, Allergan, Inc., 2008; Study No. 192024-032: Full Clinical Study Report.
  5. Smith S, Fagien S, Whitcup SM, et al. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol. 2012;66(5):801-806.
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