- On October 23, 2013 the U.S. Food and Drug Administration (FDA) approved JUVÉDERM VOLUMA™ X as the first and only filler to temporarily correct age-related volume loss in the cheek area in adults age 21 and over. It helps create a more youthful appearance to the face and provides natural-looking and long-lasting results – up to two years with optimal treatment.
- As people age, the cheek area can lose volume, causing the cheeks to flatten out and the skin to droop and sag.2,3 Age-related facial volume loss is a growing need in the field of aesthetic medicine. The 2013 American Society for Dermatological Surgery (ASDS) Consumer Survey on Cosmetic Procedures revealed that one of the top reasons why people choose to undergo a cosmetic procedure is because they want to look as young as they feel, with sixty-one percent of respondents most bothered by sagging facial skin.
- JUVÉDERM VOLUMA™ XC is a non-surgical treatment option that is performed in the physician’s office.
- JUVEDERM VOLUMA TM XC is a gel that is injected into the cheek area to gently lift the skin. It temporarily corrects age-related volume loss in the cheek area helps create a more youthful appearance to the face.
- JUVÉDERM VOLUMA™ XC is made from a modified form of hyaluronic acid. Hyaluronic acid is a natural complex sugar that occurs within the body.
- JUVÉDERM VOLUMA™ XC is made with Allergan’s proprietary VYCROSS™ technology, an advanced manufacturing process that results in a smooth gel that flows easily and consistently. The unique formulation in JUVÉDERM VOLUMA™ XC contributes to the lift capacity and to the duration of the product.
- JUVÉDERM VOLUMA™ XC also contains a small amount of lidocaine which helps to numb the treatment area during the injection procedure.
- The side effects observed in more than five percent of patients in the clinical trial included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Most were moderate in severity and resolved within two to four weeks.
- The JUVÉDERM VOLUMA™ formulation without lidocaine was first introduced in Europe in 2005. JUVÉDERM VOLUMA™ with lidocaine was first introduced outside the U.S., in 2009. As of Aug, 31, 2013, JUVÉDERM VOLUMA™ with lidocaine (branded as Juvéderm VOLUMA XC in the U.S.) is distributed in 72 countries, including markets in Europe, Latin America, Middle East, Asia Pacific region, and Canada. The JUVÉDERM® family of products, including JUVÉDERM® Ultra and Ultra Plus are marketed and sold in 85 countries outside the United States.
- JUVÉDERM VOLUMA™ XC is the latest product offering from the JUVÉDERM® family of products, the number one prescribed dermal filler brand in the United States.8
- For further product information and important safety information please visit www.juvederm.com.
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 the product if you have severe allergies with a history of severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the proteins (gram-positive bacterial proteins) used to make the hyaluronic acid (HA) in JUVÉDERM VOLUMA™ XC.
What precautions should my doctor advise me about?
- The safety of JUVÉDERM VOLUMA™ XC injectable gel for use during pregnancy, in women who are breastfeeding, or in patients with very thin skin in the cheek area has not been studied
- The safety for use in patients under 35 years or over 65 years has not been studied
- The safety and effectiveness for treatment in areas other than the cheek area have not been established
- The safety for use in patients with a history of excessive scarring or pigmentation disorders has not been studied and may result in additional scars or changes in pigmentation
- The long-term safety of repeat treatments has not been established
- Patients who experience skin injury near the site of injection may be at a higher risk for side effects
- Tell your doctor if you are on therapy used to decrease the body’s immune response (immunosuppressive therapy). Use 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 with any injection, this may result in increased bruising or bleeding at the injection site
- Minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment
What are possible side effects?
Side effects are moderate (uncomfortable) and generally last 2 to 4 weeks. 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.
To report a side effect, please call Allergan Product Surveillance at 1-877-345-5372.
JUVÉDERM VOLUMA™ XC injectable gel is available by prescription only.