See Approved Uses, Important Safety Information, and Prescribing Information
APPROVED USES, IMPORTANT SAFETY INFORMATION AND PRESCRIBING INFORMATION
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indications
BOTOX®Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Moderate to severe lateral canthal lines associated with orbicularis oculi activity
- Moderate to severe forehead lines associated with frontalis activity
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX®Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved usesand approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.
CONTRAINDICATIONS
BOTOX®Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability Between Botulinum Toxin Products
The potency units of BOTOX®Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX®Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX®Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX®injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX®to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX®for unapproved uses have not been established.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX®Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
Cardiovascular System
There have been reports following administration of BOTOX®of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects With Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (seeWarnings 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 (seeBoxed 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).
Dry Eye in Patients Treated With BOTOX®Cosmetic
There have been reports of dry eye associated with BOTOX®Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX®Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).
The most frequently reported adverse reaction following injection of BOTOX®Cosmetic for lateral canthal lines was eyelid edema (1%).
The most frequently reported adverse reactions following injection of BOTOX®Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).
DRUG INTERACTIONS
Co-administration of BOTOX®Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX®Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated byadministration 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 afteradministration of BOTOX®Cosmetic.
USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX®Cosmetic in pregnant women.There are no data on the presence of BOTOX®Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.
Please see BOTOX® Cosmetic fullPrescribing Informationincluding Boxed Warning andMedication Guide.
JUVÉDERM® Collection of Fillers Important Information
INDICATIONS
JUVÉDERM® VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21. JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21. JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21. JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). JUVÉDERM® Ultra XC injectable gel is also indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.
WARNINGS
- Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
- Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
PRECAUTIONS
- To minimize the risks of potential complications, this product should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
- The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
- The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each product have not been established in controlled clinical studies
- The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
- The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age for cheek augmentation and in patients between 22 and 80 years of age for chin augmentation
- The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
- As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
- Dermal fillers should be used with caution in patients on immunosuppressive therapy
- Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
- Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
- If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
- The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
- The safety of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
- JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
- The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
- Patients may experience late-onset adverse events with use of these dermal fillers, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
- Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
ADVERSE EVENTS
The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA® XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA® XC, most resolved within 30 days.
To report an adverse reaction with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please visitJuvedermDFU.comfor more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
KYBELLA® (deoxycholic acid) injection 10 mg/mL Important Information
INDICATION
KYBELLA® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
The safe and effective use of KYBELLA® for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
KYBELLA® is contraindicated in the presence of infection at the injection sites.
WARNINGS AND PRECAUTIONS
Marginal Mandibular Nerve Injury
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported in 4% of subjects in the clinical trials; all cases resolved spontaneously (range 1-298 days, median 44 days). KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve.
Dysphagia
Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions, eg, pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously (range 1-81 days, median 3 days). Avoid use of KYBELLA® in patients with current or prior history of dysphagia as treatment may exacerbate the condition.
Injection-Site Hematoma/Bruising
In clinical trials, 72% of subjects treated with KYBELLA® experienced hematoma/bruising. KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.
Risk of Injecting Into or in Proximity to Vulnerable Anatomic Structures
To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1 cm-1.5 cm) to salivary glands, lymph nodes, and muscles. Care should be taken to avoid inadvertent injection directly into an artery or a vein as it can result in vascular injury.
Injection Site Alopecia
Cases of injection site alopecia have been reported with administration of KYBELLA®. Onset and duration may vary among individuals and may persist. Consider withholding subsequent treatments until resolution.
Injection Site Ulceration and Necrosis
Injections that are too superficial into the dermis may result in skin ulceration and necrosis. Cases of injection site ulceration and necrosis have been reported with administration of KYBELLA®. Do not administer KYBELLA® into affected area until complete resolution.
ADVERSE REACTIONS
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.
Please see KYBELLA® fullPrescribing Information.
