This tool is for visualization and illustrative purposes
only and is not a substitute for a consultation with a qualified healthcare
professional. When you decide on and consult with a qualified healthcare
professional, he/she will determine the severity of your wrinkles and folds and
whether JUVÉDERM® is right for you. He/she may recommend a
different treatment based on your individual needs to help you achieve your
desired result. Allergan and www.JUVÉDERM.com are not engaged in providing
medical advice or services, and do not endorse or warrant any specific
technique, method of treatment, or outcome. It is up to your individual
healthcare professional to use his/her best medical judgment when making
recommendations and determining appropriate patient care.
A Brief Description of Relevant Indications for Use,
Contraindications, Warnings, Precautions, and Adverse Events for
JUVÉDERM® Injectable Gel
Indication: In the United States, JUVÉDERM®
injectable gel is indicated for correction of moderate to severe facial wrinkles
and folds (such as nasolabial folds).
Contraindications: JUVÉDERM® injectable gel should not be used in
patients who have severe allergies marked by a history of anaphylaxis or history
or presence of multiple severe allergies. JUVÉDERM® injectable
gel should not be used in patients with a history of allergies to Gram-positive
bacterial proteins.
Warnings: JUVÉDERM® 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: The safety of JUVÉDERM® injectable
gel for use during pregnancy, in breastfeeding females, or in patients under 18
years has not been established. The safety and effectiveness of
JUVÉDERM® injectable gel for the treatment of areas other than facial
wrinkles and folds (such as lips) have been established in controlled clinical
studies. Patients who are using substances that can prolong bleeding, such as
aspirin or ibuprofen, as with any injection, may experience increased bruising
or bleeding at injection site. Patients should inform their physician before
treatment if they are using these types of substances. As with all
skin-injection procedures, there is a risk of infection. JUVÉDERM®
injectable gel should be used with caution in patients on immunosuppressive
therapy, or therapy used to decrease the body’s immune response, as there may be
an increased risk of infection. The safety of JUVÉDERM®
injectable gel in patients with a history of excessive scarring (eg,
hypertrophic scarring and keloid formations) and pigmentation disorders has not
been studied. If laser treatment, chemical peel, or any other procedure based on
active dermal response is considered after treatment with JUVÉDERM®
injectable gel, or if JUVÉDERM® injectable gel is administered
before the skin has healed completely after such a procedure, there is a
possbile risk of an inflammatory reaction at the treatment site.
Adverse events: The most commonly reported side effects are
temporary injection-site redness, swelling, pain/tenderness, firmness,
lumps/bumps, and bruising. Most side effects are mild or moderate in nature, and
their duration is short lasting (7 days or less).
Important: For full safety information, please visit
www.juvederm.com or call Allergan Product Support at 1-877-345-5372.
CAUTION: This device is restricted to sale by or on the order of a
physician.