ALYGLO™ helps
provide proven
protection and
extra purification

Less sick time.
More you time.

ALYGLO is an immunoglobulin or “IG” replacement therapy that is given through an IV, which is why it’s often called "IVIG."1 By helping replace antibodies, ALYGLO helps reduce sick time so you have more time for the things that make you shine.2

The ALYGLO clinical study

  • ALYGLO was studied in 33 adults ages 17-70 in North America2
  • One of the goals of the study was to measure how many acute serious bacterial infections (ASBIs) patients had over 1 year. ASBIs are short-term but serious infections that need immediate medical care. Examples of ASBI include bacterial pneumonia and bacterial meningitis.2,a
  • The study also evaluated the impact of ALYGLO in people’s lives, including incidence of other infections, missed days of work or school, number of unscheduled physician visits, and days on therapeutic antibiotics2
  • Another goal of the study was to evaluate the safety and tolerability of ALYGLO2

How effective is ALYGLO?

Patients receiving ALYGLO in the clinical study experienced an average of only2:

0.03 SERIOUS
INFECTIONS
per patient year
2.4 INFECTIONS
OF ANY KIND
per patient year
0.2 DAYS OF
HOSPITALIZATION
per patient year
6 DAYS OF MISSED
WORK OR SCHOOL
per year

The most common side effects included2:

  • Headache (39%)
  • Nausea (33%)
  • Fatigue (18%)
  • Nasal congestion (15%)
  • Rash (12%)
  • Joint pain (9%)
  • Diarrhea (9%)
  • Muscle pain/aches (6%)
  • Infusion site pain/swelling (6%)
  • Abdominal pain/discomfort (6%)
  • Cough (6%)
  • Dizziness (6%)

Did you know?

IVIG is made from donated human blood plasma and contains certain immunoglobulins called IgG—a type of antibody that fights infection.1 All IVIG treatments are manufactured with the goal of providing pure IgG. However, other blood-based molecules that can cause side effects can remain in treatment.3

Less contaminants.
More purity.

Like all IVIG treatments, the production of ALYGLO involves multiple purification steps, including1:

  • Initial donor screening
  • Viral removal/inactivation
  • Filtration for impurities

However, during the production of ALYGLO, we take an extra step to remove a molecule called “clotting factor XIa,” which has been linked to blood clots, resulting in stroke, heart attack, or pulmonary embolism.1,3

While the extra step does not completely eliminate the risk of blood clots, ALYGLO provides a safe, effective, and clean IVIG treatment.

ALYGLO is produced with cation exchange (CEX) chromatography, which results in extra-purified IVIG.

aThe FDA defines ASBIs as: bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscesses, and osteomyelitis/septic arthritis.

References:

  1. Immunoglobulin replacement therapy. Immune Deficiency Foundation. Accessed May 9, 2024. https://‌primaryimmune.org/‌understanding-primary-immunodeficiency/‌treatment/‌immunoglobulin-replacement-therapy
  2. ALYGLO Prescribing Information. GC Biopharma; 2023.
  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.
+

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.