Dosing & Uses
Dosage Forms & Strengths
injection, powder for reconstitution
- 300 units/vial
- 500 units/vial
Cervical Dystonia
Indicated for cervical dystonia
Initial: 500 unit IM divided among affected muscles
Retreat every 12-16 weeks or longer: 250-1000 unit IM
Titrate in 250-unit steps
Spasticity
Indicated for treatment of spasticity in adults
Select dose based on muscles affected, severity of muscle activity, prior response to treatment, and adverse event history (EMG guidance recommended)
Do not inject >1 mL at any single injection site; the maximum total dose (upper and lower limb combined) is 1500 units
Repeat treatment when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection
A majority of patients are retreated between 12-16 weeks, although some may have a longer response (eg, 20 wk)
Upper limb spasticity
-
Dose per muscle
- In the clinical trial, doses of 500-1000 units were divided among selected upper limb muscles at a given treatment session
- Flexor carpi radialis: 100-200 units in 1-2 sites
- Flexor carpi ulnaris: 100-200 units in 1-2 sites
- Flexor digitorum profundus: 100-200 units in 1-2 sites
- Flexor digitorum sublimis: 100-200 units in 1-2 sites
- Brachialis: 200-400 units in 1-2 sites
- Brachioradialis: 100-200 units in 1-2 sites
- Biceps brachii: 200-400 units divided in 1-2 sites
- Pronator Teres: 100-200 units in 1 site
Lower limb spasticity
-
Dose per muscle
- In the clinical trial, doses of 1000-1500 units were divided among selected lower limb muscles at a given treatment session
- Gastrocnemius medial head: 100-150 units in 1 site
- Gastrocnemius lateral head: 100-150 units in 1 site
- Soleus: 330-500 units in 3 sites
- Tibialis posterior: 200-300 units in 2 sites
- Flexor digitorum longus: 130-200 units in 1-2 sites
- Flexor hallucis longus: 70-200 units in 1 site
Glabellar Lines
Indicated for temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults aged <65 years
50 units total divided in 5 equal doses IM to affected muscles
Retreat no sooner than 3 months
Dosage Modifications
Renal or hepatic impairment: No dose adjustment necessary
Essential Blepharospasm (Orphan)
Orphan indication sponsor
- Porton International, Inc; 1155 15th Street, N.W., #315; Washington, DC 20005
Spasmodic Torticollis (Orphan)
Treatment of spasmodic torticollis (cervical dystonia)
Orphan indication sponsor
- Ipsen Biopharm Limited; 1 Bath Road Maidenhead, Berkshire, SL6 4UH; UK
Dosage Forms & Strengths
injection, powder for reconstitution
- 300 units/vial
- 500 units/vial
Spasticity
Indicated for spasticity in children aged ≥2 yr
Upper limb
- 8-16 units/kg per limb
- Maximum total dose per treatment session: 16 units/kg or 650 units, whichever is lower
-
Dosage range per muscle
- Brachialis: 3-6 units/kg divided in 1-2 injection sites
- Brachioradialis: 1.5-3 units/kg in 1 injection site
- Biceps brachii: 3-6 units/kg divided in 1-2 injection sites
- Pronator teres: 1-2 units/kg in 1 injection site
- Pronator quadratus: 0.5-1 units/kg in 1 injection site
- Flexor carpi radialis (FCR): 2-4 units/kg divided in 1-2 injection sites
- Flexor carpi ulnaris (FCU): 1.5-3 units/kg in 1 injection site
- Flexor digitorum profundus (FDP): 1-2 units/kg in 1 injection site
- Flexor digitorum superficialis (FDS): 1.5-3 units/kg divided in up to 4 injection sites
Lower limb
- 10-15 units/kg per limb
-
Maximum doses
- Unilateral limb injection: 15 units/kg or 1000 units, whichever is lower
- Bilateral limb injections: 30 units/kg or 1000 units, whichever is lower
- Maximum total dose per treatment session: 30 units/kg or 1000 units, whichever is lower
-
Dosage range per muscle per leg
- Gastrocnemius (unilateral injection): 6-9 units/kg divided in up to 4 injection sites
- Soleus (unilateral injection): 4-6 units/kg divided in 1-2 injection sites
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (4)
- incobotulinumtoxinA
incobotulinumtoxinA, abobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
abobotulinumtoxinA, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin. - onabotulinumtoxinA
onabotulinumtoxinA, abobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
- prabotulinumtoxinA
abobotulinumtoxinA, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
prabotulinumtoxinA, abobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin. - rimabotulinumtoxinB
rimabotulinumtoxinB, abobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
Monitor Closely (82)
- aclidinium
abobotulinumtoxinA increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- amikacin
amikacin increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- amikacin liposome inhalation
amikacin liposome inhalation increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- amitriptyline
abobotulinumtoxinA increases effects of amitriptyline by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- amoxapine
abobotulinumtoxinA increases effects of amoxapine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- arbaclofen
arbaclofen increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- atracurium
atracurium increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Neuromuscular blockers may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- atropine
abobotulinumtoxinA increases effects of atropine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- baclofen
baclofen increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- carisoprodol
carisoprodol increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- chlorpromazine
abobotulinumtoxinA increases effects of chlorpromazine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- chlorzoxazone
chlorzoxazone increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- cisatracurium
cisatracurium increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Neuromuscular blockers may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- clomipramine
abobotulinumtoxinA increases effects of clomipramine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- clozapine
abobotulinumtoxinA increases effects of clozapine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- colistin
abobotulinumtoxinA increases effects of colistin by pharmacodynamic synergism. Use Caution/Monitor. Potentiation of neuromuscular blockade; risk of respiratory arrest.
