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Drug updated on 5/17/2024

Dosage FormInjection (subcutaneous; 150 mg/1 mL [150 mg/ml] in a single-dose prefilled syringe, 300 mg/2 mL [150 mg/mL] in a single-dose prefilled syringe, 300 mg/2 mL [150 mg/mL] in a single-dose vial)
Drug ClassPlasma kallikrein inhibitors
Ongoing and
Completed Studies


  • Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) attacks in adult and pediatric patients 2 years and older.

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  • Lanadelumab-flyo (Takhzyro) is indicated for the prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients aged 2 years and older. It has been found to be more effective than berotralstat in preventing HAE attacks, demonstrating statistically significantly higher effectiveness.
  • The analysis is based on three systematic reviews/meta-analyses that focused on the safety, effectiveness, population types, and subgroup considerations of Takhzyro compared to other drugs used for the prevention of HAE attacks.
  • While no direct comparison regarding safety profiles was made in these studies, it is highlighted that treatments for HAE, including Takhzyro, minimize the risk of death but are not curative. Understanding efficacy, route, and timing of administration is crucial, though specific comparative data were not provided.
  • The studies primarily involved individuals with Type I and II HAE; however, there was no information provided about Type III or direct subgroup analyses. This indicates a need for further research into diverse populations.
  • In addition to reducing the frequency of attacks, Takhzyro also increases the quality of life compared with placebo while decreasing the severity of breakthroughs when they occur, indicating dual benefits that enhance the overall well-being of patients.
  • Takhzyro shows a high level of effectiveness in preventing HAE attacks, notably higher than berotralstat in indirect comparison. The safety profile appears in line with other therapeutic options, with no increased risk of serious adverse events reported. However, this conclusion is drawn from indirect comparisons and individual drug assessments rather than head-to-head clinical trials, suggesting a cautious interpretation of superiority claims until robust data become available.

Product Monograph / Prescribing Information

Document TitleYearSource
Takhzyro (Lanadelumab-flyo) Prescribing Information.2023Takeda Pharmaceuticals U.S.A. Inc., Lexington, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines