INDICATION
DAXXIFY® (daxibotulinumtoxinA-lanm) injection is an acetylcholine release
inhibitor and neuromuscular blocking agent indicated for the temporary
improvement in the appearance of moderate to severe glabellar lines
associated with corrugator and/or procerus muscle activity in adult
patients.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DAXXIFY® and all botulinum toxin products may spread from
the area of injection to produce symptoms consistent with botulinum toxin
effects. These symptoms have been reported hours to weeks after injection.
Swallowing and breathing difficulties can be life threatening and there
have been reports of death. DAXXIFY® is not approved for the treatment of
spasticity or any conditions other than glabellar lines.
IMPORTANT SAFETY INFORMATION
Contraindications
DAXXIFY® contraindications include hypersensitivity to any botulinum toxin preparation
or any of the components in the formulation and infection at the injection site(s).
Warnings and Precautions
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
The potency Units of DAXXIFY® are not interchangeable with other
preparations of other botulinum toxin products. Recommended dose and
frequency of administration should not be exceeded. Patients should seek
immediate medical attention if respiratory, speech or swallowing
difficulties occur. Use caution when administering to patients with
pre-existing cardiovascular disease. Concomitant neuromuscular disorders may
exacerbate clinical effects of treatment.
Adverse Reactions
The most commonly observed adverse reactions (≥1%) were headache (6%), eyelid
ptosis (2%) and facial paresis (1%).
Drug Interactions
Co-administration of DAXXIFY® and aminoglycoside antibiotics, anticholinergic
agents or any other agents interfering with neuromuscular transmission or muscle
relaxants should only be performed with caution as the effect of DAXXIFY® may
be potentiated. The effect of administering different botulinum neurotoxins during
course of treatment with DAXXIFY® is unknown.
Use in Specific Populations
DAXXIFY® is not recommended for use in children or pregnant women.
Please see DAXXIFY® full
Prescribing Information, including Boxed Warning and
Medication Guide.
DAXI-001720.2
PLEASE SEE FULL DIRECTIONS FOR USE
RHA® Collection of Fillers, by Teoxane
Indications:
The RHA® Collection of resilient hyaluronic acid (HA) fillers
includes RHA® Redensity™, RHA® 2, RHA®
3 and RHA®
4.
RHA® Redensity™ is 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 is
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 in adults 22 or older. RHA® 3 is 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 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 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.
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 reaction with any RHA®
product, please call Revance at
(877) 373-8669.
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-002436.3
REFERENCES
1. DAXXIFY®. Prescribing Information. Revance Therapeutics, Inc; 2023
2. Fabi SG, Cohen JL, Green LJ, et al. DaxibotulinumtoxinA for Injection for
the treatment of glabellar lines: efficacy results from SAKURA 3, a large, open-label,
phase 3 safety study. Dermatol Surg. 2020;47(1):48-54.
3. BOTOX® Cosmetic. Prescribing Information. Allergan Inc; 2023.
4. Carruthers JD, Fagien S, Joseph JH, et al. DaxibotulinumtoxinA for Injection
for the treatment of glabellar lines: results from each of two multicenter, randomized,
double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2).
Plast Reconstr Surg.
2020;145(1):45-58.
5. XEOMIN®. Prescribing Information. Merz Pharmaceuticals GmbH; 2024.
6. DYSPORT®. Prescribing Information. Ipsen Biopharmaceuticals Ltd; 2023.
7. JEUVEAU®. Prescribing Information. Evolus, Inc; 2020.
8. Bertucci V, Solish N, Kaufman-Janette J, et al. DaxibotulinumtoxinA for Injection
has a prolonged duration of response in the treatment of glabellar lines: pooled
data from two multicenter, randomized, double-blind, placebo-controlled, phase
3 studies (SAKURA 1 and SAKURA 2).
J Am Acad Dermatol. 2020;82(4):838-845.
9. RHA® Direction for Use. Nashville, TN: Revance Therapeutics, Inc,
2023.
