s Agents
Because ASCENIV is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variantCreutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician orother healthcare provider to ADMA Biologics at (1-800-458-4244). Before prescribing ASCENIV, the physician should discuss therisks and benefits of its use with the patient (see Patient Counseling Information [17]).
5.9 Monitoring Laboratory Tests
• Periodic monitoring of renal function and urine output is particularly important in patients at increased risk ofdeveloping acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) andserum creatinine, before the initial infusion of ASCENIV and at appropriate intervals thereafter.
• Because of the potentially increased risk of thrombosis with IGIV treatment, consider baseline assessment of bloodviscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedlyhigh triacylglycerols (triglycerides), or monoclonal gammopathies.
• If signs and/or symptoms of hemolysis are present after an infusion of ASCENIV, perform appropriate laboratory testingfor confirmation.
• If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product andpatient’s serum.
5.10 Interference with Laboratory Tests
After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yieldpositive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyteantigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test.
6 ADVERSE REACTIONS
The most common adverse reactions to ASCENIV (reported in ≥5% of clinical study subjects) were headache, sinusitis,
diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials cannot bedirectly compared to rates in the clinical trials of another product and may not reflect the rates observed in clinical practice.
In a multicenter, open-label, non-randomized clinical trial, 59 subjects with PI, on regular IGIV replacement therapy, received dosesof ASCENIV ranging from 284 to1008 mg/kg (mean dose 505 mg/kg) every 3 weeks or 4 weeks for up to 12 months (mean 346days; range 36 to 385 days) (see Clinical Studies [14]). The use of pre-medication was discouraged; however, if after two infusionsof ASCENIV subjects required pre-medication (antipyretic, antihistamine, or antiemetic agent) for recurrent reactions, they couldcontinue those medications for the duration of the trial. Of the 793 infusions administered during this trial, only 7 (11.9%) subjectsreceived premedication prior to 7 (0.9%) infusions.
Fifty-eight subjects (98%) had an adverse reaction during the study. The proportion of subjects who had at least one adversereaction was similar for both the 3- and 4-week cycles. The most common adverse reactions observed in this clinical trial werehe |
