IMPORTANT SAFETY INFORMATION for DAXXIFY® (daxibotulinumtoxinA-Ianm) for 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
