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
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.
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® and RHA Redensity® are registered trademarks of TEOXANE SA,
manufactured in Switzerland. The Teoxane RHA® Collection is exclusively
distributed by Revance®.
Available by Prescription only
RHA-00221.11
