Applies to daxibotulinumtoxinA: intramuscular powder for injection.
Warning
The botulinum toxin contained in daxibotulinumtoxinA (Daxxify) can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.
Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
The botulinum toxin contained in daxibotulinumtoxinA (Daxxify) can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulinum toxin injections, even for cosmetic purposes.
Call your doctor at once if you have any of these side effects (up to several hours or several weeks after an injection):
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hoarse voice, trouble breathing, talking, or swallowing;
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vision changes, eye pain, blurred vision, drooping eyelids, severely dry or irritated eyes (your eyes may be more sensitive to light);
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unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
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chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats; or
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loss of bladder control.
Common side effects may include:
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drooping eyelids;
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headache; or
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loss of the ability to move the muscles in the face.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to daxibotulinumtoxinA: intramuscular powder for injection.
General
Injection site reactions were the most common adverse reactions. The most common side effects from treatment with this drug usually occur within one to two weeks after injection and while generally transient, may have a duration of several weeks or months.[Ref]
Immunologic
Treatment emergent binding antibodies were reported to be developed against daxibotulinumtoxinA-lanm and RTP004 (amino acid excipient) in 0.8% and 1.2% patients respectively.[Ref]
Uncommon (0.1% to 1%): Immunogenicity[Ref]
Local
Common (1% to 10%): Injection site reactions[Ref]
Injection site reactions included injection site pain, injection site erythema, injection site edema, injection site bruising, injection site hematoma, injection site papule, injection site pruritus.[Ref]
Nervous system
Common (1% to 10%): Facial paresis, headache[Ref]
Ocular
Common (1% to 10%): Eyelid ptosis[Ref]
