Molecule
Ecallantide is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. It is available as injection for subcutaneous use. MedsAcross supplies Ecallantide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Hereditary angioedema (HAE) is a rare genetic disorder caused by mutations to C1-esterase-inhibitor (C1-INH) located on Chromosome 11q and inherited as an autosomal dominant trait. HAE is characterized by low levels of C1-INH activity and low levels of C4. C1-INH functions to regulate the activation of the complement and intrinsic coagulation (contact system pathway) and is a major endogenous inhibitor of plasma kallikrein. The kallikrein-kinin system is a complex proteolytic cascade involved in the initiation of both inflammatory and coagulation pathways. One critical aspect of this pathway is the conversion of High Molecular Weight (HMW) kininogen to bradykinin by the protease plasma kallikrein. In HAE, normal regulation of plasma kallikrein activity and the classical complement cascade is therefore not present.
Source: US FDA prescribing information
30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. If an attack persists, an additional dose of 30 mg may be administered within a 24 hour period. KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema.
Source: US FDA prescribing information
Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR.
Source: US FDA prescribing information
Boxed warning (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. Hypersensitivity Reactions Including Anaphylaxis: Anaphylaxis has occurred in 4% of treated patients. Administer KALBITOR in a setting equipped to manage anaphylaxis and hereditary angioedema. Given the similarity in hypersensitivity symptoms and acute HAE symptoms, monitor patients closely for hypersensitivity reactions.
Source: US FDA prescribing information
Hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR. The most common adverse reactions occurring in ≥3% of KALBITOR-treated patients and greater than placebo are headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis.
Source: US FDA prescribing information
No formal drug interactions studies were performed. No in vitro metabolism studies were performed.
Source: US FDA prescribing information
KALBITOR should be kept refrigerated (2°C to 8°C/36°F to 46°F). Vials removed from refrigeration should be stored below 86°F/30°C and used within 14 days or returned to refrigeration until use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Ecallantide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Kalbitor 10 mg/1 mL injectionSubcutaneous Cold chain | Takeda Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 1 December 2009 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Ecallantide and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ecallantide, including Kalbitor.
Yes. The US FDA first approved Ecallantide on 1 December 2009, according to Drugs@FDA.
At least one listed presentation of Ecallantide must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Ecallantide is classified under ATC code B06AC03 (Ecallantide).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.