Dosing & Uses
Dosing Form & Strengths
injection, lyophilized powder for reconstitution
- 50 units/single-dose vial
- 100 units/single-dose vial
- 200 units/single-dose vial
Chronic Sialorrhea
Indicated for chronic sialorrhea
Inject into the parotid and submandibular glands on both sides (ie, 4 injection sites per treatment session)
Recommended total dose is 100 units per treatment session; divide dose into a ratio of 3:2 between the parotid and submandibular gland; do not exceed cumulative dose of 400 units per treatment session
Dosing by glands
- Parotid glands: 30 units/side; total dose is 60 units
- Submandibular gland(s): 20 Units/side; total dose is 40 units
- Both glands: 50 Units/side; total dose is 100 units
Repeat treatment based on the actual clinical need of the individual patient; frequency of treatments should be no sooner than every 16 weeks
Upper Limb Spasticity
Indicated for the treatment of upper limb spasticity in adults
Adjust dosage, frequency, and number of injection sites to the individual patient based on the size, number, and location of muscles to be treated, severity of spasticity, presence of local muscle weakness, patient’s response to previous treatment, and adverse event history with incobotulinumtoxinA
Frequency of treatments should be no sooner than every 12 weeks
If not previously treated with botulinum toxins, initial dosing should begin at the low end of the recommended dosing range and titrated as clinically necessary
Do not exceed cumulative dose of 400 units per treatment session
Recommended dose per muscle
-
Clenched fist
- Flexor digitorum superficialis: 25-100 units divided in 2 sites
- Flexor digitorum profundus: 25-100 units divided in 2 sites
-
Flexed wrist
- Flexor carpi radialis: 25-100 units divided in 1-2 sites
- Flexor carpi ulnaris: 20-100 units divided in 1-2 sites
-
Flexed elbow
- Brachioradialis: 25-100 units divided in 1-3 sites
- Biceps: 50-200 units divided in 1-4 sites
- Brachialis: 25-100 units divided in 1-2 sites
-
Pronated forearm
- Pronator quadratus: 10-50 units in 1 site
- Pronator teres: 25-75 units divided in 1-2 sites
-
Thumb-in-palm
- Flexor pollicis longus: 10-50 units in 1 site
- Adductor pollicis: 5-30 units in 1 site
- Flexor pollicis brevis/Opponens pollicis: 5-30 units in 1 site
Cervical Dystonia
Indicated to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated patients
Consider past dose, response to treatment, duration of effect, and adverse event history when determining dose
Optimum dose and number of injection sites in treated muscle(s) individualized by MD for each patient based on number and location of muscle(s) to be treated, degree of spasticity/dystonia, muscle mass, body weight, and response to any previous botulinum toxin injections
Total dose is 120 units IM per treatment session; higher doses not shown to provide additional efficacy and were associated with increased adverse effects
Usually injected into sternocleidomastoid, splenius capitis, levator scapulae, scalenus, and/or trapezius muscles(s)
Frequency of repeat treatments should be determined by clinical response and generally be no more frequent than every 12 weeks Do not exceed cumulative dose of 400 units per treatment session
Blepharospasm
Indicated for treatment of blepharospasm
Optimum dose and number of injection sites in treated muscle(s) individualized for each patient as determined by MD
Treatment-naïve, initial dose: 25 units per eye
Previously treated: In patients previously treated with a botulinum toxin A, their past dose, response to treatment, duration of effect, and adverse event history should be taken into consideration when determining the dose
Not to exceed 100 units per treatment session (ie, 50 units per eye)
Frequency of repeat treatments should be determined by clinical response and generally be no more frequent than every 12 weeks
Glabellar Lines
Indicated for temporary improvement of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity
