Rx Item-Asceniv human immunoglobulin g liquid 10% 5GM 50ML BY Adama Biologics
ASCENIV is supplied in a single-use, tamper-evident vial. The components used in the packaging for ASCENIV are not made with natural rubber latex.
ASCENIV is supplied in 50 mL size containing 5 grams of protein.
Refrigerate between 2 to 8�C (36 to 46�F).
Do not freeze or heat. Do not use any solutions that have been frozen or heated.
Do not use after expiration date. hese highlights do not include all the information needed to use ASCENIV� safely and effectively.
See full prescribing information for ASCENIV.
ASCENIV (immune globulin intravenous, human � slra)
10% Liquid
Initial U.S. Approval: 2019
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
See full prescribing information for complete boxed 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. [5.3]
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. [2.1, 2.3, 5.3]
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). [1]
DOSAGE AND ADMINISTRATION
For intravenous use only.
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)
Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue ASCENIV if renal function deteriorates. [5.3]
For patients at risk of renal dysfunction or thrombotic events, administer ASCENIV at the minimum infusion rate practicable. [5.2, 5.3]
DOSAGE FORMS AND STRENGTHS
ASCENIV is a liquid solution containing 10% IgG (100 mg/mL) for intravenous infusion; (5g in 50 mL solution). [3]
CONTRAINDICATIONS
History of anaphylactic or severe systemic reactions to human immunoglobulin. [4]
IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. [4, 5.1]
WARNINGS AND PRECAUTIONS
IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available to treat any acute severe hypersensitivity reactions. [4, 5.1]
Thrombotic events have occurred in patients receiving IGIV treatments. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. [5.2, 5.4]
In patients at risk of developing acute renal failure. monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output. [5.3, 5.9]
Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV treatment. [5.4]
Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. [5.5]
Hemolytic anemia can develop subsequent to IGIV treatment. Monitor patients for hemolysis and hemolytic anemia. [5.6]
Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion-related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. [5.7]
Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. [5.8]
ADVERSE REACTIONS
The most common adverse reactions to ASCENIV (?5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. [6]
To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (1-800-458-4244) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Passive transfer of antibodies may transiently interfere with the immune response to live virus vaccines, such as measles, mumps, rubella, and varicella. [7]
Passive transfer of antibodies may confound the results of serological testing. [5.10]
USE IN SPECIFIC POPULATIONS
Geriatric Use: In patients over age 65 or in any patient at risk of developing renal insufficiency, do not exceed the recommended dose, and infuse ASCENIV at the minimum infusion rate practicable. [8.5]
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2019
