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DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA and is currently under regulatory review.

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INDICATION
DaxibotulinumtoxinA for Injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. 

WARNING: DISTANT SPREAD OF TOXIN EFFECT

The effects of DaxibotulinumtoxinA for Injection and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DaxibotulinumtoxinA for Injection is not approved for the treatment of spasticity or any conditions other than glabellar lines.

IMPORTANT SAFETY INFORMATION

Contraindications
DaxibotulinumtoxinA for Injection contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s).

Warnings and Precautions
Please refer to Boxed Warning for Distant Spread of Toxin Effect.

The potency Units of DaxibotulinumtoxinA for Injection are not interchangeable with other preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.

Adverse Reactions
The most commonly observed adverse reactions (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).

Drug Interactions
Co-administration of DaxibotulinumtoxinA for Injection and aminoglycoside antibiotics, anticholinergic agents or any other agents interfering with neuromuscular transmission or muscle relaxants should only be performed with caution as the effect of DaxibotulinumtoxinA for Injection may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DaxibotulinumtoxinA for Injection is unknown.

Use in Specific Populations
DaxibotulinumtoxinA for Injection is not recommended for use in children or pregnant women.

Please see DaxibotulinumtoxinA for Injection full Prescribing Information, including Boxed Warning and Medication Guide.