Total dose is 20 units per treatment session divided into 5 equal IM injections of 4 units each (2 injections in each corrugator muscle and 1 injection in procerus muscle)
Retreat no more frequently than q3months
Do not exceed cumulative dose of 400 units per treatment session
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 50 units/single-dose vial
- 100 units/single-dose vial
- 200 units/single-dose vial
Chronic sialorrhea
Indicated for the chronic sialorrhea in children and adolescents aged ≥2 years
<2 years or <12 kg: Safety and efficacy not established
≥2 years and ≥12 kg
- Body-weight adjusted dose is divided between parotid and submandibular glands (a ratio of 3:2)
- Repeat treatment based on clinical need of individual, and no sooner than every 16 week
-
Parotid gland
- ≥12 to <15 kg: 6 units (0.24 mL) per side
- ≥15 to <19 kg: 9 units (0.36 mL) per side
- ≥19 to <23 kg: 12 units (0.48 mL) per side
- ≥23 to <27 kg: 15 units (0.6 mL) per side
- ≥27 to <30 kg: 18 units (0.72 mL) per side
- ≥30 kg: 22.5 units (0.9 mL) per side
-
Submandibular gland (each side)
- ≥12 to <15 kg: 4 units (0.16 mL) per side
- ≥15 to <19 kg: 6 units (0.24 mL) per side
- ≥19 to <23 kg: 8 units (0.32 mL) per side
- ≥23 to <27 kg: 10 units (0.4 mL) per side
- ≥27 to <30 kg: 12 units (0.48 mL) per side
- ≥30 kg: 15 units (0.6 mL) per side
-
Total dose, both glands, both sides
- ≥12 to <15 kg: 20 units
- ≥15 to <19 kg: 30 units
- ≥19 to <23 kg: 40 units
- ≥23 to <27 kg: 50 units
- ≥27 to <30 kg: 60 units
- ≥30 kg: 75 units
Upper Limb Spasticity
Indicated for upper limb spasticity in pediatric patients aged 2-17 years, excluding spasticity caused by cerebral palsy
Frequency of treatments should be no sooner than every 12 weeks
Tailor exact dosage, frequency, and number of injection sites to the individual patient based on size, number and localization of involved muscles; severity of spasticity; and presence of local muscle weakness
Single upper limb: Maximum dose is 8 units/kg, divided among affected muscles, not to exceed 200 units per single upper limb
Both upper limbs are treated: Do not exceed total dose of 16 units/kg, up to a maximum of 400 Units
Dosage range per muscle
- Brachioradialis: 1-2 units/kg (maximum of 50 units) divided in 1-2 sites
- Biceps: 2-3 units/kg (maximum of 75 units) divided in 1-3 sites
- Brachialis: 1-2 units/kg (maximum of 50 units) divided in 1-2 sites
- Flexor carpi radialis: 1 unit/kg (maximum of 25 units) in 1 site
- Flexor carpi ulnaris: 1 unit/kg (maximum of 25 units) in 1 site
- Pronator quadratus: 0.5 unit/kg (maximum of 12.5 units) in 1 site
- Pronator teres: 1-2 units/kg (maximum of 50 units) in 1-2 sites
- Flexor digitorum superficialis: 1 unit/kg (maximum of 25 units) in 1 site
- Flexor digitorum profundus: 1 unit/kg (maximum of 25 units) in 1 site
- Flexor pollicis longus: 1 unit/kg (maximum of 25 units) in 1 site
- Adductor pollicis: 0.5 unit/kg (maximum of 12.5 units) in 1 site
- Flexor pollicis brevis/ opponens pollicis: 0.5 unit/kg (maximum of 12.5 units) in 1 site
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (12)
- abobotulinumtoxinA
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. - amikacin
amikacin increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- amphotericin B deoxycholate
amphotericin B deoxycholate increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- gentamicin
gentamicin increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- glycopyrronium tosylate topical
glycopyrronium tosylate topical, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- neomycin PO
neomycin PO increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- onabotulinumtoxinA
onabotulinumtoxinA, 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.
- polymyxin B
polymyxin B increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of resp. depression.
- prabotulinumtoxinA
prabotulinumtoxinA, 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.
- pramlintide
pramlintide, incobotulinumtoxinA. pharmacodynamic synergism. Avoid or Use Alternate Drug. Synergistic inhibition of GI motility.
- streptomycin
streptomycin increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- tobramycin
tobramycin increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
Monitor Closely (43)
- anticholinergic/sedative combos
anticholinergic/sedative combos, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- arbaclofen
arbaclofen, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- atracurium
atracurium increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Neuromuscular blockers may enhance the effects of prabotulinumtoxinA. Closely monitor for increased neuromuscular blockade.
- atropine
atropine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- baclofen
baclofen, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- belladonna alkaloids
belladonna alkaloids, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- benperidol
benperidol, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- benztropine
benztropine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- capreomycin
capreomycin increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- carisoprodol
carisoprodol, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- chlorpromazine
chlorpromazine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- chlorzoxazone
chlorzoxazone, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- clindamycin
clindamycin increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- clozapine
clozapine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- cyclobenzaprine
cyclobenzaprine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- dantrolene
dantrolene, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- diazepam
diazepam, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- dimenhydrinate
dimenhydrinate, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- droperidol
droperidol increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.
- fluphenazine
fluphenazine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- haloperidol
haloperidol, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- huperzine A
huperzine A increases and incobotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- iloperidone
iloperidone, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- loxapine
loxapine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- loxapine inhaled
loxapine inhaled, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- metaxalone
metaxalone, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- methocarbamol
methocarbamol, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- olanzapine
olanzapine increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.
- orphenadrine
orphenadrine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- perphenazine
perphenazine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- pimozide
pimozide increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.
- prochlorperazine
prochlorperazine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- promethazine
promethazine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- quetiapine
quetiapine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- quinidine
quinidine, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- risperidone
risperidone, incobotulinumtoxinA. Either increases effects of the other 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 incobotulinumtoxinA 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 incobotulinumtoxinA by Other (see comment). Use Caution/Monitor. Comment: Magnesium may potentiate the effects of the neuromuscular blocking agents.
- thioridazine
thioridazine increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.
- thiotepa
thiotepa increases levels of incobotulinumtoxinA by unspecified interaction mechanism. Use Caution/Monitor.
- thiothixene
thiothixene increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.
- tobramycin inhaled
tobramycin inhaled increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- trifluoperazine
trifluoperazine increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.
Minor (9)
- acetazolamide
acetazolamide decreases effects of incobotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- amlodipine
amlodipine increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- nifedipine
nifedipine increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- nisoldipine
nisoldipine increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- primidone
primidone decreases effects of incobotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- rufinamide
rufinamide decreases effects of incobotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- sevoflurane
sevoflurane increases levels of incobotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown.
- tiagabine
tiagabine decreases effects of incobotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- topiramate
