Prescription medicine
Ecallantide Brand names: Kalbitor
Ecallantide (Kalbitor) is a prescription medicine with an FDA approval on record since 2009. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ecallantide FDA label on DailyMed (effective July 1, 2025, Takeda Pharmaceuticals America, Inc.); the BLA 125277 record on Drugs@FDA; every ecallantide label on DailyMed.
Highlights of the record
FDA label of July 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ANAPHYLAXIS Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR. [ see Contraindications (4), Warnings and Precautions (5.1), and Adverse Reactions (6) ] WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning Anaphylaxis has been reported after administration of KALBITOR ® . Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR [ see Contraindications (4), Warnings and Precautions (5.1), and Adverse Reactions (6) ].
Used for
From the label: indications and usageKALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
Forms and strengths
- 10 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- December 1, 2009 Kalbitor, Dyax Corp.; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2017 0 Class I among all firms' recalls; latest March 17, 2017
- FAERS reports
- 1,861 through July 30, 2026
What is ecallantide used for?
From the label: indications and usageKALBITOR ® (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 pharmacologic class: Plasma Kallikrein Inhibitor.
Source: FDA drug label (Kalbitor), BLA125277 (Dyax Corp.), as published by Takeda Pharmaceuticals America, Inc., effective July 1, 2025 (SPL set f56aec67-c662-477c-b866-bfc23e8809cf), via openFDA; the full label on DailyMed
What does the patient leaflet for ecallantide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information that I should know about KALBITOR?Serious allergic reactions may happen in some people who receive KALBITOR. These allergic reactions can be life-threatening and usually happen within 1 hour after receiving KALBITOR. KALBITOR should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions and hereditary angioedema (HAE) can be treated. Symptoms of a serious allergic reaction to KALBITOR can be similar to the symptoms of HAE, the condition that you are being treated for. Your doctor or nurse should watch you for any signs of a serious allergic reaction after treatment with KALBITOR. Tell your doctor or nurse right away if you have any of these symptoms of a serious allergic reaction during or after treatment with KALBITOR: wheezing, shortness of breath, cough, chest tightness, or trouble breathing dizziness, fainting, fast or weak heartbeat, or feeling nervous reddening of the face, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing runny nose, nasal congestion, or sneezing
Source: FDA drug label (Kalbitor), BLA125277 (Dyax Corp.), as published by Takeda Pharmaceuticals America, Inc., effective July 1, 2025 (SPL set f56aec67-c662-477c-b866-bfc23e8809cf), via openFDA; the full label on DailyMed
Is there a generic for ecallantide (Kalbitor)?
No generic ecallantide is approved (Drugs@FDA, October 8, 2026).
- 2009 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has ecallantide been recalled?
The FDA's Enforcement Report lists 1 recall naming ecallantide since 2017: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 17, 2017 | Class II | Shire | Presence of Particulate Matter: Glass |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for ecallantide?
The FDA Adverse Event Reporting System holds 1,861 reports that list ecallantide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 34 are coded as a death and 778 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other plasma kallikrein inhibitors
- the pharmacologic class, with prices and generics
- Ecallantide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other