DAXXIFY® (daxibotulinumtoxinA-lanm) injection IMPORTANT SAFETY INFORMATION
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-00389.4
RHA® Collection of Fillers, by Teoxane
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
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.
Available by Prescription only
RHA-00221
SkinPen®
Indication
SkinPen systems are microneedling devices and accessories intended to be used as a treatment for
adults aged 22 years and older to improve the appearance of facial acne scars for all Fitzpatrick
skin types and wrinkles of the neck for Fitzpatrick skin types II–IV. Indications and body treatment
areas may vary based on your country.
Contraindications
The use of SkinPen systems should not be used on patients who have active skin cancer in the treatment
area(s), have open wounds, sores, or irritated skin in the treatment area(s), have an allergy
to stainless steel or anesthetics, have a hemorrhagic (bleeding) disorder or hemostatic (bleeding)
dysfunction, are pregnant or nursing, are currently taking drugs with the ingredient isotretinoin
(such as Accutane®). Note: These products are not intended for transdermal (under the skin) delivery
of topical products such as cosmetics, drugs, or biologics.
For full safety information, instructions for use manual and clinical trial details, as
applicable, visit 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; 2024
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; 2023.
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.
