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Jeuveau

PRABOTULINUM TOXIN TYPE A

Manufacturer: Evolus, Inc.

Score: 144.0

Quick Summary

Jeuveau is a botulinum toxin type A indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. It works by blocking neuromuscular transmission, resulting in a localized reduction in muscle activity. The recommended dose is 20 Units, administered as 0.1 mL (4 Units) intramuscular injections into each of five sites. Important safety information includes the risk of distant spread of toxin effect, which can cause swallowing and breathing difficulties, and contraindications such as hypersensitivity to any botulinum toxin preparation or infection at the injection site. Special population considerations include use in pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Temporary improvement in the appearance of moderate to severe glabellar lines
  • Associated with corrugator and/or procerus muscle activity in adult patients

Important Safety Information

Warning

Distant spread of toxin effect can cause swallowing and breathing difficulties, which can be life-threatening

Contraindications

  • Hypersensitivity to any botulinum toxin preparation
  • Infection at the injection site

Adverse Reactions

  • Headache
  • Eyelid ptosis
  • Upper respiratory tract infection
  • Increased white blood cell count

Dosing Recommendations

General Guidance

Retreatment should be administered no more frequently than every three months

Glabellar lines

Adult Dose

20 Units, administered as 0.1 mL (4 Units) intramuscular injections into each of five sites

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Limited available data are insufficient to inform a drug-associated risk of adverse developmental outcomes

Nursing Mothers

  • No information available

Pediatric Use

  • Safety and effectiveness have not been established

Geriatric Use

  • No differences in safety or efficacy were observed between older and younger subjects, but clinical studies did not include sufficient numbers of subjects aged 65 and over

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