Juvederm

Generic Name: hyaluronic acid gel
Brand Names: Juvederm Ultra, Juvederm Ultra XC, Juvederm Ultra Plus, Juvederm Ultra Plus XC

Company: Allergan, Inc.
Treatment for: Correction of Facial Wrinkles and Folds

What is Juvederm?

Juvederm is a family of injectable hyaluronic acid dermal fillers used to provide 9 months to one year of correction for moderate to severe facial wrinkles and folds, such as nasolabial folds (lines from the nose to the corners of the mouth). It is not indicated for use in lip augmentation.

Juvederm products are a smooth consistency gel, compared to some hyaluronic gel products that have a granular consistency. Juvederm products are developed using the Hylacross technology to allow a smoother, malleable gel. Hyaluronic acid is a naturally occurring sugar found in the body. Hyaluronic acid works by holding in water at the injection site and acting as a cushioning agent. It adds temporary volume and a smoother appearance to skin. Most patients need one treatment to achieve optimal results.

Some Juvederm XC products also contain the local anesthetic lidocaine for a more comfortable injection. Juvederm Ultra XC and Juvederm Ultra Plus XC both contain 0.3% preservative-free lidocaine and numb the treatment area within seconds. The Juvederm Ultra Plus products contain more highly cross-linked formulations for volumizing and correction of deeper folds and wrinkles.

Juvederm Clinical Trials

In the two primary U.S. clinical studies evaluating Juvederm Ultra or Juvederm Ultra Plus for safety and effectiveness, roughly 145 subjects were followed for 24 weeks after the Juvederm injection in one nasolabial fold. Compared to Zyplast dermal filler (bovine-based collagen) which was injected into the opposite nasolabial fold, Juvederm injection site reactions were similar in duration and frequency, mild to moderate in severity, did not require intervention, and typically lasted about 7 days. Redness, pain/tenderness, firmness, swelling and lumps/bumps occurred in roughly 80-90% of patients, bruising in 60% of patients, and itching and discoloration in roughly 35% of patients.

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The percent of patients who maintained improvement with Juvederm at 24 weeks was 88-90% compared to 36-40% with Zyplast. At study end, 84-88% of the patients expressed a preference for Juvederm Ultra injectable gel, 5-10% had a preference for Zyplast, and 5-6% of patients had no preference.

Of 146 subjects, 111-116 (76-79%) returned for a complimentary repeat treatment at an average of 36 weeks after their last injection. Forty-eight subjects returned after 36 weeks. Subjects who maintained improvement with Juvederm Ultra injectable gel was 75-81%. Patients rated their improvement prior to injection as mainly mild to moderate (between 1 and 2 on a scale going from 0 [no improvement] to 4 [extreme improvement]) from 2 weeks until greater than 36 weeks after injection.

Important Safety Information

Contraindications: Juvederm injectable gel should not be used in patients who have severe allergies marked by a history of anaphylaxis or a history or presence of multiple severe allergies. Juvederm should not be used in patients with a history of allergies to Gram-positive bacterial proteins. Juvederm Ultra XC and Juvederm Ultra Plus XC should not be used in patients with a history of allergies to lidocaine.

Warnings: Juvederm injectable gel should not be injected into blood vessels. If there is an active inflammatory process or infection at specific injection sites, treatment should be deferred until the underlying process is controlled.

Precautions: Juvederm should only be administered under the supervision of a licensed health care practitioner.

  • Patients should inform their physician if they are using substances that may prolong bleeding or bruising, such as aspirin, or ibuprofen, or naproxen.
  • Inflammation may occur at the treatment site if laser treatment, chemical peeling, or any other dermal procedure is performed after Juvederm treatment.
  • Use with caution in patients on immunosuppressive therapy due to the possibility of increased infection risk.
  • Safety for use during pregnancy, in breast-feeding, or in patients under 18 years has not been established.
  • Safety in patients with excessive scarring (e.g., hypertrophic scarring or keloid formation) and pigmentation disorders has not been studied.
Juvederm Side Effects: Most Juvederm side effects are mild in nature and short-lived, usually resolving in 7 days or less. The most common side effects include injections site reactions, such as:
  • Redness
  • Pain/tenderness
  • Firmness
  • Swelling
  • Lumps/bumps
  • Bruising
  • Itching
  • Discoloration
  • Risk of infection

If continued redness or visible swelling lasts for more than a few days, notify your physician or call the Allergan Product Support line at 1-877-345-5372.

Patient Information

How painful are Juvederm injections?

There may be some discomfort during and after the injection. Juvederm is injected directly into the skin with a fine needle. Some Juvederm products contain the local anesthetic lidocaine to help lessen discomfort during injection, or the physician may choose to numb the site prior to injection. You should discuss these options with your physician prior to the procedure.

What is expected after the procedure?

Within the first 24 hours, avoid:

  • strenuous exercise
  • extensive sun or heat exposure
  • alcoholic beverages

Exposure to any of the above may lead to temporary redness, swelling, and/or itching at the injection site. If swelling occurs, place an ice pack over the swollen area. Ask the physician how long to wait until make-up can be re-applied after the procedure.

How long does the Juvederm correction last?

Correction with Juvederm is temporary. Re-injections may be needed, typically between 9 months and one year after the initial injection. Smaller injections (about half the amount) are needed for repeat procedures.

What other treatments are available for correction of facial wrinkles and folds?

References

  1. Juvederm Ultra. [package insert] Allergan 2007. Accessed May 3, 2012. http://www.juvederm.com/Content/pdf/juvederm-safety.pdf
  2. Juvederm Ultra Plus. [package insert] Allergan 2007. Accessed May 3, 2012. http://www.juvederm.com/Content/pdf/patient-safety-juvederm-ultra-plus.pdf
  3. Juvederm Ultra XC. [package insert] Allergan 2007. Accessed May 3, 2012. http://www.juvederm.com/Content/pdf/final-patient-labeling-ultra-xc.pdf
  4. Juvederm Ultra Plus XC. [package insert] Allergan 2007. Accessed May 3, 2012. http://www.juvederm.com/Content/pdf/final-patient-labeling-ultra-plus-xc.pdf

Latest Revision: May 2012

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