Lanadelumab-flyo

(Takhzyro®)

Lanadelumab-flyo

Drug updated on 9/4/2024

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
ClinicalTrials.gov

Indication

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

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • Takhzyro (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Lanadelumab (300 mg every 2 or 4 weeks) demonstrated statistically significant effectiveness over berotralstat (150 mg or 110 mg once daily) in reducing hereditary angioedema (HAE) attack rates per 28 days and achieving a ≥90% reduction in monthly HAE attacks.
  • All drugs except avoralstat were effective in reducing the number of HAE attacks compared to placebo, with lanadelumab and various forms of C1-INH notably effective in reducing the severity of breakthrough attacks. Quality of life improvements were observed for avoralstat, berotralstat, C1-INH (all forms), and lanadelumab compared to placebo.
  • The findings apply to individuals with Type I and II HAE, with no data available for Type III HAE. The effectiveness of lanadelumab and C1-INH in reducing the severity of breakthrough attacks was highlighted, but data on other drugs for this outcome were lacking.
  • In the systematic review, adverse events, including serious adverse events, occurred at rates comparable to placebo for all drugs studied (avoralstat, berotralstat, subcutaneous C1-INH, plasma-derived C1-INH, nanofiltered C1-INH, recombinant human C1-INH, danazol, and lanadelumab). Specific serious adverse events included hepatic dysfunction, hepatic toxicity, and deleterious changes in blood tests; however, data for danazol were insufficient for conclusive safety assessment.
  • No deaths were reported in any of the studies included in the systematic review.
  • There is no population type or subgroup information available in the reviewed studies.

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