BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

BOTOX 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. 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

 

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, or both at the same time.

 

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.

 

 

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 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 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: 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).

 

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.

 

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.

 

Other side effects of BOTOX® Cosmetic include: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids, and swelling of your eyelids.

 

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.

 

Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication 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 in adults over the age of 21.

 

JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus 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 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 21.

 

JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

 

JUVÉDERM VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids 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, 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, these products 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 the mid-face with JUVÉDERM VOLUMA® XC; facial wrinkles and folds with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLLURE™ XC; and the lips and perioral area with JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® 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 with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied

• The safety for use of JUVÉDERM VOLUMA® XC in patients under 35 or over 65 years, JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC in patients under 18 years, and JUVÉDERM VOLLURE™ XC and JUVÉDERM VOLBELLA® XC in patients under 22 years has not been established

• 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

• If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or if the product is administered before the skin has healed completely, there is a possible risk of an inflammatory reaction at the treatment site

• Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events

• The safety of JUVÉDERM VOLUMA® XC injectable gel for use in patients with very thin skin in the mid-face has not been established

• Patients may experience late onset nodules with use of dermal fillers, including JUVÉDERM VOLUMA® XC

• Patients may experience late onset adverse events with use of dermal fillers

 

ADVERSE EVENTS

The most commonly reported side effects for JUVÉDERM® injectable gels were 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, side effects were predominantly moderate in severity, with duration of 2 to 4 weeks; for JUVÉDERM® Ultra XC , JUVÉDERM® Ultra Plus XC, or JUVÉDERM VOLLURE™ XC, they were mostly mild or moderate in severity, with duration of 14 days or less; and for JUVÉDERM VOLBELLA® XC, they were predominantly mild or moderate, with duration of 30 days or less.

 

To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan at 1-800-433-8871. Please visit Juvederm.com for more information.

 

Products in the JUVÉDERM® Collection are available by prescription only.

 

 

KYBELLA® (deoxycholic acid) injection 10mg/mL, Indication and Important Safety Information

 

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 use outside of the submental area or in children under the age of 18.

 

Who should not receive KYBELLA®?

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

 

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.

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

Please talk to your healthcare provider or visit www.mykybella.com for full Prescribing Information.