Unaddressed
needs exist with
IG treatments

The need for more IVIG  

The need for clean IVIG  

The need for more IVIG

IG replacement is the gold standard of care for patients with PI.1 But demand is outpacing supply.2

INCREASING DEMAND

Global demand for IG treatment is increasing 6-8% per year,2 driven by:

Increasing recognition and diagnosis of PI1

The chronic
nature of PI1

Use of IVIG for other
disease states1

Supply shortages have resulted in changes to patient prioritization and infusion schedules.1 That’s why more IVIG products are critical to ensuring access to treatment for patients with PI.1

 

The need for clean IVIG

While there are many different FDA-approved IVIG options, some unaddressed needs still exist.3

Thromboembolic event (TE) incidence rates among IVIG-treated patients have ranged from 0.5% to 17% in case series and other observational studies.4

In 2010, the U.S. Food and Drug Administration (FDA) became aware of a cluster of TEs associated with coagulation factor XIa (FXIa) in IVIG5

In 2013, this led the FDA to place a boxed warning across this therapeutic class5

Regulatory bodies across the world have implemented corrective actions, encouraging manufacturers to test products at lot release and to consider dedicated steps for removing FXIa5

At GC Biopharma, we have implemented an extra step of cation exchange (CEX) chromatography to help reduce FXIa levels to undetectable limits6

Patients with PI living with comorbidities may have increased risk

Patients living with PI are at an increased risk of comorbid conditions,7 and more patients may have baseline risk factors for TEs than realized, including8:

  • Obesity
  • Diabetes
  • High cholesterol
  • Hypertension
  • Advanced age
  • History of thrombosis
  • Renal disease
  • Clotting disorder
  • Immobility

References:

  1. 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.
  2. Solís-Díez G, Turu-Pedrola M, Roig-Izquierdo M, Zara C, Vallano A, Pontes C. Dealing with immunoglobulin shortages: a rationalization plan from evidence-based and data collection. Front Public Health. 2022;10:893770.
  3. Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: a review of evidence. J Allergy Clin Immunol. 2017;139(3S):S1-S46.
  4. Ammann EM, Haskins CB, Fillman KM, et al. Intravenous immune globulin and thromboembolic adverse events: a systematic review and meta-analysis of RCTs. Am J Hematol. 2016;91(6):594-605.
  5. Ovanesov MV, Menis MD, Scott DE, et al. Association of immune globulin intravenous and thromboembolic adverse events. Am J Hematol. 2017;92(4):E44-E45.
  6. 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.
  7. Dilley M, Wangberg H, Noone J, Geng B. Primary immunodeficiency diseases treated with immunoglobulin and associated comorbidities. Allergy Asthma Proc. 2021;42(1):78-86.
  8. Immunoglobulin replacement therapy. Immune Deficiency Foundation. Accessed April 3, 2024. https://‌primaryimmune.org/‌understanding-primary-immunodeficiency/‌treatment/‌immunoglobulin-replacement-therapy
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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.