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IncobotulinumtoxinA (Xeomin): Drug information

IncobotulinumtoxinA (Xeomin): Drug information
(For additional information see "IncobotulinumtoxinA (Xeomin): Patient drug information" and see "IncobotulinumtoxinA (Xeomin): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Distant spread of toxin effects:

Postmarketing reports indicate that the effects of incobotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including lower limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.

Brand Names: US
  • Xeomin
Brand Names: Canada
  • Xeomin;
  • Xeomin Cosmetic
Pharmacologic Category
  • Neuromuscular Blocker Agent, Toxin;
  • Ophthalmic Agent, Toxin
Dosing: Adult
Blepharospasm

Blepharospasm: IM:

US labeling:

Treatment naive: Initial: 25 units per eye (50 units per treatment session); the number and location of subsequent injections may be changed in response to adverse reactions or response to treatment; maximum dose: 50 units per eye (100 units per treatment session). Administer repeat injections no more frequently than every 3 months.

Treatment experienced: Dose, response to treatment, duration of effect, and adverse events should be considered when determining dose for patients previously treated with a botulinum toxin A.

Canadian labeling: Initial: 1.25 to 2.5 units/injection site (maximum initial dose: 25 units/eye for treatment-naïve patients; 35 units/eye for patients previously receiving unknown dose). Titrate dose and interval for maximum patient benefit. Total dose should not exceed 100 units per treatment session. Administer no more frequently than every 3 months.

Cervical dystonia

Cervical dystonia: IM:

US labeling: Initial total dose: 120 units (in clinical trials, similar efficacy was noted with initial total doses of 120 and 240 units and between treatment experienced and treatment naïve patients). Dose and number of injection sites should be individualized based on prior treatment, response, duration of effect, adverse events, number/location of muscle(s) to be treated and disease severity. In clinical trials most patients received a total of 2 to 10 injections into treated muscles. Administer no more frequently than every 3 months. Maximum cumulative dose per treatment session: 400 units.

Canadian labeling: Usual total dose does not exceed 200 units (maximum: 300 units; maximum dose per injection site: 50 units); administer no more frequently than every 3 months.

Cosmetic uses

Cosmetic uses:

Reduction of forehead lines: (Xeomin Cosmetic [Canadian product]): IM: Inject 2 to 4 units into 5 horizontally aligned injection sites (at least 2 cm above the orbital rim) in the frontalis muscle for a total of 10 to 20 units; administer no more frequently than every 3 months.

Reduction of glabellar lines: IM: Inject 4 units into each of the 5 sites (2 injections in each corrugator muscle and 1 injection in the procerus muscle) for a total dose of 20 units per treatment session. Administer no more frequently than every 3 months.

Reduction of lateral canthus lines: (Xeomin Cosmetic [Canadian product]): IM:

3-point injection scheme : Inject 4 units into each of the 3 injection sites per eye (inject the first 4 units ~1 cm lateral from the bony orbital rim into the orbicularis oculi muscle and an additional 2 injections of 4 units each ~1 cm above and below the first injection) for a total of 12 units per side (24 units total).

4-point injection scheme : Inject 3 units into each of the 4 injection sites per eye (after marking the 1 cm lateral from the bony orbital rim, place the first two injections of 3 units each ~0.5 cm above and below this point; the second two injections of 3 units each should be placed ~1 cm above and below the first marked point) for a total of 12 units per side (24 units total).

Sialorrhea

Sialorrhea: Intraglandular: Inject 100 units divided between the parotid and submandibular glands on both sides (ie, 4 injection sites per treatment session); divide dose with a ratio of 3:2 between parotid and submandibular glands. Treatment may be repeated no sooner than every 16 weeks based on clinical need.

Spasticity, upper extremity

Spasticity, upper extremity: IM:

Initiate dosing at the low end of the dosing range and titrate as clinically indicated. Base dosage, frequency and number of injection sites on 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. Administer no more frequently than every 3 months. Maximum cumulative dose per treatment session: 400 units.

Clenched fist: Flexor digitorum superficialis or flexor digitorum profundus: 25 to 100 units divided into 2 injection sites.

Flexed wrist:

Flexor carpi radialis: 25 to 100 units divided into 1 to 2 injection sites.

Flexor carpi ulnaris: 20 to 100 units divided into 1 to 2 injection sites.

Flexed elbow:

Brachioradialis: 25 to 100 units divided into 1 to 3 injection sites.

