Teoxane RHA® Collection of Fillers
Approved Uses
The RHA®
Collection of resilient hyaluronic acid (HA) fillers includes RHA Redensity™, RHA® 2, RHA®
3 and RHA® 4.
RHA Redensity™
is for injection into the facial tissue for the correction of moderate to
severe dynamic perioral rhytids; and RHA®
2 and RHA®
4 are for the correction of moderate to severe dynamic facial wrinkles and
folds, such as nasolabial folds, in adults 22 or older. RHA®
3 is for the correction of moderate to severe dynamic facial wrinkles and
folds, such as nasolabial folds, and also used to augment lip fullness 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 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 a side effect with any RHA®
product, please call Revance at (877) 373-8669. Please visit RHACollection.com
or talk to your doctor for more information.
RHA® is a registered trademark of TEOXANE SA, manufactured
in Switzerland. The RHA® Collection is exclusively
distributed by Revance Aesthetics™.
Available by prescription only.
RHA-P-002435.3