CoolSculpting® Treatment Important Information
Indications
The CoolSculpting® procedure is FDA-cleared for the treatment of visible fat bulges in the thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm in patients with a Body Mass Index (BMI) of ≤ 30 and in submental and submandibular areas in patients with a BMI of ≤ 46.2. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments.
Important Safety Information
CoolSculpting® is contraindicated in patients with cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Ask your patient about any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.
During the procedure patients may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment.
Rare side effects may also occur. Paradoxical hyperplasia (visibly enlarged tissue volume in the treated area) may develop 2-5 months after treatment, will not resolve on its own, and may require surgical intervention for correction.
As with any medical procedure, a consultation should be done by a licensed healthcare professional to determine if the patient is a candidate for treatment. Consult the CoolSculpting® System User Manual for a complete list of Contraindications, Warnings, Precautions, and potential side effects. Treatment applications that deviate from the guidelines are not recommended.
CoolTone® Treatment Information
Indications
The CoolTone® device is indicated for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone is also indicated for strengthening, toning, and firming of buttocks and thighs.
Important Safety Information
CoolTone® treatment is contraindicated in placing the active applicator over metal, electrical, or electronic implants/devices in the treatment area like cardiac pacemakers, cochlear implants, intrathecal pumps, implanted defibrillators, implanted neurostimulators, drug pumps, or hearing aids.
CoolTone® is also contraindicated in placing the active applicator over menstruating uterus, over areas of the skin that lack normal sensation, and in patients with fever, malignant tumor, hemorrhagic conditions, epilepsy, recent surgical procedure, pulmonary insufficiency, or pregnancy.
CoolTone® should be used with caution in patients with Graves’ disease, active bleeding disorders, or seizure disorders.
Women who are close to menstruation may find that it comes sooner, or cramping is increased or intensified with CoolTone® treatments, therefore, it is recommended to not undergo treatment during this time of the month.
CoolTone® should not be used in the heart or head areas, areas of growth plate, over the carotid sinus nerves, or over the neck or mouth. CoolTone® should not be applied over swollen, infected, inflamed areas or skin eruptions. Caution should be used for patients with suspected or diagnosed heart problems.
Ensure that persons with pacemakers are not present in vicinity of the device during treatment.
Common adverse effects may include, but may not be limited to muscular pain, temporary muscle spasm, temporary joint or tendon pain, and local erythema or skin redness.
Consult the CoolTone® User Manual for a complete list of Contraindications, Warnings, Precautions, and potential side effects. Treatment applications that deviate from the guidelines are not recommended.
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
WARNINGS
- Breast implants are not considered lifetime devices. The longer patients have them, the greater the chance they will develop complications, some of which will require more surgery
- Breast implants have been associated with the development of a cancer of the immune system called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL
- Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement
INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
- Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants.This includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery
- Breast reconstruction.This 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
CONTRAINDICATIONS
Breast implant surgery should not be performed in:
- Women with active infection anywhere in their body
- Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions
- Women who are currently pregnant or nursing
ADDITIONAL WARNINGS
- See Boxed Warning
- Avoid damage during surgery:Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Forcing of implants through too small an opening or applying concentrated localized pressure on the implants may result in localized weakening of the breast implant shell, potentially leading to shell damage and possible implant rupture. An incision should be of appropriate length to accommodate the style, size, and profile of the implants. Use care when using surgical instruments in proximity with the breast implant
- Follow recommended fill volumes for saline implants to decrease possibility of shell wrinkling and crease-fold failure
PRECAUTIONS
Safety and effectiveness have not been established in patients with the following:
- Autoimmune diseases (eg, lupus and scleroderma)
- A compromised immune system (eg, currently receiving immunosuppressive therapy)
- Planned chemotherapy or radiation following breast implant placement
- Conditions or medications that interfere with wound healing and blood clotting
- Reduced blood supply to breast tissue
- Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery
ADVERSE EVENTS
Possible adverse events with breast implant surgery include implant rupture with silicone implants, implant deflation with saline-filled implants, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, infection, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy. Other systemic conditions have been reported with breast implants.
