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Daxxify (daxibotulinumtoxinA-lanm)
daxibotulinumtoxinA
Black Box Warnings .
Distant Spread of Toxin Effect
effects of all botulinum toxin products may spread beyond tx area to produce symptoms consistent with botulinum toxin; symptoms including asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties; life-threatening swallowing and breathing difficulties can occur; deaths reported; symptoms may occur hours to weeks after injection; risk greatest in children treated for spasticity but can occur in adults, especially if underlying risk factors; in unapproved uses, including spasticity in children, and in approved indications, spread of effect reported at doses comparable to or lower than max recommended total dose
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = daxibotulinumtoxinA-lanm
glabellar lines, moderate-severe
- [40 units IM divided equally in 5 sites x1]
- Info: may repeat no more frequently than q3mo
cervical dystonia
- [125-250 units IM divided among affected muscles x1]
- Info: adjust dose in 50-75 unit increments; may repeat no more frequently than q3mo
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- injection site infection
- caution: atrophy at injection site
- caution: neuromuscular disease
- caution: cardiovascular disease
- caution: dysphagia
- caution: dyspnea
- caution: neck muscle mass, small (cervical dystonia use)
- caution: injection site inflammation (glabellar line use)
- caution: ptosis (glabellar line use)
- caution: deep dermal scarring (glabellar line use)
- caution: facial asymmetry (glabellar line use)
- caution: sebaceous skin, thick (glabellar line use)
- caution: dermatochalasis (glabellar line use)
- caution: facial anatomy surgery history (glabellar line use)
Drug Interactions .
Overview
botulinum toxin
acetylcholine release inhibitor
- anticholinergic effects
- neuromuscular blocking effects
Avoid/Use Alternative
- aclidinium inhaled
- amikacin
- amikacin inhaled
- benztropine
- clozapine
- colistimethate
- gentamicin
- glycopyrrolate inhaled
- glycopyrronium topical
- ipratropium inhaled
- neomycin
- olanzapine
- paromomycin
- plazomicin
- polymyxin B
- revefenacin inhaled
- sofpironium topical
- streptomycin
- tiotropium inhaled
- tobramycin
- tobramycin inhaled
- umeclidinium inhaled
Monitor/Modify Tx
- amitriptyline
- atracurium
- botulinum toxin
- cisatracurium
- clomipramine
- desflurane
- desipramine
- gepotidacin
- imipramine
- isoflurane
- nortriptyline
- protriptyline
- rocuronium
- sevoflurane
- succinylcholine
- vecuronium
Caution Advised
- alfentanil
- amantadine
- amoxapine
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- asenapine
- atropine
- atropine ophthalmic
- baclofen
- baclofen intrathecal
- belladonna alkaloids
- brexpiprazole
- brompheniramine
- buprenorphine
- butorphanol
- carbinoxamine
- cariprazine
- carisoprodol
- chlophedianol
- chlorcyclizine
- chloroquine
- chlorpheniramine
- chlorpromazine
- chlorzoxazone
- clemastine
- clidinium
- codeine
- cyclobenzaprine
- cyclopentolate ophthalmic
- cyproheptadine
- dantrolene
- darifenacin
- dexbrompheniramine
- dexchlorpheniramine
- dicyclomine
- dihydrocodeine
- dimenhydrinate
- diphenhydramine
- disopyramide
- doxepin
- doxepin topical
- doxylamine
- fentanyl
- fesoterodine
- flavoxate
- fluphenazine
- glycopyrrolate
- homatropine
- hydrocodone
- hydromorphone
- hydroxychloroquine
- hydroxyzine
- hyoscyamine
- iloperidone
- ipratropium nasal
- isocarboxazid
- levorphanol
- loxapine
- lumateperone
- lurasidone
- meclizine
- meperidine
- metaxalone
- methadone
- methocarbamol
- methscopolamine
- milsaperidone
- mirabegron
- mirtazapine
- molindone
- morphine
- nalbuphine
- oliceridine
- opium
- orphenadrine
- oxybutynin
- oxycodone
- oxymorphone
- paliperidone
- pentazocine
- perphenazine
- phenelzine
- pheniramine
- pimozide
- procainamide
- prochlorperazine
- promethazine
- pyrilamine
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- remifentanil
- risperidone
- scopolamine
- solifenacin
- sufentanil
- tapentadol
- thioridazine
- thiothixene
- tizanidine
- tolterodine
- topiramate
- tramadol
- tranylcypromine
- trifluoperazine
- trihexyphenidyl
- trimipramine
- triprolidine
- tropicamide ophthalmic
- trospium
- vibegron
- ziprasidone
- zonisamide
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- toxin effect spread
- dysphagia, severe (cervical dystonia use)
- respiratory failure (cervical dystonia use)
Common Reactions
- headache
- injection site reaction
- muscle weakness
- URI
- musculoskeletal pain (cervical dystonia use)
- dysphagia (cervical dystonia use)
- arthralgia (cervical dystonia use)
- ptosis (glabellar line use)
- ocular dryness
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
may use during pregnancy; risk of fetal harm not expected based on limited human data and expected limited systemic absorption
Lactation
Clinical Summary
may use while breastfeeding; inadequate human data available, though risk of infant harm and adverse effects on milk production not expected based on limited systemic absorption in breastfeeding patients
Pharmacology .
Metabolism: for botulinum toxin A: unknown; CYP450: unknown; Info: minimal to no systemic absorption
Excretion: for botulinum toxin A: unknown; Half-life: unknown
Subclass: Cosmetic, Dermatologic ; Dystonias/Parkinson Disease
Mechanism of Action
for botulinum toxin A: inhibits acetylcholine release from nerve endings, reducing neuromuscular transmission and local muscle activity (neurotoxin)
Formulary .
No Formulary Selected
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