Quick answers
- What is C1 esterase inhibitor recombinant used for?
- The FDA-approved label (Ruconest, Pharming Healthcare Inc., April 30, 2020) says: “RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks. RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does C1 esterase inhibitor recombinant have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of C1 esterase inhibitor recombinant?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has C1 esterase inhibitor recombinant been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes C1 esterase inhibitor recombinant?
- 1 company lists prescription products of C1 esterase inhibitor recombinant in the FDA NDC Directory, including Pharming Healthcare Inc..
What C1 esterase inhibitor recombinant is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks. RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). …
— FDA label: Ruconest, Pharming Healthcare Inc., effective April 30, 2020. 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.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Ruconest |
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.
- Pharming Healthcare Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125495 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1599836, 1599841 |
|---|---|
| SPL set ID of the quoted label | 66d3fecb-32a4-7781-e053-2a91aa0a83ca |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125495 |
| Active ingredients (FDA) | CONESTAT ALFA |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ruconest, Pharming Healthcare Inc., effective April 30, 2020; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →