JUVÉDERM VOLBELLA® XC Important Information
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
This product 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 this product.
Do not inject into blood vessels. Introduction of this product 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
- In order to minimize the risk of potential complications, this product 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 lips and perioral area for lip augmentation and correction of perioral rhytids with 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 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 may experience late onset adverse events with use of dermal fillers, including JUVÉDERM VOLBELLA® XC
The most commonly reported side effects for JUVÉDERM VOLBELLA® XC injectable gel were temporary injection-site redness,
swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, itching, and dryness.
They were predominantly mild or moderate, with a duration of 30 days or less.
To report an adverse reaction with JUVÉDERM VOLBELLA® XC, please call Allergan at 1-800-433-8871. Please also visit JuvedermDFU.com for more information.
JUVÉDERM VOLBELLA® XC injectable gel is available by prescription only.