ASCENIV

ASCENIV- human immunoglobulin g liquid
ADMA Biologics, Inc.

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors (see Warnings and Precautions [5.2], Patient Counseling Information [17]).
  • 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 ( see Dosage and Administration [2.1, 2.3], Warnings and Precautions [5.3]).

1 INDICATIONS AND USAGE

ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, 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).

2 DOSAGE AND ADMINISTRATION

2.1 Dose

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.

For intravenous use only.

Table 1
Dose Initial Infusion Rate Maintenance Infusion Rate (if tolerated)
300-800 mg/kg every 3-4 weeks 0.5 mg/kg/min (0.005 mL/kg/min) for the first 15 minutes Increase gradually every 15 minutes (if tolerated) up to 8 mg/kg/min (0.08 mL/kg/min)

2.2 Preparation and Handling

  • ASCENIV is a clear to opalescent, colorless to pale yellow solution. Inspect visually for particulate matter and discoloration prior to administration. Do not use if the liquid is cloudy or turbid, or if it contains visible particulate matter.
  • Allow refrigerated product to come to room temperature before use and maintain ASCENIV at room temperature during administration.
  • DO NOT MICROWAVE.
  • DO NOT SHAKE.
  • DO NOT MIX with other IGIV products or other intravenous medications.
  • DO NOT DILUTE.
  • ASCENIV contains no preservatives. Each vial is for single use only. Do not reuse or save for future use.
  • If large doses are required, several vials may be pooled using aseptic technique into sterile infusion bags and infused.

2.3 Administration

Begin with an initial infusion rate of 0.5 mg/kg/min. If there are no adverse reactions, the infusion rate for subsequent infusions can be slowly increased to the maximum rate.

Monitor patient vital signs throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a slower rate which is comfortable for the patient.

Ensure that patients with pre-existing renal insufficiency are not volume-depleted. For patients judged to be at risk for renal dysfunction or thrombotic events, administer ASCENIV at the minimum infusion rate practicable, and consider discontinuation of administration if renal function deteriorates ( see Boxed Warning, Warnings and Precautions [5.2, 5.3]).

3 DOSAGE FORMS AND STRENGTHS

ASCENIV is a liquid solution containing 10% IgG (100 mg/mL) for intravenous infusion.

4 CONTRAINDICATIONS

ASCENIV is contraindicated in:

  • patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
  • IgA-deficiency patients with antibodies to IgA and a history of hypersensitivity.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Severe hypersensitivity reactions may occur with IGIV products, including ASCENIV. In case of hypersensitivity, discontinue ASCENIV infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for treatment of acute hypersensitivity reactions.

ASCENIV contains trace amounts of IgA (≤ 200 micrograms per milliliter) (see Description [11]). Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. ASCENIV is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity reaction (see Contraindications [4]).

5.2 Thrombosis

Thrombosis may occur following treatment with immune globulin products, including ASCENIV. 4,5,6 Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.

Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including patients with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, 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 (see Boxed Warning, Dosage and Administration [2], Patient Counseling Information [17]).

5.3 Acute Renal Dysfunction and Acute Renal Failure

Acute renal dysfunction/failure, osmotic nephrosis, and death 1,2 may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering ASCENIV. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. 2 Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of ASCENIV and at appropriate intervals thereafter. If renal function deteriorates, consider discontinuing ASCENIV (see Patient Counseling Information [17]). In patients who are at risk of developing renal dysfunction, because of pre-existing renal insufficiency or predisposition to acute renal failure (such as diabetes mellitus, hypovolemia, overweight, use of concomitant nephrotoxic medicinal products or age of >65 years), administer ASCENIV at the minimum infusion rate practicable (see Dosage and Administration [2]).

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