Biceps: 50 to 200 units divided into 1 to 4 injection sites.

Brachialis: 25 to 100 units divided into 1 to 2 injection sites.

Pronated forearm:

Pronator quadratus: 10 to 50 units in 1 injection.

Pronator teres: 25 to 75 units divided into 1 to 2 injections.

Thumb-in-palm:

Flexor pollicis longus: 10 to 50 units in 1 injection.

Adductor pollicis: 5 to 30 units in 1 injection.

Flexor pollicis brevis/opponens pollicis: 5 to 30 units in 1 injection.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing. Initiate therapy at lowest recommended dose.

Dosing: Pediatric

(For additional information see "IncobotulinumtoxinA (Xeomin): Pediatric drug information")

Note: Potency units are specific to product and assay method utilized; do not interchange botulinum toxin products. The lowest recommended dose should be used when initiating treatment (regardless of indication); for any indication, the maximum cumulative dose is 400 units per treatment session.

Sialorrhea, chronic

Sialorrhea, chronic: Children ≥2 years weighing ≥12 kg and Adolescents: Intraglandular injection: See the following table for the weight-directed dose that is divided between the parotid and submandibular glands on both sides (ie, 4 injection sites per treatment session); divide dose with a ratio of 3:2 between parotid and submandibular glands. Treatment may be repeated no sooner than every 16 weeks based on clinical need.

Weight

Parotid gland

Administer dose shown on each side

Submandibular gland

Administer dose shown on each side

Total Dose

Both glands, both sides

12 to <15 kg

6 units

4 units

20 units

15 to <19 kg

9 units

6 units

30 units

19 to <23 kg

12 units

8 units

40 units

23 to <27 kg

15 units

10 units

50 units

27 to <30 kg

18 units

12 units

60 units

≥30 kg

22.5 units

15 units

75 units

Spasticity, upper extremity

Spasticity, upper extremity: Note: Individualize dose based on patient size, extent, and location of muscle involvement, degree of spasticity, local muscle weakness, and response to prior treatment.

Children ≥2 years and Adolescents ≤17 years: IM: Usual dose: See the following table for dose range for specific muscle group and maximum dose. If a single upper extremity being treated, the total dose should not exceed 8 units/kg divided among affected muscles up to a maximum of 200 units per single upper limb; if both upper limbs treated, total dose should not exceed 16 units/kg up to a maximum of 400 units. May repeat therapy when the therapeutic effect of previous treatment has diminished; generally, it should be no sooner than 12 weeks from previous injection; in trials, most patients re-treated between 12 and 14 weeks. Refer to prescribing information for specific diagrams of recommended injection sites.

Muscle

Dosage Range

Maximum Dose (units)

Number of Injection Sites Per Muscle

Adductor pollicis

0.5 units/kg

12.5

1

Biceps

2 to 3 units/kg

75

1 to 3

Brachialis

1 to 2 units/kg

50

1 to 2

Brachioradialis

1 to 2 units/kg

50

1 to 2

Flexor carpi radialis

1 unit/kg

25

1

Flexor carpi ulnaris

1 unit/kg

25

1

Flexor digitorum profundus

1 unit/kg

25

1

Flexor digitorum superficialis

1 unit/kg

25

1

Flexor pollicis brevis/Opponens pollicis

0.5 unit/kg

12.5

1

Flexor pollicis longus

1 unit/kg

25

1

Pronator quadratus

0.5 units/kg

12.5

1

Pronator teres

1 to 2 units/kg

50

1 to 2

Adolescents ≥18 years: IM: Up to 400 units divided among affected muscles. See the following table for dose range for specific muscle group and maximum dose. May repeat therapy when the therapeutic effect of previous treatment has diminished; generally, it should be no sooner than 12 weeks from previous injection; in trials, most patients re-treated between 12 and 14 weeks. Maximum total dose per treatment session: 400 units. Refer to prescribing information for specific diagrams of recommended injection sites.

Muscle

Dosage Range (divided)

Number of Injection Sites

Adductor pollicis

5 to 30 units

1

Biceps

50 to 200 units

1 to 4

Brachialis

25 to 100 units

1 to 2

Brachioradialis

25 to 100 units

1 to 3

Flexor carpi radialis

25 to 100 units

1 to 2

Flexor carpi ulnaris

20 to 100 units

1 to 2

Flexor digitorum profundus

25 to 100 units

2

Flexor digitorum superficialis

25 to 100 units

2

Flexor pollicis brevis/Opponens pollicis

5 to 30 units

1

Flexor pollicis longus

10 to 50 units

1

Pronator quadratus

10 to 50 units

1

Pronator teres

25 to 75 units

1 to 2

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As reported with adults, unless otherwise noted.

