The Teoxane RHA® Collection includes hyaluronic acid (HA) fillers with
lidocaine and mepivacaine. Revance will only distribute the Teoxane RHA® Collection with mepivacaine, thus may refer to the products without the use of
“Mepi” in the product name. The long-term efficacy and safety outcomes of
RHA® with lidocaine are applicable to RHA® with mepivacaine,
and mepivacaine has shown no significant impact on gel properties, including
rheology and degradation profile.
RHA® Collection of Fillers, by Teoxane Approved Uses
The Teoxane RHA® Collection of resilient hyaluronic acid (HA) fillers
includes RHA Redensity®, RHA® 2, RHA® 3 and RHA® 4 with lidocaine and RHA Redensity® Mepi, RHA® 2 Mepi, RHA® 3 Mepi and RHA® Dynamic Volume, with mepivacaine.
RHA Redensity® and RHA Redensity® Mepi are for injection into
the facial tissue for the correction of moderate to severe dynamic perioral rhytids.
RHA® 2, RHA® 2 Mepi and RHA® 4 are for the correction
of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds
(NLFs), in adults 22 or older. RHA® 3 and RHA® 3 Mepi are for
the correction of moderate to severe dynamic facial wrinkles and folds, such as
nasolabial folds (NLFs), and also used to augment lip fullness in adults 22 or older.
RHA® Dynamic Volume is for correction of moderate to severe dynamic
facial wrinkles and folds, such as nasolabial folds (NLFs) and for cheek augmentation
and/or correction of age-related midface contour deficiencies in adults 22 or older.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any RHA® injectable
gel formulation?
Do not receive if you have a history of multiple severe allergies or severe
allergic reactions; if you are allergic to lidocaine or mepivacaine or gram-positive
bacterial proteins; or if you have a bleeding disorder.
What precautions should I discuss with my doctor?
• Tell your doctor if you are pregnant or breastfeeding as the
safety of these products for use during pregnancy or while breastfeeding
has not been studied
• Tell your doctor if you have a history of excessive scarring,
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 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
• Tell your doctor if you are on immunosuppressive therapy used to
decrease your 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 increase bruising or bleeding at the injection site
• The safety and effectiveness of RHA® fillers in areas
other than those indicated have not been established in U.S. clinical
studies
• Patients who experience skin injury near the site of injection
with this product may be at a higher risk for side effects
• 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 commonly reported side effects included injection-site redness, swelling,
pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching.
One of the risks with using these products 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.
Delayed-onset inflammation near the site of dermal filler injections is
one of the known side effects associated with dermal fillers. Cases of
delayed-onset inflammation have been reported to occur at the treatment
site following viral or bacterial illnesses or infections, vaccinations,
or dental procedures.
Typically, the reported inflammation was responsive to being treated or
resolved on its own.
As with all skin injection procedures, there is a risk of infection and
recurrence of herpetic eruptions.
To report an adverse event with any RHA® product to Revance, please visit Safety.Revance.com or call at 1 (877) 373-8669.
Please visit RHACollection.com or talk to your doctor for more information.
RHA® and RHA Redensity® are registered trademarks of TEOXANE SA,
manufactured in Switzerland. The Teoxane RHA® Collection is exclusively
distributed by Revance®. All other trademarks are the property of their
respective owners.
Available by prescription only.
RHA-00220
