About DAXXIFY®

What is DAXXIFY®?

DAXXIFY® is FDA approved to smooth moderate to severe lines between the brows. It is the only frown line treatment powered by a peptide.

The active ingredient in DAXXIFY® is a purified protein called botulinum toxin type A.

Is DAXXIFY® for me?

DAXXIFY® could be for you if you would like to improve the look of your frown lines with a product that’s fast-acting, long-lasting and delivers a smooth look.* Find a DAXXIFY® provider in your area.

How can I get treated with DAXXIFY®?

Find a provider near you who offers DAXXIFY®.

Why does DAXXIFY® have a peptide?

All frown line treatments require a special ingredient to stabilize botulinum toxin A, the protein responsible for helping smooth moderate to severe frown lines. For instance, Botox® Cosmetic uses human serum albumin (HSA), a blood product, as its stabilizer. Dysport®, another frown line treatment, uses HSA as a stabilizer and cow’s milk protein as a protectant.

DAXXIFY® is unique because it is the only formulation that uses a novel peptide as a stabilizer and does not contain human or animal byproducts.

How is DAXXIFY® different from other frown line treatments?

DAXXIFY® is the only frown line treatment powered by a peptide. It’s fast acting, long lasting and slow to wear off.*

All frown line treatments require a special ingredient to stabilize botulinum toxin A, the protein responsible for helping smooth moderate to severe frown lines. For instance, Botox® Cosmetic uses human serum albumin (HSA), a blood product, as its stabilizer. Dysport®, another frown line treatment, uses HSA as a stabilizer and cow’s milk protein as a protectant.

DAXXIFY® is unique because it is the only formulation that uses a novel peptide as a stabilizer and does not contain human or animal byproducts.

*Results as early as the next day and typically within 2 days. At least 50% of patients in clinical studies had no or minor frown lines 6 months after treatment.

Will I need the same number of Units as my current frown line treatment?

In short, no, and here’s why. Units are like fingerprints—they are a proprietary measurement of a treatment’s unique potency.

Because of the differences in how treatments are formulated and tested, you cannot compare or convert Units between them, just like you cannot compare 2 fingerprints.

A clearer way to understand dosing is to look at how many nanograms of active ingredient (botulinum toxin type A) a product has.

Double the Units does not mean double the dose.

DAXXIFY®

Approved frown line dose: 40 Units

Amount of active ingredient: 0.18 nanograms

Botox® Cosmetic

Approved frown line dose: 20 Units

Amount of active ingredient: 0.18 nanograms

Dysport®

Approved frown line dose: 50 units

Amount of active ingredient: 0.27 nanograms

As you can see, despite the number of Units, DAXXIFY® isn’t 2x the dose of Botox® Botox® Cosmetic and Dysport® isn't 2.5x the dose of Botox® Cosmetic. Each product is unique. Talk to your provider about DAXXIFY® and your aesthetic goals.

Where is DAXXIFY® made?

DAXXIFY® is manufactured in California, and the only prescription frown line treatment made in the United States. Conventional frown line treatments are manufactured in other countries, then imported into the United States.

How was DAXXIFY® created?

In 2002, physicians and entrepreneurs founded a start-up in Silicon Valley, California to explore the use of peptides in biologics for different therapeutic uses. Their goal was to utilize peptides to transport biologics, typically large molecules, through the skin.

The initial idea was to formulate botulinum toxin type A, the active ingredient in DAXXIFY®, with a peptide to see if it could be applied topically to the skin to treat crow’s feet wrinkles. Through this process, scientists discovered that the formulation was optimally administered through injection. Several clinical studies were created to determine the correct dose for an injectable product that would treat frown lines.

Safety

Is DAXXIFY® safe?

DAXXIFY® was studied in the largest-ever clinical study for a frown line treatment and included more than 2,800 people across different ages and skin types. Here are some things you should know about DAXXIFY®:

  • There were no serious treatment-related side effects
  • The active ingredient in DAXXIFY® is botulinum toxin type A, an ingredient that has been used in frown line treatments for more than 20 years
  • 96% of people treated with DAXXIFY® were satisfied with their results

DAXXIFY® may cause serious side effects that can be life threatening. Please talk to your aesthetic provider about possible side effects and consult with the Prescribing Information and Medication Guide.

‡96% of patients reported they were satisfied on a 7-point scale when evaluated at 4 weeks in clinical studies.

Does DAXXIFY® work on all skin types?

The safety and efficacy of DAXXIFY® is well established, with more than 20 years of research. In fact, DAXXIFY® has been studied in the largest-ever phase 3 clinical trial conducted for a frown line treatment and included more than 2,800 people across different ages and with different skin types. DAXXIFY® was studied in patients with varying skin types.

Do long-lasting results mean potentially long-lasting side effects?

No, not necessarily. The most common side effects observed in clinical trials occurred within one to two weeks after injection and lasted only a short while. This is consistent with other frown line treatments.

DAXXIFY® is well-studied, with no serious treatment-related side effects seen in large-scale clinical trials.

Preparing for your treatment

How should I prepare for my DAXXIFY® treatment?

Ask your aesthetic provider for pre-treatment instructions prior to your DAXXIFY® appointment.

