JUVÉDERM VOLUMA® XC

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

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.

WARNINGS

• 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

PRECAUTIONS

• In order to minimize 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 mid-face have not been established in controlled clinical studies
• The safety for use during pregnancy and in breastfeeding females has not been established
• The safety for use in patients under 35 or over 65 years has 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 in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
• 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 increasedbruising or bleeding at treatment sites
• Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
• The safety 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® XCADVERSE 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 JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871. JUVÉDERM VOLUMA® XC injectable gel is available by prescription only.

  APPROVED USE

  JUVÉDERM VOLUMA® XC Before-and-After Photos (Christine2)

  Actual patient. Results may vary. Unretouched photos taken before treatment and 1 month after treatment with JUVÉDERM VOLUMA® XC. A total of 5.8 mL of JUVÉDERM VOLUMA® XC was injected into the cheek area.

  JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over the age of 21.

  IMPORTANT SAFETY INFORMATION

  Are there any reasons why I should not receive JUVÉDERM VOLUMA® XC?
  Do not use if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to the proteins (gram-positive bacterial proteins) used to make hyaluronic acid (HA) or to the lidocaine in this product.

  What precautions should my doctor advise me about?

  • Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied

  • The safety of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years has not been studied
  • The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area have not been established in clinical studies
  • Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
  • Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
  • Patients who experience skin injury near the site of injection with these products may be at higher risk for side effects

  Available by prescription only.

  • Tell your doctor if you are on immunosuppressive therapy used to decrease the body’s immune response, as use of these products may result in an increased risk of infection

  • Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site

  • Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment

  What are possible side effects?

  The most common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Side effects are moderate (uncomfortable) and generally last 2 to 4 weeks.

  One of the risks with using this product is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.

  As with all skin injection procedures, there is a risk of infection.
  To report a side effect with JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at

  1-800-624-4261.

  For more information, please see Juvederm.com or call Allergan Medical Information at 1-800-433-8871.