AOM Infusion Selected as a Limited Distribution Specialty Pharmacy for QIVIGY, A New Immune Globulin Therapy

AOM Infusion, a leading specialty infusion pharmacy and provider, today announced it has joined Kedrion Biopharma's limited distribution network for QIVIGY^®, a new 10% immune globulin (Ig) liquid indicated for treatment of adults with Primary Humoral Immunodeficiency (PI).

The addition of QIVIGY expands AOM's immune globulin portfolio and strengthens its ability to help patients and providers access innovative therapies for complex immune disorders. This announcement builds on AOM's recent collaboration with Kedrion for YIMMUGO^®, a 10% immune globulin liquid also indicated for the treatment of PI.

QIVIGY is a ready-to-use, sterile, non-pyrogenic liquid solution of human immune globulin (IgG) for IV administration. It supplies a broad spectrum of antibodies against bacterial and viral agents to support patients with Primary Immunodeficiency Disorders (PID).

Kedrion selected AOM as a distribution partner for its deep expertise in immune globulin therapy, national reach, and patient-centered clinical model. AOM's recognition as one of the first specialty providers in the nation to earn the Distinction in Ig Therapy from the ACHC and IgNS further demonstrates its commitment to clinical excellence, patient safety, and outcomes-driven care.

"We're proud to make QIVIGY available nationwide, offering a reliable new option for patients in need of IVIG therapy," said Bob Rossilli, Chief Commercial Officer of Kedrion. "Through our long-standing relationship with AOM Infusion, we aim to reach patients where they are and ensure access to the therapies they need most. By combining our expertise and resources, we can bring QIVIGY to more communities and help support patients and families."

"This partnership with Kedrion reflects our shared commitment to improving access to life-enhancing therapies for patients with complex immune disorders," says Karmen Stowe, Vice President of Trade Relations & Supply Chain. "By expanding our Ig portfolio with QIVIGY, we are strengthening our ability to support providers with reliable therapy options and helping patients receive high-quality infusion care that best supports their lives."

INDICATION

QIVIGY (immune globulin intravenous, human-kthm) is a 10% immune globulin (Ig) liquid indicated for the treatment of adults with primary humoral immunodeficiency.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

See full prescribing information for complete boxed warning.

• Thrombosis may occur with immune globulin 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.

WARNINGS AND PRECAUTIONS

• Severe hypersensitivity reactions, including anaphylaxis, may occur. In case of hypersensitivity, 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.
For more information about QIVIGY, please see the full prescribing information.