Alyglo

Generic name: immune globulin intravenous, human-stwk
Dosage form: intravenous injection (10%)
Drug class: Immune globulins

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 26, 2024.

What is Alyglo?

Alyglo is an immune globulin liquid for intravenous injection used to treat primary humoral immunodeficiency (PI) in adults.  Alyglo is an immunoglobulin replacement therapy used to boost the immune system to reduce the number of infections, sick days, and hospitalizations due to infections. Alyglo contains a broad spectrum of neutralizing IgG antibodies to bacterial and viral pathogens and their toxins.

Alyglo is made from pooled human plasma from US donors, which has undergone processes to reduce the risk of virus transmission and also a process to remove coagulation factor XIa (FXIa) to reduce the risk of thromboembolic events in patients who receive the injection. 

Alyglo received FDA approval on December 17, 2023, as a treatment of primary humoral immunodeficiency in adults, which includes but is not limited to congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

What is primary humoral immunodeficiency?

Primary humoral immunodeficiency is when the body's ability to produce antibodies to fight infection is impaired this results in more frequent infections that can be severe or ongoing. Treatment with replacement immunoglobulins reduces the risk or severity of infections. Other treatment options include vaccinations and antibiotics.

Alyglo side effects

Common Alyglo side effects include headache, nausea/vomiting, tiredness, nose or sinus, congestion, rash, joint pain, diarrhea, muscle pain/aches, pain or swelling at the infusion site, tummy pain or discomfort, cough, dizziness, which occurred in 5% or more of patients.

 Serious Alyglo side effects. Call your doctor at once if you have:

• a blood cell disorder - pale or yellowed skin, dark colored urine, fever, confusion or weakness;
• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
• kidney problems - little or no urination, swelling, rapid weight gain, feeling short of breath;
• lung problems - chest pain, trouble breathing, blue colored lips, fingers, or toes;
• signs of a new infection - fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or
• signs of a blood clot - shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling and warmth or discoloration in an arm or leg.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Hypersensitivity IgA-deficient patients with antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions to Alyglo. Epinephrine should be available immediately to treat any severe acute hypersensitivity reactions. Alyglo should not be used in IgA-deficient patients with antibodies against IgA or a history of hypersensitivity reaction.

Thrombotic Events have occurred in patients receiving immune globulin intravenous treatments. Patients with known risk factors for thrombotic events should be monitored, and consider baseline assessment of blood viscosity for patients at risk of hyperviscosity.

Renal Failure In patients at risk of developing acute renal failure monitoring should be done of renal function, including blood urea nitrogen and serum creatinine, and urine output.

Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia or pseudohyponatremia may occur in patients receiving immune globulin intravenous (IGIV) therapy.

Aseptic Meningitis Syndrome (AMS) may occur, especially with high doses or rapid infusion.

Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to IGIV treatments. Risk factors for hemolysis include high doses and non-O blood group. Closely monitor patients for hemolysis and hemolytic anemia.

Transfusion-Related Acute Lung Injury (TRALI) Monitor patients for pulmonary adverse reactions, transfusion-related acute lung injury.

Transmissible Infectious Agents Alyglo is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Who should not use Alyglo?

Alyglo should not be used in patients who are IgA-deficient with antibodies against IgA or have a history of hypersensitivity reactions.

Before taking this medicine

You may not be able to use Alyglo if:

• you have had an allergic reaction to immune globulin or blood product;
• you have immune globulin A (IgA) deficiency with antibody to IgA; or
• you are allergic to corn.

Alyglo can cause blood clots or kidney problems, especially in older adults or in people with certain conditions. Tell your doctor if you have ever had:

• heart problems, blood circulation problems, or "thick blood";
• a stroke or blood clot;
• kidney disease;
• diabetes;
• an infection called sepsis;
• if you use estrogens (birth control pills or hormone replacement therapy);
• if you have been on long-term bedrest; or
• if you have a central intravenous (IV) catheter in place.

You may need a dose adjustment if you are exposed to measles or if you travel to an area where this disease is common.

Tell your doctor if you are pregnant or breastfeeding.

Immune globulin is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks.

How will I receive Alyglo

Alyglo is given as an infusion into a vein; the frequency of immunoglobulin injections varies from patient to patient. A healthcare provider will give you this injection.

Drink plenty of liquids while you are using Alyglo to help improve your blood flow and keep your kidneys working properly.

You may need frequent blood or urine tests.

Alyglo can affect the results of certain medical tests. Tell any doctor who treats you that you are using immunoglobulin replacement therapy.

Dosing information

Alyglo (immune globulin intravenous, human-stwk) is a liquid solution containing 10% IgG (100 mg/mL) for intravenous infusion. The dose and frequency of Alyglo varies from patient to patient.

Related/similar drugs

Hizentra, Privigen, immune globulin intravenous, Gamunex-C, Gammagard Liquid, Octagam

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using immune globulin intravenous?

Ask your doctor before receiving a "live" vaccine while using Alyglo. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Alyglo?

This injection can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may affect IGIV, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage

• Keep in the original carton to protect it from light.
• Store in the refrigerator at 2°C to 8°C [36°F to 46°F] for up to 36 months. Do not freeze. 
• Store at room temperature at 8°C to 25°C [46°F to 77°F] for up to 24 months. Do not return to refrigeration after Alyglo has been stored at room temperature. 
• Expiration dates for both conditions are printed on the outer carton and vial label. Do not use after the expiration date.
• Alyglo contains no preservatives. 
• The bottle is for single use only. Use promptly any bottle that has been entered or opened and discard partially used bottles. • Dispose of any unused product or waste material in accordance with local requirements.

Company

Manufactured by: GC Biopharma Corp. 107 Ihyeon-ro 30-beongil, Giheung-gu, Yongin-si, Gyeonggi-do 16924, Republic of Korea. 

Distributed by: GC Biopharma USA, Inc. 500 Frank W. Burr Boulevard, Teaneck, NJ 07666, USA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer