Reviews Privigen


No reviews yet.

Privigen Drug Description
Privigen™
Immune Globulin Intravenous (Human), 10% Liquid

WARNING
ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Immune Globulin Intravenous (Human) (IGIV) products have been reported
to be associated with renal dysfunction, acute renal failure, osmotic nephrosis,
and death.1 Patients predisposed to acute renal failure include
patients with any degree of pre-existing renal insufficiency, diabetes mellitus,
age greater than 65, volume depletion, sepsis, paraproteinemia, or patients
receiving known nephrotoxic drugs. In such patients, IGIV products should
be administered at the minimum rate of infusion practicable. While these reports
of renal dysfunction and acute renal failure have been associated with the
use of many of the licensed IGIV products, those containing sucrose as a stabilizer
accounted for a disproportionate share of the total number. Privigen™
does not contain sucrose. (See DOSAGE AND ADMINISTRATION
and WARNINGS and PRECAUTIONS
for important information intended to reduce the risk of acute renal failure.)


DRUG DESCRIPTION
Privigen™ is a ready-to-use, sterile, 10% protein liquid preparation
of polyvalent human immunoglobulin G (IgG) for intravenous administration. 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.
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.

All plasma units used in the manufacture of Privigen™ are tested using
FDA-licensed serological assays for hepatitis B surface antigen and antibodies
to HCV and HIV-½ as well as FDA-licensed Nucleic Acid Testing (NAT) for HCV
and HIV-1 and found to be nonreactive (negative). For HBV, an investigational
NAT procedure is used and the plasma units found to be negative; however, the
significance of a negative result has not been established.
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 3 shows the virus clearance during the manufacturing
process for Privigen™, expressed as the mean log10 reduction factor (LRF).

Table 3: Virus Inactivation/Removal in Privigen™




 
HIV-1
PRV
BVDV
WNV
EMCV
MVM


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
nd
≥ 2.7
≥ 5.9
≥ 3.7
≥ 5.5


Overall reduction (log10 units)
≥ 16.0
≥ 12.2
≥ 9.4
≥ 16.7
≥ 7.9
≥ 7.8


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; nd, not determined; nt, not tested.



The manufacturing process was also investigated for its capacity to decrease
the infectivity of an experimental agent of TSE, considered a model for CJD
and its variant vCJD.16 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.
REFERENCES
1. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after
intravenous immune globulin therapy: a report of two cases and an analysis of
the literature. J Am Soc Nephrol 1997;8:1788-1793.
16. Gregori L, Maring J-A, MacAuley C, Stühler A, Löwer J, Blümel
J. Partitioning of TSE infectivity during ethanol fractionation of human plasma.
Biologicals 2004;32:1-10.
Last reviewed on RxList: 8/27/2007




Privigen Drug Description
Privigen™
Immune Globulin Intravenous (Human), 10% Liquid

WARNING
ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Immune Globulin Intravenous (Human) (IGIV) products have been reported
to be associated with renal dysfunction, acute renal failure, osmotic nephrosis,
and death.1 Patients predisposed to acute renal failure include
patients with any degree of pre-existing renal insufficiency, diabetes mellitus,
age greater than 65, volume depletion, sepsis, paraproteinemia, or patients
receiving known nephrotoxic drugs. In such patients, IGIV products should
be administered at the minimum rate of infusion practicable. While these reports
of renal dysfunction and acute renal failure have been associated with the
use of many of the licensed IGIV products, those containing sucrose as a stabilizer
accounted for a disproportionate share of the total number. Privigen™
does not contain sucrose. (See DOSAGE AND ADMINISTRATION
and WARNINGS and PRECAUTIONS
for important information intended to reduce the risk of acute renal failure.)


DRUG DESCRIPTION
Privigen™ is a ready-to-use, sterile, 10% protein liquid preparation
of polyvalent human immunoglobulin G (IgG) for intravenous administration. 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.
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.

All plasma units used in the manufacture of Privigen™ are tested using
FDA-licensed serological assays for hepatitis B surface antigen and antibodies
to HCV and HIV-½ as well as FDA-licensed Nucleic Acid Testing (NAT) for HCV
and HIV-1 and found to be nonreactive (negative). For HBV, an investigational
NAT procedure is used and the plasma units found to be negative; however, the
significance of a negative result has not been established.
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 3 shows the virus clearance during the manufacturing
process for Privigen™, expressed as the mean log10 reduction factor (LRF).

Table 3: Virus Inactivation/Removal in Privigen™




 
HIV-1
PRV
BVDV
WNV
EMCV
MVM


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
nd
≥ 2.7
≥ 5.9
≥ 3.7
≥ 5.5


Overall reduction (log10 units)
≥ 16.0
≥ 12.2
≥ 9.4
≥ 16.7
≥ 7.9
≥ 7.8


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; nd, not determined; nt, not tested.



