Now FDA approved for cervical dystonia

DAXXIFY® is the first new botulinum toxin to be approved for cervical dystonia in adults in over 10 years, featuring proven, long-lasting symptom relief.*

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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.

What is cervical dystonia?

Portrait of older woman

A painful and often debilitating condition

With cervical dystonia, the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck.

Close up image of vials of products

Proven to deliver long-lasting symptom relief

  • In a large clinical trial, DAXXIFY® treatment effect lasted longer than the traditional 12-week injection cycle for most people*
  • Formulated with a proprietary peptide and no animal byproducts
  • Low rate of adverse events (side effects)†

*Duration of effect was 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). For half of all patients, duration was calculated as between 15 and 28 weeks. 25% had >28 weeks, and 25% of patients had <15 weeks response.

†The most common side effects of DAXXIFY® in adults for cervical dystonia include headache (9%), injection site pain (8%), injection site erythema (5%), muscular weakness (5%), and upper respiratory tract infection (5%).

True innovation for the treatment of cervical dystonia

Hear from experts about the challenges of cervical dystonia

Dr. Joseph Jankovic

Professor of Neurology, Distinguished Chair of Movement Disorders

Janet Hieshetter

Executive Director, Dystonia Medical Research Foundation

Advocacy groups can provide additional information, support, and resources.

Connect with organizations using these links:

Link to dystonia research foundation
Link to NSTA site

The benefits of the DAXXIFY® Patient Savings Program*

For eligible commercially insured patients, the DAXXIFY® Patient Savings Program can help with⁠⁠ eligible, out-of-pocket costs associated with DAXXIFY® treatments.

  • Pay as little as $0 for your DAXXIFY® treatment
  • Save up to $5,000 per year on out-of-pocket costs for eligible DAXXIFY® treatments

*Terms and conditions may apply. Not a guarantee of coverage.

Download, complete and fax the form below to
1-855-FAX-DAXI (1-855-329-3294).

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FAQs

IMPORTANT SAFETY INFORMATION for DAXXIFY (daxibotulinumtoxinA-Ianm) Injection

DAXXIFY® may cause serious side effects that can be life threatening.

Get medical help right away if you have any of these problems any time (hours to weeks) after injection of DAXXIFY®:

Problems swallowing, speaking, or breathing due to weakening of associated muscles can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection.

• Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms that include loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.

These symptoms could make it unsafe for you to drive a car or do other activities.

Do not receive DAXXIFY® if you are allergic to any of the ingredients in DAXXIFY® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®), abobotulinumtoxinA (DYSPORT®), or incobotulinumtoxinA (XEOMIN®); or have a skin infection at the planned injection site.

DAXXIFY® dosing units are not the same as, or comparable to, any other botulinum toxin product.

Tell your healthcare provider about all your medical conditions, especially if you have ALS (Lou Gehrig's disease) or any other muscle or nerve conditions. You should also tell your healthcare provider about any previous side effects from other botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; are pregnant or breastfeeding or plan to become pregnant or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using DAXXIFY® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received DAXXIFY® in the past, or are currently receiving DAXXIFY®.

• Tell your healthcare provider if you have received any other botulinum toxin product in the last 4 months or any in the past, and exactly which product you received (such as BOTOX®, MYOBLOC®, DYSPORT®, or XEOMIN®). DAXXIFY® may cause serious side effects, including allergic reactions (such as itching, rash, redness, swelling, wheezing, trouble breathing, or dizziness or feeling faint), heart problems (such as irregular heartbeat and heart attack), and eye problems (including dry eye, reduced blinking, and corneal problems). Tell your healthcare provider or get medical help right away if you experience a serious side effect. No serious adverse events of distant spread of toxin effect associated with use of DAXXIFY® have been reported in clinical studies at the dose of 125 Units and 250 Units for cervical dystonia. The most common side effects of DAXXIFY® in adults for cervical dystonia include headache, injection site pain, , injection site erythema, muscular weakness, and upper respiratory tract infection.

These are not all the possible side effects of DAXXIFY®. For more information, see the full Prescribing Information, including Boxed Warning, and refer to the Medication Guide or talk with your doctor. 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.

APPROVED USE

DAXXIFY® is a prescription medicine that is injected into muscles and used to treat cervical dystonia (CD) in adults.

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