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Xeomin
incobotulinumtoxinA
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, incl. lower limb spasticity in children, and in approved indications, spread of effect reported at doses comparable to tx doses for cervical dystonia and at lower doses
Adult Dosing .
Dosage forms: INJ
sialorrhea, chronic
- [100 units intra-glandularly divided in 4 sites x1]
- Info: inject 30 units in parotid gland and 20 units in submandibular gland on both sides; may repeat no more frequently than q16wk
upper limb spasticity
- [flexor digitorum superficialis or profundus]
- Dose: 25-100 units IM divided in 2 sites x1; Max: 400 units/total dose divided among all affected muscles; 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]
- Dose: 25-100 units IM divided in 1-2 sites x1; Max: 400 units/total dose divided among all affected muscles; 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 ulnaris]
- Dose: 20-100 units IM divided in 1-2 sites x1; Max: 400 units/total dose divided among all affected muscles; 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: 25-100 units IM divided in 1-3 sites x1; Max: 400 units/total dose divided among all affected muscles; Info: individualize dose based on spasticity severity, presence of local muscle weakness, prior response or adverse rxns; may repeat no more frequently than q12wk
- [biceps brachii]
- Dose: 50-200 units IM divided in 1-4 sites x1; Max: 400 units/total dose divided among all affected muscles; 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: 25-100 units IM divided in 1-2 sites x1; Max: 400 units/total dose divided among all affected muscles; 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: 400 units/total dose divided among all affected muscles; 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: 25-75 units IM divided in 1-2 sites x1; Max: 400 units/total dose divided among all affected muscles; 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 longus]
- Dose: 10-50 units IM in 1 site x1; Max: 400 units/total dose divided among all affected muscles; 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, flexor pollicis brevis, or opponens pollicis]
- Dose: 5-30 units IM in 1 site x1; Max: 400 units/total dose divided among all affected muscles; 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
- [120-240 units IM divided among affected muscles x1]
- Info: individualize dose based on prior tx regimen, adverse rxns, number/location of muscles, muscle mass, body wt, spasticity severity; may repeat no more frequently than q12wk
blepharospasm
- [25 units/eye IM divided among affected muscles x1]
- Max: 50 units/eye; Info: individualize dose based on prior tx regimen, prior response or adverse rxns; may repeat no more frequently than q12wk
glabellar lines, moderate-severe
- [20 units IM divided equally in 5 sites x1]
- Max: 20 units/total dose; Info: may repeat no more frequently than q3mo
forehead lines, moderate-severe
- [20 units IM divided equally in 5 sites x1]
- Max: 20 units/total dose; Info: treat w/ glabellar lines to decr. brow ptosis; may repeat no more frequently than q3mo
lateral canthal lines, moderate-severe
- [24 units IM divided equally in 6 sites x1]
- Max: 24 units/total dose; Info: 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 .
- Dosage forms: INJ
sialorrhea, chronic
- [2-17 yo, 12-15 kg]
- Dose: 20 units intra-glandularly divided in 4 sites x1; Info: inject 6 units in parotid gland and 4 units in submandibular gland on both sides; may repeat no more frequently than q16wk
- [2-17 yo, 15-19 kg]
- Dose: 30 units intra-glandularly divided in 4 sites x1; Info: inject 9 units in parotid gland and 6 units in submandibular gland on both sides; may repeat no more frequently than q16wk
- [2-17 yo, 19-23 kg]
- Dose: 40 units intra-glandularly divided in 4 sites x1; Info: inject 12 units in parotid gland and 8 units in submandibular gland on both sides; may repeat no more frequently than q16wk
- [2-17 yo, 23-27 kg]
- Dose: 50 units intra-glandularly divided in 4 sites x1; Info: inject 15 units in parotid gland and 10 units in submandibular gland on both sides; may repeat no more frequently than q16wk
- [2-17 yo, 27-30 kg]
- Dose: 60 units intra-glandularly divided in 4 sites x1; Info: inject 18 units in parotid gland and 12 units in submandibular gland on both sides; may repeat no more frequently than q16wk
- [2-17 yo, >30 kg]
- Dose: 75 units intra-glandularly divided in 4 sites x1; Info: inject 22.5 units in parotid gland and 15 units in submandibular gland on both sides; may repeat no more frequently than q16wk
upper limb spasticity
- [2-17 yo]
- Dose: 8 units/kg/single upper limb IM divided in multiple sites x1; Max: 8 units/kg up to 200 units/total dose in single upper limb, or 16 units/kg up to 400 units/total dose in both upper limbs; 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]