Safety

BOTOX® Cosmetic Consumer Important Information

BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Approved Uses

BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of both moderate to severe crow’s feet lines and frown lines between the eyebrows in adults.
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, trouble saying words clearly, 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, any other 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, crow’s feet lines, or both at the same time.

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 difficulty swallowing and 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; take a sleep medicine; take aspirin-like products or blood thinners.
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. To report a side effect, please call Allergan at 1-800-433-8871.

 

 

JUVÉDERM® XC Indication and Important Safety Information

JUVÉDERM® XC Important Information

INDICATION

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).

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, 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

• In order to minimize the risk of potential complications, JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC injectable gels should only be used by

healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy

• Healthcare professionals are encouraged to discuss the potential risks of soft-tissue injections with their patients prior to treatment and ensure that patients

are aware of signs and symptoms of potential complications

• The safety and effectiveness for the treatment of anatomic regions other than moderate to severe facial wrinkles and folds with JUVÉDERM® XC, and the

lips and perioral area for lip augmentation with JUVÉDERM® Ultra XC, have not been established in controlled clinical studies

• As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials

• The safety for use during pregnancy, in breastfeeding females, and in patients under 18 years has not been established

• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied

• Use with caution in patients on immunosuppressive therapy

• Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased

bruising or bleeding at treatment sites

ADVERSE EVENTS

The most commonly reported side effects are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration,

and itching. Most side effects are mild or moderate in nature, lasting 14 days or less.

To report a problem with JUVÉDERM® Ultra XC or JUVÉDERM® Ultra Plus 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 and JUVÉDERM® Ultra Plus XC injectable gels are available by prescription only.