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Kalbitor (Ecallantide): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
10 mg/mL
Active ingredient:

Patient information: uses, side effects, how to take - Kalbitor

What is KALBITOR?

KALBITOR is a prescription medicine used to treat sudden attacks of hereditary angioedema (HAE) in people 12 years of age and older.

KALBITOR is not a cure for HAE.

It is not known if KALBITOR is safe and effective in children under 12 years of age.

Who should not receive KALBITOR?

Do not receive KALBITOR if you are allergic to KALBITOR.

What should I tell my doctor before I receive KALBITOR?

Before receiving KALBITOR, tell your doctor if you:

  • have ever had an allergic reaction to KALBITOR. See "Who should not receive KALBITOR?"
  • are pregnant or plan to become pregnant. It is not known if KALBITOR will harm your unborn baby.

  • are breast-feeding or plan to breast-feed. It is not known if KALBITOR passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

How will I receive KALBITOR?

For each dose, you will receive 3 injections just under the skin (subcutaneous or SC injections) of your abdomen, thigh, or upper arm.

What are the possible side effects?

KALBITOR can cause serious allergic reactions. See "What is the most important information I should know about KALBITOR?"

Common side effects of KALBITOR include:

  • headache
  • nausea
  • diarrhea
  • fever
  • injection site reactions, such as redness, rash, swelling, itching, or bruising
  • stuffy nose

Call your doctor for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about KALBITOR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide gives you the most important information about KALBITOR. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about KALBITOR that is written for health professionals.

What are the ingredients of KALBITOR?

Active Ingredient: ecallantide

Inactive ingredients: disodium hydrogen orthophosphate (dihydrate), monopotassium phosphate, potassium chloride, sodium chloride in water for injection.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

For more information, visit www.kalbitor.com or call 1-877-TAKEDA-7 (1-877-825-3327).

Manufactured by:

Takeda Pharmaceuticals U.S.A., Inc.

Cambridge, MA 02142

U.S. License No. 1898

KALBITOR and the KALBITOR Logo are registered trademarks of Dyax Corp.

Takeda and are registered trademarks of Takeda Pharmaceutical Company Limited.

© 2025 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.

Revised: 6/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 125277 · View the label on DailyMed

Revision date stated in the text: June 2025

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Kalbitor

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Plasma Kallikrein Inhibitor
Active ingredient Ecallantide 10 mg/mL
Dosage form Injection, solution
Route Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) DYAX CORP.
FDA approval BLA 125277Biologics License Application (BLA) Approved December 1, 2009
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
10 mg/mL – 1 ml in 1 vial, glass / 3 in 1 carton NDC 47783-101-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.