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TAKHZYRO

lanadelumab-flyo · Solution

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
TAKHZYRO
Generic name
lanadelumab-flyo
Dosage form
Solution
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
Takeda Pharmaceuticals America, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
52% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Lanadelumab 150 mg/mL — —
Lanadelumab 300 mg/2mL — —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Subcutaneous
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Kallikrein Inhibitors [MoA] MoA 3 members — no class page
Plasma Kallikrein Inhibitor [EPC] EPC 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
761090
Application type
BLA · Biologics License Application
Approval date
August 23, 2018
Sponsor
DYAX CORP.
Products on application
2
Submissions recorded
5
Products approved under application 761090.
Product Trade name Form Strength Ingredient Status TE Flags
761090-001 TAKHZYRO SOLUTION LANADELUMAB-FLYO Prescription —
761090-002 TAKHZYRO SOLUTION LANADELUMAB-FLYO Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 761090.
Type No. Action Status Date Review
Supplement 20 Labeling Approved August 20, 2026 Standard
Supplement 10 Efficacy Approved February 3, 2023 Priority
Supplement 3 Manufacturing (CMC) Approved February 8, 2022 N/A
Supplement 1 Labeling Approved November 16, 2018 Standard
Original application 1 Type 1 - New Molecular Entity Approved August 23, 2018 Priority

Review documents

  • 0 · Supplement · August 25, 2026
  • 0 · Supplement · August 21, 2026
  • 0 · Supplement · February 7, 2023
  • 0 · Supplement · February 6, 2023
  • 0 · Supplement · June 1, 2022
  • 0 · Supplement · November 20, 2018
  • 0 · Supplement · November 20, 2018
  • 0 · Original application · September 20, 2018
  • 0 · Original application · September 18, 2018
  • 0 · Original application · August 24, 2018

Adverse event reports

Source: openFDA FAERS
3,165
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LANADELUMAB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
47783-645-01 47783-645 Takeda Pharmaceuticals America, Inc. 1 SYRINGE, GLASS in 1 CARTON (47783-645-01) / 1 mL in 1 SYRINGE, GLASS February 3, 2023
47783-646-01 47783-646 Takeda Pharmaceuticals America, Inc. 1 SYRINGE, GLASS in 1 CARTON (47783-646-01) / 2 mL in 1 SYRINGE, GLASS February 8, 2022
47783-645 47783-645 Takeda Pharmaceuticals America, Inc. — February 3, 2023
47783-646 47783-646 Takeda Pharmaceuticals America, Inc. — February 8, 2022

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 9 sections on this page.