- cyclobenzaprine
cyclobenzaprine increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- dantrolene
dantrolene increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- darifenacin
abobotulinumtoxinA increases effects of darifenacin by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- desipramine
abobotulinumtoxinA increases effects of desipramine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- diazepam
diazepam increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- dicyclomine
abobotulinumtoxinA increases effects of dicyclomine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- dosulepin
abobotulinumtoxinA increases effects of dosulepin by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- doxepin
abobotulinumtoxinA increases effects of doxepin by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- fesoterodine
abobotulinumtoxinA increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- fluphenazine
abobotulinumtoxinA increases effects of fluphenazine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- gentamicin
gentamicin increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- glycopyrrolate
abobotulinumtoxinA increases effects of glycopyrrolate by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- glycopyrrolate inhaled
abobotulinumtoxinA increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- haloperidol
abobotulinumtoxinA increases effects of haloperidol by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- homatropine
abobotulinumtoxinA increases effects of homatropine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- hyoscyamine
abobotulinumtoxinA increases effects of hyoscyamine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- hyoscyamine spray
abobotulinumtoxinA increases effects of hyoscyamine spray by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- iloperidone
abobotulinumtoxinA increases effects of iloperidone by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- imipramine
abobotulinumtoxinA increases effects of imipramine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- ipratropium
abobotulinumtoxinA increases effects of ipratropium by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- levodopa
abobotulinumtoxinA increases effects of levodopa by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- lofepramine
abobotulinumtoxinA increases effects of lofepramine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- loxapine
abobotulinumtoxinA increases effects of loxapine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- loxapine inhaled
abobotulinumtoxinA increases effects of loxapine inhaled by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- maprotiline
abobotulinumtoxinA increases effects of maprotiline by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- meclizine
abobotulinumtoxinA increases effects of meclizine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- metaxalone
metaxalone increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- methocarbamol
methocarbamol increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- methscopolamine
abobotulinumtoxinA increases effects of methscopolamine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- neomycin PO
neomycin PO increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- nortriptyline
abobotulinumtoxinA increases effects of nortriptyline by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- olanzapine
abobotulinumtoxinA increases effects of olanzapine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- orphenadrine
orphenadrine increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
abobotulinumtoxinA increases effects of orphenadrine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. - oxybutynin
abobotulinumtoxinA increases effects of oxybutynin by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- oxybutynin topical
abobotulinumtoxinA increases effects of oxybutynin topical by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- oxybutynin transdermal
abobotulinumtoxinA increases effects of oxybutynin transdermal by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- paliperidone
abobotulinumtoxinA increases effects of paliperidone by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- pancuronium
pancuronium increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Neuromuscular blockers may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- perphenazine
abobotulinumtoxinA increases effects of perphenazine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- pimozide
abobotulinumtoxinA increases effects of pimozide by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- plazomicin
plazomicin increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- prochlorperazine
abobotulinumtoxinA increases effects of prochlorperazine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- propantheline
abobotulinumtoxinA increases effects of propantheline by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- protriptyline
abobotulinumtoxinA increases effects of protriptyline by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- quetiapine
abobotulinumtoxinA increases effects of quetiapine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- risperidone
abobotulinumtoxinA increases effects of risperidone by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- rocuronium
rocuronium increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Neuromuscular blockers may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- scopolamine
abobotulinumtoxinA increases effects of scopolamine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases effects of abobotulinumtoxinA by Other (see comment). Use Caution/Monitor. Comment: Magnesium may potentiate the effects of the neuromuscular blocking agents.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases effects of abobotulinumtoxinA by Other (see comment). Use Caution/Monitor. Comment: Magnesium may potentiate the effects of the neuromuscular blocking agents.
