incobotulinumtoxinA

incobotulinumtoxinA

(in-koe-bot-ue-li-num-tox-in-A) ,

Xeomin

(trade name)

Classification

Therapeutic: antispasticity agents
Pharmacologic: neurotoxins
Pregnancy Category: C

Indications

Treatment of cervical dystonia in adults.Treatment of blepharospasm in adults who had prior treatment with onabotulinumtoxinA.Temporary improvement of moderate to severe glabellar (frown) lines in adults.

Action

Inhibits release of acetylcholine from peripheral cholinergic nerve endings, resulting chemical denervation of treated muscle.

Therapeutic effects

Localized reduction of muscle activity, with decrease in spasticity, abnormal head position and neck pain related to cervical dystonia.
Decreased appearance of blepharospasm or glabellar lines.

Pharmacokinetics

Absorption: Minimal but may be significant in selected populations.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (improvement in spasticity/appearance of lines)

ROUTEONSETPEAKDURATION
IMwithin 1 wk†unknownup to 4 mo
†For blepharospasm, may be up to 4 wk for other indications.

Contraindications/Precautions

Contraindicated in: Hypersensitivity to botulinum toxin products or additives ; Infection at injection site.
Use Cautiously in: Previous surgical facial alterations, marked facial asymmetry, known weakness/atrophy of muscle in question, inflammation or skin abnormality at injection site, ptosis; Compromised respiratory function or dysphagia; Peripheral motor neuropathic disorders (may exacerbate clinical effects and ↑ the risk of severe dysphagia and respiratory compromise); Hyperhydrosis (safety not established); Blepharospasm—if diplopia occurs, lower lid injection should not be repeated); Cervical dystonia— patients with smaller neck muscle mass and those requiring bilateral sternocledomastoid injections (↑ risk of dysphagia, smaller doses may be necessary); Glabellar lines—ptosis may occur; Geriatric: Use cautiously; consider concurrent diseases and drug therapy; Obstetric: Use in pregnancy only if potential benefit justifies potential risk to fetus; Pediatric: Safety and effectiveness has not been established.

Adverse Reactions/Side Effects

Blepharospasm

Central nervous system

  • headache (most frequent)

Ear, Eye, Nose, Throat

  • ptosis (most frequent)
  • dry eye (most frequent)
  • impaired vision (most frequent)
  • nasopharyngitis (most frequent)
  • ↓ blinking
  • corneal exposure/ulceration
  • diplopia

Gastrointestinal

  • diarrhea (most frequent)
  • dry mouth (most frequent)
  • dyspepsia (most frequent)

Miscellaneous

  • allergic reactions, including anaphylaxis
  • spread of toxin effect (life-threatening)
  • flu-like symptoms

Cervical dsytonia

Gastrointestinal

  • dysphagia (most frequent)

Local

  • injection site pain (most frequent)

Musculoskeletal

  • muscle weakness (most frequent)
  • musculoskeletal pain (most frequent)
  • neck pain (most frequent)

Miscellaneous

  • allergic reactions, including anaphylaxis
  • spread of toxin effect (life-threatening)
  • flu-like symptoms

Glabellar lines

Central nervous system

  • headache (most frequent)

Local

  • injection site pain/reaction

Miscellaneous

  • allergic reactions, including anaphylaxis
  • spread of toxin effect (life-threatening)
  • flu-like symptoms

Interactions

Drug-Drug interaction

Concurrent use of aminoglycosides, or agents interfering with neuromuscular transmission including curare-like agents or muscle relaxants may ↑ effect. Concurrent use of anticholinergics ↑ systemic anticholinergic effects.

Route/Dosage

Note: Doses are NOT interchangeable with other botulinumtoxin products.

Blepharospasm

Intramuscular (Adults) Dose, number of injections and location is based on previous dosing of onabotulinumtoxinA (Botox), if this is unknown then initial dose is 1.25–2.5 Units/site; (mean dose is 5.6 Units/injection site, 6 injections/eye).

Cervical dystonia

Intramuscular (Adults) 120 Units total/treatment session; dose, number and location based on number and location of involved sites.

Glabellar lines

Intramuscular (Adults) 20 Units/session consisting of 5 injections (2 in each corrugator muscle, one in the procerus muscle) of 4 units apiece. Not to be repeated more frquently than every 3 mo.

Availability

Lyophilized powder for local injection (requires reconstitution): 50 Units/vial, 100 Units/vial

Nursing implications

Nursing assessment

  • Assess effects of injection. Effects occur within 7 days and usually last up to 3 mo; may be longer or shorter in each individual.
  • Assess for signs of anaphylactic reaction (dyspnea, rash, pruritus, laryngeal edema, wheezing) following administration. Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction.
  • Monitor for asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. Medication may spread from the injection site to distant parts of the body.

Potential Nursing Diagnoses

Disturbed body image (Indications)
Impaired physical mobility (Indications)

Implementation

  • Clinicians administering incobotulinumtoxinA should understand neuromuscular anatomy of the area involved and potential alterations.
    • Botulinum toxin products are not interchangeable. Determine appropriate product prior to administration.
    • Injections should be made no more frequently than every 3 mo and using the lowest effective dose.
  • Reconstitute vial with 0.9% NaCl without preservatives according to package insert. Gently inject diluent slowly into vial. Discard vial if vacuum does not pull diluent into vial. Rotate vial gently and record date and time of reconstitution on label. Solution should be clear, colorless, and free of particulate matter. Refrigerate solution and use within 24 hr of reconstitution; do not freeze. Discard unused solution. Unopened vials should be stored in refrigerator.
  • Intramuscular: Follow specific dose and administration recommendations for each indication.

Patient/Family Teaching

  • Review Medication Guide with patient prior to each administration.
  • Inform patient that the material has the potential to spread from the injection site to distant parts of the body. May occur within hrs or several wks after injection. Advise patient or caregiver to notify health care professional immediately if swallowing, speech, or respiratory disorders arise.
  • May cause loss of strength, muscle weakness, blurred vision, or drooping eyelids. Caution patient to avoid driving or other activities requiring alertness and dexterity until response to injection is known.
  • Advise sedentary or previously immobile patients to gradually resume activities after injection for cervical dystonia or blephrospasm.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • ↓ brow furrow.
  • ↓ muscle tone in upper limbs.
  • ↓ severity of abnormal head position and neck pain.
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References in periodicals archive ?
The sBLA is based on a Phase III randomized, double-blind, placebo-controlled, multicenter 184 subject trial, which met both of its co-primary endpoints for subjects administered 100 U incobotulinumtoxinA by achieving statistically significant change in unstimulated salivary flow rate, and in the subjects' Global Impression of Change Scale.
He typically injects a medium dose of one of three neuromodulators--such as 6-10 U of onabotulinumtoxinA (Botox), 6-10 U of incobotulinumtoxinA (Xeomin) or 14-18 U of abobotulinumtoxinA (Dysport).