The manufacturing process was also investigated for its capacity to decrease
the infectivity of an experimental agent of TSE, considered a model for CJD
and its variant vCJD.16 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.
REFERENCES
1. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after
intravenous immune globulin therapy: a report of two cases and an analysis of
the literature. J Am Soc Nephrol 1997;8:1788-1793.
16. Gregori L, Maring J-A, MacAuley C, Stühler A, Löwer J, Blümel
J. Partitioning of TSE infectivity during ethanol fractionation of human plasma.
Biologicals 2004;32:1-10.
Last reviewed on RxList: 8/27/2007




Privigen Drug Description
Privigen™
Immune Globulin Intravenous (Human), 10% Liquid

WARNING
ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Immune Globulin Intravenous (Human) (IGIV) products have been reported
to be associated with renal dysfunction, acute renal failure, osmotic nephrosis,
and death.1 Patients predisposed to acute renal failure include
patients with any degree of pre-existing renal insufficiency, diabetes mellitus,
age greater than 65, volume depletion, sepsis, paraproteinemia, or patients
receiving known nephrotoxic drugs. In such patients, IGIV products should
be administered at the minimum rate of infusion practicable. While these reports
of renal dysfunction and acute renal failure have been associated with the
use of many of the licensed IGIV products, those containing sucrose as a stabilizer
accounted for a disproportionate share of the total number. Privigen™
does not contain sucrose. (See DOSAGE AND ADMINISTRATION
and WARNINGS and PRECAUTIONS
for important information intended to reduce the risk of acute renal failure.)


DRUG DESCRIPTION
Privigen™ is a ready-to-use, sterile, 10% protein liquid preparation
of polyvalent human immunoglobulin G (IgG) for intravenous administration. 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.
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.

All plasma units used in the manufacture of Privigen™ are tested using
FDA-licensed serological assays for hepatitis B surface antigen and antibodies
to HCV and HIV-½ as well as FDA-licensed Nucleic Acid Testing (NAT) for HCV
and HIV-1 and found to be nonreactive (negative). For HBV, an investigational
NAT procedure is used and the plasma units found to be negative; however, the
significance of a negative result has not been established.
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 3 shows the virus clearance during the manufacturing
process for Privigen™, expressed as the mean log10 reduction factor (LRF).

Table 3: Virus Inactivation/Removal in Privigen™




 
HIV-1
PRV
BVDV
WNV
EMCV
MVM


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
nd
≥ 2.7
≥ 5.9
≥ 3.7
≥ 5.5


Overall reduction (log10 units)
≥ 16.0
≥ 12.2
≥ 9.4
≥ 16.7
≥ 7.9
≥ 7.8


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; nd, not determined; nt, not tested.



The manufacturing process was also investigated for its capacity to decrease
the infectivity of an experimental agent of TSE, considered a model for CJD
and its variant vCJD.16 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.
REFERENCES
1. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after
intravenous immune globulin therapy: a report of two cases and an analysis of
the literature. J Am Soc Nephrol 1997;8:1788-1793.
16. Gregori L, Maring J-A, MacAuley C, Stühler A, Löwer J, Blümel
J. Partitioning of TSE infectivity during ethanol fractionation of human plasma.
Biologicals 2004;32:1-10.
Last reviewed on RxList: 8/27/2007




Privigen Drug Description
Privigen™
Immune Globulin Intravenous (Human), 10% Liquid

WARNING
ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Immune Globulin Intravenous (Human) (IGIV) products have been reported
to be associated with renal dysfunction, acute renal failure, osmotic nephrosis,
and death.1 Patients predisposed to acute renal failure include
patients with any degree of pre-existing renal insufficiency, diabetes mellitus,
age greater than 65, volume depletion, sepsis, paraproteinemia, or patients
receiving known nephrotoxic drugs. In such patients, IGIV products should
be administered at the minimum rate of infusion practicable. While these reports
of renal dysfunction and acute renal failure have been associated with the
use of many of the licensed IGIV products, those containing sucrose as a stabilizer
accounted for a disproportionate share of the total number. Privigen™
does not contain sucrose. (See DOSAGE AND ADMINISTRATION
and WARNINGS and PRECAUTIONS
for important information intended to reduce the risk of acute renal failure.)


DRUG DESCRIPTION
Privigen™ is a ready-to-use, sterile, 10% protein liquid preparation
of polyvalent human immunoglobulin G (IgG) for intravenous administration. 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.
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.

