Privigen
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Uses
Privigen is an Immune Globulin Intravenous (Human), 10% Liquid indicated for the treatment of the following conditions.
Privigen is indicated as replacement therapy for primary humoral immunodeficiency (PI). This 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.
Privigen is indicated for the treatment of patients with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.
History
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Other Information
Privigen is a ready-to-use, sterile, 10% protein liquid preparation of polyvalent human immunoglobulin G (IgG) for intravenous administration. Privigen has a purity of at least 98% IgG, consisting primarily of monomers. The balance consists of IgG dimers (≤12%), small amounts of fragments and polymers, and albumin. Privigen contains ≤25 mcg/mL IgA. The IgG subclass distribution (approximate mean values) is IgG1, 67.8%; IgG2, 28.7%; IgG3, 2.3%; and IgG4, 1.2%. Privigen has an osmolality of approximately 320 mOsmol/kg (range: 240 to 440) and a pH of 4.8 (range: 4.6 to 5.0).
Privigen contains approximately 250 mmol/L (range: 210 to 290) of L-proline (a nonessential amino acid) as a stabilizer and trace amounts of sodium. Privigen contains no carbohydrate stabilizers (e.g., sucrose, maltose) and no preservative.
Privigen is prepared from large pools of human plasma by a combination of cold ethanol fractionation, octanoic acid fractionation, and anion exchange chromatography. The IgG proteins are not subjected to heating or to chemical or enzymatic modification. The Fc and Fab functions of the IgG molecule are retained. Fab functions tested include antigen binding capacities, and Fc functions tested include complement activation and Fc-receptor-mediated leukocyte activation (determined with complexed IgG). Privigen does not activate the complement system or prekallikrein in an unspecific manner.
All plasma units used in the manufacture of Privigen have been tested and approved for manufacture using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to HCV and HIV-1/2 as well as FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV and HIV-1 and found to be nonreactive (negative). In addition, the plasma has been tested for B19 virus (B19V) DNA by NAT. Only plasma that passed virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL.
The manufacturing process for Privigen includes three steps to reduce the risk of virus transmission. Two of these are dedicated virus clearance steps: pH 4 incubation to inactivate enveloped viruses and virus filtration to remove, by size exclusion, both enveloped and non-enveloped viruses as small as approximately 20 nanometers. In addition, a depth filtration step contributes to the virus reduction capacity.
These steps have been independently validated in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses.
Table 5 shows the virus clearance during the manufacturing process for Privigen, expressed as the mean log10 reduction factor (LRF).
| HIV-1 | PRV | BVDV | WNV | EMCV | MVM | |
|---|---|---|---|---|---|---|
| HIV-1, human immunodeficiency virus type 1, a model for HIV-1 and HIV-2; PRV, pseudorabies virus, a nonspecific model for large enveloped DNA viruses (e.g., herpes virus); BVDV, bovine viral diarrhea virus, a model for hepatitis C virus; WNV, West Nile virus; EMCV, encephalomyocarditis virus, a model for hepatitis A virus; MVM, minute virus of mice, a model for a small highly resistant non-enveloped DNA virus (e.g., parvovirus); LRF, log10 reduction factor; nt, not tested. | ||||||
|
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| Virus property | ||||||
| Genome | RNA | DNA | RNA | RNA | RNA | DNA |
| Envelope | Yes | Yes | Yes | Yes | No | No |
| Size (nm) | 80-100 | 120-200 | 50-70 | 50-70 | 25-30 | 18-24 |
| Manufacturing step | Mean LRF | |||||
| pH 4 incubation | ≥5.4 | ≥5.9 | 4.6 | ≥7.8 | nt | nt |
| Depth filtration | ≥5.3 | ≥6.3 | 2.1 | 3.0 | 4.2 | 2.3 |
| Virus filtration | ≥5.3 | ≥5.5 | ≥5.1 | ≥5.9 | ≥5.4 | ≥5.5 |
| Overall reduction (log10 units) | ≥16.0 | ≥17.7 | ≥11.8 | ≥16.7 | ≥9.6 | ≥7.8 |
The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant vCJD.18 Several of the production steps have been shown to decrease TSE infectivity of an experimental model agent. TSE reduction steps include octanoic acid fractionation (≥6.4 log10), depth filtration (2.6 log10), and virus filtration (≥5.8 log10). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.
