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General Information

Asceniv is specifically indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). PI 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 immunodeficiencies (SCID).

Asceniv is supplied as an injection for intravenous administration. The recommended dose of Asceniv for replacement therapy in primary humoral immunodeficiency (PI) is 300 to 800 mg/kg body weight administered every 3 to 4 weeks. The dose may be adjusted over time to achieve the desired trough levels and clinical response.

Asceniv dose adjustments may be required in patients who fail to maintain trough total IgG concentrations of at least 500 mg/ dL with a target of 600 mg/dL. Starting with the second infusion, adjust the dose proportionally, targeting a trough of ≥ 600 mg/dL, based on the previous trough and the associated dose.

Dose: 300-800 mg/kg every 3-4 weeks | Initial Infusion Rate: 0.5 mg/kg/min (0.005 mL/kg/min) for the first 15 minutes | Maintenance Infusion Rate (if tolerated): increase gradually every 15 minutes (if tolerated) up to 8 mg/kg/min (0.08 mL/kg/min)

Clinical Results

FDA Approval

The FDA approval of Asceniv was based on a prospective, open-label, single-arm, multicenter trial which assessed the efficacy, safety, and pharmacokinetics of Asceniv in 59 adult and pediatric subjects with PI. Study subjects were receiving regular IGIV replacement therapy, with a stable dose between 300 and 800 mg/kg for at least 3 months prior to participation in this trial. Subjects received an Asceniv infusion administered every 3 or 4 weeks (both the dose and schedule depending on their prior therapy) for 12 months. The study assessed the efficacy of Asceniv in preventing serious bacterial infections (SBIs), defined as a rate of <1.0 cases of bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, visceral abscess, and bacterial meningitis per person-year. During the 12-month study period, zero (0) serious acute bacterial infections occurred. Thus, the mean event rate of serious, acute, bacterial infections per year was 0.0 (with an upper 1-sided 99% confidence interval of <1.0 per subject year, which met the study’s primary efficacy endpoint).

Side Effects

Adverse effects associated with the use of Asceniv may include, but are not limited to, the following:

headache

sinusitis

diarrhea

gastroenteritis viral

nasopharyngitis

upper respiratory tract infection

bronchitis

nausea

The Asceniv drug label comes with the following Black Box Warning: • Thrombosis may occur with immune globulin intravenous (IGIV) products, including Asceniv. 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 nephrosis, 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. Asceniv does not contain sucrose. • For patients at risk of thrombosis, renal dysfunction or renal failure, administer Asceniv 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.

Mechanism of Action

Asceniv (10% immune globulin liquid) is a replacement therapy and contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against various infectious agents reflecting the IgG activity found in the donor population. Asceniv is a replacement therapy for patients with primary humoral immunodeficiency (PI) (e.g. agammaglobulinemia, hypogammaglobulinemia, CVID, SCID). The broad spectrum of neutralizing IgG antibodies against bacterial and viral pathogens and their toxins helps to avoid recurrent serious opportunistic infections. IgG antibodies are opsonins that increase phagocytosis and elimination of pathogens from the circulation. The mechanism of action has not been fully elucidated in PI. Asceniv contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against various infectious agents, reflecting the IgG activity found in the donor population. Asceniv, which is prepared from pooled plasma from not less than 1,000 donors, has an IgG subclass distribution similar to that of native human plasma. Adequate doses of IGIV can restore an abnormally low IgG level to the normal range.