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