Prescription medicine
Human immunoglobulin g Brand names: Bivigam, Asceniv, Qivigy
Human immunoglobulin g (Asceniv) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the human immunoglobulin g FDA label on DailyMed (effective February 2, 2026); every human immunoglobulin g label on DailyMed.
Highlights of the record
FDA label of February 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE.
Thrombosis may occur with immune globulin products, including QIVIGY. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors [see Warnings and Precautions (5.2) ]. Renal dysfunction, acute renal failure, osmotic nephrosis may occur with immune globulin intravenous (IGIV) products in predisposed patients. Such events require immediate medical intervention, if not recognized or managed appropriately, may result in persistent or significant disability or incapacity or lead to fatal outcome. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs [see Warnings and Precautions (5.3) ]. For patients at risk of thrombosis, renal dysfunction or failure, administer QIVIGY at the minimum dose available and the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. […]
Used for
From the label: indications and usageQIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for the treatment of adults with Primary Humoral Immunodeficiency (PI).
Forms and strengths
- 5 g/50ml
- 10 g/100ml
Injection (solution); liquid.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 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)
- No recall recorded
- FAERS reports
- 20,363 through July 30, 2026
What is human immunoglobulin g used for?
From the label: indications and usageQIVIGY (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. QIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for treatment of adults with primary humoral immunodeficiency (PI).
FDA pharmacologic class: Human Immunoglobulin G.
Source: FDA drug label (QIVIGY kthm), Kedrion S.p.A., effective February 2, 2026 (SPL set 6f1933e0-240f-48f4-b246-8a30e63a4160), via openFDA; the full label on DailyMed
Is there a generic for human immunoglobulin g (Asceniv)?
No generic human immunoglobulin g is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the human immunoglobulin g label say about other medicines?
The human immunoglobulin g label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | warnings and precautions | Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions. |
Source: FDA drug label (QIVIGY kthm), Kedrion S.p.A., effective February 2, 2026 (SPL set 6f1933e0-240f-48f4-b246-8a30e63a4160), via openFDA; the full label on DailyMed
What do FAERS reports show for human immunoglobulin g?
The FDA Adverse Event Reporting System holds 20,363 reports that list human immunoglobulin g among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,729 are coded as a death and 7,768 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 human immunoglobulin gs
- the pharmacologic class, with prices and generics
- Human immunoglobulin g side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other