Fewer infections.
More connections.

ALYGLO was proven effective
in a clinical trial1

The clinical value of ALYGLO was evaluated in a prospective, open-label, multicenter, single-arm study in 33 adults with PI, aged 17-70 years. The study evaluated the efficacy, safety, and tolerability of ALYGLO.

  • Before enrollment, all subjects were receiving stable doses between 300 and 900 mg/kg of a commercially available IVIG treatment
    • The approved dosing for ALYGLO is between 300 and 800 mg/kg
  • For 12 months, subjects received ALYGLO infusion administered every 21 or 28 days (both the dose and schedule depending on their prior therapy)
  • Primary endpoint was annualized rate of acute serious bacterial infections (ASBIs), defined as bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, and osteomyelitis/septic arthritis per patient year
  • Secondary endpoints were annual rate or days of other infections, days out of work/school/daycare or unable to perform normal activities due to infection, days on antibiotics, and days of hospitalization due to infection per patient year
    • Number of days is presented as a median
  • The phase 3 study included both adult and pediatric populations during enrollment. However, study results and FDA approval only reflect the adult cohort

Proven protection from infection1

Patients receiving ALYGLO experienced an average of only:

0.03

ASBIs

per patient year

Upper one-sided 99% confidence limit was 0.31, which met the
predefined success rate of <1 acute serious bacterial infection
(ASBI) per patient year (intent-to-treat [ITT] population).

Reduced impact on daily living1

Patients receiving ALYGLO experienced an average of only:

2.4

other infections

per patient year

6

days of missed work,
school, or normal activities

per patient year

14

days on antibiotics

per patient year

0.2

days of
hospitalization

per patient year

Safety profile of ALYGLO

  • No pre-medications were provided to patients ahead of infusions per study protocol2
  • >98% of infusions were completed without discontinuation, interruption, or rate reductions3
  • Common adverse events were defined as those occurring in >5% of patients3
  • The majority of adverse events reported during the study were mild in intensity3
  • No adverse events led to withdrawal from the study1

common adverse events (AEs)1

Infusions with AEs
(N=427)		 Patients reporting AEs
(N=33)
Headache 32 (7.5) 13 (39)
Nausea/vomiting 20 (4.7) 11 (33)
Fatigue 18 (4.2) 6 (18)
Nasal/sinus congestion 5 (1.2) 5 (15)
Rash 4 (0.9) 4 (12)
Arthralgia 4 (0.9) 3 (9)
Diarrhea 3 (0.7) 3 (9)
Muscle pain/aches 7 (1.6) 2 (6)
Infusion site pain/swelling 6 (1.4) 2 (6)
Abdominal pain/discomfort 3 (0.7) 2 (6)
Cough 2 (0.5) 2 (6)
Dizziness 2 (0.5) 2 (6)

References:

  1. ALYGLO Prescribing Information. GC Biopharma; 2023.
  2. Data on file. GC Biopharma; 2019.
  3. Perez EE, Hébert J, Ellis AK, et al. Efficacy, safety and tolerability of a new 10% intravenous immunoglobulin for the treatment of primary immunodeficiencies. Front Immunol. 2021;12:707463.
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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

WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin intravenous (IGIV) products, including ALYGLO. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

  • Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients.

  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ALYGLO does not contain sucrose.

  • For patients at risk of thrombosis, renal dysfunction or renal failure, administer ALYGLO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

  • Contraindications: ALYGLO is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
  • Hypersensitivity: In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. Epinephrine should be available for immediate treatment of severe acute hypersensitivity reactions.
  • Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur.
  • Aseptic Meningitis Syndrome (AMS): Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion. AMS usually begins within several hours to 2 days following ALYGLO treatment. Discontinuation of treatment has resulted in remission of AMS within several days without sequelae.
  • Hemolysis: Delayed hemolytic anemia due to enhanced red blood cell (RBC) sequestration and acute hemolysis consistent with intravascular hemolysis have been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors.
  • Transfusion-Related Acute Lung Injury: Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilator support. Monitor patients for pulmonary adverse reactions.
  • Transmissible Infectious Agents: Because ALYGLO is made from human blood, it may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent).
  • Interference with Laboratory Tests: After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for a misleading interpretation.
  • Adverse reactions (observed in ≥ 5% of study subjects) were headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness.
  • It is recommended that ALYGLO be administered separately from other drugs or medications.

For more information about ALYGLO, please see full Prescribing Information.

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