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.
PLEASE SEE FULL DIRECTIONS FOR USE
RHA® Collection of Fillers, by Teoxane
Indications 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 indicated for injection
into the dermis and superficial dermis of the face, for the correction of moderate to
severe dynamic perioral rhytids in adults 22 or older. RHA® 2 and RHA® 2 Mepi are indicated for injection into the mid-to-deep dermis 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 indicated for injection into
the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles
and folds, such as nasolabial folds (NLFs) and is also indicated for injection into the
vermillion body, vermillion border and oral commissure to achieve lip augmentation and
lip fullness in adults 22 or older. RHA® 4 is indicated for injection in the
deep dermis to superficial subcutaneous tissue for the correction of moderate to severe
dynamic facial wrinkles and folds, such as nasolabial folds (NLFs) in adults 22 or
older. RHA® Dynamic Volume is indicated for injection in the deep dermis to superficial
subcutaneous tissue for the correction of moderate to severe dynamic facial wrinkles and folds,
such as nasolabial folds (NLFs) and for injection into the subcutaneous to supraperiosteal
layers for cheek augmentation and/or correction of age-related midface contour deficiencies
in adults 22 or older.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not use in patients who have severe allergies, marked by a history of anaphylaxis or
multiple severe allergies, or in patients with a history of allergies to gram-positive
bacterial proteins or local anesthetics of the amide type, such as lidocaine and
mepivacaine.
Do not use in patients with bleeding disorders.
Warnings
Do not inject into blood vessels. Introduction of these products into the vasculature
may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra
care when injecting soft-tissue fillers; for example, inject the product slowly and
apply the least amount of pressure necessary. Rare, but serious, adverse events
associated with the intravascular injection of soft-tissue fillers in the face have been
reported and include temporary or permanent vision impairment, blindness, cerebral
ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to
underlying facial structures.
Immediately stop the injection if a patient exhibits any of the following symptoms:
changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or
shortly after the procedure. Patients should receive prompt medical attention and,
possibly, evaluation by an appropriate healthcare professional specialist should an
intravascular injection occur.
Product use at specific sites in which an active inflammatory process or infection is
present should be deferred until the underlying process has been controlled.
Precautions
These products should only be used by healthcare professionals who have appropriate
training, experience, and knowledge of facial anatomy.
Discuss the potential risks of soft-tissue injections with your patients prior to
treatment and ensure that patients are aware of signs and symptoms of potential
complications.
The safety and effectiveness for the treatment of anatomic regions other than the
labeled indications have not been established in controlled U.S. clinical studies
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection.
Standard precautions associated with injectable materials should be followed.
The safety for use in sites in the presence of other implants, during pregnancy, in
breastfeeding females, and in patients with known susceptibility to keloid formation,
hypertrophic scarring, and pigmentation disorders has not been studied.
Use with caution in patients on immunosuppressive therapy.
Patients who are using products that can prolong bleeding (such as thrombolytics,
anticoagulants, or inhibitors of platelet aggregation) may experience increased bruising
or bleeding at treatment sites.
Patients with a history of herpetic eruptions may experience reactivation of the herpes.
There is a possible risk of inflammation at the implant site if laser treatments or a
chemical peel are performed after treatment.
Use as supplied. Modification or use of the product outside the Directions for Use may
adversely impact the sterility, safety, homogeneity, or performance of the product.
For single patient use. Do not reuse a syringe between two treatments and/or between two
patients. Do not resterilize.
Adverse Events
The most commonly reported side effects were firmness, redness, tenderness, swelling,
lumps/bumps, bruising, discoloration, pain and itching. Most of these events were mild
or moderate and resolved within 14 days.
Delayed-onset inflammation near the site of dermal filler injections is one of the known
adverse events associated with dermal fillers. Cases of delayed-onset inflammation have
been reported to occur at the dermal filler treatment site following viral or bacterial
illnesses or infections, vaccinations, or dental procedures. Typically, the reported
inflammation was responsive to treatment or resolved on its own.
To report an adverse event with any RHA® product to Revance, please visit
Safety.Revance.com or call at 1 (877) 373-8669.
RHA® and RHA Redensity® are registered trademarks of TEOXANE
SA. MLT MULTI LAYERING TECHNIQUETM is a trademark of TEOXANE SA. The
Teoxane RHA® Collection is manufactured by Teoxane SA in Switzerland and exclusively
distributed by Revance. All other trademarks are the property of their respective owners.
Available by Prescription only
RHA-00221
REFERENCES:
- Data on File. TEO-RHA-2004. Geneva, Switzerland, Teoxane S.A., 2025.
- RHA® Directions for Use.
- Faivre J, Gallet M, Tremblais E, Trévidic P, Bourdon F. Advanced concepts in rheology
for the evaluation of hyaluronic acid-based soft tissue fillers. Dermatol Surg. 2021;47(5):e159-e167.
- Vantou C, Moreno C, Clerc E, et al. Unveiling the key characteristics of the preserved
network technology (PNT): manufacturing the dynamic RHA® fillers. Poster presented
at: American Society for Dermatologic Surgery Annual Meeting; October 17-20, 2024.
- Monheit G, Kaufman-Janette J, Joseph JH, Shamban A, Dover JS, Smith S. Efficacy and
safety of two resilient hyaluronic acid fillers in the treatment of moderate-to-severe
nasolabial folds: A 64-week, prospective, multicenter, controlled, randomized,
double-blinded, and within-subject study. Dermatol Surg. 2020;46(12):1521-1529.
- Kaufman-Janette J, Taylor SC, Cox SE, Weinkle SH, Smith S, Kinney BM. Efficacy and
safety of a new resilient hyaluronic acid dermal filler, in the correction of
moderate-to-severe nasolabial folds: A 64-week, prospective, multicenter, controlled,
randomized, double-blind and within-subject study. J Cosmet Dermatol. 2019;18(5):1244-1253.
- Sundaram H, Shamban A, Schlessinger J, et al. Efficacy and safety of a new resilient
hyaluronic acid filler in the correction of moderate-to-severe dynamic perioral
rhytides: A 52-week prospective, multicenter, controlled, randomized, evaluator-blinded
study. Dermatol Surg. 2022;48(1):87-93.
- Mashburn et al. Evaluation of the impact of hyaluronic acid (HA) filler manufacturing
technologies on HA chain degradation. Poster presented at AAD VMX, 2021.
