Kedrion’s distribution model is designed to provide broad access across specialty pharmacies, infusion centers, hospitals, and other sites of care nationwide, ensuring consistent supply and scalable reach as demand for IVIG therapies continues to grow.
Approved by the U.S. Food and Drug Administration in late 2025, QIVIGY represents a significant milestone for Kedrion as its first fully proprietary IVIG. The therapy was developed, manufactured, and released through the company’s integrated global network, reflecting more than a decade of scientific research and manufacturing investment and reinforcing long term product consistency, quality, and supply reliability.
To prepare for commercialization, Kedrion’s focus turned to building a distribution infrastructure capable of supporting diverse care settings across the U.S. The company established a broad distribution model supported by experienced specialty distributors and aligned group purchasing organizations, providing the commercial foundation needed for efficient ordering, dependable supply, and long-term scalability.
The distribution strategy includes leading specialty distributors CuraScript SD; Cencora, Inc.; Cardinal Health, Inc; McKesson Plasma and Biologics; and BioCare, Inc., as well as our exclusive Group Purchasing Organization (GPO) relationships across both acute and nonacute care environments—Premier, Inc. and Premier Innovatix. These pathways are designed to support streamlined onboarding and adoption across hospitals, infusion centers, specialty pharmacies, and other sites of care, while maintaining flexibility as market needs evolve.
Beyond distribution, the availability of QIVIGY reflects Kedrion’s fully integrated international manufacturing network and strategy to expand access to high quality plasma derived therapies worldwide. This integrated approach supports rigorous quality standards and reliability for healthcare providers and the patients they serve.
“QIVIGY’s nationwide availability is a defining moment for our company and for patients with Primary humoral immunodeficiency,” added Bob Rossilli, Chief Commercial Officer of Kedrion. “QIVIGY strengthens our U.S. immunoglobulin portfolio and reinforces our commitment to providing customers and patients with broad access, dependable supply, and the infrastructure needed to support consistent care delivery.”
IMPORTANT SAFETY INFORMATION
QIVIGY (immune globulin intravenous, human-kthm) is a 10% immune globulin (Ig) liquid indicated for the treatment of adults with primary humoral immunodeficiency. QIVIGY may cause:
Blood clots (thrombosis) may occur in people taking Ig intravenous (IGIV) products, including QIVIGY.
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.
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. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Do NOT use QIVIGY if:
You have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA deficient patients with antibodies against IgA and history of hypersensitivity. WARNINGS AND PRECAUTIONS
Severe hypersensitive reactions, including anaphylaxis, may occur. In case of hypersensitive, discontinue QIVIGY infusion and manage as appropriate.
Hyperproteinemia, hyperviscosity, and hyponatremia may occur in patients receiving IGIV treatment, including QIVIGY.
Aseptic meningitis syndrome may occur in patients receiving IGIV treatment, especially with high doses or rapid infusion.
Hemolysis can develop subsequent to IGIV treatment. Monitor patients for hemolysis.
Transfusion-related acute lung injury: Monitor patients for pulmonary adverse reactions.
Transmissible infectious agents: QIVIGY is made from human plasma and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Interference with laboratory tests: After infusion of Ig, transitory rise of passively transferred antibodies may yield positive serological results, with potential for misleading interpretation.
ADVERSE REACTIONS
The most common adverse reactions occurring in > 5% of patients treated were headache, fatigue, infusion-related reaction, Coombs direct test positive, nausea, sinusitis, dizziness, and diarrhea.
To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-3KDRION
(1-855-353-7466) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for complete prescribing details, including Boxed Warning.
About Kedrion Biopharma
Kedrion Biopharma collects and fractionates blood plasma to produce and distribute plasma-derived therapies for rare, ultra-rare, and debilitating conditions like Coagulation and Neurological Disorders, Immunodeficiencies, and Rh sensitization. We employ approximately 5,200 people worldwide and our industrial network includes 68 plasma collection centers in the United States and 8 in the Czech Republic, and 7 production facilities across 5 countries. We are committed to creating a world where science and care know no bounds, partnering with the medical-scientific community, institutions, patient advocacy groups, and research bodies to foster innovation and improve patient care. Every connection we make impacts someone, somewhere.
Forward Looking Statements:
This release includes “forward-looking statements,” within the meaning of the securities laws and certain other jurisdictions, based on current expectations and projections about future events. All statements other than statements of historical facts included in this release, including, without limitation, statements regarding our future financial position, risks and uncertainties related to our business, strategy, capital expenditures and our plans and objectives for future operations, may be deemed to be forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties. Words such as “believe,” “expect,” “anticipate,” “may,” “assume,” “plan,” “intend,” “will,” “should,” “estimate,” “risk,” “target,” “objectives,” “outlook,” “probably,” “project,” “seek” and similar expressions or the negatives of these expressions are intended to identify forward-looking statements. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For information: Jessica Fetrow – US Communications
