How long does Daxxify take to work?

In clinical studies with Daxxify, improvements on frown (glabellar) lines were typically seen within 2 days after administration. Some people saw results as early as the next day after treatment.

Research has shown that Daxxify can last as long as 6 months, with some people maintaining results on frown lines for up to 9 months.

When was Daxxify approved?

In September 2022, Daxxify was approved as a botulinum toxin product given by injection into muscles in five specific areas to temporarily improve the look of moderate to severe frown lines between the eyebrows.

In August 2023, Daxxify was also approved to treat cervical dystonia in adults. Cervical dystonia is an ongoing disease in which the neck muscles contract involuntarily, causing painful abnormal movements and posture of the head and neck.

Before you receive treatment with Daxxify, tell your doctor if you are receiving treatment with other botulinum toxin products.

Studies of Daxxify

FDA approval of Daxxify (daxibotulinumtoxinA-lanm) for glabellar lines, from Revance Therapeutics, was based on data from the SAKURA Phase 3 clinical studies, which included over 2,700 patients and about 4,200 treatments.

• In these studies, 74% of subjects achieved a two-grade or greater improvement in glabellar lines at week 4.
• Also, 98% of participants achieved a "none" or "mild" wrinkle severity at week 4.
• Results were typically seen within 2 days after administration, but some participants saw effects on frown lines by the first day.

Approval of Daxxify for cervical dystonia was based on data from the 52-week ASPEN Phase 3 clinical studies, which included 301 patients and 1,240 treatments across up to five injection cycles over an 88-week time span.

• Daxxify was found to be generally safe and well tolerated across both dose groups, 125U and 250U, with a median duration of effect of 24 and 20.3 weeks for the two dose groups. respectively.
• Effectiveness was measured by the mean change in the TWSTRS total score from baseline averaged over weeks 4 and 6. TWSTRS evaluates the patient-perceived severity, disability, and pain of dystonia (scores from 0 to 85).
• The mean change from baseline in the total TWSTRS score was significantly greater for both dosage groups of Daxxify than for placebo (point reduction of 12.7 [125U] and 10.9 [250U], compared to 4.3 [placebo]).

How does Daxxify work?

Daxxify (daxibotulinumtoxinA-lanm), a botulinimum toxin, is an acetylcholine release inhibitor and neuromuscular blocking agent that blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine.

It is indicated for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines in adult patients. It works by temporarily relaxing the facial muscles that cause glabellar (frown) lines, thereby reducing their appearance.

It is given as an injection by a healthcare provider into muscles in five specific areas to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).

Dosage

• Glabellar Lines: the recommended dose is 0.1 mL (8 Units) by intramuscular injection into each of five sites, for a total dose of 40 Units.

Cervical dystonia

Daxxify works in cervical dystonia by blocking nerve and muscle communication which relaxes the muscle to alleviate abnormal involuntary movements and postures.

In this condition, it is given intramuscularly (IM) as a divided dose among affected muscles.

Dosage

• Cervical Dystonia: the recommended dose is 125 Units to 250 Units given intramuscularly as a divided dose among affected muscles.

How long does Daxxify last?

Research has shown that Daxxify can last as long as 6 months for treatment of glabellar lines, with some people maintaining results on frown lines for up to 9 months.

You should not receive Daxxify more frequently than one treatment every 3 months for any indication.

Daxxify is a long-acting neuromodulator stabilized with Peptide Exchange Technology™ (PXT) which makes it longer-lasting compared to conventional neuromodulators.

Conventional neuromodulators such as Botox usually last for 3 to 4 months, but your results may vary.

The potency units of Daxxify are not interchangeable with other preparations of other botulinum toxin products (for example, Botox or Botox Cosmetic).

Are there side effects?

As with most drugs, there are common side effects and more serious warnings. The most common side effects (adverse reactions) in people who received treatment for glabellar lines include:

• headache - occurred in 6% of study participants (6 out of every 100 people)
• eyelid ptosis (eyelid drooping) - occurred in 2% of study participants
• facial paresis (loss of the ability to move the muscles in your face) - occurred in 1% of study participants

In people who received treatment for cervical dystonia, the most common side effects were:

• headache (9%)
• injection site pain (8%)
• injection site erythema / redness) (5%)
• muscular weakness (5%)
• upper respiratory tract infection (5%)

The Daxxify product label also carries a Boxed Warning for the distant spread of botulinum toxin from the injection site, which may cause swallowing and breathing difficulties that can be life threatening; there have been reports of death.

• Distant spread can occur hours, days or weeks after the injection.
• The risk of symptoms is probably greatest in children treated for spasticity, an unapproved use for Daxxify. However, symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms.

If you experience serious side effects, contact your healthcare provider or call for emergency medical help (911) right away.

This is not all the information you need to know about Daxxify (daxibotulinumtoxinA-lanm) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.