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General Information
Alyglo is a liquid solution containing 10% immunoglobulin G (100 mg/mL) for intravenous infusion.
Alyglo is specifically indicated for the treatment of primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiency (SCID).
Dose | Infusion Number | Initial Infusion Rate | Maintenance Infusion Rate |
300 ‒ 800 mg/kg body weight every 21 or 28 days | For the 1st Infusion | 1 mg/kg/min (0.01 mL/kg/min) | Double the infusion rate every 30 minutes (if tolerated) up to 8 mg/kg/min (0.08 mL/kg/min) |
300 ‒ 800 mg/kg body weight every 21 or 28 days | From the 2nd Infusion | 2 mg/kg/min (0.02 mL/kg/min) | Double the infusion rate every 15 minutes (if tolerated) up to 8 mg/kg/min (0.08 mL/kg/min) |
Mechanism of Action
Alyglo (immune globulin intravenous, human-stwk) supplies a broad spectrum of neutralizing IgG antibodies to bacterial and viral pathogens, and their toxins. The mechanism of action for PI is not fully understood. Alyglo is manufactured from pooled human plasma from US donors. The manufacturing process includes three steps to reduce the risk of virus transmission. These include fractionation, solvent/detergent treatment, and nanofiltration.
Side Effects
Adverse effects associated with the use of Alyglo may include, but are not limited to, the following:
- headache
- nausea/vomiting
- fatigue
- nasal/sinus congestion
- rash
- arthralgia
- diarrhea
- muscle pain/aches
- infusion site pain/swelling
- abdominal pain/discomfort
- cough
- dizziness
The Alyglo drug label comes with the following Black Box Warning:
- 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.
Clinical Trial Results
The FDA approval of Alyglo was based on a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study to assess the efficacy and safety of Alyglo in patients with a confirmed diagnosis of PI. The studies were conducted in the United States and Canada. Key findings from the phase 3 clinical trial for patients aged 17 years and older include the following:
- A primary efficacy end point of 0.03 acute serious bacterial infections (aSBIs) per patient-year, which met the FDA efficacy requirement of less than one aSBI per patient-year.
- The proportion of infusions with temporally associated adverse events occurring during or within 72 hours after infusion was 0.22, which met the FDA-required prespecified end point of less than 0.40.
- Efficacy was also demonstrated by the low mean annualized rate of hospitalizations due to infection (0.1 day) and the mean annualized duration of hospitalizations (0.1 day). The mean rate of intravenous and oral antibiotic use was 0.1 day and 13.2 days, respectively. There was a mean of 7.1 days of missed work, school, or daycare days.