abobotulinumtoxinA

onabotulinumtoxinA (Toxin type A)

Botox, Botox Cosmetic, Vistabel (UK), Xeomin (UK)

abobotulinumtoxinA (Toxin type A)

Dysport

incobotulinumtoxinA (Toxin type A)

Xeomin

rimabotulinumtoxinB (Toxin type B)

Myobloc, NeuroBloc (UK)

Pharmacologic class: Neurotoxin

Therapeutic class: Neuromuscular blocker

Pregnancy risk category C

Toxin type A (onabotulinumtoxinA)

Toxin types A and B (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotu-linumtoxinB)

Toxin type A (onabotulinumtoxinA) when administered for eye disorders

Toxin type A (abobotulinumtoxinA)

Toxin type B (rimabotulinumtoxinB)

FDA Box Warning

• Postmarketing reports indicate that the effects of 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, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These signs and symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and deaths have occurred.

• The risk of signs and symptoms is probably greatest in children treated for spasticity, but signs and symptoms can also occur in adults treated for spasticity and other conditions, particularly in patients who have underlying conditions that would predispose them to these symptoms.

• In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at dosages comparable to those used to treat cervical dystonia and at lower dosages.

Action

Blocks neuromuscular transmission by binding to receptor sites on motor nerve terminals and inhibiting acetylcholine release, thereby causing localized muscle denervation. As a result, local muscle paralysis occurs, which leads to muscle atrophy and reinnervation due to development of new acetylcholine receptors.

Availability

Toxin type A-(onabotulinumtoxinA)

Powder for injection: 100 units/vial

Toxin type A-abobotulinumtoxinA

Freeze-dried powder for injection: 300 units/vial, 500 units/vial

Toxin type A-(incobotulinumtoxinA)

Powder for injection, lyophilized: 50 units in single-use vials, 100 units in single-use vials

Toxin type B-(rimabotulinumtoxinB)

Solution for injection: 5,000-units/ml vial

Indications and dosages

Toxin type A (onabotulinumtoxinA)

Temporary improvement in appearance of moderate to severe glabellar lines associated with corruga-tor or procerus muscle activity

Adults ages 65 and younger: Botox cosmetic only-Total of 20 units (0.5-ml solution) injected I.M. as divided doses of 0.1 ml into each of five sites: two in each corrugator muscle and one in procerus muscle. Injection usually needs to be repeated q 3 to 4 months to maintain effect. Dysport-50 units I.M. in five equal aliquots of 10 units each to achieve clinical effect

Xeomin-Or, 20 units per treatment session divided into five equal I.M. injections of 4 units each.

Treatment of blepharospasm in patients previously treated with onabotulinumtoxinA (Botox)

Adults: Xeomin-When initiating therapy, base dose, number, and location of injections on the previous dosing of onabotulinumtoxinA (Botox). If previous dose of Botox isn't known, the recommended starting dose is 1.25 to 2.5 units per injection site.

Upper limb spasticity

Adults: Botox-75 to 360 units I.M. divided among selected muscles at a given treatment session. Dose can be repeated no sooner than 12 weeks after the previous injection.

Prophylaxis of headaches in patients with chronic migraine (15 or more days per month with headache lasting 4 hours a day or longer)

Adults: Botox-155 units as 0.1-ml (5 units) injections per each site divided across seven head and neck muscles

Severe axillary hyperhidrosis inadequately managed by topical agents

Adults: Botox-50 units per axilla injected into defined hyperhidrotic area

Blepharospasm

Adults: 1.25 to 2.5 units injected into medial and lateral pretarsal orbicularis oculi of upper eyelid and lateral pretarsal orbicularis oculi of lower eyelid

Strabismus

Adults: 1.25 to 5 units injected into eyelid (dosage varies with strabismus severity). Dose can be repeated in 7 to 14 days if patient has adequate response; with inadequate response, dosage may be doubled.

Toxin types A and B (onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotu-linumtoxinB)

Treatment of cervical dystonia to decrease severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients

Adults: Xeomin-120 units injected I.M. into affected muscles per treatment session.

To relax skeletal muscles and reduce severity of abnormal head position and neck pain associated with cervical dystonia

Adults: Botox-Usual dosage is 236 units injected I.M. locally into affected muscles. Dosage ranges from 198 to 300 units. Dysport-500 units I.M. as a divided dose among affected muscles in patients with or without a history of prior treatment with botulinum toxin.

Myobloc-2,500 to 5,000 units I.M. injected locally into affected muscles.

