Daxxify (DaxibotulinumtoxinA-lanm) injection is used for the temporary improvement of frown lines (glabellar lines) and for the treatment of cervical dystonia in adults. Daxxify is a long-lasting Botulinum toxin injection that relaxes the affected muscles, which can reduce frown lines or the spasming and stiffness from cervical dystonia. Daxxify lasts longer than other first-generation botulinum toxins as it is formulated with a unique stabilizer (cell-penetrating peptide).

Daxxify is an acetylcholine release inhibitor and neuromuscular blocking agent. Daxxify works by blocking the transmission of specific chemical signals from nerves, mainly signals those cause muscles to contract. It works on frown lines by temporarily relaxing the facial muscles that cause the lines, which reduces their appearance. Daxxify works to treat cervical dystonia by relaxing muscles, which relieves abnormal involuntary movements and postures. 

Daxxify became an FDA-approved medicine on September 8, 2022, for moderate to severe frown lines (glabellar lines) in adults. Then on August 11, 2023, it became FDA-approved to treat cervical dystonia in adults. Approval for cervical dystonia was based on positive results from the Phase 3 clinical program (ASPEN 1, ASPEN OLS), which showed a median length of time that it lasted for cervical dystonia was 24.0 and 20.3 weeks for each trial.

This medicines may cause serious side effects that can be life-threatening. Call your healthcare provider or get medical help right away if you have any of these problems after treatment:

Problems swallowing, speaking, or breathing. These problems can happen hours, days, or weeks after an injection of Daxxify if the muscles that you use to breathe and swallow become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment.

• People with certain breathing problems may need to use muscles in their necks to help them breathe. These people may be at greater risk for serious breathing problems with these injections.
• Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving this medicine have the highest risk of getting these problems.

Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include:

• loss of strength and muscle weakness all over the body
• blurred vision and drooping eyelids
• trouble saying words clearly
• trouble breathing
• double vision
• hoarseness or change or loss of voice
• loss of bladder control
• trouble swallowing

These symptoms can happen hours, days, or weeks after you receive an injection.

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

• This medicine is an injection that your healthcare provider will give you.
• It is injected into your affected muscles.
• Your healthcare provider may change your dose until you and your healthcare provider find the best dose for you.
• You should not receive this injection more than 1 time every 3 months.
• Your healthcare provider will tell you how often you will receive your dose of Daxxify injections.

Usual Adult Dose for Glabellar Lines

Dose: 0.1 mL (8 Units) by intramuscular injection into each of five sites, for a total dose of 40 Units.

Usual Adult Dose for Cervical Dystonia

Dose: 125 Units to 250 Units given intramuscularly as a divided dose among affected muscles.

Daxxify is available as 50 Units or 100 Units of sterile lyophilized powder in a single-dose vial.

Before receiving this medicine, tell your healthcare provider about all of your medical conditions, including if you:

• have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis, or Lambert-Eaton syndrome). See Important information.
• have had any side effects from any other botulinum toxin in the past
• have or have had a breathing problem, such as asthma or emphysema
• have or have had swallowing problems
• have or have had heart problems
• have or have had bleeding problems
• have weakness of your forehead muscles, such as trouble raising your eyebrows
• have drooping eyelids
• plan to have surgery
• have had surgery on your face
• have had dry eye problems with the use of botulinum toxin products in the past

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Daxxify can harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Daxxify passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

Who should not receive Daxxify?

You should not receive Daxxify if you:

• are allergic to Daxxify or any of the other ingredients. See the end of this page for a list of ingredients.
• had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myobloc), onabotulinumtoxinA (Botox, Botox Cosmetic), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin) or prabotulinumtoxinA-xvfs (Jeuveau).
• have a skin infection at the planned injection site.

Daxxify may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of receiving this inejction. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Common Daxxify side effects 

Side effects when used for frown lines:

• Headache (6%),
• eyelid drooping (2%),
• loss of the ability to move the muscles in your face (1%).

Side effects when used for Cervical Dystonia:

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

Serious Daxxify side effects

Also see Warnings below.

Heart problems. Irregular heartbeat and heart attack that have resulted in death, have happened in some people who received botulinum toxin products.

Eye problems. Dry eye, reduced blinking, and corneal problems have happened in some people who receive this medicine to treat glabellar lines. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.

Allergic reactions. Symptoms of an allergic reaction may include itching, rash, redness, swelling, wheezing, trouble breathing, dizziness, or feeling faint. Tell your healthcare provider or get medical help right away if you have wheezing or trouble breathing or if you feel dizzy or faint.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Revance Therapeutics, Inc. at 1-877-373-8669.

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.

Especially tell your healthcare provider if you:

• have received any other botulinum toxin product in the last 4 months.
• have received injections of botulinum toxin such as rimabotulinumtoxinB (Myobloc), onabotulinumtoxinA (Botox, Botox Cosmetic), abobotulinumtoxinA (Dysport), prabotulinumtoxinA (Jeuveau) and incobotulinumtoxinA, (Xeomin) in the past. Be sure your healthcare provider knows exactly which product you received.
• muscle relaxants 
• aminoglycosides or other agents interfering with neuromuscular transmission
• anticholinergic drugs.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.