BOTOX® Cosmetic

IMPORTANT SAFETY INFORMATION & APPROVED USES 

BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic :

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• 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, and trouble swallowing.
   

BOTOX® Cosmetic dosing units are 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, and/or forehead lines.

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BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

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

Do not receive 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.

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Tell your doctor about all your muscle or nerve conditions, such as 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.

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Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have 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 (it is not known if BOTOX® Cosmetic passes into breast milk).

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Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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.

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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 (tell your doctor 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.

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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 and eyebrows, swelling of your eyelids and dry eyes.

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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.

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

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To report a side effect, please call Allergan at 1-800-678-1605.

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

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JUVÉDERM® Injectable Gel Fillers Indications and Important Safety Information

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JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over 21. JUVÉDERM VOLLURE™ XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over 21. JUVÉDERM® XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). JUVÉDERM® Ultra XC is for injection into the lips and perioral area for lip augmentation in adults over the age of 21. JUVÉDERM VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over the age of 21.

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IMPORTANT SAFETY INFORMATION

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Are there any reasons why I should not receive any JUVÉDERM® injectable gel formulation?

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Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products.

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What precautions should my doctor advise me about?

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• Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied

• The safety of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years, the safety of JUVÉDERM® XC and JUVÉDERM® Ultra XC injectable gels in patients under 18 years, and the safety of JUVÉDERM VOLLURE™ XC and JUVÉDERM VOLBELLA® XC in patients under 22 years has not been studied

• The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area, JUVÉDERM® XC and JUVÉDERM VOLLURE™ XC for areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC in areas other than the lips and perioral area have not been established in clinical studies 

• Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation

• Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment

• Patients who experience skin injury near the site of injection with this product may be at a higher risk for side effects

• Tell your doctor if you are on immunosuppressive therapy used to decrease the body’s immune response, as use of these products may result in an increased risk of infection

• Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site

• Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment
   

What are possible side effects?

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The most commonly reported side effects with JUVÉDERM® injectable gels included injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM VOLBELLA® XC, dryness was also reported. For JUVÉDERM VOLUMA® XC, most side effects were moderate and lasted 2to 4 weeks. For JUVÉDERM® XC, JUVÉDERM VOLLURE™ XC, and JUVÉDERM® Ultra XC injectable gels, most side effects were mild or moderate and lasted 14 days or less. For JUVÉDERM VOLBELLA® XC, most side effects were mild or moderate and lasted 30 days or less.

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One of the risks with using these products is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.

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

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To report a side effect with any JUVÉDERM® product, please call Allergan at 1-800-433-8871. Please visit Juvederm.com or talk to your doctor for more information.

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Available by prescription only.

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KYBELLA®

APPROVED USE AND IMPORTANT SAFETY INFORMATION

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What is KYBELLA®?

KYBELLA® is a prescription medicine used in adults to improve the appearance and profile of moderate to severe fat below the chin (submental fat), also called “double chin.”

It is not known if KYBELLA® is safe and effective for the treatment of fat outside of the submental area or in children under 18 years of age.

Who should not receive KYBELLA®?

Do not receive KYBELLA® if you have an infection in the treatment area.

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Before receiving KYBELLA®, tell your healthcare provider about all of your medical conditions, including if you: Have had or plan to have surgery on your face, neck, or chin; have had cosmetic treatments on your face, neck, or chin; have had or have medical conditions in or near the neck area; have had or have trouble swallowing; have bleeding problems; are pregnant or plan to become pregnant (it is not known if KYBELLA® will harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if KYBELLA®passes into your breast milk).

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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take a medicine that prevents the clotting of your blood (antiplatelet or anticoagulant medicine). 

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What are the possible side effects of KYBELLA®? 

KYBELLA® can cause serious side effects, including

• Nerve injury in the jaw (which can cause an uneven smile or facial muscle weakness)

• Trouble swallowing

• Injection site problems including: bruising, hair loss, open sores (ulcers), damage and tissue cell-death (necrosis) around the injection site. Call your healthcare provider if you develop open sores or drainage from the treatment area
   

The most common side effects of KYBELLA® include swelling, pain, numbness, redness, and areas of hardness in the treatment area.  

These are not all of the possible side effects of KYBELLA®. Call your doctor for medical advice about side effects.

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Please see KYBELLA® full Prescribing Information. 

Please see accompanying full Prescribing Information, or ask your healthcare provider, or visit MyKybella.com.

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KYB1113215  01/18  180481

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