daxibotulinumtoxinA

Actions and Spectrum 

daxibotulinumtoxinA (botulinum toxin type A) is a neurotoxin produced by the spore-forming anaerobic bacillus Clostridium botulinum that inhibits the production of acetylcholine and prevents cholinergic transmission at the neuromuscular junction.

DRUG INTERACTION

Contraindicated  

Serious Use Alternative  

Monitor Closely  

Minor  

Frequency defined  

<1% 

Injection site pruritus (<1%)  

Injection site papule (<1%) 

1-10% 

Injection site erythema (3%) 

Edema (2%) 

Facial paresis (1%) 

Injection site bruising (1%) 

Injection site pain (4%) 

Erythema (2%) 

Eyelid ptosis (1-2%) 

Injection site reactions (6%) 

Headache (5-6%) 

Injection site edema (3%) 

Black Box Warning 

All botulinum toxin products, including daxibotulinumtoxinA, may cause symptoms that are like those caused by the toxin to spread from the injection site. These signs have been noted anywhere between hours and weeks following the injection.

Breathing and swallowing issues can be fatal, and there have been cases of deaths. Other than glabellar lines, daxibotulinumtoxinA has not been approved for any conditions. 

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity to daxibotulinumtoxinA or any other botulinum toxin preparation, as well as its excipients. 

Caution: 

• Increased dosages or more frequent administration could lead to the production of neutralising antibodies and a reduction in effectiveness. 
• Use with care in patients who have cardiovascular disease; after administration, arrhythmia and myocardial infarction have been reported.  
• Swallowing or breathing problems may develop as a result of treatment; they may appear within hours to weeks, last for several months, and require the use of a feeding tube. 

Pregnancy consideration: 

Pregnancy category: N/A 

Lactation: Excretion into human milk is unknown  

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.  

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women. 

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 

Category N: There is no data available for the drug under this category. 

Pharmacology  

When injected into skeletal muscle, the drug enters the nerve terminal, moves into the neuron’s cytoplasm, and then cleaves SNAP25, a protein required for synaptic vesicle membrane docking and the release of acetylcholine that results in a dose-dependent reduction in muscle performance. 

Pharmacodynamics 

The steady restoration of activity is brought on by the breakdown of the neurotoxic light chain within the neurons, with some assistance from the development of axonal sprouts. 

Pharmacokinetics 

Limited information available on ADME

Administration 

daxibotulinumtoxinA is administered as an injection through intramuscular route within 72 hours after reconstitution.

Patient information leaflet 

Generic Name: daxibotulinumtoxinA 

Why do we use daxibotulinumtoxinA? 

It is recommended for adults to use daxibotulinumtoxinA for a transient improvement in the appearance of moderate to severe glabellar lines linked to corrugator or procerus muscle activation. Adults can temporarily reduce the appearance of face wrinkles by using daxibotulinumtoxinA.