Dosage & 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) |
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Asceniv Prescribing Information
- 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 factors (see Warnings and Precautions [5.2], Patient Counseling Information [17]).
- 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.
- 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 ( see Dosage and Administration [2.1, 2.3], Warnings and Precautions [5.3]).
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). 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 immunodeficiencies (SCID).
Dose
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.
| 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) |
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.
Administration
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]).
ASCENIV is a liquid solution containing 10% IgG (100 mg/mL) for intravenous infusion.
Pregnancy
Risk Summary
No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with ASCENIV. It is not known whether ASCENIV can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20% respectively. ASCENIV should be given to pregnant women only if clearly needed. 17,18
Lactation
Risk Summary
No human data are available to indicate the presence or absence drug-associated risk. The developmental and health benefits of breast feeding should be considered along with the mother’s clinical need for ASCENIV and any potential adverse effects on the breast-fed infant from ASCENIV or from the underlying maternal condition.
Pediatric Use
ASCENIV was evaluated in 11 pediatric subjects (6 children less than 12 years and 5 adolescents age 12 – 16 years) with primary humoral immunodeficiency (PI). The pharmacokinetic (PK), safety, and effectiveness profile of ASCENIV in adolescent subjects appeared to be comparable to that demonstrated in adult subjects. There are insufficient PK, safety, and effectiveness data from pediatric subjects younger than 12 years. Safety and effectiveness has not been studied in pediatric patients with PI who are under the age of 3 years ( see Clinical Studies [14]).
Geriatric Use
Clinical studies of ASCENIV did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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 hypersensitivity.