incobotulinumtoxinA (Rx)

Brand and Other Names:Xeomin
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Dosing & Uses

AdultPediatric

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
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Interactions

Interaction Checker

and incobotulinumtoxinA

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            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.

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              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

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              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
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              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.

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              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

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              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

              • 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
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              Images

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              Patient Handout

              Patient Education
              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 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.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.