JUVÉDERM® VOLBELLA® XC Important Information
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing 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soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary.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
- To minimize the risks of potential complications, this product should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
- The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
- The safety and effectiveness for the treatment of anatomic regions other than the lips, perioral rhytids, and infraorbital hollows have not been established in controlled clinical studies
- The safety for use of this product 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 in patients under 22 years has not been established
- As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
- Dermal fillers should be used with caution in patients on immunosuppressive therapy
- Patients taking medications 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 before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
- Patients may experience late-onset adverse events with use of dermal fillers
- Injection of more than 6.0 mL of JUVÉDERM® VOLBELLA® XC injectable gel for lip augmentation and correction of perioral rhytids, and more than 2.2 mL per infraorbital hollow, has not been studied
- Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
The most commonly reported side effects for JUVÉDERM® VOLBELLA® XC injectable gel were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, itching, and dryness. Most were predominantly mild or moderate in severity, with duration of 30 days or less.
To report an adverse reaction with JUVÉDERM® VOLBELLA® XC, please call the Allergan® Product Support Department at 1-877-345-5372. Please visit JuvedermDFU.com for more information.
JUVÉDERM® VOLBELLA® XC injectable gel is available only by a licensed physician or properly licensed practitioner.