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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.
[DAXI- 004727]
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.
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• 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.
[DAXI- 004727]