ARLINGTON, Texas--(BUSINESS WIRE)--AOM Infusion, a leading provider of specialty infusion therapy, announced today that it has been selected by GC Biopharma as a limited distribution partner for ALYGLO™, an FDA-approved immunoglobulin replacement therapy indicated for the treatment of primary humoral immunodeficiency (PI). ALYGLO™ uses a novel Cation Exchange Chromatography (CEX) process, which results in extra-purified IVIG.
ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Patients treated with ALYGLO™ receive one infusion every three to four weeks administered by a nurse either at home or at an infusion center.
GC Biopharma selected AOM Infusion as a partner because of its national reach and its expertise in specialized care for chronic conditions. AOM Infusion serves patients with over 80 different chronic conditions, with long-term treatment managed by clinical pharmacists and administered by skilled infusion nurses. The company also provides support services, including pharmacy services, referral management, insurance verification, and patient education and training.
“We are proud to have AOM Infusion as part of our ALYGLO™ network of distribution partners,” says Woo Jin Lee, chief executive officer of GC Biopharma. “The AOM team’s commitment to superior patient care and focus on providing the best treatments aligns with our company’s mission and vision.”
“We’re committed to providing care that enhances people’s lives,” says Karmen Stowe, AOM Vice President of Trade Relations & Supply Chain for AOM Infusion. “We’re honored GC Biopharma entrusts AOM to offer this high-purity IVIG therapy enabling us to provide our patients with another safe and effective treatment option.”
For more information about ALYGLO™, visit: https://www.alyglo.com/
For more information about AOM Infusion, visit: https://aominfusionrx.com/
About GC Biopharma USA, Inc.
GC Biopharma USA, Inc., headquartered in Teaneck, NJ, established its sales, marketing, and business operations in 2018 to serve customers and patients throughout the U.S. Our foundation is built on the expertise of our parent company, GC Biopharma’s, – a leading biopharmaceutical company delivering plasma therapies and vaccines worldwide. With GC Biopharma USA, Inc., GC Biopharma further extends its footprint, bringing its expertise and legacy to the United States. For more information, please visit www.GCBiopharma.us.
About AOM Infusion
AOM Infusion has been a leader in infusion care for 30 years, with a pharmacy license in all 50 states. The company specializes in the care of patients with chronic conditions who may require a more complex level of treatment, and has deep experience providing therapy for over 80 chronic conditions. AOM Infusion is focused on expanding its therapy solutions and investing in innovative platforms to deliver state-of-the-art care to more patients across the country.
INDICATION
ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
IMPORTANT SAFETY INFORMATION
- Thrombosis (blood clot formation) can happen with ALYGLO. Factors that increase this risk include advanced age, prolonged immobility, certain medical conditions, and cardiovascular risk factors.
- ALYGLO may affect the kidneys. In some cases, it can lead to acute renal failure or death.
- If you’re at risk for blood clots or kidney problems, your doctor should give you ALYGLO at the lowest effective dose and infusion rate. Staying well-hydrated before treatment is essential.
- ALYGLO is not suitable for people who have had severe allergic reactions to immune globulin or those with IgA deficiency and a history of hypersensitivity.
- If you experience any signs of hypersensitivity during the infusion, treatment should be stopped and epinephrine (an emergency medication) should be administered immediately.
- ALYGLO may cause hyperproteinemia, increased serum viscosity, and hyponatremia (low sodium levels).
- Aseptic Meningitis Syndrome (AMS) is a rare condition that can occur after receiving ALYGLO, especially with high doses or rapid infusion. Symptoms usually start within a few hours to 2 days after treatment. If AMS occurs, stopping ALYGLO usually leads to improvement within several days without lasting effects.
- Hemolysis, a breakdown of red blood cells, may occur. Some patients may experience delayed hemolytic anemia due to increased sequestration of red blood cells. Severe hemolysis-related kidney dysfunction or disseminated intravascular coagulation has been reported.
- Transfusion-Related Acute Lung Injury (TRALI) is a rare complication characterized by severe respiratory distress, pulmonary edema, and fever. Patients with TRALI may need oxygen therapy and ventilator support.
- ALYGLO is made from human blood, which may carry a risk of transmitting infectious agents (such as viruses).
- After receiving ALYGLO, some antibodies from the treatment may temporarily show up in blood tests. This could lead to misleading results, so your healthcare provider will consider this when interpreting lab results.
- Common side effects include headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness.
For more information about ALYGLO, please see full Prescribing Information.
