JUVÉDERM® Collection of Fillers Important Information
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
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 the
age of 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
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.
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 softtissue 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
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
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
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
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 antiinflammatory 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
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
Patients may experience late onset adverse events with use of dermal fillers
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 JuvedermDFU.com for more information.
Products in the JUVÉDERM® Collection are available by prescription only.