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. 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®, 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
The Teoxane RHA® Collection includes hyaluronic acid (HA) fillers with lidocaine and
mepivacaine. Revance will only distribute the Teoxane RHA® Collection with
mepivacaine, thus may refer to the products without the use of “Mepi” in the product name. The
long-term efficacy and safety outcomes of RHA® with lidocaine are applicable to RHA® with mepivacaine, and mepivacaine has shown no significant impact on gel properties, including rheology
and degradation profile.
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 with lidocaine
and RHA Redensity® Mepi, RHA® 2 Mepi, RHA® 3 Mepi and RHA® Dynamic Volume, with mepivacaine.
RHA Redensity® and RHA Redensity® Mepi are for injection into the facial
tissue for the correction of moderate to severe dynamic perioral rhytids. RHA® 2, RHA® 2 Mepi and RHA® 4 are for the correction of moderate to severe dynamic facial
wrinkles and folds, such as nasolabial folds (NLFs), in adults 22 or older. RHA® 3
and RHA® 3 Mepi are for the correction of moderate to severe dynamic facial wrinkles
and folds, such as nasolabial folds (NLFs), and also used to augment lip fullness in adults 22
or older. RHA® Dynamic Volume is for correction of moderate to severe dynamic facial wrinkles
and folds, such as nasolabial folds (NLFs) and for cheek augmentation and/or correction of age-related
midface contour deficiencies 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 an adverse event with any RHA® product to Revance, please visit Safety.Revance.com or call at 1 (877) 373-8669.
Please visit RHACollection.com or talk to your doctor for more information.
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
