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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]