For more information, please see the full Directions for Use atwww.allergan.com/products.
To report a problem withNatrelle® Breast Implants, please call Allergan® at 1-800-624-4261.
The sale and distribution of this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Allergan®.
REVOLVE™ Advanced Adipose System
Indications and Important Safety Information
INDICATIONS
The REVOLVE™ Advanced Adipose System (REVOLVE™ System) is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. This system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. REVOLVE™ System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Contraindications to autologous fat transfer include the presence of any disease processes that adversely affect wound healing, and poor overall health status of the individual.
WARNINGS
REVOLVE™ System must be used within the same surgical procedure. Reuse of this device in the same patient in a subsequent surgical procedure, or for more than one patient, may result in infection and/or transmission of communicable diseases. Do not use the product if sterile packaging is damaged.
This device will not, in and of itself, produce significant weight reduction. This device should be used with extreme caution in patients with chronic medical conditions such as diabetes, heart, lung, or circulatory system disease or obesity. The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and patient safety. The capability of providing adequate, timely replacement is essential for patient safety.
PRECAUTIONS
REVOLVE™ System is designed to remove localized deposits of excess fat through small incision and subsequently transfer the tissue back to the patient. Use of this device is limited to those physicians who, by means of formal professional training or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction lipoplasty and tissue transfer. Results of this procedure will vary depending upon patient age, surgical site, and experience of the physician. Results of this procedure may or may not be permanent. The amount of fat removed should be limited to that necessary to achieve a desired cosmetic effect. Filling the device with adipose tissue over the maximum fill volume line can lead to occlusion of the mesh resulting in mesh tear.
ADVERSE EFFECTS
Some common adverse effects associated with autologous fat transfer are asymmetry, over- and/or under-correction of the treatment site, tissue lumps, bleeding, and scarring. Potential adverse effects associated with REVOLVE™ System include fat necrosis, cyst formation, infection, chronic foreign body response, allergic reaction, and inflammation.
REVOLVE™ System is available by prescription only.
For more information, please see theInstructions for Use (IFU)andUser Manualfor REVOLVE™ Systemavailable atwww.allergan.com/REVOLVEIFUor call 1.800.678.1605.
To report an adverse reaction, please call Allergan at 1.800.367.5737.
SkinMedica®
Most of the SkinMedica® products described on this website are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA, and the statements on these pages have not been evaluated by the FDA.
SkinMedica® Total Defense + Repair Broad Spectrum Sunscreens (SPF 34, SPF 34 Tinted, and SPF 50+) and Essential Defense Broad Spectrum Sunscreens (Everyday Clear SPF 47, Mineral Shield Tinted SPF 32, and Mineral Shield SPF 35) are over-the-counter drug products which are formulated and marketed pursuant to FDA’s governing regulations set forth at 21 C.F.R. Part 352.
SkinMedica® Purifying Foaming Wash is an over-the-counter drug product that are formulated and marketed pursuant to the FDA’s governing regulations set forth at 21 CFR Part 333 Subpart D.
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.
Important Safety Information
Contraindications: LATISSE®is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients.
Warnings and Precautions:In patients usingLUMIGAN®(bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use ofLATISSE®may interfere with the desired reduction in IOP. Patients using prostaglandin analogs includingLUMIGAN®for IOP reduction should only useLATISSE®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 whereLATISSE®solution comes in repeated contact with skin surfaces. ApplyLATISSE®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®should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Adverse Reactions:The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema. These reactions occurred in less than 4% of patients.
Postmarketing Experience:The following adverse reactions have been identified during postapproval use ofLATISSE®: dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hordeolum, 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), trichiasis, and vision blurred.
For more information on LATISSE®, please see the accompanying full Prescribing Information.
Please see LATISSE®fullPrescribing Information.
For more information on LATISSE®, please see the full Prescribing Information.
FAQs
How do I get an Allergan account? ›
What is the process to set up a new account with Allergan? Contact Allergan Brand Ambassadors at 1-844-NEW-2AGN (844-639-2246).
