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Clinical Information

With the approval of JUVÉDERM®, you can now offer a “next-generation” hyaluronic acid dermal filler to patients seeking treatment for moderate to severe facial wrinkles and folds, such as nasolabial folds and oral commissures. JUVÉDERM® injectable gel is a nonsurgical, physician-administered treatment made from the naturally occurring substance hyaluronic acid. There is minimal recovery or downtime and the risks of allergic reactions are minimal.

With JUVÉDERM® injectable gel, innovative HYLACROSS® technology provides:

Resistance to degradation

  • Clinically proven persistence up to 1 year in both formulations ¹
  • High concentration of hyaluronic acid (HA)
    • 24 mg/mL
  • High concentration of cross-linked HA

Smooth consistency gel for enhanced performance

JUVÉDERM® injectable gel is the only smooth consistency gel—other hyaluronic acid dermal fillers currently on the market are made of granular consistency gels.*

JUVÉDERM & Restylane

JUVÉDERM®                                              RESTYLANE†

*Dry test, extrusion of a small amount (≈.025 mL) of JUVÉDERM® injectable gel and RESTYLANE onto a glass surface at 9x magnification.

†RESTYLANE is a registered trademark of Q-Med AB.

JUVÉDERM® was the subject of the largest investigational device exemption (IDE) study ever conducted on hyaluronic acid dermal fillers¹

  • About 146 subjects in each study arm (439 total subjects in 3-arm trial)
  • Within-subject control, JUVÉDERM® injectable gel in one nasolabial fold (NLF) and ZYPLAST® dermal filler in the other
  • Primary end point: Improvement in NLF severity over the 6-month follow-up period
    • NLF severity was ranked on a 5-point scale
    • Assessed by a masked Independent Expert Reviewer through 24 weeks

JUVÉDERM® Ultra: A highly cross-linked formulation for versatility in contouring and volumizing facial wrinkles and folds.

88% of subjects maintained at least 1 grade improvement at 6 months

JUVÉDERM® Ultra Plus: A robust formulation for volumizing and correcting deeper folds and wrinkles.

94% of subjects rated as severe at baseline maintained at least 1 grade improvement at 6 months

Patient Preference

  • Patients overwhelmingly preferred JUVÉDERM® products over study control
     
    • 78%-88% of patients preferred JUVÉDERM® injectable gel at 6 months post-treatment
       

Safety Profile

  • Frequency and severity of treatment site responses were similar to control.
     
  • The smooth, uniform consistency of JUVÉDERM® allows it to flow easily and consistently into the skin. Click here to learn more about administering JUVÉDERM® injectable gel.
     
  • Studies with JUVÉDERM® showed no increased risk of hyperpigmentation or hypertrophic scarring in patients of color.
     

Materials for Healthcare Professionals and Patients

JUVÉDERM® Ultra Directions for Use

JUVÉDERM® Ultra Plus Directions for Use

JUVÉDERM® Ultra Patient Safety Information

JUVÉDERM® Ultra Plus Patient Safety Information

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JUVÉDERM® injectable gel is available...

... in two formulations to treat moderate to severe wrinkles and folds, allowing you to tailor treatment to your patients' facial aesthetic needs.

Learn More.

References

¹ JUVÉDERM® Ultra and JUVÉDERM® Ultra Plus Package Inserts

² Data on file, Allergan, Inc.

JUVÉDERM® is part of the Allergan portfolio of products and this is the JUVÉDERM® website. For information on BOTOX® Cosmetic, visit www.botoxcosmetic.com.

JUVÉDERM® Safety Information

*JUVÉDERM® is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

Important JUVÉDERM® Safety Information

JUVÉDERM® injectable gel (including JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and JUVÉDERM® Ultra Plus XC) is indicated for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Side effects were usually mild to moderate, lasting 7 days or less, and included temporary injection-site reactions such as redness, pain, firmness, swelling, and bumps. JUVÉDERM® is not for people with severe allergies. For more information, please click on the About Safety link at www.juvederm.com or call the Allergan Product Support line at 1-877-345-5372. JUVÉDERM® injectable gel is available by prescription only.

BOTOX® Cosmetic Important Information

Indication

BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary).

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.

  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing.

There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.

Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® or Dysport™; have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions such as such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® Cosmetic.

Tell your doctor about all your medical conditions, including if you have: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (It is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breastfeed (It is not known if BOTOX® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products.

BOTOX® Cosmetic may cause loss of strength or general muscle weakness, or vision problems. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see BOTOX® Cosmetic Full Product Information including Medication Guide.