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Botox
onabotulinumtoxinA
Black Box Warnings .
Distant Spread of Toxin Effect
effects of all botulinum toxin products may spread beyond tx area to produce sx consistent w/ botulinum toxin; sx incl. 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; sx may occur hours to weeks after injection; risk greatest in children treated for spasticity but can occur in adults, esp. if underlying risk factors; in unapproved uses and in approved indications, spread of effect reported at doses comparable to tx doses for cervical dystonia and spasticity, and at lower doses
Adult Dosing .
Dosage forms: INJ
Special Note
- [dosing clarification]
- Info: max cumulative dose is 400 units q12wk when using onabotulinumtoxinA for 1 or more indications
overactive bladder
- [100 units IM divided equally in 20 sites x1]
- Info: may repeat no more frequently than q12wk
detrusor overactivity, neurogenic
- [200 units IM divided equally in 30 sites x1]
- Info: may repeat no more frequently than q12wk
migraine prophylaxis, chronic
- [155 units IM divided equally in 31 sites q12wk]
- Info: see pkg insert for divided dose and number of sites per muscle area
upper limb spasticity
- [biceps brachii]
- Dose: 60-200 units IM divided in 2-4 sites x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [brachioradialis]
- Dose: 45-75 units IM divided in 1-2 sites x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [brachialis]
- Dose: 30-50 units IM divided in 1-2 sites x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [pronator teres]
- Dose: 15-25 units IM in 1 site x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [pronator quadratus]
- Dose: 10-50 units IM in 1 site x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [flexor carpi radialis or ulnaris]
- Dose: 12.5-50 units IM in 1 site x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [flexor digitorum profundus or sublimis]
- Dose: 30-50 units IM in 1 site x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [lumbricals or interossei]
- Dose: 5-10 units IM in 1 site x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [adductor pollicis or flexor pollicis longus]
- Dose: 20 units IM in 1 site x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [flexor pollicis brevis or opponens pollicis]
- Dose: 5-25 units IM in 1 site x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
lower limb spasticity
- [gastrocnemius medial head, gastrocnemius lateral head, soleus, or tibialis posterior]
- Dose: 75 units IM divided in 3 sites x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [flexor hallucis longus or flexor digitorum longus]
- Dose: 50 units IM divided in 2 sites x1; Max: 50 units/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
cervical dystonia
- [198-300 units IM divided among affected muscles x1]
- Max: 50 units/site; Info: individualize dose based on head/neck position, pain localization, muscle hypertrophy, adverse rxns; may repeat after 3mo
hyperhidrosis, primary axillary
- [50 units/axilla intradermally divided in 10-15 sites x1]
- Info: repeat when effects diminish
blepharospasm
- [1.25-2.5 units/site IM q3mo]
- Max: cumulative dose 200 units/30 days
strabismus
- [1.25-5 units/site IM q3mo]
- Max: 25 units/site
spasmodic dysphonia (off-label)
- [1.25-7.5 units IM divided among affected muscles x1]
- Start: 2.5-5 units IM divided among affected muscles x1; Info: individualize dose; repeat when effects diminish
anal fissure, chronic (off-label)
- [20-100 units IM x1 in internal anal sphincter]
- Info: may consider retreatment if anal fissure persists
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Special Note
- [dosing clarification]
- Info: max cumulative dose is 10 units/kg up to 340 units q12wk when using onabotulinumtoxinA for 1 or more indications
detrusor overactivity, neurogenic
- [5 yo and older, <34 kg]
- Dose: 6 units/kg IM divided equally in 20 sites x1; Info: may repeat no more frequently than q12wk
- [5 yo and older, >34 kg]
- Dose: 200 units IM divided equally in 20 sites x1; Info: may repeat no more frequently than q12wk
upper limb spasticity
- [2-17 yo]
- Dose: 3-6 units/kg IM divided in multiple sites x1; Max: 6 units/kg up to 200 units/total dose (in upper limb); 50 units/site; Info: see pkg insert for dose per site; individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
lower limb spasticity
- [2-17 yo]
- Dose: 4-8 units/kg IM divided in multiple sites x1; Max: 8 units/kg up to 300 units/total dose (in lower limb); 50 units/site; Info: see pkg insert for dose per site; individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
cervical dystonia
- [16 yo and older]
- Dose: 198-300 units IM divided among affected muscles x1; Max: 50 units/site; Info: individualize dose based on head/neck position, pain localization, muscle hypertrophy, adverse rxns; may repeat after 3mo
blepharospasm
- [12 yo and older]
- Dose: 1.25-2.5 units/site IM q3mo; Max: cumulative dose 200 units/30 days
strabismus
- [12 yo and older]
- Dose: 1.25-5 units/site IM q3mo; Max: 25 units/site
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to albumin
- injection site infection
- UTI, acute (OAB or neurogenic detrusor overactivity use)
- urinary retention, acute (OAB or neurogenic detrusor overactivity use)
- caution: neuromuscular dz
- caution: cardiovascular dz
- caution: dysphagia
- caution: dyspnea
- caution: pulmonary impairment (spasticity or neurogenic detrusor overactivity use)
- caution: neck muscle mass, small (cervical dystonia use)
- caution: facial nerve disorder (facial muscle 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
- 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
- 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 rxn
- anaphylaxis
- toxin effect spread
- MI
- arrhythmia
- dysphagia, severe
- respiratory failure (cervical dystonia use)
- respiratory compromise (neurogenic detrusor overactivity or spasticity use)
- autonomic dysreflexia (neurogenic detrusor overactivity use)
- urinary retention (OAB or neurogenic detrusor overactivity use)
- retrobulbar hemorrhage (strabismus use)
- corneal ulcer (blepharospasm use)
- myasthenia gravis exacerbation (blepharospasm use)
- facial paralysis, focal (blepharospasm use)
- facial paresis (chronic migraine use)
- seizures (spasticity use)
- viral transmission risk
Common Reactions
- injection site rxn
- ptosis (facial muscle use)
- UTI (OAB or neurogenic detrusor overactivity use)
- dysphagia (cervical dystonia use)
- ocular vertical deviation (strabismus use)
- urinary retention (OAB or neurogenic detrusor overactivity use)
- URI
- neck pain
- extremity pain (spasticity use)
- superficial punctate keratitis (blepharospasm use)
- ocular dryness (blepharospasm use)
- headache
- fatigue
- asthenia
- muscle weakness
- sweating, non-axillary (hyperhidrosis use)
- fever
- infection
- hematuria (neurogenic detrusor overactivity use)
- dysuria (OAB or neurogenic detrusor overactivity use)
- nausea (spasticity use)
- pruritus
- seizures (spasticity use)
- arthralgia (spasticity use)
- myalgia (spasticity use)
- back pain (spasticity or cervical dystonia use)
- appetite decr. (peds pts)
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 pts
Pharmacology .
Metabolism: unknown; CYP450: unknown; Info: minimal to no systemic absorption
Excretion: unknown; Half-life: unknown
Subclass: Anal Fissures ; Antispasmodics, Urinary ; Cosmetic, Dermatologic ; Dystonias/Parkinson Disease ; Headache/Migraine ; Neurotoxins, Ophthalmic
Mechanism of Action
inhibits acetylcholine release from nerve endings, reducing neuromuscular transmission and local muscle activity (neurotoxin)
Formulary .
No Formulary Selected
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