Is Allergan good Botox? ›Today, there are various Botulinum toxin type A injectables available, marketed under different brand names such as Dysport and Xeomin, but Allergan Botox is still considered the gold standard.
Where does Allergan make Botox? ›Allergan has four manufacturing facilities in Ireland and 2,000 employees there. In fact, it says 1 in 10 of its workforce is in the country. The opening of the plant comes just ahead of the expected closing of AbbVie's $63 billion merger with Dublin-based Allergan.
What's Allergan Botox? ›APPROVED USES
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, and frown lines between the eyebrows in adults.
- Allergan Direct. 1 855-246-3728.
- Direct to Physician Account Setup. 1 844-639-2246.
- Allergan Partner Privileges. 1 877-277-7764.
- Alle. 1 888-912-1572.
- BotoxOne. 1 800-442-6869 (800-44 Botox)
Preventive prescription drugs are covered at 100%. Non-preventive and cosmetic drug/ device/procedures are discounted really well. Skin Medica and Botox, for example, are discounted with company benefit.
Which brand is best Botox? ›- Botox. Botox is a unique, time-tested medication from the American brand Allergan. ...
- Xeomin. Xeomin is a German-made rejuvenating agent from Merz Pharmaceuticals. ...
- Dysport. The analog of “Botox” by the French manufacturer Ipsen Pharma. ...
- Botulax.
It works by relaxing the fine facial muscles that cause movement, allowing the skin to appear smoother with reduced lines and wrinkles.
How long does Allergan Botox last? ›How long does BOTOX® COSMETIC last? You may begin to notice results within 24 to 48 hours, with full results in 30 days, with results lasting up to four months for moderate to severe frown lines.
What is Allergan called now? ›...
Allergan.
| Type | Subsidiary of AbbVie Inc. |
|---|---|
| Website | www.allergan.com |
| Footnotes / references | |
Is Allergan the only maker of Botox? ›
About Allergan
It makes many well-known brands including Botox, Linzess, Viberzi, and Lexapro and Celexa. The company has its headquarters in Dublin, Ireland.
Allergan
Is 400 units of Botox a lot? ›In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 Units, in a 3-month interval. In pediatric patients, the total dose should not exceed the lower of 10 Units/kg body weight or 340 Units, in a 3-month interval [see Dosage and Administration (2.7)].
What is the cost of 100 units of Botox? ›The cost for Botox injectable powder for injection 100 units is around $677 for a supply of 1 powder for injection, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
How long does Allergan Botox take to work? ›Botox injections usually begin working one to three days after treatment. Depending on the problem being treated, the effect may last three months or longer. To maintain the effect, you'll need regular follow-up injections.
Where is Allergan headquarters located? › What do you do with an Allergan implant? ›If you have Allergan textured breast implants and were diagnosed with cancer, the FDA recommends that you have your implants removed. You may also be eligible to file a lawsuit against the manufacturer.
Which Allergan implants are being recalled? ›The specific Allergan implants recalled are:
Natrelle Silicone-Filled Textured Breast Implants (Styles 110, 115, 120, TRL, TRLP, TRM, TRF, TRX, TCL, TCLP, TCM, TCF, TCX, TSL, TSLP, TSM, TSF, TSX)
Company Culture at AbbVie
83% of employees at AbbVie say it is a great place to work compared to 57% of employees at a typical U.S.-based company.
AbbVie Employees, their families, and friends are eligible for Employee Discounts, Special Pricing, and Perks on products and services used every day. Find discounts on travel, insurance, prescriptions, cell phones, tires, movies, Theme parks, and more.
What is Alle flash? ›
What is Alle Flash? Alle Flash is a new and exciting program in Alle where you can get surprise points for more savings. You'll need the Alle app on your phone. But don't worry, it's easy to download when you visit the office. Once you arrive at our office, you will scan a special QR code at the front desk.
