NAV

DaxibotulinumtoxinA

Identification

Summary

DaxibotulinumtoxinA is a botulinum toxin used to treat glabellar lines and cervical dystonia in adults.

Brand Names
Botox, Botox Cosmetic, Daxxify, Dysport, Jeuveau, Xeomin
Generic Name
DaxibotulinumtoxinA
DrugBank Accession Number
DB17929
Background

DaxibotulinumtoxinA is an acetylcholine release inhibitor and neuromuscular blocking agent. It is a botulinum toxin without accessory proteins purified from the bacterium Clostridium botulinum type A,4 the gram-positive anaerobic bacterium primarily present in soil. C. botulinum is known to produce toxins that can cause botulism in humans.1,5

DaxibotulinumtoxinA was first approved by the FDA on September 8, 2022, for the temporary improvement of glabellar lines.6 On August 14, 2023, the drug was also approved for the treatment of cervical dystonia.7 DAXI or DAXXIFY, a product of daxibotulinumtoxinA, incorporates RTP004, a proprietary synthetic stabilizing peptide for enhanced product stability.2,3

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Other protein based therapies
Protein Chemical Formula
Not Available
Protein Average Weight
150000.0 Da (approximate)
Sequences
Not Available
Synonyms
Not Available
External IDs
  • RT002
  • RTI150
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Pharmacology

Indication

DaxibotulinumtoxinA is 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. It is also used for the treatment of cervical dystonia in adult patients.4

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Management ofDystonia, cervical•••••••••••••••••
Management ofModerate glabellar frown lines (gl)•••••••••••••••••
Management ofSevere glabellar frown lines (gl)•••••••••••••••••
Contraindications & Blackbox Warnings
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Pharmacodynamics

DaxibotulinumtoxinA is a neuromuscular blocking agent that causes partial paralysis at the injection site.1 In clinical studies, daxibotulinumtoxinA was shown to reduce the appearance of frown lines and ameliorate neck spasms in cervical dystonia. DaxibotulinumtoxinA had a median effect duration of 24 weeks and its effects lasted up to six months.2

Mechanism of action

DaxibotulinumtoxinA blocks neuromuscular transmission at the neuromuscular junction by binding to glycoprotein structures on cholinergic presynaptic nerve terminals, inhibiting the pre-synaptic release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a soluble N-ethylmaleimide-sensitive factor attachment receptor protein. SNAP-25 facilitates the docking and release of synaptic vesicle membrane contents, such as acetylcholine, within nerve endings. Recovery of neurotransmission occurs gradually as the neuromuscular junction recovers from SNAP25 cleavage and as new nerve endings are formed.4 Inhibition of acetylcholine release is reversible; however, the duration of action of daxibotulinumtoxinA decreases as there is a subsequent reduction in neurotransmitter release at the neuromuscular junction. This leads to decreased muscular contractions near the injection site.1,5

Absorption

Using currently available analytical technology, it is not possible to detect daxibotulinumtoxinA in the peripheral blood following intramuscular injection at the recommended dose.4 Botulinum toxins are predominantly absorbed at the injection site.5

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism

Botulinum toxins may be degraded by circulating proteases or dislodged and transported via the bloodstream to the liver for cleavage and conjugation.5

Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

There is limited information regarding acute toxicity (LD50) of daxibotulinumtoxinA. The estimated human LD50 of botulinum toxins falls ranges from 1 to 3 ng/kg.5

Excessive doses of daxibotulinumtoxinA may produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of the respiratory muscles. In the event of an overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis. Symptomatic treatment may be necessary. Symptoms of overdose are not likely to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis. The antitoxin raised against botulinum toxin may be requested through the Centers for Disease Control and Prevention (CDC) in the US; however, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration.4

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
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interactions in your software
AcetyldigitoxinThe risk or severity of Cardiac Arrhythmia can be increased when DaxibotulinumtoxinA is combined with Acetyldigitoxin.
AclidiniumAclidinium may increase the neuromuscular blocking activities of DaxibotulinumtoxinA.
AmantadineAmantadine may increase the neuromuscular blocking activities of DaxibotulinumtoxinA.
AmikacinAmikacin may increase the neuromuscular blocking activities of DaxibotulinumtoxinA.
AmitriptylineAmitriptyline may increase the neuromuscular blocking activities of DaxibotulinumtoxinA.
Food Interactions
No interactions found.

