IG treatment is
the gold standard
for primary
immunodeficiency

If you’ve been diagnosed with primary immunodeficiency, or PI, the gold standard that can help protect against infection is immunoglobulin (IG) replacement therapy.1

How PI is treated

People with PI are missing antibodies or have antibodies that do not function properly.2 Because antibodies play an important role in the immune system, people with PI experience an increased risk of infection.2

IG replacement therapy provides functional antibodies, or immunoglobulins called IgG, that help enable the body to fight off infections.2

IG treatment can be delivered in 2 ways2:

Intravenous IG (or IVIG)

is delivered through an IV

Subcutaneous IG (or SCIG)

is self-administered with a
needle under the skin

How IG treatments are made

All IG products are made from donated human plasma, the liquid component of blood that contains antibodies.2

  • To create the medication, plasma is pooled from thousands of donors2
  • Each batch of medication undergoes a rigorous purification process designed to ensure the safety of the resulting treatment2

Not all IG treatments are the same

While rare, blood clots causing stroke, heart attack, or pulmonary embolism have been associated with IVIG infusions.2

One of the causes of IVIG-related blood clots is a plasma-based molecule called clotting factor XIa.2

Different IVIG products use different purification processes to remove clotting factor XIa.

We incorporate extra steps into our process to reduce clotting factor XIa to undetectable levels.3

References:

  1. Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: a review of evidence. J Allergy Clin Immunol. 2017;139(3S):S1-S46.
  2. Immunoglobulin replacement therapy. Immune Deficiency Foundation. Accessed May 9, 2024. https://‌primaryimmune.org/‌understanding-primary-immunodeficiency/‌treatment/‌immunoglobulin-replacement-therapy
  3. Kang GB, Huber A, Lee J, et al. Cation exchange chromatography removes FXIa from a 10% intravenous immunoglobulin preparation. Front Cardiovasc Med. 2023;10:1253177.
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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 here.