Which brand of Botox lasts longest? ›The main difference between the DAXI and Botox (Dysport, and Xeomin) is how long it lasts. “Instead of having your treatment last about three to four months, we've seen that DAXI lasts a lot longer at about six to eight months,” Dr. Katz says.
What's the strongest Botox? ›A comparative study conducted on the content of Botulinum toxin found in Botox®/Vistabel®, Dysport®/Azzalure®, and Xeomin®/Bocouture® showed that Xeomin had the highest neurotoxin activity, then the Dysport followed by Botox which has the lowest specific activity level (Frevert, J.
What are the 3 types of Botox? ›Wrinkle relaxing botulinum toxin type A injections 'neurotoxins' are the most common non-invasive aesthetic procedure in the U.S. While they are commonly called “Botox,” there are actually four different FDA-approved neurotoxins: Botox, Dysport, Jeuveau, and Xeomin.
Does Botox cause blood clots? ›Botox is a neurotoxic protein and acts by paralysing the muscles around where it is injected. It is therefore unlikely to be the cause of blood clots.
Is Allergan Botox FDA approved? ›Allergan Aesthetics has adhered to rigorous quality and safety requirements for over 30 years. On April 15, 2002, the FDA approved BOTOX® as a temporary cosmetic treatment for moderate to severe frown lines in adults and requested the product be marketed as BOTOX® Cosmetic to distinguish cosmetic from therapeutic uses.
What is the best Korean Botox? ›Meditoxin currently has the most clinical data and the greatest number of indications for use among Korean botulinum toxin products, according to Medytox.
Is 40 units of Botox a lot? ›For horizontal forehead lines, practitioners can inject up to 15–30 units of Botox. For “11” lines between the eyes (or glabellar lines), up to 40 units are indicated, with higher doses needed in male patients .
Is 20 units of Botox a lot? ›10 to 15 Units Of Botox On Average
On average 10 to 15 units of Botox will be injected around each eye. In total of 20 to 30 units. Outer lateral canthal lines or 'Crowsfeet' are the lines around the corners of your eyes. The amount of units that you need for your 11 lines is dependent on how severe your lines are.
The results from Botox last anywhere between 2-6 months; the average result lasts about 3-4 months. Why does Botox eventually stop working? Your body makes new neurotransmitters all the time, so the “blocking” effect of Botox gradually wears off as these chemicals start circulating in your body again.
Is Allergan Botox Made in USA? ›
At Dermatology & Aesthetic Center of El Paso, we use trustworthy brands with the holographic seal that is sent directly from the Allergan company who makes the Botox® neurotransmitter in the United States of America. You will receive the care, products, and treatments you deserve.
Who tried buying Allergan? ›AbbVie to acquire Allergan for $63 billion in megamerger of pharma giants. AbbVie said Tuesday it will acquire Allergan for $63 billion — the latest megamerger between two pharma giants seeking new ways to grow.
Who bought Botox? ›AbbVie acquired Botox owner Allergan two quarters ago and that combination resulted in a 52% year-over-year increase in AbbVie revenue in the September quarter, to $12.9 billion.
Is there a generic version of Botox? ›Unfortunately, there are no generic versions of Xeomin or Botox available.
How much is Allergan aesthetics worth? ›Including debt, the deal values Allergan at $83 billion.
Does Allergan make Juvederm? ›JUVÉDERM® Collection of Fillers | Dermal Filler - Allergan Aesthetics.
Does Allergan own Pfizer? ›Transaction Details
A wholly owned subsidiary of Allergan will be merged with and into Pfizer, and subject to receipt of shareholder approval, the Allergan parent company will be renamed “Pfizer plc” after the closing of the transaction.
Allergan is now part of AbbVie.
Who did Allergan merge with? ›Under the terms of the agreement, Allergan shareholders will receive 0.8660 AbbVie shares and $120.30 in cash for each Allergan share they hold. One member of Allergan's board will join AbbVie's board of directors now the transaction has been completed: retired executive vice-president Thomas C Freyman.
How do you make Botox last longer? ›- Avoid Sun Damage. ...