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
BotoxInjection, powder, lyophilized, for solution100 [USP'U]/1Intradermal; IntramuscularAllergan, Inc.1989-12-15Not applicableUS flag
BotoxInjection, powder, lyophilized, for solution200 [USP'U]/1Intradermal; IntramuscularAllergan, Inc.2010-01-11Not applicableUS flag
BOTOX CosmeticInjection, powder, lyophilized, for solution50 [USP'U]/1IntramuscularAllergan, Inc.2008-07-15Not applicableUS flag
BOTOX CosmeticInjection, powder, lyophilized, for solution100 [USP'U]/1IntramuscularAllergan, Inc.2008-05-20Not applicableUS flag
DaxxifyInjection, powder, lyophilized, for solution100 U/1.2mLIntramuscularRevance Therapeutics, Inc.2022-09-20Not applicableUS flag

Categories

ATC Codes
M03AX01 — Botulinum toxin
Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
Not Available

Chemical Identifiers

UNII
E211KPY694
CAS number
93384-43-1

References

General References
  1. Mussarat A, Mustafa MS, Azam ST, Nafees Uddin MM, Nasrullah RMU, Siddiq MA: DAXI (DaxibotulinumtoxinA) - An Innovative Approach for Frown Lines. Int J Gen Med. 2023 Apr 10;16:1267-1269. doi: 10.2147/IJGM.S406563. eCollection 2023. [Article]
  2. Solish N, Carruthers J, Kaufman J, Rubio RG, Gross TM, Gallagher CJ: Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A. Drugs. 2021 Dec;81(18):2091-2101. doi: 10.1007/s40265-021-01631-w. Epub 2021 Nov 17. [Article]
  3. Bertucci V, Solish N, Kaufman-Janette J, Yoelin S, Shamban A, Schlessinger J, Snyder D, Gallagher C, Liu Y, Shears G, Rubio RG: DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol. 2020 Apr;82(4):838-845. doi: 10.1016/j.jaad.2019.06.1313. Epub 2019 Nov 29. [Article]
  4. FDA Approved Drug Products: DAXXIFY (daxibotulinumtoxinA-lanm) for injection, for intramuscular use (August 2023) [Link]
  5. StatPearls: DaxibotulinumtoxinA-Ianm [Link]
  6. Fierce Pharma; With long-awaited FDA nod, Revance set to take on AbbVie's Botox with its longer-lasting Daxxify [Link]
  7. Business Wire: U.S. FDA Approves First Therapeutic Indication for Revance’s DAXXIFY® (DaxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia [Link]
RxNav
2612452
Wikipedia
Botulinum_toxin

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Not Yet RecruitingTreatmentBenign Essential Blepharospasm / Hemifacial Spasm1
4RecruitingTreatmentAging1
3CompletedTreatmentCervical Dystonia2
3CompletedTreatmentGlabellar Frown Lines (GL)3
2CompletedTreatmentFrown Lines1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, powder, lyophilized, for solutionIntradermal; Intramuscular100 [USP'U]/1
Injection, powder, lyophilized, for solutionIntradermal; Intramuscular200 [USP'U]/1
Injection, powder, lyophilized, for solutionIntramuscular100 [USP'U]/1
Injection, powder, lyophilized, for solutionIntramuscular50 [USP'U]/1
Injection, powder, lyophilized, for solutionIntramuscular100 U/1.2mL
Injection, powder, lyophilized, for solutionIntramuscular300 U/1
Injection, powder, lyophilized, for solutionIntramuscular500 U/1
PowderIntramuscular100 [USP'U]/1
Injection, powder, lyophilized, for solutionIntramuscular200 [USP'U]/1
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Drug created at June 24, 2023 04:26 / Updated at December 06, 2023 04:53