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
RHA® Collection of Fillers, by Teoxane
Approved Uses
The Teoxane RHA® Collection of resilient hyaluronic acid
(HA) fillers includes RHA Redensity® , RHA® 2,
RHA® 3 and RHA® 4.
RHA Redensity® is for injection into the facial tissue for
the correction of moderate to severe dynamic perioral rhytids; and RHA® 2 and RHA® 4 are for the correction of moderate to severe
dynamic facial wrinkles and folds, such as nasolabial folds, in adults
22 or older. RHA® 3 is for the correction of moderate to severe
dynamic facial wrinkles and folds, such as nasolabial folds, and also used
to augment lip fullness in adults 22 or older.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any RHA® injectable
gel formulation?
Do not receive if you have a history of multiple severe allergies or severe
allergic reactions; if you are allergic to lidocaine or mepivacaine or gram-positive
bacterial proteins; or if you have a bleeding disorder.
What precautions should I discuss with my doctor?
• Tell your doctor if you are pregnant or breastfeeding as the
safety of these products for use during pregnancy or while breastfeeding
has not been studied
• Tell your doctor if you have a history of excessive scarring,
keloid formations or pigmentation disorders, as use of these products
may result in additional scars or changes in pigmentation
• Tell your doctor if you are planning laser treatments or a
chemical peel, as there is a possible risk of inflammation at the
treatment site if these procedures are performed after treatment
• Tell your doctor if you are on immunosuppressive therapy used to
decrease your immune response, as use of these products may result in an
increased risk of infection
• Tell your doctor if you are using medications that can prolong
bleeding, such as aspirin, ibuprofen, or other blood thinners, as this
may increase bruising or bleeding at the injection site
• The safety and effectiveness of RHA® fillers in
areas other than those indicated have not been established in U.S.
clinical studies
• Patients who experience skin injury near the site of injection
with this product may be at a higher risk for side effects
• Minimize strenuous exercise, exposure to extensive sun or heat,
and alcoholic beverages within the first 24 hours following treatment
What are possible side effects?
The most commonly reported side effects included injection-site redness,
swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration,
and itching.
One of the risks with using these products is unintentional injection
into a blood vessel, and while rare, the complications can be serious
and may be permanent. These complications, which have been reported for
facial injections, can include vision abnormalities, blindness, stroke,
temporary scabs, or permanent scarring.
Delayed-onset inflammation near the site of dermal filler injections is
one of the known side effects associated with dermal fillers. Cases of
delayed-onset inflammation have been reported to occur at the treatment
site following viral or bacterial illnesses or infections, vaccinations,
or dental procedures.
Typically, the reported inflammation was responsive to being treated or
resolved on its own.
As with all skin injection procedures, there is a risk of infection and
recurrence of herpetic eruptions.
To report a side effect with any RHA® product, please call
Revance at (877) 373-8669.
Please visit RHACollection.com or talk to your doctor for more information.
©2025 REVANCE. RHA® and RHA
Redensity® are registered trademarks of TEOXANE SA,
manufactured in Switzerland. The Teoxane RHA® Collection
is exclusively distributed by Revance®. All other
trademarks are the property of their respective owners.
Available by prescription only.
RHA-00220
