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.
INDICATION
DAXXIFY® (daxibotulinumtoxinA-lanm) injection is an acetylcholine release
inhibitor and neuromuscular blocking agent indicated for the treatment of cervical dystonia in
adults.
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 (≥5%) were 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-004725]
REFERENCES
1. DAXXIFY®. Prescribing Information. Revance
Therapeutics, Inc; 2023. 2. Data on File. ASPEN CSR. Newark, CA: Revance Therapeutics, Inc, 2018. 3. Data on File. ASPEN OLS CSR. Newark, CA: Revance Therapeutics, Inc, 2018. 4. Centers for Medicare & Medicaid Services (CMS). Medicare Coverage
Database. Local Coverage Determinations (LCD): Botulinum Toxin Type A & Type B. CMS website.
Updated 2022. Accessed June 26, 2023. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=34635. 5. Aetna Better Health. Pharmacy Prior Authorization. Clinical
Guideline—Botulinum Toxins. Aetna Better Health website. Updated 2023. Accessed June 26,
2023. https://www.aetnabetterhealth.com/illinois/assets/pdf/botox.pdf. 6. BOTOX®. Prescribing Information. Allergan Inc; 2022. 7. XEOMIN®. Prescribing Information. Merz Pharmaceuticals GmbH; 2021. 8. DYSPORT®. Prescribing Information. Ipsen Biopharm Ltd; 2020. 9. JEUVEAU®. Prescribing Information. Evolus, Inc; 2020. 10. Myobloc®. Prescribing Information. Supernus® Pharmaceuticals; 2021 11. Data on File. Time to retreatment. Newark, CA: Revance Therapeutics, Inc,
2024