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
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, 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
