prabotulinumtoxina

General

Pronunciation:
pra-bot-ue-lye-numtox-inay


Trade Name(s)

  • Jeuveau

Ther. Class.

cosmetic agents

Pharm. Class.

neurotoxins

Indications

Temporary improvement of moderate to severe glabellar (frown) lines.

Action

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

Therapeutic Effect(s):

Decreased appearance of glabellar lines.

Pharmacokinetics

Absorption: Minimal systemic absorption.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: Unknown.

TIME/ACTION PROFILE (improvement in appearance of glabellar lines)

ROUTEONSETPEAKDURATION
IMwithin 4 wkunknownup to 3 mo

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity to botulinum toxin products or additives
  • Infection at injection site.

Use Cautiously in:

  • Previous surgical facial alterations, marked facial asymmetry, ptosis, known weakness/atrophy of muscle in question, or inflammation/skin abnormality at injection site
  • Atrophy of muscle in question or inflammation or skin abnormality at injection site
  • Cardiovascular disease
  • Peripheral motor neuropathic disorders (may exacerbate clinical effects and ↑ the risk of severe dysphagia and respiratory compromise)
  • Swallowing or breathing difficulties (may exacerbate underlying condition)
  • OB:   Use during pregnancy only if potential maternal benefit justifies potential fetal risk
  • Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
  • Pedi:   Safety and effectiveness not established in children.

Adverse Reactions/Side Effects

CV: MI, ARRHYTHMIA

EENT: blurred vision, diplopia, drooping eyelid, dry eye, dysphonia

GI: dysphagia

GU: urinary incontinence

MS: muscle weakness

Neuro: headache, dysarthria

Resp: dyspnea

Misc: hypersensitivity reactions (including anaphylaxis), SPREAD OF TOXIN EFFECT

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

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

Route/Dosage

PrabotulinumtoxinA is not interchangeable with other botulinum toxin products.

IM (Adults): 20 units, divided in five equal aliquots of 4 units; may be repeated every 3 mo.

Availability

Lyophilized powder for injection: 100 units/vial

Assessment

  • Monitor for asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. Medication may spread from injection site to distant parts of the body.
  • Assess for signs of hypersensitivity reaction (dyspnea, rash, pruritus, laryngeal edema, wheezing), dysphagia, and breathing difficulties following administration. Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction.

Implementation

  • 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.
  • To reduce complication of eyelid ptosis: avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes; place lateral corrugator injections at least 1 cm above the bony supraorbital ridge; ensure injected volume/dose is accurate and kept to a minimum; and avoid injecting toxin closer than 1 centimeter above the central eyebrow.
  • IM Reconstitute each vial slowly with 2.5 mL of 0.9% NaCl for a concentration of 4 units/0.1 mL. Discard the vial if a vacuum does not pull the diluent into the vial. Rotate vial to mix. Solution is clear and colorless; do not administer solution that are cloudy, discolored, or contain particulate matter. Solution is stable for up to 24 hr if refrigerated and protected from light. Do not freeze. Use vial for only 1 injection session. Discard unused solution. Draw at least 0.5 mL of reconstituted toxin into syringe and expel any air bubbles in syringe barrel. Remove needle and attach a 30-33 gauge needle. Confirm patency of needle. Inject 0.1 mL (4 Units) IM into each of five sites: inferomedial and superior middle of each corrugator, and one in mid-line of procerus muscle, for total dose of 20 Units.

Patient/Family Teaching

  • Explain purpose and effects of  Jeuveau  to patient.
  • Advise patient to inform health care professional if any unusual symptoms (including difficulty with swallowing, speaking or breathing) occur, or if any known symptom persists or worsens.
  • May cause loss of strength, muscle weakness, blurred vision, or drooping eyelids. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Inform patients  Jeuveau  may cause eye dryness. Advise patient to notify health care professional if symptoms of eye dryness (eye pain, eye irritation, photosensitivity, changes in vision) occur.
  • Inform patient that injection may to spread from injection site to distant parts of the body. May occur within hrs or several wks after injection. Advise patient to notify health care professional immediately if swallowing, speech, or respiratory disorders arise.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Decreased appearance of glabellar (frown) lines.