ASCENIV (immune globulin intravenous, human) 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
Important Safety Information for ASCENIV™
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
Renal dysfunction, acute renal failure, osmotic nephrosis, and
death may occur with the administration of Immune Globulin
Intravenous (Human) (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.
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
Warnings and Precautions
Severe hypersensitivity reactions may occur with IGIV products,
including ASCENIV. In case of hypersensitivity, discontinue ASCENIV
infusion immediately and institute appropriate treatment. Patients
with known antibodies to IgA may have a greater risk of developing
potentially severe hypersensitivity and anaphylactic reactions.
Thrombosis may occur following treatment with immunoglobulin
products and in the absence of known risk factors. Consider baseline
assessment of blood viscosity in patients at risk for hyperviscosity
and ensure adequate hydration before administration. For patients at
risk of thrombosis, administer ASCENIV at the minimum dose and
infusion rate practicable. Monitor for signs and symptoms of
thrombosis and assess blood viscosity in patients at risk for
Acute renal dysfunction/failure, osmotic nephrosis, and death 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. Assess renal function, including measurement of blood urea
nitrogen (BUN) and serum creatinine, before the initial infusion of
ASCENIV and at appropriate intervals thereafter. Discontinue ASCENIV
if renal function deteriorates. In at risk patients, administer
ASCENIV at the minimum infusion rate practicable.
Hyperproteinemia, increased serum viscosity, and hyponatremia or
pseudohyponatremia may occur in patients receiving IGIV treatment,
including ASCENIV. It is critical to clinically distinguish true
hyponatremia from a pseudohyponatremia that is associated with or
causally related to hyperproteinemia. Treatment aimed at decreasing
serum free water in patients with pseudohyponatremia may lead to
volume depletion, a further increase in serum viscosity, and a
possible predisposition to thrombotic events.
Aseptic meningitis syndrome (AMS) may occur with IGIV treatments,
including ASCENIV. AMS usually begins within several hours to 2 days
following IGIV treatment. AMS may occur more frequently in
association with high doses (2 g/kg) and/or rapid infusion of IGIV.
Conduct a thorough neurological examination on patients exhibiting
signs and symptoms of AMS, including cerebrospinal fluid (CSF)
studies, to rule out other causes of meningitis.
IGIV products, including ASCENIV, may contain blood group antibodies
that can act as hemolysins and induce in vivo coating of red blood
cells (RBCs) with immunoglobulin, causing a positive direct
antiglobulin reaction and hemolysis. Monitor patients for clinical
signs and symptoms of hemolysis, including appropriate confirmatory
Non-cardiogenic pulmonary edema may occur with IV administered IG.
Monitor patients for pulmonary adverse reactions. If suspected,
perform appropriate tests for presence of anti-neutrophil in both
product and patient serum. May be managed using oxygen therapy with
adequate ventilatory support.
Because ASCENIV is made from human blood, it may carry a risk of
transmitting infectious agents, e.g., viruses, the variant
Creutzfeldt-Jakob disease (vCJD) and theoretically, the
Creutzfeldt-Jakob disease (CJD) agent. All infections suspected by a
physician to possibly have been transmitted by this product should
be reported to ADMA Biologics at (1-800-458-4244).
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
misleading interpretation. Passive transmission of antibodies to
erythrocyte antigens (e.g., A, B, and D) may cause a positive direct
or indirect antiglobulin (Coombs’) test.
The most common adverse reactions to ASCENIV (≥5% of study subjects)
were headache, sinusitis, diarrhea, gastroenteritis viral,
nasopharyngitis, upper respiratory tract infection, bronchitis, and
You are encouraged to report side effects of prescription drugs to
ADMA Biologics @ 1-800-458-4244 or the FDA. Visit
or call 1-800-FDA-1088.
For additional safety information about ASCENIV, please see
full Prescribing Information.
ASCENIV Prescribing Information, ADMA Biologics, 2019.