Section 09 · Monograph

IncobotulinumtoxinA

Reviewed Nov 2026FDA label

XeominNeurotoxin · injectable

Black Box Warning

DISTANT SPREAD OF TOXIN EFFECT: The effects of Xeomin and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects, including asthenia, generalized muscle weakness, diplopia, 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 related to spread of toxin effect.
The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults, particularly those with underlying conditions that predispose them to these symptoms.

Upper limb spasticity in adults.FDA-labeled
Upper limb spasticity in pediatric patients 2-17 years of age — as of a June 26, 2026 FDA label update, this indication now includes spasticity due to cerebral palsy (previously excluded).FDA-labeled
Chronic sialorrhea in patients ≥2 years of age.FDA-labeled
Cervical dystonia in adults.FDA-labeled
Blepharospasm in adults (in patients previously treated with onabotulinumtoxinA).FDA-labeled
Temporary improvement in the appearance of moderate to severe glabellar lines, horizontal forehead lines, and lateral canthal lines (upper facial lines) in adults.FDA-labeled

Lower limb spasticity (adult) — commonly used clinically though FDA labeling is specific to upper limb spasticity.Off-label
Post-stroke hemiplegic shoulder pain.Off-label
Focal dystonias other than cervical dystonia and blepharospasm.Off-label

IncobotulinumtoxinA is a purified botulinum toxin type A, formulated without the accessory/complexing proteins present in some other botulinum toxin products (the 150-kDa neurotoxin itself, without hemagglutinin/non-hemagglutinin complexing proteins).
Blocks cholinergic transmission at the neuromuscular junction (and neuroglandular junction, relevant to its sialorrhea indication) by inhibiting the calcium-dependent release of acetylcholine from presynaptic nerve terminals via cleavage of SNAP-25.
Produces temporary, reversible chemodenervation of the injected muscle(s)/gland(s), reducing excessive muscle tone (spasticity) or glandular secretion (sialorrhea).

NOT INTERCHANGEABLE with other botulinum toxin products (onabotulinumtoxinA/Botox, abobotulinumtoxinA/Dysport, rimabotulinumtoxinB/Myobloc) — Xeomin Units are specific to this preparation and cannot be converted to any other botulinum toxin product using a standard ratio.
Adult upper limb spasticity: individualized dosing by muscle group and pattern of spasticity; total dose per session up to 400 Units, divided among affected muscles; minimum 12-week interval between treatment sessions.
Cervical dystonia: total dose individualized (typically 120-240 Units divided among affected neck muscles); re-treatment no sooner than every 12 weeks.
Reconstitute lyophilized powder with preservative-free 0.9% sodium chloride injection per labeling; administer promptly after reconstitution.
Median onset of effect within about 4-7 days; typical duration of clinical effect up to approximately 12 weeks.

Pediatric upper limb spasticity (2-17 years): weight-based dosing individualized by muscle and severity; minimum 12-week re-treatment interval.
Chronic sialorrhea: 100 Units total, divided as 30 Units into each parotid gland and 20 Units into each submandibular gland (adults); pediatric dosing is weight-tiered per labeling; minimum 16-week interval between treatments for sialorrhea.

Known hypersensitivity to botulinum neurotoxin type A preparations or any component of the formulation (Xeomin is free of complexing/accessory proteins but the neurotoxin itself can still trigger hypersensitivity).
Infection at the proposed injection site(s).

Aminoglycosides and other agents interfering with neuromuscular transmission may potentiate the toxin's effect.
Anticholinergic drugs may potentiate systemic anticholinergic effects.
Muscle relaxants may exacerbate weakness when combined with botulinum toxin therapy.
Concomitant administration with other botulinum toxin products is not recommended; effects of using different botulinum toxin products concurrently or within several months of each other are unknown and may increase risk of excessive weakness/spread of effect.

Upper limb spasticity (adults): most common include nasopharyngitis, muscular weakness, dizziness, arthralgia, seizure (reported in stroke population), fall.
Pediatric upper limb spasticity: nasopharyngitis, upper respiratory infection, injection-site pain, cough, muscular weakness.
Chronic sialorrhea: dry mouth, dysphagia, dental caries, diarrhea, toothache.
Cervical dystonia: dysphagia, neck pain, musculoskeletal pain, muscular weakness, headache.
Blepharospasm: eyelid ptosis, dry eye, vision blurred.
Class effects: dysphagia (risk of aspiration), injection-site reactions, hypersensitivity reactions (rare), development of neutralizing antibodies with repeat dosing.

Monitor for signs/symptoms of distant spread of toxin effect, especially in pediatric spasticity patients and patients with pre-existing neuromuscular disease.
Monitor respiratory status in patients with compromised pulmonary function or dysphagia at baseline.
Reassess muscle tone/spasticity pattern and adverse effects before each re-treatment; do not exceed maximum recommended dose or re-treat sooner than the minimum labeled interval.
Watch for reduced clinical response over time, which may indicate neutralizing antibody formation.
Check injection site for active infection before each treatment session.

Pregnancy: No adequate human data. Xeomin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies showed embryotoxic/fetotoxic effects at higher, maternally toxic doses.
Lactation: No data on presence in human milk, effects on the breastfed infant, or on milk production.