• 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.
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]
