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 and for the treatment of cervical dystonia in adults.
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 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 are:
Glabellar lines (≥1%): headache (6%), eyelid ptosis (2%) and facial paresis (1%).
Cervical dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (5%), muscular
weakness (5%), and upper respiratory tract infection (5%).
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.
To report side effects associated with DAXXIFY®, please visit safety.revance.com, or call 1-877-373-8669. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch
[DAXI-004726]
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 Redensity® Eye, 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 Redensity® Eye is indicated for injection
into the sub-dermis and supraperiosteum, for the correction of moderate to severe tissue volume
deficiencies in the infraorbital region in adults aged 22 years 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 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 and granulomas near the site of dermal filler injections are 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. Granulomas may appear weeks or months after
injection and may require medical intervention.
As with all skin injection procedures, there is a risk of infection and recurrence of herpetic
eruptions.
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,
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
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 regenerativemarketing@revance.com.
SkinPen®
Indications for Use
The SkinPen® Precision Elite, SkinPen® Precision and MicroPen EVO™ systems are microneedling
devices 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. Indications and body
treatment areas may vary based on your country.
Contraindications
The use of the SkinPen® Precision Elite, SkinPen® Precision and MicroPen EVO™ 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 us at skinpen.com and micropenevo.com.