topiramate decreases effects of incobotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
Adverse Effects
>10%
Cervical dystonia
- Musculoskeletal and connective tissue disorders (23-32%)
- Dysphagia (13-18%)
- Nervous system disorders (16-17%)
- General disorders and administration site condition (11-16
- Neck pain (7-15%)
- Infections and infestations (13-14%)
- Respiratory, thoracic, and mediastinal disorders (10-13%)
- Muscular weakness (7-11%)
Blepharospasm
- Eyelid ptosis (19%)
- Dry eye (16%)
- Xerostomia (16%)
- Nervous system disorders (14%)
- Visual impairment, including blurred vision (12%)
- Respiratory, thoracic, and mediastinal disorders (11%)
1-10%
Chronic sialorrhea
- Tooth extraction (5%)
- Dry mouth (4%)
- Diarrhea (4%)
- Hypertension (4%)
- Fall (3%)
- Bronchitis (3%)
- Dysphonia (3%)
- Back pain (3%)
- Dry eye (3%)
Upper limb spasticity
- Seizure (3%)
- Nasopharyngitis (2%)
- Dry mouth (2%)
- Upper respiratory tract infection (2%)
Cervical dystonia
- Injection site pain (9%)
- Neck pain (7%)
- Muscular weakness (7%)
- Musculoskeletal pain (4-7%)
Blepharospasm
- Diarrhea (8%)
- Headache (7%)
- Dyspnea (5%)
- Nasopharyngitis (5%)
- Respiratory tract infection (5%)
Glabellar lines
- Headache (5.4%)
<1%
Glabellar lines
- General disorders and administration site conditions
- Injection site hematoma
- Injection site pain
- Facial pain
- Injection site swelling
- Sensation of pressure
- Eye disorders
- Eyelid edema
- Blepharospasm
- Eyelid ptosis
Postmarketing Reports
Allergic disorders: Hypersensitivity, eye swelling/edema, allergic dermatitis
Gastroenterology: Nausea
Body as a whole: Flu-like symptoms
Local reactions: Injection site pain, injection site reaction, localized allergic reactions (eg, swelling, edema, erythema, pruritus, rash)
Infection: Herpes zoster
Musculoskeletal: Muscular weakness, muscle spasm, myalgia
Neurologic: Dysarthria, dysphagia
Warnings
Black Box Warnings
Distant spread of toxin effect
- Botulinum toxin products may spread from injected area to produce symptoms consistent with botulinum toxin effects (eg, asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, respiratory distress)
- These symptoms have been reported hours to weeks after injection
Swallowing and breathing difficulties
- Can be life threatening and there have been reports of death
- Greatest risk in children treated for spasticity
- Can also occur in adults, particularly in those with underlying conditions that would predispose them to these symptoms (eg, peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders [myasthenia gravis, Lambert-Eaton syndrome])
Contraindications
Hypersensitivity
Infection at proposed injection site(s)
Cautions
Dose NOT interchangeable with other botulinum toxin products
Symptoms consistent with spread of toxin effect reported at doses comparable to or lower than doses used to treat cervical dystonia
Can cause swallowing and breathing difficulties, caution with compromised respiratory function or dysphagia
Concomitant neuromuscular disorders may exacerbate adverse effects
Serious hypersensitivity reactions reported with botulinum toxin products, including anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea; if serious and/or immediate hypersensitivity reactions occur, discontinue further injections and institute appropriate medical therapy immediately
Discontinue and immediately initiate medical therapy if hypersensitivity reaction occurs (eg, anaphylaxis, serum sickness, urticaria, edema, dyspnea)
This product contains albumin, a derivative of human blood; based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases; consider a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD)
Cervical dystonia
- Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia
- Limit dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia
Blepharospasm
- Injection into orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation
- Lower lid injections should not be repeated if diplopia occurred with previous botulinum toxin injections
- Ecchymosis easily occurs in the soft tissues of the eyelid
- Immediate gentle pressure at the injection site can limit that risk
Glabellar lines
- Risk of ptosis
- Do not exceed the recommended dosage and frequency of administration
- To reduce the complication of ptosis, avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes, and place corrugator injections at least 1 cm above the bony supraorbital ridge
Drug interaction overview
- Coadministration with aminoglycosides or other agents interfering with neuromuscular transmission (eg, tubocurarine-type muscle relaxants) may potentiate the effect of the toxin; use with caution
- Use of anticholinergic drugs after administration of incobotulinumtoxinA may potentiate systemic anticholinergic effects; effects of administering different botulinum toxin products at the same time or within several months of each other is unknown
- Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin
- Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of incobotulinumtoxinA
