You go the extra
step for your patients.
So do we.

G-XI™ Technology: an extra step to remove
activated coagulation factor XI (FXIa)

Product end-testing is conducted to help ensure undetectable levels of FXIa in every lot.

How G-XI™ Technology works

During this step, cation exchange (CEX) chromatography is implemented using a unique ceramic resin under specific conditions that aid in the removal of FXIa.1

Before G-XI

16%

FXla remains

Residual activated coagulation factor XI remained in the solution.1

During G-XI

Positively charged IG and FXla initially bind to the negatively charged ceramic resin.1

Then, under specific conditions, IG flows through while the FXIa remains bound to the resin, enabling IG to effectively separate from FXIa.1

After G-XI

>99%

FXla FREE

Once IG is collected, FXIa levels are undetectable in the final intravenous immunoglobulin (IVIG) preparations.1

Representation of undetectable limits.

IgG, immunoglobulin G.

Learn more about G-XI™ Technology

An extra study to confirm our
technology works

G-XI™ Technology was proven to remove >99% of FXIa in a published, multi-step study1:

  • A western blot analysis was used to prove our technology works1
  • A spiking study pressure-tested G-XI for its capacity to remove FXIa, even at elevated levels1
  • Results from the study are highlighted below. Read the full publication here

WESTERN BLOT ANALYSIS

Measured coagulation factor levels at each phase of the manufacturing process

Other coagulation factors were removed during fractionation but residual FXI/FXIa was present until the G-XI™ Technology step.1

After G-XI™ Technology, FXIa levels were undetectable.1

SPIKING STUDY

Samples were spiked with large quantities of FXIa (32-fold and 158-fold) prior to the step of G-XI™ Technology, and assays were used to confirm FXIa levels.1

Even in samples spiked >158x normal levels of FXIa protein, G-XI was proven to reduce FXIa below detection limits.1

Reference:

  1. 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.

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. Thrombosis may occur in the absence of known risk factors.

  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.

  • 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 acute 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).
  • Monitoring Laboratory Tests: Assess blood urea nitrogen (BUN), serum creatinine, renal function, and urine output before and during ALYGLO treatment in patients at risk of acute renal failure. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity. Evaluate suspected hemolysis with confirmatory laboratory testing, including baseline and 36–96 hours post-infusion hemoglobin and/or hematocrit in higher-risk patients. If TRALI is suspected, test the product and patient serum for anti-neutrophil antibodies.
  • 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.
  • Drug Interactions: It is recommended that ALYGLO be administered separately from other drugs or medications. The passive transfer of antibodies with IGIV administration may interfere with the response to live virus vaccines.

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