Products
Aesthetics Clinical ProgramUpdate
PIPELINE
Scroll to see timeline >PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
AESTHETICS
DAXXIFY® (DaxibotulinumtoxinA-lanm) injection
Glabellar (frown) lines
FDA Approved
Forehead lines
Lateral canthal lines
Upper facial lines
Positive results in all three open label Phase 2 studies to evaluate dosing and injection patterns
OTHER
Neuromodulators
Biosimilar to BOTOX®
Topical
Partnered with Viatris, Inc.
Neuromodulator Uses
- A – Glabellar (Frown) Lines
- B – Forehead Lines
- C – Lateral Canthal Lines (Crow’s Feet)
- A, B, C – Upper Facial Lines
DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection was approved in September 2022 for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults. DaxibotulinumtoxinA for Injection has also been evaluated in a Phase 2 head-to-head, active comparator study (BELMONT).
References
1 – Nowell Solish, et al. A Phase 2a Dose-Escalation Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Dynamic Forehead Lines Following Glabellar Line Injections: An Interim Analysis. Poster presentation at 2020 Annual Maui Derm for Dermatologists meeting. 25-29 January 2020. Maui, Hawaii.
2 – Tung, R, et al., Treatment of lateral canthal rhytides with a medium depth chemical peel with or without pretreatment with onabotulinum toxin type A: a randomized control trial. International Journal of Women’s Dermatology, Volume 2, Issue 1, 1 March 2016, Pages 31-34.
3 – US Food and Drug Administration Guidance Document. Upper Facial Lines: Developing Botulinum Toxin Drug Products Available at: https://www.fda.gov/media/89195/download (2014), Accessed Aug 2019
IMPORTANT SAFETY INFORMATION for DAXXIFY® (daxibotulinumtoxinA-Ianm) for injection
Indications
(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 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 are:
Glabeller lines (≥1%) were 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