All plasma units used in the manufacture of Privigen™ are tested using
FDA-licensed serological assays for hepatitis B surface antigen and antibodies
to HCV and HIV-½ as well as FDA-licensed Nucleic Acid Testing (NAT) for HCV
and HIV-1 and found to be nonreactive (negative). For HBV, an investigational
NAT procedure is used and the plasma units found to be negative; however, the
significance of a negative result has not been established.
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 3 shows the virus clearance during the manufacturing
process for Privigen™, expressed as the mean log10 reduction factor (LRF).

Table 3: Virus Inactivation/Removal in Privigen™




 
HIV-1
PRV
BVDV
WNV
EMCV
MVM


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
nd
≥ 2.7
≥ 5.9
≥ 3.7
≥ 5.5


Overall reduction (log10 units)
≥ 16.0
≥ 12.2
≥ 9.4
≥ 16.7
≥ 7.9
≥ 7.8


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; nd, not determined; nt, not tested.



The manufacturing process was also investigated for its capacity to decrease
the infectivity of an experimental agent of TSE, considered a model for CJD
and its variant vCJD.16 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.
REFERENCES
1. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after
intravenous immune globulin therapy: a report of two cases and an analysis of
the literature. J Am Soc Nephrol 1997;8:1788-1793.
16. Gregori L, Maring J-A, MacAuley C, Stühler A, Löwer J, Blümel
J. Partitioning of TSE infectivity during ethanol fractionation of human plasma.
Biologicals 2004;32:1-10.
Last reviewed on RxList: 8/27/2007




Privigen Drug Description
Privigen™
Immune Globulin Intravenous (Human), 10% Liquid

WARNING
ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Immune Globulin Intravenous (Human) (IGIV) products have been reported
to be associated with renal dysfunction, acute renal failure, osmotic nephrosis,
and death.1 Patients predisposed to acute renal failure include
patients with any degree of pre-existing renal insufficiency, diabetes mellitus,
age greater than 65, volume depletion, sepsis, paraproteinemia, or patients
receiving known nephrotoxic drugs. In such patients, IGIV products should
be administered at the minimum rate of infusion practicable. While these reports
of renal dysfunction and acute renal failure have been associated with the
use of many of the licensed IGIV products, those containing sucrose as a stabilizer
accounted for a disproportionate share of the total number. Privigen™
does not contain sucrose. (See DOSAGE AND ADMINISTRATION
and WARNINGS and PRECAUTIONS
for important information intended to reduce the risk of acute renal failure.)


DRUG DESCRIPTION
Privigen™ is a ready-to-use, sterile, 10% protein liquid preparation
of polyvalent human immunoglobulin G (IgG) for intravenous administration. 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.
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.

All plasma units used in the manufacture of Privigen™ are tested using
FDA-licensed serological assays for hepatitis B surface antigen and antibodies
to HCV and HIV-½ as well as FDA-licensed Nucleic Acid Testing (NAT) for HCV
and HIV-1 and found to be nonreactive (negative). For HBV, an investigational
NAT procedure is used and the plasma units found to be negative; however, the
significance of a negative result has not been established.
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 3 shows the virus clearance during the manufacturing
process for Privigen™, expressed as the mean log10 reduction factor (LRF).

Table 3: Virus Inactivation/Removal in Privigen™




 
HIV-1
PRV
BVDV
WNV
EMCV
MVM


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
nd
≥ 2.7
≥ 5.9
≥ 3.7
≥ 5.5


Overall reduction (log10 units)
≥ 16.0
≥ 12.2
≥ 9.4
≥ 16.7
≥ 7.9
≥ 7.8


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; nd, not determined; nt, not tested.



The manufacturing process was also investigated for its capacity to decrease
the infectivity of an experimental agent of TSE, considered a model for CJD
and its variant vCJD.16 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.
REFERENCES
1. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after
intravenous immune globulin therapy: a report of two cases and an analysis of
the literature. J Am Soc Nephrol 1997;8:1788-1793.
16. Gregori L, Maring J-A, MacAuley C, Stühler A, Löwer J, Blümel
J. Partitioning of TSE infectivity during ethanol fractionation of human plasma.
Biologicals 2004;32:1-10.
Last reviewed on RxList: 8/27/2007





Other reviews about Privigen on wordpress

CSL Behring Announces FDA Approval of Privigen-- First Proline-Stabilized 10 Percent Liquid IVIg
  by scidstuff
CSL Behring Announces FDA Approval of Privigen-- First Proline-Stabilized 10 Percent Liquid IVIg KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Jul 27, 2007 - CSL Behring (ASX: CSL) today announced that the […]


Study Shows Privigenâ„¢10% Liquid Immunoglobulin Preparation for Intravenous Use, Is an Effective Replacement Therapy in Patients with Primary Immune Deficiencies
  by scidstuff
March 17, 2008 10:46 AM Eastern Daylight Time Study Shows Privigenâ„¢10% Liquid Immunoglobulin Preparation for Intravenous Use, Is an Effective Replacement Therapy in Patients with Primary Immune […]


