Quick answers
- What is Human immunoglobulin g used for?
- The FDA-approved label (QIVIGY kthm, Kedrion S.p.A., February 2, 2026) says: “QIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for the treatment of adults with Primary Humoral Immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Human immunoglobulin g have a boxed warning?
- Yes. The FDA label for QIVIGY kthm has a boxed warning (“WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Human immunoglobulin g?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Human immunoglobulin g been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Human immunoglobulin g?
- 2 companies list prescription products of Human immunoglobulin g in the FDA NDC Directory, including ADMA Biologics, Inc. and Kedrion S.p.A..
What Human immunoglobulin g is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
QIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for the treatment of adults with Primary Humoral Immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. …
— FDA label: QIVIGY kthm, Kedrion S.p.A., effective February 2, 2026. 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.
This label has a boxed warning. Its heading: WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution · Liquid |
|---|---|
| Route | Intravenous |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Bivigam, Qivigy Kthm, Asceniv |
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.
- ADMA Biologics, Inc.3 products
- Kedrion S.p.A.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
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) | 2726016, 2726023, 2726025, 2726026 |
|---|---|
| SPL set ID of the quoted label | 6f1933e0-240f-48f4-b246-8a30e63a4160 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125389, BLA125590, BLA125822 |
| Active ingredients (FDA) | HUMAN IMMUNOGLOBULIN G |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — QIVIGY kthm, Kedrion S.p.A., effective February 2, 2026; 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 →