- solifenacin
abobotulinumtoxinA increases effects of solifenacin by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- streptomycin
streptomycin increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- succinylcholine
succinylcholine increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Neuromuscular blockers may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- thioridazine
abobotulinumtoxinA increases effects of thioridazine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- thiothixene
abobotulinumtoxinA increases effects of thiothixene by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- tiotropium
abobotulinumtoxinA increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- tobramycin
tobramycin increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- tobramycin inhaled
tobramycin inhaled increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- tolterodine
abobotulinumtoxinA increases effects of tolterodine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- trifluoperazine
abobotulinumtoxinA increases effects of trifluoperazine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- trihexyphenidyl
abobotulinumtoxinA increases effects of trihexyphenidyl by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- trimipramine
abobotulinumtoxinA increases effects of trimipramine by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- trospium chloride
abobotulinumtoxinA increases effects of trospium chloride by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- umeclidinium bromide
abobotulinumtoxinA increases effects of umeclidinium bromide by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- umeclidinium bromide/vilanterol inhaled
abobotulinumtoxinA increases effects of umeclidinium bromide/vilanterol inhaled by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .
- vecuronium
vecuronium increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Neuromuscular blockers may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
Minor (0)
Adverse Effects
>10%
Dysphagia (15%)
Dry mouth (13%)
Headache (11%)
Inj site discomfort (13%)
Muscle weakness (16%)
Fatigue (12%)
1-10%
Dyspnea (3%)
Facial paresis (5%)
Dysphonia (6%)
Injection site pain (5%)
Musculoskeletal pain (7%)
Eye disorders (7%)
Postmarketing Reports
Hypoesthesia
Warnings
Black Box Warnings
Effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects
These symptoms may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties
These symptoms have been reported hours to weeks after injection
Swallowing and breathing difficulties can be life threatening, and death have been reported
The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms
In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses
Contraindications
Hypersensitivity
Allergy to cow milk protein
Injection site infection
Cautions
Exercise caution when administering to patients with surgical alterations to facial anatomy, excessive weakness or atrophy in the target muscle(s), marked facial asymmetry, inflammation at the injection site(s), ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart
Not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of abobotulinumtoxin cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method
Toxin may spread - watch for dyspnea, dysphagia or speech impairment
Product contains albumin, a derivative of human blood; based on effective donor screening and product manufacturing processes; carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD); there is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote; no cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products
Neutralizing antibody formation and loss of efficacy associated with higher doses or more frequent administration of the drug
Arrhythmia and myocardial infarction reported with use
Dysphagia reported with use for cervical dystonia; may persist for several weeks following administration and could cause the patient to require alternative feeding methods, including a feeding tube; smaller neck muscle mass, injections into the elevator scapulae or injections into the sternocleidomastoid muscle may increase risk of dysphagia; risk of aspiration may result from severe dysphagia when swallowing is already compromised; occurrence may be reduced by limiting the dose injected into sternocleidomastoid muscle
Use caution in patients with neuromuscular disease, including myasthenia gravis and Eaton-Lambert syndrome, and neuropathic disorders, such as, amyotrophic lateral sclerosis
Injection of the orbicularis muscle may reduce blinking and lead to corneal exposure and ulceration, when treating blepharospasm
Use caution when treating patients with preexisting respiratory disease; treatment of cervical dystonia, may weaken accessory muscles necessary to patients to maintain adequate ventilation; serious breathing difficulties, including respiratory failure reported
Dry eye has been reported in the treatment of glabellar lines; reduce tear production, reduced blinking, and corneal disorders, may occur with use of botulinum toxins; if symptoms of dry eye (eg, eye irritation, photophobia, visual changes) persist, consider referring patient to an ophthalmologist