Pregnancy & Lactation
Pregnancy
There are no adequate data on the developmental risk associated with the use of incobotulinumtoxinA in pregnant women
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
Animal data
- IncobotulinumtoxinA was embryotoxic in rats and increased abortions in rabbits when given at doses higher than the maximum recommended human dose (MRHD) for cervical dystonia (120 units), on a body weight basis
Lactation
There are no data on the presence in human milk, the effects on the breastfed infant, or the effects on milk production
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
Blocks cholinergic transmission at the neuromuscular junction by inhibiting acetylcholine release from the peripheral cholinergic nerve endings
Pharmacokinetics
The return of increased muscle tone following injection typically occurs within 3-4 months
General characteristics of the active substance: It is not possible to detect incobotulinumtoxinA in the peripheral blood following IM or intraglandular injection at the recommended doses
Administration
IM Preparation and Dilution
Reconstitution
- Reconstitute each vial with sterile, preservative-free 0.9% NaCl
- Draw up an appropriate amount of 0.9% NaCl to result in desired units/0.1 mL (refer per prescribing information)
- Upper limb spasticity in children and adolescents: Based on selected dose, a reconstituted solution at a concentration between 1.25-5 units/0.1 mL is recommended (refer to prescribing information)
- Sialorrhea (adults): Concentration used in clinical trial was 5 units/0.1mL
- Sialorrhea (pediatrics): Concentration used in clinical trial was 2.5 units/0.1mL
- Gently inject 0.9% NaCl into vial
- If vacuum does not pull solvent into vial, then discard vial (vacuum seal compromised)
- Gently mix by rotating the vial (do not shake to prevent flocculation)
- Reconstituted solution should be clear, colorless, and free of particulate matter
- Do not use if reconstituted solution is cloudy or contains floccular or particulate matter
IM Administration
For IM injection or intra-salivary gland injection only
After reconstitution, use for only 1 injection session and for only 1 patient
If proposed injection sites are marked with a pen, product must not be injected through pen marks; otherwise a permanent tattooing effect may occur
Number of injection sites is dependent upon the size of the muscle to be treated and the volume of reconstituted incobotulinumtoxinA injected
Inject carefully when administration sites are close to sensitive structures (eg, carotid artery, lung apices, esophagus)
Chronic sialorrhea
- Adults or pediatrics: Use a sterile needle (eg, 27-30 gauge [0.30-0.40 mm diameter], 12.5 mm length) for intra-salivary gland administration
- Use ultrasound imaging to locate salivary glands
Upper limb spasticity
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Adults
- Use a sterile needle (eg, 26-gauge [0.45 mm diameter], 37 mm length for superficial muscles; or 22-gauge [0.70 mm diameter], 75 mm length for injections into deeper muscles) in the IM administration
- Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques may be useful
-
Children and adolescents
- Use a sterile needle (eg, 30-gauge (0.30 mm diameter), 25 mm length for superficial muscles; or 27-gauge (0.40 mm diameter), 37 mm length for deeper musculature) in IM administration
- Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques may be useful
Cervical dystonia
- Use a sterile needle (eg, 26-gauge [0.45 mm diameter], 37 mm length for superficial muscles; or 22-gauge [0.70 mm diameter], 75 mm length for injections into deeper muscles) in the IM administration
- Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques may be useful
Blepharospasm
- Use a suitable sterile needle (eg, 30-gauge [0.40 mm diameter], 12.5 mm length) in the intramuscular administration
Glabellar lines
- Use a sterile needle (eg, 30-33 gauge [0.3-0.2 mm diameter], 13 mm length) should be used in the IM administration
Monitoring to assess effectiveness
- Median first onset of incobotulinumtoxinA effect occurs within 7 days after injection
- Typical duration of effect of each treatment is up to 3 months; however, the effect may last significantly longer, or shorter, in individual patients
Storage
Unopened vials
- Unopened vials: Store at room temperature 20-25°C (68-77°F), in a refrigerator at 2-8°C (36-46°F), or a freezer at -20 to 10°C (-4 to 14°F); do not use after the expiration date on the vial
Reconstituted vials
- Refrigerate at 2-8°C (36-46°F) for up to 24 hr until time of use; discard any unused portion
Images
Patient Handout
incobotulinumtoxinA 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 last or get worse, 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 last or get worse, 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 December 2021. Copyright(c) 2023 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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