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BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Approved Use

BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).

IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities

The dose of BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® Cosmetic.

Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breast-feed (it is not known if BOTOX® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.

Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin, such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; or take a sleep medicine.

Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 .

Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.

LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information

Indication

LATISSE® is a prescription treatment for hypotrichosis (inadequate or not enough lashes) to grow eyelashes longer, fuller and darker.

IMPORTANT SAFETY INFORMATION

If you use/used prescription products for eye pressure problems, use LATISSE® under doctor care. LATISSE® may cause increased brown pigmentation of the colored part of the eye which is likely permanent. Eyelid skin darkening may occur and may be reversible. Only apply at the base of the upper eyelashes. DO NOT APPLY to lower lid. Hair may grow on skin that LATISSE® solution frequently touches. If you have eye problems/surgery, consult your doctor about use of LATISSE®. Common side effects are itchy and red eyes. If discontinued, lashes will gradually return to their previous appearance.

You are encouraged to report negative side effects of prescriptions drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full LATISSE® Product Information.

JUVÉDERM® XC Important Information

Indication

JUVÉDERM® XC injectable gel is injected in the areas of facial tissue where moderate to severe facial wrinkles and folds occur to temporarily add volume to skin, which may give appearance of a smoother surface.

IMPORTANT SAFETY INFORMATION

Most side effects are mild or moderate in nature, and their duration is short lasting (7 days or less). The most common side effects include, but are not limited to, temporary injection-site reactions such as: redness, pain/tenderness, firmness, swelling, lumps/bumps, bruising, itching and discoloration.

As with all skin-injection procedures, there is a risk of infection.

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

For more information, please see the About Safety page at www.juvederm.com or call the Allergan Product Support line at 1-800-433-8871.

JUVÉDERM® XC injectable gel is available by prescription only.

Natrelle® Important Safety Information

Indications

Who may get breast implants (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.

IMPORTANT SAFETY INFORMATION

Who should NOT get breast implants
(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.

What else should I consider (WARNINGS)?
Breast implants are not lifetime devices or necessarily a one-time surgery. You may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast, which may be permanent. Breast implants may affect your ability to produce milk for breastfeeding. Silicone-filled implants may rupture without symptoms. MRI examinations 3 years after surgery and then 2 years after can detect ruptures. Symptoms of a ruptured implant may be hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning or hardening. Talk to your doctor about removing ruptured implants. Inform any other doctor if you have implants.

What types of conditions require more study
(PRECAUTIONS)?

Caution: Notify your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher: autoimmune diseases, a weakened 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 and eating disorders. These disorders should be resolved or stabilized prior to surgery.

What are some complications with breast implants
(COMPLICATIONS)?

Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring or wrinkling/rippling. Talk to your doctor about other complications.

Talk to your doctor. For more information see the Patient Brochures at www.allergan.com/labeling/usa.htm 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.


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©2015 Allergan, Inc. Irvine, CA 92612 ® marks owned by Allergan, Inc.
JUVÉDERM® mark owned by Allergan Industrie SAS.

Dysport® is a registered trademark of Ipsen Biopharm Limited
Myobloc® is a registered trademark of Solstice Neurosciences, Inc
Xeomin is a registered trademark of Merz Pharma GmbH & Co. KGaA.
Restylane and Perlane are trademarks of HA North American Sales AB.
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