Upper limb spasticity and cervical dystonia:

>10%:

Gastrointestinal: Dysphagia (cervical dystonia: 13% to 18%)

Infection: Infection (cervical dystonia: 13% to 14%)

Nervous system: Myasthenia (cervical dystonia: 7% to 11%)

Neuromuscular & skeletal: Neck pain (cervical dystonia: 7% to 15%)

Respiratory: Respiratory system disorder (cervical dystonia: 10% to 13%)

1% to 10%:

Gastrointestinal: Xerostomia (upper limb spasticity: 2%)

Immunologic: Antibody development (neutralizing; cervical dystonia, upper limb spasticity: children, adolescents, and adults: ≤2%)

Local: Pain at injection site (cervical dystonia: 9%)

Nervous system: Seizure (upper limb spasticity: 3%)

Neuromuscular & skeletal: Limb pain (upper limb spasticity: children and adolescents: 2%), musculoskeletal pain (cervical dystonia: 4% to 7%)

Respiratory: Bronchitis (upper limb spasticity: children and adolescents: 2% to 3%), nasopharyngitis (upper limb spasticity: children, adolescents, and adults: 2% to 6%), pharyngitis (upper limb spasticity: children and adolescents: ≤2%), tonsillitis (upper limb spasticity: children and adolescents: ≤2%), upper respiratory tract infection (upper limb spasticity: children and adolescents: 2%), viral respiratory tract infection (upper limb spasticity: children and adolescents: 1% to 2%)

Blepharospasm, chronic sialorrhea, and glabellar lines:

>10%:

Gastrointestinal: Xerostomia (blepharospasm: 16%; chronic sialorrhea: 4%)

Ophthalmic: Blepharoptosis (blepharospasm: 16% to 19%; reduction of glabellar lines: <1%), dry eye syndrome (blepharospasm: 16%; chronic sialorrhea: 3%), visual disturbance (blepharospasm: 12%)

1% to 10%:

Cardiovascular: Hypertension (chronic sialorrhea: 4%)

Gastrointestinal: Diarrhea (blepharospasm, chronic sialorrhea: 4% to 8%), nausea and vomiting (chronic sialorrhea: children and adolescents: 1%), tooth loss (chronic sialorrhea: 5%)

Nervous system: Headache (blepharospasm: 7%; reduction of glabellar lines: 5%; chronic sialorrhea: children and adolescents: 1%), voice disorder (chronic sialorrhea: 3%)

Neuromuscular & skeletal: Back pain (chronic sialorrhea: 3%)

Respiratory: Bronchitis (chronic sialorrhea: children, adolescents, and adults: 1% to 3%), dyspnea (blepharospasm: 5%), nasopharyngitis (blepharospasm: 5%; chronic sialorrhea: children: 6%), respiratory tract infection (blepharospasm: 5%)

<1% (any indication):

Immunologic: Antibody development (neutralizing)

Local: Hematoma at injection site, pain at injection site

Nervous system: Facial pain, facial paresis

Ophthalmic: Blepharospasm, eye disease, eyelid edema

Postmarketing (any indication):

Cardiovascular: Edema

Dermatologic: Allergic dermatitis, ecchymoses (eyelid), erythema of skin, pruritus, skin rash, urticaria

Gastrointestinal: Nausea

Genitourinary: Urinary incontinence

Hypersensitivity: Anaphylaxis, local hypersensitivity reaction, hypersensitivity reaction, serum sickness

Infection: Herpes zoster infection

Local: Inflammation at injection site, injection site reaction

Nervous system: Dysarthria

Neuromuscular & skeletal: Asthenia, muscle spasm, myalgia

Ophthalmic: Blurred vision, diplopia, reduced blinking, swelling of eye

Respiratory: Flu-like symptoms, respiratory failure

Miscellaneous: Drug toxicity (botulinum toxin effects; observed beyond the site of local injection)

Contraindications

Hypersensitivity to botulinum toxin or any component of the formulation; infection at the proposed injection site(s).

