abobotulinumtoxinA

abobotulinumtoxinA

(ab-oh-bot-yoo-lye-num tox-in ay) ,

Dysport

(trade name)

Classification

Therapeutic: antispasticity agents
Pharmacologic: neurotoxins
Pregnancy Category: C

Indications

Treatment of cervical dystonia in adults in order to decrease severity of abnormal head position and neck pain.Temporary improvement of moderate to severe glabellar (frown) lines in adult patients <65 yr.

Action

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

Therapeutic effects

Localized reduction of muscle activity, with decreased spasticity in cervical dystonia.
Decreased appearance of 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 4 wkunknownup to 4 mo

Contraindications/Precautions

Contraindicated in: Hypersensitivity to botulinum toxin products or additives ; Allergy to cow's-milk protein ; 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; Peripheral motor neuropathic disorders (may exacerbate clinical effects and ↑ the risk of severe dysphagia and respiratory compromise); Hyperhydrosis (safety not established); Geriatric: Use cautiously; consider concurrent diseases and drug therapy; Obstetric: Use only if potential benefit justifies potential risk to the fetus; Pediatric: Safety and effectiveness has not been established.

Adverse Reactions/Side Effects

Cervical dsytonia

Central nervous system

  • fatigue (most frequent)
  • headache (most frequent)

Ear, Eye, Nose, Throat

  • dysphonia (most frequent)
  • eye disorder (most frequent)

Gastrointestinal

  • dry mouth (most frequent)
  • dysphagia (most frequent)

Local

  • injection site pain (most frequent)

Musculoskeletal

  • muscular weakness (most frequent)
  • neck pain (most frequent)

Miscellaneous

  • spread of toxin effect (life-threatening)

Glabellar lines

Central nervous system

  • headache, (most frequent)

Ear, Eye, Nose, Throat

  • nasopharyngitis (most frequent)
  • eyelid edema
  • eyelid ptosis
  • sinusitus (most frequent)

Respiratory

  • nasopharyngitis (most frequent)
  • dyspnea

Gastrointestinal

  • nausea (most frequent)
  • dysphagia

Local

  • injection site pain/reaction (most frequent)

Miscellaneous

  • spread of toxin effect (life-threatening)

Interactions

Drug-Drug interaction

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

Route/Dosage

Cervical dystonia

Intramuscular (Adults) 500 Units as a divided dose among affected muscles; may be repeated every 12–16 wk, based on return of symptoms (range 250 and 1000 Units). Increments may be made in 250 Unit steps according to response.

Glabellar lines

Intramuscular (Adults <65 yr) 50 Units, divided in five equal aliquots of 10 Units; may be repeated every 3 mo.

Availability

Freeze dried powder for reconstitution: 500 Unit/vial, 300 Unit/vial

Nursing implications

Nursing assessment

  • Assess heart rate in patients with history of heart disease. May cause a slight (3 beats per minute) reduction in heart rate 30 min following injection.
  • Cervical Dystonia: Assess amount of spasticity prior to and following therapy.
  • Glabellar Lines: Assess level of glabellar lines prior to and following therapy.
  • Lab Test Considerations: May cause slight ↑ of blood glucose.

Potential Nursing Diagnoses

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

Implementation

  • The potency Units of abobotulinumtoxinA are not interchangeable with other botulinum toxin products.
  • Cervical Dystonia
  • Intramuscular: Reconstitute each single-use 500 mg vial with 1 mL or 300 mg vial with 0.6 mL of 0.9% NaCl without preservatives. Concentration: 500 mg/mL or 250 mg/mL, respectively. Swirl gently to dissolve. Solution should be clear and colorless; do not administer solutions that are discolored or contain particulate matter. Refrigerate solution and protect from light; do not freeze. Administer into affected muscles within 4 hrs using a 23 or 25 gauge needle. Discard remaining solution.
  • Glabellar Lines
  • Intramuscular: Reconstitute each 300 mg vial with 2.5 mL or 1.5 mL of 0.9% NaCl without preservatives. Concentration: 10 Units/0.8 mL or 10 Units/0.5 mL, respectively. Using a 21 gauge needle, insert at a 45° angle into abobotulinumtoxinA vial and allow the vacuum to pull 0.9% NaCl into vial. Discard vial if vacuum has been lost. Gently rotate until white substance is fully dissolved; do not shake. Solution should be clear and colorless; do not administer solutions that are discolored or contain particulate matter. Solution is stable for 4 hrs if refrigerated and protected from light; do not freeze. Draw up single dose and expel any air bubbles in syringe barrel. Exchange needle for a 30 gauge needle for administration. Administer 5 equally divided aliquots of 10 Units each into 5 sites (2 in each corrugator muscle, 1 in procerus muscle).

Patient/Family Teaching

  • Inform patient of purpose of abotulinumtoxinA. Advise patient to read Patient Medication Guide prior to treatment.
  • Inform patient that effects of abotulinumtoxinA may spread beyond the site of local injection. Advise patient to notify health care professional immediately if problems swallowing, speaking, or breathing occur or if signs and symptoms of spread (asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysarthria, urinary incontinence, breathing difficulties) occur. May occur hrs to wks after injection.
  • May cause loss of strength, muscle weakness, blurred vision, or drooping eyelids. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Localized reduction of muscle activity, with decreased spasticity in cervical dystonia.
  • Decreased appearance of glabellar lines.
Mentioned in ?
References in periodicals archive ?
51] AbobotulinumtoxinA is usually injected at a dose level of 500 U.
Prospective randomised controlled trial comparing trigone-sparing versus trigone-including intradetrusor injection of abobotulinumtoxinA for refractory idiopathic detrusor overactivity.
The second type, abobotulinumtoxinA received approval for the same indication in 2009.
Ninety patients were given injections of onabotulinumtoxinA and of abobotulinumtoxinA on either side of their faces.
According to the researchers, the difference between the two agents was significant when participants contracted the muscles as much as possible, with abobotulinumtoxinA producing a greater effect.
an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), today announced results from a Phase III study (NCT01249417) evaluating the investigational use of abobotulinumtoxinA (Dysport[sup.
This global, multicenter, double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of abobotulinumtoxinA (ABO) versus placebo on the mean change from baseline in ankle joint hypertonicity in 241 children with cerebral palsy.
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DYSPORT([R]) is differentiated from other marketed botulinum toxin products with the unique name abobotulinumtoxinA.
Ipsen's abobotulinumtoxinA approved simultaneously for the treatment of cervical dystonia and glabellar lines under a single trade name, DYSPORT(TM)
Additionally, DYSPORT(TM) is differentiated from other marketed botulinum toxin products with the unique established name abobotulinumtoxinA.
Do not take XEOMIN if you: are allergic to XEOMIN or any of the ingredients in XEOMIN; had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myobloc), onabotulinumtoxinA (Botox, Botox Cosmetic), or abobotulinumtoxinA (Dysport(TM)); have a skin infection at the planned injection site.