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Prescription medicine

Ecallantide

Brand names: Kalbitor

Drug class: Plasma Kallikrein Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
1Recalls (FDA reports)
1Companies
2009First FDA approval on file

Quick answers

What is Ecallantide used for?
The FDA-approved label (Kalbitor, Takeda Pharmaceuticals America, Inc., July 1, 2025) says: “KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ecallantide have a boxed warning?
Yes. The FDA label for Kalbitor has a boxed warning (“WARNING: ANAPHYLAXIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Ecallantide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ecallantide been recalled?
FDA enforcement reports list 1 recall of products of this medicine; the newest started March 17, 2017 (Class II). A recall usually concerns specific lots, not every product.
Who makes Ecallantide?
1 company lists prescription products of Ecallantide in the FDA NDC Directory, including Takeda Pharmaceuticals America, Inc..

What Ecallantide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.

— FDA label: Kalbitor, Takeda Pharmaceuticals America, Inc., effective July 1, 2025. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: ANAPHYLAXIS. Read it on the full label →

Forms and how it is given

Dosage formsInjection, solution
RouteSubcutaneous
Prescription products1 in the FDA NDC Directory
Brand namesKalbitor

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
BLA125277
KALBITOR		 Dyax Corp.December 1, 2009 7, latest December 28, 2020
2020: Labeling · 2014: Labeling · 2014: Efficacy

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. March 17, 2017 · Class II · Terminated · D-0625-2017

    Presence of Particulate Matter: Glass

    Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01 — Shire

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)884698, 884702
SPL set ID of the quoted labelf56aec67-c662-477c-b866-bfc23e8809cf
FDA labels (SPL)1
FDA applicationsBLA125277
Active ingredients (FDA)ECALLANTIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Kalbitor, Takeda Pharmaceuticals America, Inc., effective July 1, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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