Canadian labeling: Additional contraindications (not in US labeling): Generalized disorders of muscle activity (eg, myasthenia gravis, Lambert-Eaton syndrome); inflammation at the proposed injection site(s).

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Serious hypersensitivity (eg, serum sickness, urticaria, soft tissue edema, dyspnea) and anaphylactic reactions may occur; discontinue therapy immediately with signs/symptoms of hypersensitivity. Immediate medical treatment should be available.

• Antibody formation: Higher doses, more frequent administration and/or onset of disease at a younger age may result in neutralizing antibody formation and loss of efficacy.

• Cardiovascular events: Rarely, arrhythmia and myocardial infarction have been reported with use of another botulinum toxin product, sometimes in patients with preexisting cardiovascular disease.

• CNS depression: May impair ability to drive and/or operate machinery due to the intended effects of treatment; if loss of strength, muscle weakness, or impaired vision occur, patients should avoid driving or engaging in other hazardous activities.

• Dysphagia: Common when used for cervical dystonia; may occur within hours to weeks and persist for several months after administration. In severe cases, patients may require alternative feeding methods. Risk factors include smaller neck muscle mass and bilateral injections into the sternocleidomastoid muscle. Incidence of dysphagia may be reduced by limiting dose administered into sternocleidomastoid muscle.

• Hematologic: Use with caution in patients with bleeding disorders and/or receiving anticoagulation therapy.

• Systemic toxicity: [US Boxed Warning]: Distant spread of botulinum toxin beyond the site of injection has been reported; dysphagia and breathing difficulties have occurred and may be life threatening; other symptoms reported include blurred vision, diplopia, dysarthria, dysphonia, generalized muscle weakness, ptosis, and urinary incontinence which may develop within hours or weeks following injection. The risk is likely greatest in children treated for spasticity. Systemic effects have occurred following use in approved and unapproved uses, including low doses. Use caution in patients with underlying conditions which may predispose them to these symptoms. Immediate medical attention required if respiratory, speech, or swallowing difficulties appear.

Disease-related concerns:

• Neuromuscular disease: Avoid use in patients with myasthenia gravis (MG) (AAN [Narayanaswami 2021]); use with caution in patients with other neuromuscular diseases such as Lambert- Eaton syndrome. Use with caution in patients with peripheral motor neuropathic disease or amyotrophic lateral sclerosis. Risk of adverse events including severe dysphagia and respiratory compromise may be increased.

• Ocular diseases: Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure and ulceration when treating blepharospasm. Careful testing of corneal sensation, avoidance of lower lid injections to prevent ectropion, and treatment of epithelial defects are necessary. Therapeutic soft contact lenses, application of protective drops or ointment, or covering the affected eye may help. Gentle pressure at injection site may limit bruising of eyelid. Use caution in patients with angle-closure glaucoma.

• Respiratory disease: Use extreme caution in patients with pre-existing respiratory disease; treatment of cervical dystonia using botulinum toxin may weaken accessory muscles that are necessary for these patients to maintain adequate ventilation. Risk of aspiration resulting from severe dysphagia is increased in patients with decreased respiratory function.

Dosage form specific issues:

• Albumin: Product contains albumin and may carry a remote risk of virus transmission and variant Creutzfeldt-Jakob disease (vCJD). There also is a theoretical risk for transmission of CJD.

• Product interchangeability: Botulinum products (incobotulinumtoxinA, abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB) are not interchangeable; potency units are specific to each preparation and cannot be compared or converted to any other botulinum product.

Other warnings/precautions:

• Chronic therapy: Long-term effects of chronic therapy unknown.

• Injection site: Use with caution if there is excessive weakness or atrophy at the proposed injection site(s); use is contraindicated if infection is present.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intramuscular [preservative free]:

Xeomin: 50 units (1 ea); 100 units (1 ea); 200 units (1 ea) [latex free; contains albumin human]

Xeomin: 50 units (1 ea) [contains albumin human]

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Xeomin Intramuscular)

50 unit (per each): $312.00

100 unit (per each): $595.20

200 unit (per each): $1,190.40

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intramuscular:

Xeomin: 50 units (1 ea); 100 units (1 ea) [contains albumin human]

Xeomin Cosmetic: 100 units (1 ea) [contains albumin human]

Administration: Adult

IM: Note: Do not inject through pen marks (if proposed injection sites are marked with a pen); permanent tattooing effect may occur.