Possibility of an immune reaction when injected intradermally is unknown; safety for the treatment of hyperhidrosis has not been established; approved only for IM injection
Drug interaction overview
-
Aminoglycosides and other agents interfering with neuromuscular transmission
- Coadministration with aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like agents) should only be used with caution because the effect of the botulinum toxin may be potentiated
- If coadministered, closely monitor patients
-
Anticholinergic drugs
- Use of anticholinergic drugs after administration may potentiate systemic anticholinergic effects such as blurred vision
-
Other botulinum neurotoxin products
- Effect of administering botulinum neurotoxin products, at the same time or within several months of each other is unknown
- Excessive weakness may be exacerbated by another administration of botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin
-
Muscle relaxants
- Excessive weakness may be exaggerated by administration of a muscle relaxant before or after botulinum toxin administration
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled clinical studies in pregnant women
Use only during pregnancy if the potential benefit justifies the potential risk to the fetus
In rats, abobotulinumtoxinA produced adverse effects on mating behavior and fertility
Animal data
- AbobotulinumtoxinA produced embryofetal toxicity in relation to maternal toxicity when given to pregnant rats and rabbits at doses lower than or similar to the maximum recommended human dose (MRHD) of 1000 units on a body weight (units/kg) basis
Lactation
There are no data on the presence in human or animal milk, the effects on the breastfed infant, or the effects on milk production
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Neurotoxin from Clostridium botulinum; prevents ACh release from presynaptic membrane
Pharmacokinetics
Onset of action: Cervical Dystonia: 2-4 weeks
Duration cervical dystonia: Up to 4 months
Administration
Instructions for safe use
Potency units of abobotulinumtoxinA are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of abobotulinumtoxinA cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method
IM Preparation
Only use sterile preservative-free 0.9% NaCl injection for reconstituting vials
Swirl gently to dissolve
Visually inspect for particulate matter and discoloration prior to administration
Reconstituted solution should be a clear, colorless, and free of particulate matter, otherwise it should not be injected
Dilution
- Dilute with preservative-free 0.9% NaCl
-
500 units/vial
- Reconstitute with 1 mL 0.9% NaCl (yields 50 units/0.1 mL)
- Reconstitute with 2 mL 0.9% NaCl (yields 25 units/0.1 mL)
- Reconstitute with 2.5 mL 0.9% NaCl (yields 20 units/0.1 mL)
- Reconstitute with 5 mL 0.9% NaCl (yields 10 units/0.1 mL)
-
300 units/vial
- Reconstitute with 0.6 mL 0.9% NaCl (yields 50 units/0.1 mL)
- Reconstitute with 1.5 mL 0.9% NaCl (yields 20 units/0.1 mL)
- Reconstitute with 2.5 mL 0.9% NaCl (yields 12 units/0.1 mL)
- Reconstitute with 3 mL 0.9% NaCl (yields 10 units/0.1 mL)
Recommended concentration for adults
- Cervical dystonia: 50 units/0.1 mL or 25 units/0.1 mL
- Glabellar lines: 12 units/0.1 mL or 20 units/0.1 mL
- Spasticity: 10 units/0.1 mL or 20 units/0.1 mL
Recommended concentration for children and adolescents
- Spasticity: 20 units/0.1 mL or 50 units/0.1 mL
IM Administration
IM administration only
Reconstituted solution should be a clear, colorless solution, free of particulate matter, otherwise it should not be injected
Expel any air bubbles in the syringe barrel
After reconstitution, use for only 1 injection session and for only 1 patient
Storage
Store unreconstituted vials in refrigerator at 2-8°C (36-46°F)
Use each vial for only 1 injection session and for only 1 patient
Once reconstituted, store in the original container, refrigerated at 2-8°C (36-46°F) for up to 24 hr (must discard if not used within 24 hr)
Protected from light
Do not freeze reconstituted solution
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Dysport intramuscular - | 500 unit vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
abobotulinumtoxinA intramuscular
BOTULINUM TOXIN - INJECTION
(BOT-ue-LYE-num)
WARNING: See also Uses section.This medication can spread to other parts of the body after your injection, causing serious (possibly fatal) side effects. These can occur hours or even weeks after the injection. However, the chances of such serious side effects occurring when this medication is used for migraines or skin conditions such as wrinkles, eye spasm, or excessive sweating are extremely unlikely.Children being treated for muscle stiffness/spasms have the greatest risk of these effects, as well as anyone that has certain medical conditions (see Precautions section). Discuss the risks and benefits of this medication with your doctor.Get medical help right away if any of these very serious side effects occur: chest pain, difficulty breathing, excessive muscle weakness, irregular heartbeat, severe difficulty swallowing or speaking, loss of bladder control.
