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

  •  Aminoglycosides  or other  agents interfering with neuromuscular transmission, including  muscle relaxants, may ↑ effect.
  •  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 signs of the spread of toxin effects (asthenia, general muscle weakness, diplopia, ptosis, dysphagia, dysphonia, urinary incontinence, dyspnea). Pre-existing motor neuropathic or neuromuscular disorders ↑ risk of generalized muscle weakness.  If difficulties with swallowing, speech, or respiration occur,  immediately stop injections and provide appropriate medical care.
  • 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 ≥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 cm 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 one injection session. Discard unused solution. Draw ≥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 midline of procerus muscle, for total dose of 20 units.

Patient/Family Teaching

  • Explain purpose and effects of  Jeuveau  to patient.
  • Inform patient that effects of prabotulinumtoxinA may spread beyond the site of local injection. Advise patient to notify health care provider 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 hours to weeks after injection.
  • 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 that  Jeuveau  may cause eye dryness. Advise patient to notify health care provider if symptoms of eye dryness (eye pain, eye irritation, photosensitivity, changes in vision) occur.
  • Rep:  Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Decreased appearance of glabellar (frown) lines.