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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 glabellar lines.
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 glabellar lines.
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.
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
PLEASE SEE FULL DIRECTIONS FOR USE
RHA® Collection of Fillers
Indications
The 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. 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-P-002436.3
REFERENCES
- DAXXIFY®. Prescribing Information. Revance Therapeutics, Inc; 2022.
- 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.
- BOTOX® Cosmetic. Prescribing Information. Allergan, Inc; 2020.
- Xeomin®. Prescribing Information. Merz Pharmaceuticals GmbH; 2021.
- Dysport®. Prescribing Information. Ipsen Biopharmaceuticals, Ltd; 2020.
- Jeuveau®. Prescribing Information. Evolus, Inc; 2020.
- 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.
- RHA® Directions for Use. Nashville, TN: Revance Therapeutics, Inc, 2023.
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©2024 REVANCE AESTHETICS. DAXXIFY, REVANCE THERAPEUTICS, AND THE REVANCE LOGO ARE REGISTERED TRADEMARKS OF REVANCE THERAPEUTICS, INC. RHA is a registered trademark of TEOXANE SA. RHA Redensity is a trademark of TEOXANE SA. All other trademarks are the property of their respective owners.
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