USES: There are different types of botulinum toxin products (toxin A and B) with different uses (eye problems, muscle stiffness/spasms, migraines, cosmetic, overactive bladder). Different brands of this medication deliver different amounts of medication. Your doctor will choose the correct product for you.Botulinum toxin is used to treat certain eye disorders such as crossed eyes (strabismus) and uncontrolled blinking (blepharospasm), to treat muscle stiffness/spasms or movement disorders (such as cervical dystonia, torticollis), and to reduce the cosmetic appearance of wrinkles. It is also used to prevent headaches in people with very frequent migraines. Botulinum toxin relaxes muscle by blocking the release of a chemical called acetylcholine.Botulinum toxin is also used to treat overactive bladder by patients who do not respond to or who cannot tolerate the side effects of other medications. It helps to reduce leaking of urine, feeling of needing to urinate right away, and frequent trips to the bathroom.It is also used to treat severe underarm sweating and drooling/excess saliva. Botulinum toxin works by blocking the chemicals that turn on the sweat and salivary glands.Botulinum toxin is not a cure, and your symptoms will gradually return as the medication wears off.
HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get an injection. If you have any questions regarding the information, consult your doctor or pharmacist.This medication is given by injection by an experienced health care professional. It is injected into the affected muscles (intramuscularly) when treating eye disorders, muscle stiffness/spasms, and wrinkles. When used to prevent migraines, it is injected into the muscles of the head and neck. It is injected into the skin (intradermally) for the treatment of excessive sweating. For the treatment of drooling/excess saliva, this medication is injected into the salivary glands. When treating overactive bladder, it is injected into the bladder.Your dose, the number of injections, the site of injections, and how often you receive the medication will be determined by your condition and your response to therapy. For children, the dose is also based on weight. Most people start to see an effect within a few days to 2 weeks, and the effect usually lasts 3 to 6 months.
SIDE EFFECTS: See also Warning section.Because this medication is given at the site of your condition, most of the side effects occur close to where the medication is injected. Redness, bruising, infection, and pain at the injection site may occur.Dizziness, mild difficulty swallowing, respiratory infections such as cold or flu, pain, nausea, headache, and muscle weakness may occur when this medication is used to relax muscles. Double vision, drooping or swollen eyelid, eye irritation, dry eyes, tearing, reduced blinking, and increased sensitivity to light may also occur.If any of these effects persist or worsen, notify your doctor or pharmacist promptly. You may require protective eye drops/ointments, an eye patch, or other treatment.When this medication is used to prevent migraines, side effects such as headache, neck pain, and drooping eyelid may occur.When this medication is used for excessive sweating, side effects such as non-underarm sweating, respiratory infections such as cold or flu, headache, fever, neck or back pain, and anxiety may occur.When this medication is used for overactive bladder, side effects such as urinary tract infections, burning/painful urination, fever, or difficulty urinating may occur.If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as cow's milk protein found in some products), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, diabetes, signs of infection near the injection site, urinary tract infection, inability to urinate, muscle/nerve disorders (such as Lou Gehrig's disease-ALS, myasthenia gravis), seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia), treatment with any botulinum toxin product (especially in the last 4 months).This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.Before having surgery, tell your doctor or dentist that you are using this medication.Some brands of this medication contain albumin made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get serious infections from the medication. Consult your doctor or pharmacist for more information.Older adults using this drug for overactive bladder may be more sensitive to the side effects of this drug, especially urinary effects.Children using this drug for muscle spasms may be more sensitive to the side effects of this drug, including difficulty breathing or swallowing. See Warning section. Discuss the risks and benefits with the doctor.This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Use for the cosmetic treatment of wrinkles is not recommended during pregnancy.It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: certain antibiotics (including aminoglycosides such as gentamicin, polymyxin), anticoagulants (such as warfarin), Alzheimer's disease drugs (such as galantamine, rivastigmine, tacrine), myasthenia gravis drugs (such as ambenonium, pyridostigmine), quinidine.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. An antitoxin is available but must be used before symptoms of overdose become apparent. Symptoms of overdose may be delayed, and may include serious muscle weakness, breathing problems and paralysis.
NOTES: It is important to understand the risks and benefits of this therapy. Discuss any questions or concerns with your health care professional.
MISSED DOSE: Not applicable.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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