tsreceiving IGIV treatment. [5.4]
• Aseptic meningitis syndrome (AMS) has been reported withIGIV 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 transfusionrelatedacute lung injury is suspected, test the product andpatient for antineutrophil antibodies. [5.7]
• Because this product is made from human blood, it maycarry 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 studysubjects) were headache, sinusitis, diarrhea, gastroenteritis viral,nasopharyngitis, upper respiratory tract infection, bronchitis, andnausea. [6]
To report SUSPECTED ADVERSE REACTIONS, contactADMA 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 withthe immune response to live virus vaccines, such asmeasles, mumps, rubella, and varicella. [7]
• Passive transfer of antibodies may confound the results ofserological testing. [5.10]
USE IN SPECIFIC POPULATIONS
Geriatric Use: In patients over age 65 or in any patient at risk ofdeveloping 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
Issued: April 2019
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FULL PRESCRIBING INFORMATION: CONTENTS*WARNING:THROMBOSIS, RENAL DYSFUNCTION AND ACUTERENAL FAILURE
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose
2.2 Preparation and Handling
2.3 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
5.2 Thrombosis
5.3 Acute Renal Dysfunction and Acute Renal Failure
5.4 Hyperproteinemia, Increased Serum Viscosity, andHyponatremia
5.5 Aseptic Meningitis Syndrome (AMS)
5.6 Hemolysis
5.7 Transfusion-Related Acute Lung Injury (TRALI)
5.8 Transmissible Infectious Agents
5.9 Monitoring Laboratory Tests
5.10 Interference with Laboratory Tests
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
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FULL PRESCRIBING INFORMATION
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 |
