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 cervical dystonia and 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
The long-term efficacy and safety outcomes of RHA® with lidocaine are applicable to RHA® with mepivacaine and have 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.
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
and mepivacaine. Do not use in patients with bleeding disorders.
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.
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.
©2025 REVANCE. 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-00221
SkinPen®
Indication
The SkinPen® system is a microneedling device and accessories intended to be
used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick
skin types II – IV and to improve the appearance of facial acne scars in adults
with all Fitzpatrick skin types aged 22 years and older. Rx only. To view SkinPen®
intended use, important safety information, and clinical trial details (data
on file), contact us at info@skinpen.com.
REFERENCES
DAXXIFY®. Prescribing Information. Revance Therapeutics, Inc; 2023.
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.
BOTOX® Cosmetic. Prescribing Information. Allergan Inc.
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.
XEOMIN®. Prescribing Information. Merz Pharmaceuticals GmbH; 2024.
DYSPORT®. Prescribing Information. Ipsen Biopharmaceuticals Ltd; 2023.
JEUVEAU®. Prescribing Information. Evolus, Inc.
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.
RHA®. Directions for Use. Geneva, Switzerland: Teoxane S.A.
