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Dysport
abobotulinumtoxinA
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 or lower than max recommended total dose
Adult Dosing .
Dosage forms: INJ
cervical dystonia
- [250-1000 units IM divided among affected muscles x1]
- Start: 500 units IM divided among affected muscles x1; Info: adjust dose in 250 unit increments; may repeat no more frequently than q12wk
glabellar lines, moderate-severe
- [<65 yo]
- Dose: 50 units IM divided equally in 5 sites x1; Info: may repeat no more frequently than q3mo
upper limb spasticity
- [biceps brachii]
- Dose: 200-400 units IM divided in 1-2 sites x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
- [brachialis]
- Dose: 200-400 units IM divided in 1-2 sites x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
- [brachioradialis]
- Dose: 100-200 units IM divided in 1-2 sites x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
- [flexor carpi radialis or ulnaris]
- Dose: 100-200 units IM divided in 1-2 sites x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
- [flexor digitorum profundus or superficialis]
- Dose: 100-200 units IM divided in 1-2 sites x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
- [pronator teres]
- Dose: 100-200 units IM in 1 site x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
lower limb spasticity
- [flexor digitorum longus]
- Dose: 130-200 units IM divided in 1-2 sites x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
- [flexor hallucis longus]
- Dose: 70-200 units IM in 1 site x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
- [gastrocnemius medial head or gastrocnemius lateral head]
- Dose: 100-150 units IM in 1 site x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
- [soleus]
- Dose: 330-500 units IM divided in 3 sites x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
- [tibialis posterior]
- Dose: 200-300 units IM divided in 2 sites x1; Max: 1500 units/total dose (upper and lower limb combined); 1 mL/site; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response, and/or adverse rxns; may repeat no more frequently than q12wk
anal fissure, chronic (off-label)
- [60-300 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
upper limb spasticity
- [2 yo and older, >10 kg]
- Dose: 8-16 units/kg IM divided in multiple sites x1; Max: 16 units/kg up to 640 units/total dose (in upper limb); 0.5 mL/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 q16wk
lower limb spasticity
- [2 yo and older]
- Dose: 10-15 units/kg/limb IM divided in up to 6 sites/limb x1; Max: 15 units/kg/limb up to 1000 units/total dose (upper and lower limb combined); 0.5 mL/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
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]