Molecule
Human c1-esterase inhibitor is a human C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE). MedsAcross supplies Human c1-esterase inhibitor 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.
CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE). CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients (6 years of age and older) with Hereditary Angioedema (HAE).
Source: US FDA prescribing information
C1 inhibitor is a normal constituent of human blood and is one of the serine proteinase inhibitors (serpins). The primary function of C1 inhibitor is to regulate the activation of the complement and intrinsic coagulation (contact system) pathway. C1 inhibitor also regulates the fibrinolytic system. Regulation of these systems is performed through the formation of complexes between the proteinases and the inhibitor, resulting in inactivation of both and consumption of the C1 inhibitor. HAE patients have low levels of endogenous or functional C1 inhibitor. Although the events that induce attacks of angioedema in HAE patients are not well defined, it is thought by some that increased vascular permeability and the clinical manifestation of HAE attacks are primarily mediated through contact system activation.
Source: US FDA prescribing information
For intravenous use only. For Intravenous Use Only Prior to reconstitution, protect from light. A silicone-free syringe is recommended. Store at 36°F to 77°F (2°C to 25°C). Do not freeze. To obtain a 500 International Units (IU) CINRYZE dose, reconstitute one CINRYZE vial with one vial of Sterile Water for Injection, USP (5 mL). To obtain a 1,000 IU CINRYZE dose, reconstitute two CINRYZE vials with two vials of Sterile Water for Injection, USP (5 mL each). Use aseptic sterile technique. Administer at room temperature within 3 hours of reconstitution. Routine Prophylaxis Dosing.
Source: US FDA prescribing information
CINRYZE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product. Patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product.
Source: US FDA prescribing information
Hypersensitivity reactions may occur. Have epinephrine immediately available for treatment of acute severe hypersensitivity reaction. Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of C1 esterase inhibitor (human) products, including CINRYZE, following administration in patients with HAE. Risk factors may include presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives, certain androgens, morbid obesity, and immobility. Benefits of CINRYZE for routine prophylaxis of HAE attacks should be weighed against the risks of TE events in patients with underlying risk factors. Monitor patients with known risk factors for TE events during and after CINRYZE administration.
Source: US FDA prescribing information
The most common adverse reactions (≥5%) observed were headache, nausea, rash, vomiting, and fever.
Source: US FDA prescribing information
Store the vial in the original carton to protect it from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Human c1-esterase inhibitor, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human) kit | CSL Behring | US FDA | Available on request |
| Berinert kit | CSL Behring | US FDA | Available on request |
| Cinryze kit | Takeda Pharmaceuticals | US FDA | Available on request |
| Cinryze 500 IU/5 mL powder for injectionIntravenous | Takeda Pharmaceuticals | US FDA | Available on request |
3 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | Not recorded | — |
| 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 4 presentations of Human c1-esterase inhibitor and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Human c1-esterase inhibitor, including Berinert, Cinryze, HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human).
No listed presentation of Human c1-esterase inhibitor is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.