Sources
Privigen Manufacturers
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Csl Behring Ag
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Privigen | Csl Behring Ag
Table 1: Recommended Dosage and Administration for Privigen Indication Dose Initial infusion rate Maintenance infusion rate
(as tolerated) Primary Immunodeficiency 200-800 mg/kg (2-8 mL/kg)
every 3-4 weeks 0.5 mg/kg/min
(0.005 mL/kg/min) Increase to
8 mg/kg/min (0.08 mL/kg/min) Chronic Immune Thrombocytopenic Purpura 1 g/kg (10 mL/kg) for 2 consecutive days 0.5 mg/kg/min
(0.005 mL/kg/min) Increase to
4 mg/kg/min (0.04 mL/kg/min) 2.1 Dosage for Primary Humoral Immunodeficiency (PI)As there are significant differences in the half-life of IgG among patients with PI, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.
The recommended dose of Privigen for patients with PI is 200 to 800 mg/kg (2 to 8 mL/kg), administered every 3 to 4 weeks. If a patient misses a dose, administer the missed dose as soon as possible, and then resume scheduled treatments every 3 or 4 weeks, as applicable.
Adjust the dosage over time to achieve the desired serum IgG trough levels and clinical responses. No randomized, controlled trial data are available to determine an optimal trough level in patients receiving immune globulin therapy.
2.2 Dosage for Chronic Immune Thrombocytopenic Purpura (ITP)The recommended dose of Privigen for patients with chronic ITP is 1 g/kg (10 mL/kg) administered daily for 2 consecutive days, resulting in a total dosage of 2 g/kg.
Carefully consider the relative risks and benefits before prescribing the high dose regimen (e.g., 1 g/kg/day for 2 days) in patients at increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload [see Warnings and Precautions (5.8)].
2.3 Preparation and Handling Privigen is a clear or slightly opalescent, colorless to pale yellow solution. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is cloudy, turbid, or if it contains particulate matter. DO NOT SHAKE. Do not freeze. Do not use if Privigen has been frozen. Privigen should be at room temperature (up to 25ºC [77ºF]) at the time of administration. Do not use Privigen beyond the expiration date on the product label. The Privigen vial is for single-use only. Promptly use any vial that has been entered. Privigen contains no preservative. Discard partially used vials or unused product in accordance with local requirements. Infuse Privigen using a separate infusion line. Prior to use, the infusion line may be flushed with Dextrose Injection, USP (D5W) or 0.9% Sodium Chloride for Injection, USP. Do not mix Privigen with other IGIV products or other intravenous medications. However, Privigen may be diluted with Dextrose Injection, USP (D5W). An infusion pump may be used to control the rate of administration. If large doses of Privigen are to be administered, several vials may be pooled using aseptic technique. Begin infusion within 8 hours of pooling. 2.4 AdministrationPrivigen is for intravenous administration only.
Monitor the patient's 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 lower rate that 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 thrombosis, administer Privigen at the minimum dose and infusion rate practicable, and discontinue Privigen administration if renal function deteriorates [see Boxed Warning, Warnings and Precautions (5.2, 5.3)].
The following patients may be at risk of developing systemic reactions (mimicking symptoms of an inflammatory response or infection) on rapid infusion of Privigen (greater than 4 mg/kg/min [0.04 mL/kg/min]): 1) those who have never received Privigen or another IgG product or who have not received it within the past 8 weeks, and 2) those who are switching from another IgG product. These patients should be started at a slow rate of infusion (e.g., 0.5 mg/kg/min [0.005 mL/kg/min] or less) and gradually increase as tolerated.
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