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, talk to your doctor and see the
Product Information.
