What is the most important information I should know about DAXXIFY?
DAXXIFY 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 with DAXXIFY:
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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 with DAXXIFY.
- People with certain breathing problems may need to use muscles in their neck to help them breathe. These people may be at greater risk for serious breathing problems with DAXXIFY.
- 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 DAXXIFY have the highest risk of getting these problems.
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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:
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- loss of strength and muscle weakness all over the body
- blurred vision and drooping eyelids
- trouble saying words clearly
- trouble breathing
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- double vision
- hoarseness or change or loss of voice
- loss of bladder control
- trouble swallowing
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These symptoms can happen hours, days, or weeks after you receive an injection of DAXXIFY.
These problems could make it unsafe for you to drive a car or do other dangerous activities. See "What should I avoid while receiving DAXXIFY?" |
What is DAXXIFY?
DAXXIFY is a prescription medicine for adults that is injected into muscles and used:
- to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines)
- to treat cervical dystonia (CD)
It is not known if DAXXIFY is safe and effective in children less than 18 years of age. |
Do not receive DAXXIFY if you:
- are allergic to DAXXIFY or to any of the ingredients in DAXXIFY. See the end of this Medication Guide for a complete list of ingredients in DAXXIFY.
- have 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.
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Before receiving DAXXIFY, 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 "What is the most important information I should know about DAXXIFY?"
- have had any side effect 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.
- are pregnant or plan to become pregnant. It is not known if DAXXIFY can harm your unborn baby.
- 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 with DAXXIFY.
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.
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. |
How will I receive DAXXIFY?
- DAXXIFY is an injection that your healthcare provider will give you.
- DAXXIFY is injected into your affected muscles.
- Your healthcare provider may change your dose of DAXXIFY until you and your healthcare provider find the best dose for you.
- DAXXIFY should not be received more than 1 time every 3 months.
- Your healthcare provider will tell you how often you will receive your dose of DAXXIFY injections.
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What should I avoid while receiving DAXXIFY?
DAXXIFY may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of receiving DAXXIFY. If this happens, do not drive a car, operate machinery, or do other dangerous activities. See "What is the most important information I should know about DAXXIFY?" |
What are the possible side effects of DAXXIFY? DAXXIFY may cause serious side effects, including:
- See "What is the most important information I should know about DAXXIFY?"
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Allergic reactions. Symptoms of an allergic reaction to DAXXIFY may include itching, rash, redness, swelling, wheezing, trouble breathing, or 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.
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Heart problems. Irregular heartbeat and heart attacks that have resulted in death have happened in some people who received botulinum toxin products.
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Eye problems. Dry eye, reduced blinking, and corneal problems have happened in some people who receive DAXXIFY to treat glabellar lines. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.
The most common side effects of DAXXIFY in people with glabellar lines include: |
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- loss of the ability to move the muscles in your face
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| The most common side effects of DAXXIFY in people with cervical dystonia include: |
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- injection site pain
- upper respiratory tract infection
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These are not all the possible side effects of DAXXIFY.
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. |
General information about the safe and effective use of DAXXIFY.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about DAXXIFY that is written for health professionals. |
What are the ingredients in DAXXIFY?
Active ingredient: daxibotulinumtoxinA-lanm
Inactive ingredients: L-histidine, L-histidine HCl monohydrate, polysorbate 20, RTP004 peptide, trehalose dihydrate
Manufactured by: Revance Therapeutics, Inc. Newark, CA 94560
U.S. License Number 2101
© 2023 Revance Therapeutics, Inc.
All trademarks are the property of their respective owners. MG761127-4.0 |