Now FDA approved for cervical dystonia

DAXXIFY® is the peptide-engineered, long-lasting neurotoxin for durable symptom control injection to injection.1,2*

Available — 2024
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*Median duration of effect, defined as time from treatment until loss of ≥80% of the peak effect (change from baseline in TWSTRS total score averaged across weeks 4 and 6), was 24 weeks with DAXXIFY® 125U and 20.3 weeks with DAXXIFY® 250U. In patients that requested retreatment prior to the loss of ≥80% of peak effect, median efficacy remaining was 45% to 54% in ASPEN-1. Median time to retreatment was between 16 and 17 weeks in ASPEN-1 and cycles 1 and 2 in the ASPEN OLS.2-3

Side portrait close up of a woman's neck

DAXXIFY® demonstrates durable symptom relief that extends beyond the current retreatment interval of 12 weeks.1,2,4-8*

Per the Phase 3 pivotal trial, DAXXIFY® is generally safe and well tolerated, with no serious treatment-related adverse events reported.1,2

Learn more about DAXXIFY® performance in the pivotal trial.

*Median duration of effect, defined as time from treatment until loss of ≥80% of the peak effect (change from baseline in TWSTRS total score averaged across weeks 4 and 6), was 24 weeks with DAXXIFY® 125U and 20.3 weeks with DAXXIFY® 250U. In patients that requested retreatment prior to the loss of ≥80% of peak effect, median efficacy remaining was 45% to 54% in ASPEN-1. Median time to retreatment was between 16 and 17 weeks in ASPEN-1 and cycles 1 and 2 in the ASPEN OLS.2,3

DAXXIFY® is the only botulinum toxin engineered with cell-penetrating peptide technology.1,6-10

Graphic of Peptide

Proprietary peptide 3D image

Learn more about the unique DAXXIFY® formulation from:

Conor Gallagher, PhD

VP, Medical Affairs and Scientific Innovation
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The ASPEN program

DAXXIFY® demonstrated impressive performance in the ASPEN-1 pivotal study and the ASPEN open-label study (OLS).2,3

Learn about the clinical development program.

Additional Clinical Information
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Access for physicians and patients

Revance is committed to securing broad coverage for DAXXIFY® and will provide practice support to minimize the complexity associated with reimbursement.

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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 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