Contraindications

• Hypersensitivity to drug or its components

• Allergy to cow's-milk protein (Dysport)

• Acute urinary tract infection or acute urinary retention (Botox intradetrusor injections)

• Active infection at injection site

Precautions

Use cautiously in:

• cardiovascular disease, peripheral neuropathy, neuromuscular disorders, compromised respiratory function, dysphagia

• inflammation at injection site, injections near vulnerable anatomical structures

• pregnant or breastfeeding patient

• children younger than age 12; children younger than age 18 (Dysport, Xeomin)

Administration

• Be aware that only trained professional medical personnel should inject this drug.

• Be aware that botulinum toxin products aren't interchangeable.

Toxin type A (onabotulinumtoxinA) when administered for eye disorders

• Reconstitute by slowly injecting preservative-free normal saline solution into drug vial.

• Rotate vial gently to mix drug; then draw up at least 20 units (0.5-ml solution) and expel air bubbles.

• Remove needle used for reconstitution, and attach 30G needle. Then inject drug as divided doses of 0.1 ml into each of five sites (two in each corruga-tor muscle, one in procerus muscle).

• Prepare eye with several drops of local anesthetic and ocular decongestant, as prescribed, several minutes before injection for blepharospasm or strabismus.

• When administering for upper limb spasticity, dilute with preservative-free normal saline solution to 200 units/4 ml or 100 units/2 ml. Then, using a 25G to 30G needle for superficial muscles and a longer 22G needle for deeper musculature, inject no more than 50 units per site.

Toxin type A (abobotulinumtoxinA)

• Reconstitute each 300-unit vial with 0.6 ml preservative-free normal saline solution and each 500-unit vial with 1 ml preservative-free normal saline solution.

• Swirl vial gently to mix drug.

• Remove needle used for reconstitution. Use a 23G to 25G needle for administration. Then inject 10 units into each of five sites (two in each corrugator muscle and one in the procerus muscle).

• Use within 4 hours of reconstitution.

Toxin type B (rimabotulinumtoxinB)

• Draw up prescribed dose from preservative-free, 3.5-ml single-use vial.

• Don't shake vial.

• Divide prescribed dose and inject locally into affected muscles.

Adverse reactions

CNS: headache, dizziness

CV: hypertension, arrhythmias, myocardial infarction (MI)

EENT: blepharoptosis, conjunctivitis, keratitis, eye dryness, double vision, tearing, increased sensitivity to light, sinusitis, pharyngitis

GI: nausea, dyspepsia, difficulty swallowing

Musculoskeletal: back pain, neck pain, muscle weakness

Respiratory: pneumonia, bronchitis, upper respiratory tract infection

Skin: skin tightness, ecchymosis

Other: tooth disorder, injection site redness, edema, or pain, flulike symptoms, facial muscle paralysis, infection, anaphylaxis

Interactions

Drug-drug. Aminoglycosides, anticholinesterase compounds, clindamycin, lincomycin, magnesium sulfate, other neuromuscular blockers (such as succinylcholine), polymyxin B, quinidine: increased risk of adverse effects

Patient monitoring

• Stay alert for signs and symptoms of anaphylaxis, particularly after first dose.

• Monitor vital signs and ECG, watching for evidence of hypertension, arrhythmias, and MI.

• Assess effect of drug on affected muscles; check for paralysis.

Be aware that spread of toxin effects may lead to swallowing and breathing difficulties and death. Provide immediate medical attention if respiratory, speech, or swallowing difficulties occur.

• Monitor temperature. Watch for signs and symptoms of respiratory and EENT infections as well as flulike symptoms.

Patient teaching

Instruct patient to seek immediate medical attention if respiratory, speech, or swallowing difficulties occur.

• Teach patient about desired effect of injection. Advise patient to report paralysis.

• Instruct patient to report signs and symptoms of infection, particularly flulike illness and EENT and respiratory infections.

• Inform patient being treated for ble-pharospasm (uncontrollable blinking) that he may experience transient eyelid drooping, corneal inflammation, double vision, dry eyes, tearing, and light sensitivity.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

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.
References in periodicals archive ?
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).
Information for healthcare professionals: OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc).
Prospective randomised controlled trial comparing trigone-sparing versus trigone-including intradetrusor injection of abobotulinumtoxinA for refractory idiopathic detrusor overactivity.
51] AbobotulinumtoxinA is usually injected at a dose level of 500 U.
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.
Approximately two-thirds of participants said they favored the side of their faces that was treated with abobotulinumtoxinA.
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.