A list of common avoidances before treatment include, but are not limited to:

  • Retin-A
  • Blood thinners
  • Muscle relaxants
  • Fish or oils rich in omega 3
  • Allergy medication
  • Topical steroids
  • Sleep medications and supplements
  • Aspirin
  • St. John’s Wort
  • Supplements containing Vitamin E
  • Ibuprofen

What can I expect with DAXXIFY® treatment? Does it hurt?

DAXXIFY® injections are typically performed with a small needle and people treated with frown line treatments say the injection feels like a pinch.

If you are concerned about discomfort, talk to your injector about options for minimizing pain, such as icing the area or applying a topical numbing cream. Treatment with DAXXIFY® requires minimal downtime, and you can return to your daily routine immediately after your appointment.

There is a possibility that the area around the injection site will swell, turn red, and cause pain or tenderness from the injection itself; however, these side effects are typically very minor and go away after a few hours or days.

How often will I need to get DAXXIFY®?

If you’re like most people, you probably get a frown line treatment around twice a year. But here’s the thing: conventional treatments only last 3–4 months. If you are not able to get treated every 3-4 months, that means you may spend the next 2-3 months of the year with those frown lines staring back at you between treatments. That’s up to 4-6 months of total wear off time per year!

In clinical trials, at least 50% of patients showed results in frown lines at 6 months.

Will I see results quickly?

You may see results with DAXXIFY® as early as the next day after treatment, and typically within two days.

I have an event coming up in two weeks and want to try DAXXIFY® for the first time. Is now the best time to get DAXXIFY®?

You may see results with DAXXIFY® as early as the next day after treatment, and typically within two days. You should see noticeable results within a two-week time frame. You may experience mild injection-related bruising. In most cases, bruising heals within a few days after injection.

About wrinkles & injectable treatments

How do frown lines form?

Several factors contribute to the formation of facial lines. Decreased collagen production, cellular changes, genetics, environmental damage, and sun damage may all play a role.

Facial lines are also formed by repeated muscle contractions such as frowning, squinting, or raising the eyebrows. These facial expressions cause the skin to furrow and fold, which eventually leads to the formation of wrinkles.

DAXXIFY® works below the skin's surface to temporarily reduce the underlying muscle activity responsible for moderate to severe frown lines.

How do botulinum toxins work?

Botulinum toxins are biologics, produced from a bacterium called Clostridium botulinum. They are used to inhibit the transmission of specific chemical signals from nerves, primarily those signals that cause muscular contractions. Botulinum toxin type A injections temporarily relax the facial muscles that cause wrinkles between the brows, reducing their appearance.

DAXXIFY® is the only FDA-approved peptide-powered treatment (neuromodulator) that smooths moderate to severe lines between the brows.

Injections of specific botulinum toxin formulations are also utilized in the treatment of medical conditions.

How long has botulinum toxin type A been used in facial aesthetics?

Injectable wrinkle treatments containing botulinum toxin type A have been used to improve the look of moderate to severe frown lines for more than 20 years. The first FDA-approved treatment was Botox® Cosmetic, followed by Dysport®, Xeomin®, and Jeuveau®.

Although today’s wrinkle reducers all contain botulinum toxin type A, it’s important to know that no 2 treatments are alike and cannot be interchanged with each other.

How is DAXXIFY® different from facial fillers, also known as dermal fillers?

DAXXIFY® minimizes the appearance of moderate to severe frown lines by temporarily relaxing the underlying muscles that cause these wrinkles. DAXXIFY® is a long-lasting botulinum type A treatment with a novel peptide.

Facial fillers, also known as dermal fillers, are typically made of hyaluronic acid and are used to add volume, fullness, and structure to areas of the face. They can help contour cheekbones, soften lines around the nose and mouth, and volumize lips. Dermal fillers target volume loss rather than muscle-related wrinkles.

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. Swallowing problems may last for several months.

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.

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®/BOTOX® Cosmetic), abobotulinumtoxinA (DYSPORT®), incobotulinumtoxinA (XEOMIN®) or prabotulinumtoxinA-xvfs (JEUVEAU®); 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, including any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; have had surgery on your face; 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.

Especially 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®, BOTOX® Cosmetic, MYOBLOC®, DYSPORT®, XEOMIN®, or JEUVEAU®). 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 dermatologic use of DAXXIFY® have been reported in clinical studies at the dose of 40 Units for glabellar lines. The most common side effects of DAXXIFY® include headache, eyelid drooping, and loss of ability to move the muscles in your face.

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 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 in adults to temporarily improve the look of moderate to severe frown lines between the eyebrows.

DAXI-001723.2

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. Swallowing problems may last for several months. Expand to Read More

Read Less

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. Swallowing problems may last for several months.

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.

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®/BOTOX® Cosmetic), abobotulinumtoxinA (DYSPORT®), incobotulinumtoxinA (XEOMIN®) or prabotulinumtoxinA-xvfs (JEUVEAU®); 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, including any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; have had surgery on your face; 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.

Especially 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®, BOTOX® Cosmetic, MYOBLOC®, DYSPORT®, XEOMIN®, or JEUVEAU®). 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 dermatologic use of DAXXIFY® have been reported in clinical studies at the dose of 40 Units for glabellar lines. The most common side effects of DAXXIFY® include headache, eyelid drooping, and loss of ability to move the muscles in your face.

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 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 in adults to temporarily improve the look of moderate to severe frown lines between the eyebrows.

DAXI-001723.2