Blepharospasm: Use a 30-gauge (12.5 mm length) needle. Electromyography guidance is unnecessary. Avoid injecting near the levator palpebrae superioris (may decrease ptosis). Avoid medial lower lid injections (may decrease ectropion). Apply pressure at the injection site to prevent ecchymosis in the soft eyelid tissues.

Cervical dystonia and upper limb spasticity: Use a 26-gauge (37 mm length) needle for superficial muscles and a 22-gauge (75 mm length) needle for deeper musculature; electromyography, ultrasound, or nerve stimulation may help localize the involved muscles. When used for cervical dystonia, the Canadian labeling recommends avoiding administering bilateral injections or doses >100 units to the sternocleidomastoid muscle (increased risk of adverse events, particularly dysphagia).

Reduction of forehead lines (Xeomin Cosmetic [Canadian product]): Use a 30- to 33-gauge (13 mm length) needle. To reduce the brow ptosis, injections should be at least 2 cm above the orbital rim.

Reduction of glabellar lines: Use a 30- to 33-gauge (13 mm length) needle. To reduce ptosis, corrugator injections should be ≥1 cm above the bony supraorbital ridge and injections near the levator palpebrae superioris should be avoided.

Reduction of lateral canthal lines (Xeomin Cosmetic [Canadian product]): Use a 30- to 33-gauge (13 mm length) needle. To reduce lip ptosis, avoid injections too close to the zygomaticus major muscle.

Intraglandular: Sialorrhea: Use a 27- to 30-gauge, 12.5 mm length needle. Locate salivary glands using ultrasound imaging or surface anatomical landmarks (refer to manufacturer's labeling); administer close to the center of the gland.

Administration: Pediatric

Note: Should only be administered by individuals understanding the relevant neuromuscular anatomy and any alterations to the anatomy due to prior surgical procedures and standard electromyographic techniques. Local site reactions may be minimized by careful injection into the target muscle, using a minimal volume, and slowing the rate of injection.

Sialorrhea: Administer by injection into the parotid and submandibular glands on both sides (ie, 4 injections total). Use a 27- to 30-gauge, 12.5 mm length needle. Locate salivary glands using ultrasound imaging (refer to manufacturer's labeling); administer close to the center of the gland.

Spasticity: Administer IM; manufacturer suggests a 30-gauge (25 mm length) needle for superficial muscles and a longer 27-gauge (37 mm length) needle for deeper musculature; electromyography, nerve stimulation, or ultrasound may help localize the involved muscles.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Xeomin: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125360s097lbl.pdf#page=23

Use: Labeled Indications

US labeling:

Blepharospasm: Treatment of adults with blepharospasm.

Cervical dystonia: Treatment of adults with cervical dystonia.

Glabellar lines: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Sialorrhea: Treatment of chronic sialorrhea in patients ≥2 years of age.

Upper limb spasticity: Treatment of upper limb spasticity in adult patients and pediatric patients 2 to 17 years of age (excluding spasticity caused by cerebral palsy).

Canadian labeling:

Xeomin:

Cervical dystonia: Treatment of cervical dystonia (spasmodic torticollis) in adults.

Hypertonicity disorders: Treatment of hypertonicity disorders of the seventh nerve (eg, blepharospasm, hemifacial spasm) in adults.

Sialorrhea: Treatment of chronic sialorrhea associated with neurological disorders in adult patients and pediatric patients 2 to 17 years of age weighing ≥12 kg.

Upper limb spasticity: Treatment of spasticity of upper limb(s) in adults.

Xeomin Cosmetic:

Forehead lines: Temporary improvement in the appearance of moderate to severe horizontal forehead lines in adults.

Glabellar lines: Temporary improvement in the appearance of moderate to severe glabellar lines in adults.

Lateral canthal lines: Temporary improvement in the appearance of moderate to severe lateral canthal lines in adults.

Medication Safety Issues
Other safety concerns:

Botulinum products are not interchangeable; potency differences may exist between the products.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminoglycosides: May enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Risk C: Monitor therapy

Anticholinergic Agents: Botulinum Toxin-Containing Products may enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Botulinum Toxin-Containing Products: May enhance the neuromuscular-blocking effect of other Botulinum Toxin-Containing Products. Risk C: Monitor therapy

Muscle Relaxants (Centrally Acting): May enhance the adverse/toxic effect of Botulinum Toxin-Containing Products. Specifically, the risk for increased muscle weakness may be enhanced. Risk C: Monitor therapy

Neuromuscular-Blocking Agents: Botulinum Toxin-Containing Products may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies.

