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.
|Maintenance Infusion Rate
|300-800 mg/kg every
for the first 15
|Increase gradually every 15 minutes (if tolerated) up to 8
mg/kg/min (0.08 mL/kg/min)
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.
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]).
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