- Consider Low-Intensity Workouts. ...
- Reduce Your Stress Levels. ...
- Moisturize Your Skin. ...
- Don't Use Nicotine. ...
- Take a Zinc Supplement.
Where should you not inject Botox? ›
A good injector should know where to never inject.
A qualified, experienced injector should never inject the area near the orbital bone right above the pupil. If Botox is injected here, it can drift down toward the upper eyelid and cause an eyelid droop. This can last from weeks to even months.
While Botox may help with bags and wrinkles under your eyes, the injections aren't without risks. Temporary effects such as droopy eyelids and fat bulges near the injection site are possible. You may also experience mild pain shortly after the injections.
Is 32 units of Botox a lot? ›For the frown lines, 20 – 30 units of Botox is considered enough to relax the muscles. Similarly, for forehead lines, a woman may require up to 15 units to the desired results. Furthermore, for the crow's feet area, some individuals require up to 30 units for visible results.
What is the cheapest price for Botox? ›In the United States, Botox® typically costs $10 to $20 per unit.
How long does Botox in forehead last? ›Generally speaking, Botox injections in the forehead last for approximately 4 months. However, the specific longevity of the treatment depends on the specific dosage, your tolerance to the product, exercise level, and other factors.
What happens when you stop using Botox? ›If you stop BOTOX treatments after many years of regular injections, the only effect will be that your wrinkles will return, albeit a bit more slowly than if you had not been using BOTOX. It's true: Even after you stop, you will still look younger than you would have if you had never been injected.
Does Botox make you look older after it wears off? ›There's a common misconception that Botox makes you look older when it wears off. On the contrary, regular Botox treatments make you look younger even after the neurotoxin wears off.
What Cannot do after Botox? ›- Do not rub or massage the treated area and avoid make-up if possible.
- Avoid sleeping on your face the first night.
- Do not exercise or partake in any strenuous activity for the next 12 hrs.
- Avoid excessive alcohol consumption for the next 24hrs.
Contact Galderma. If you would like to place an order for Dysport or have any related product questions, please call 1-844-GALDERM (1-844-425-3376) to speak with a sales representative or email customer service at ContactUs@GaldermaSupport.com.
How do you use alle points? ›When you're ready to use your points, just let your provider know you're an Allē Member and they'll redeem them from your Allē Wallet. Every 100 points earns you $10 in savings toward a future Allē product or treatment.
Is Dysport cheaper than Botox? ›
While cheaper than Botox, it typically it takes twice as many units of Dysport to achieve the same result. According to self-reported reviews on Real Self, that average cost of Dysport is $450 dollars per treatment nationally. Botox injections average at a slightly higher rate nationally at $550 each session.
Is Botox better than Dysport? ›Dysport is a great option for those who have moderate to severe frown lines. Botox, on the other hand, can be used to treat many different types of wrinkles, including crow's feet, forehead wrinkles, and laugh lines. If you have mild to moderate wrinkles, Botox may be a better option for you.
Which is better Botox or Jeuveau? ›The bottom line. Botox Cosmetic and Jeuveau both work well at improving the look of wrinkles, but Botox is approved to treat more types of wrinkles than Jeuveau. Both can cause mild side effects, and they should both be administered by a trained healthcare professional in a medical setting.
How much is 500 Alle points worth? ›Every 100 points can be redeemed for $1 with a 500 point minimum redemption.
How many Alle points do you get for Botox? ›| Eligible Products | Earnings Eligible Products | Allē Points Earned |
|---|---|---|
| BOTOX® Cosmetic (onabotulinumtoxinA) | Yes | 200 per treatment visit |
| JUVÉDERM® Ultra Plus XC | Yes | 200 per syringe |
| JUVÉDERM® VOLUMA® XC | Yes | 200 per syringe |
| JUVÉDERM® VOLLURE® XC | Yes | 200 per syringe |
Any Program points earned will expire twelve (12) months from the date of last Program activity. If your account is closed due to inactivity, all Program points will be forfeited.