Safety Information

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.

Dysport

Dysport is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.

Important Safety Information

What is the most important information you should know about Dysport?

Spread of Toxin Effects: In some cases, the effects of Dysport and all botulinum toxin products may affect areas of the body away from the injection site. Symptoms can happen hours to weeks after injection and may include swallowing and breathing problems, loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, or loss of bladder control.

Swallowing and breathing problems can be life threatening and there have been reports of death. You are at the highest risk if these problems are pre-existing before injection.

These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.

Do not have Dysport treatment if you: are allergic to Dysport or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow’s milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®, have a skin infection at the planned injection site, under 18 years of age, or are pregnant or breastfeeding.

The dose of Dysport is not the same as the dose of any other botulinum toxin product and cannot be compared to the dose of any other product you may have used.

Tell your practitioner about any swallowing or breathing difficulties and all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis, or Lambert-Eaton syndrome, which may increase the risk of serious side effects including difficulty swallowing and difficulty breathing.

Tell your practitioner about all of your medical conditions, including if you have surgical changes to your face, very weak muscles in the treatment area, any abnormal facial change, injection site inflammation, droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, wrinkles that can’t be smoothed by spreading them apart, or if you are pregnant or breastfeeding or planning to become pregnant or breastfeed.

Tell your practitioner about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines while taking Dysport without talking to your doctor first.

Especially tell your practitioner if you: have received any other botulinum toxin product, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA), in the last four months or any 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.

Common Side Effects

The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea.

Ask your doctor if Dysport is right for you.

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 Dysport Full Prescribing Information including Medication Guide.

JUVÉDERM®

Injectable Gel Fillers Indications and Important Safety InformationJUVÉDERM 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.Important Safety InformationAre there any reasons why I should not receive any JUVÉDERM® injectable gel formulation?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.What precautions should my doctor advise me about?

Tell your practitioner 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 practitioner 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 practitioner 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 practitioner 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 practitioner 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?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 2 to 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.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.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.Available by prescription only.

Restylane

The Restylane family of products includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Refyne, and Restylane® Defyne.

APPROVED USES

Restylane® and Restylane-L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated for injection into the lips in patients over the age of 21.

Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21.

Restylane® Silk is for lip augmentation and for correction of perioral wrinkles in patients over the age of 21.

Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.

Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.

Are there any reasons why I should not use products within the Restylane® family? (Contraindications)

To ensure a safe procedure, your doctor will talk to you about your medical history to determine if you are an appropriate candidate for treatment. You should not use products within the Restylane family if:

You have severe allergies with a history of severe reactions (anaphylaxis)
You are allergic to lidocaine or to any of the gram-positive bacterial proteins used to make hyaluronic acid
You are prone to bleeding or have been diagnosed with a bleeding disorder
Tell your doctor if you are breastfeeding, pregnant, or trying to become pregnant. The safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied
Restylane, Restylane-L, Restylane® Lyft with Lidocaine, Restylane Refyne and Restylane Defyne are intended to treat facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are also intended for lip enhancement. Treatments in other areas of the face have not been evaluated in clinical studies.
The safety and effectiveness of Restylane® Silk for areas other than the lips and perioral area have not been evaluated in clinical studies
Tell your practitioner if you have any history of scarring, particularly thick and stiff scars, or any pigmentation (skin color) disorders. These side effects can occur with hyaluronic acid fillers in general.
Tell your practitioner 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 these products may be at a higher risk for side effects
Tell your practitioner if you are on any medications to decrease your body’s immune response (immunosuppressive therapy). Using these medications may increase your risk of bruising or bleeding at the gel injection site.
Tell your practitioner if you are using any “blood thinners” such as aspirin, warfarin, or any other medications that affect bleeding. Using these medications may increase your risk of bruising or bleeding at the gel injection site.
The use of these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of product in these areas could delay healing or make your skin problems worse.

What are the possible side effects?

The most commonly observed side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, and itching at the injection site. These are typically mild in severity and typically resolve in less than 7 days in nasolabial folds and less than 14 days in lips. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site.

One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, 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 of the skin.

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

To report a side effect with any of the Restylane products, please call Galderma Laboratories, L.P at 1-855-425-8722.

The Restylane family of products is available only through a licensed practitioner.

All trademarks are the property of their respective owners.

Kybella

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; talk to your healthcare provider about the best way to feed your baby if you receive KYBELLA®).

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).

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), or trouble swallowing.

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

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

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