Juvéderm®

JUVÉDERM® is part of the ALLERGAN® Portfolio of Products, and this is the JUVÉDERM® website. For information on BOTOX® Cosmetic (onabotulinumtoxinA), visit BotoxCosmetic.com.

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How JUVÉDERM Can Improve Your Skin

JUVÉDERM® XC Important Information

Indication

JUVÉDERM® 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).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

 

JUVÉDERM® injectable gel should not be used in patients who have severe allergies marked by a history of anaphylaxis or history or presence of multiple severe allergies. JUVÉDERM®should not be used in patients with a history of allergies to Gram-positive bacterial proteins. JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC should not be used in patients with a history of allergies to lidocaine.

WARNINGS

JUVÉDERM® injectable gel should not be injected into blood vessels. If there is an active inflammatory process or infection at specific injection sites, treatment should be deferred until the underlying process is controlled.

PRECAUTIONS

The safety of JUVÉDERM® for use during pregnancy, in breast-feeding females, or in patients under 18 years has not been established. The safety and effectiveness of JUVÉDERM® injectable gel for the treatment of areas other than facial wrinkles and folds (such as lips) have not been established in controlled clinical studies.

Patients who are using substances that can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may experience increased bruising or bleeding at injection site. Patients should inform their physician before treatment if they are using these types of substances. As with all skin-injection procedures, there is a risk of infection.

JUVÉDERM® should be used with caution in patients on immunosuppressive therapy, or therapy used to decrease the body’s immune response, as there may be an increased risk of infection. The safety of JUVÉDERM® in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied.

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

ADVERSE EVENTS

The most commonly reported side effects are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, and bruising. Most side effects are mild or moderate in nature, and their duration is short lasting (7 days or less).

To report a problem with JUVÉDERM®, 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® injectable gel is available by prescription only.

JUVÉDERM VOLUMA™ XC Important Information

INDICATION

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

JUVÉDERM VOLUMA™ XC is contraindicated for patients with severe allergies, manifested by a history of anaphylaxis or history or presence of multiple severe allergies, and a history of allergies to gram-positive bacterial proteins or lidocaine.

WARNINGS

JUVÉDERM VOLUMA™ XC injectable gel must not be injected into blood vessels and should not be used in vascular-rich areas. Use in these areas, such as glabella and nose, has resulted in cases of vascular embolization, occlusion of the vessels, ischemia or infarction, or blindness. Symptoms of vessel occlusion and embolization include pain that is disproportionate to the procedure or remote to the injection site, immediate blanching extending beyond the injected area, and color changes that reflect ischemic tissue such as a dusky or reticular appearance
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

The safety and effectiveness for the treatment of anatomic regions other than the mid-face have not been established
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 very thin skin in the mid-face region has not been established
The safety for use in patients under 35 years or over 65 years has not been established
The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
JUVÉDERM VOLUMA™ XC injectable gel should be used 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
Patients who experience skin injury near the site of JUVÉDERM VOLUMA™ XC implantation may be at a higher risk for adverse events
Patients may experience late onset nodules with use of dermal fillers including JUVÉDERM VOLUMA™ XC
Patients should be limited to 20 mL of JUVÉDERM VOLUMA™ XC per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
JUVÉDERM VOLUMA™ XC should only be used by physicians who have appropriate experience and who are knowledgeable about facial anatomy and the product for use in deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation

ADVERSE EVENTS
Side effects in > 5% of subjects were temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. They were predominantly moderate in severity, with a duration of 2 to 4 weeks.

To report an adverse reaction, please call Allergan Product Surveillance at 1-877-345-5372.

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 VOLUMA™ XC injectable gel is available by prescription only.