Because data related to the use of botulinum toxins for indications such as cervical dystonia and cosmetic procedures during pregnancy are limited, use is generally avoided (Contarino 2017; Garg 2022; Morgan 2006, Trivedi 2017).

Breastfeeding Considerations

It is not known if incobotulinumtoxinA is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Mechanism of Action

IncobotulinumtoxinA is a neurotoxin produced from Clostridium botulinum that inhibits acetylcholine release from peripheral cholinergic nerve endings. Inhibition occurs sequentially via binding and internalization of the neurotoxin into presynaptic cholinergic nerve terminals, translocation to the nerve terminal cytosol, and enzymatic cleavage of SNAP25, a protein necessary for acetylcholine release. Inhibition of acetylcholine release at the neuromuscular junction produces a state of denervation. Muscle inactivation persists until new fibrils grow from the nerve and form junction plates on new areas of the muscle-cell walls.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action (improvement): ~4 to 7 days

Duration: ~3 to 4 months

Absorption: Not expected to be present in peripheral blood at recommended doses following IM injection

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Xeomin;
  • (AR) Argentina: Xeomin;
  • (AT) Austria: Bocouture | Xeomin;
  • (AU) Australia: Xeomin;
  • (BE) Belgium: Bocouture | Xeomeen;
  • (BG) Bulgaria: Bocouture | Xeomin;
  • (BR) Brazil: Xeomin;
  • (CH) Switzerland: Bocouture | Xeomin;
  • (CL) Chile: Xeomin;
  • (CO) Colombia: Xeomin;
  • (CZ) Czech Republic: Bocouture | Xeomin;
  • (DE) Germany: Bocouture | Xeomin;
  • (DO) Dominican Republic: Xeomin;
  • (EC) Ecuador: Xeomin;
  • (EE) Estonia: Bocouture | Xeomin;
  • (ES) Spain: Bocouture | Xeomin;
  • (FI) Finland: Bocouture | Xeomin;
  • (FR) France: Bocouture | Xeomin;
  • (GB) United Kingdom: Bocouture;
  • (GR) Greece: Bocouture;
  • (HK) Hong Kong: Xeomin;
  • (HU) Hungary: Xeomin;
  • (ID) Indonesia: Xeomin;
  • (IE) Ireland: Xeomin;
  • (IN) India: Xeomin;
  • (IT) Italy: Xeomin;
  • (LT) Lithuania: Xeomin;
  • (LU) Luxembourg: Bocouture | Xeomin;
  • (LV) Latvia: Bocouture | Xeomin;
  • (MX) Mexico: Xeomeen;
  • (MY) Malaysia: Xeomin;
  • (NL) Netherlands: Bocouture | Xeomin;
  • (NO) Norway: Bocouture | Xeomin;
  • (NZ) New Zealand: Xeomin;
  • (PE) Peru: Xeomeen;
  • (PL) Poland: Bocouture | Xeomin;
  • (PR) Puerto Rico: Xeomin;
  • (PT) Portugal: Bocouture | Xeomin;
  • (PY) Paraguay: Xeomin;
  • (RO) Romania: Bocouture | Xeomin;
  • (RU) Russian Federation: Xeomin;
  • (SA) Saudi Arabia: Xeomin;
  • (SE) Sweden: Bocouture | Xeomin;
  • (SG) Singapore: Xeomin;
  • (SI) Slovenia: Bocouture | Xeomin;
  • (SK) Slovakia: Bocouture | Xeomin;
  • (TW) Taiwan: Xeomin;
  • (UA) Ukraine: Xeomin;
  • (UY) Uruguay: Xeomin;
  • (ZA) South Africa: Xeomin
  1. Benecke R, Jost WH, Kanovsky P, et al. A New Botulinum Toxin Type A Free of Complexing Proteins for Treatment of Dystonia. Neurology. 2005;64(11):1949-1951. [PubMed 15955951]
  2. Contarino MF, Van Den Dool J, Balash Y, et al. Clinical practice: evidence-based recommendations for the treatment of cervical dystonia with botulinum toxin. Front Neurol. 2017;8:35. doi:10.3389/fneur.2017.00035 [PubMed 28286494]
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Topic 15586 Version 171.0

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