A Drug By Any Other Name
  by sdutchen
Viagra suggests vigor and virility and evokes the forceful flow of Niagara Falls. Zyrtec and Nexium feature fricatives that imply speed and advanced technology. Lipitor capitalizes on the […]


Baxter Analysis
  by jamesspada
I. Current Situation A. Current Performance Net Sales Baxter had a 2% increase over 2008 net sales, as the company brought in $12.6 billion during 2009.(Baxter, 2010(a)) US sales were […]


Portfolio
  by kendalbrown
The following are various examples of my professional work. For more information or to view more samples please contact me. All work is copyrighted material. RustedBlue Active Community Wellness CSL Behring : […]


CSL Behring : Privigen
  by kendalbrown
Client : CSL Behring - Privigen For two+ years I worked on a marketing team to integrate the Privigen branding throughout all marketing materials for any and all US […]



Other reviews about Privigen on web:

Get professional information about Privigen®, the first and only intravenous liquid immunoglobulin (Ig) therapy made with proline. Immune Globulin Intravenous (IVIG) Therapy | Privigen®


Learn about the prescription medication Privigen (Immune Globulin Intravenous), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Privigen (Immune Globulin Intravenous) Drug Information: Uses ...


Privigen information from Drugs.com, includes Privigen side effects, interactions and indications. Privigen Information from Drugs.com


Accurate, FDA approved Privigen information for healthcare professionals and patients - brought to you by Drugs.com. Privigen Official FDA information, side effects and uses.


Get full Privigen® prescribing information. ... Privigen Prescribing Information. Download the complete Prescribing Information. Privigen® Prescribing Information


Privigen is indicated for the treatment of patients with primary immunodeficiency (PI) associated with defects in humoral immunity, including but not limited to common variable ... Privigen: treatment of primary immunodeficiency and chronic immune ...


CSL Behring Immune Globulin Intravenous (Human), 10% Liquid Privigen ™ US Package Insert July 2007 Page 1 GRDCP2/IMMUNE GLOBULIN INTRAVENOUS (HUMAN)\IG PRO10\MANUSCRIPTS\PACKAGEINSERT ... Immune Globulin Intravenous (Human), 10% Liquid (Privigen ...


What is Privigen? Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from ... Privigen - Drugs & Treatments - Revolution Health


Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases. Privigen Information - Drugs and Treatments - MedHelp


PRIVIGEN (Immune globulin) drug information for Immunomodulators from MPR including side effects, drug interactions, dosing, contraindications and warnings/precautions. PRIVIGEN (Immune globulin) drug information from MPR





Featured Reviews

Reviews Seconal Sodium

Seconal Sodium Drug Description SECONAL SODIUM® (secobarbital sodium) Capsules, USP DRUG DESCRIPTION What are the possible side effects of secobarbital (Seconal Sodium)? Secobarbital may cause a severe allergic reaction. Stop...
Read More  |  Review This
Reviews Betapace AF

Betapace AF Drug Description BETAPACE® AF (sotalol HCL) To minimize the risk of induced arrhythmia, patients initiated or re-initiated on BETAPACE AF® should be placed for a minimum of three days (on their maintenance...
Read More  |  Review This
Reviews Calcitriol Ointment

Vectical Ointment Drug Description VECTICAL (calcitriol) Ointment 3 mcg/g For topical use only DRUG DESCRIPTION What are the possible side effects of calcitriol topical (Vectical)? Get emergency medical help if you have any...
Read More  |  Review This
Reviews Clobetasol Propionate

Olux Drug Description Olux (clobetasol propionate) Foam, 0.05% For Dermatologic Use Only Not for Ophthalmic Use DRUG DESCRIPTION What are the possible side effects of clobetasol topical? Get emergency medical help if you have...
Read More  |  Review This
Reviews Doxazosin Mesylate

Cardura Drug Description CARDURA® (doxazosin mesylate) Tablets DRUG DESCRIPTION What are the possible side effects of doxazosin (Cardura, Cardura XL)? Get emergency medical help if you have any of these signs of an allergic...
Read More  |  Review This
Recent News
59sec - the BEST lead management system around!
We tested 59sec - THE lead management system and we love it. 59sec helps small and medium companies to answer leads in maximum 59 seconds. Why...
MOVEorPAY - our favorite facebook app
We do love MOVEorPAY motivational facebook app, because it is very cool and useful. It makes you finish stuff that you know are good for you, but from various reasons, you never do...
ReviewsAZ is almost ready to be officially launched
yes, we have just a few loose ends to tie and we are ready to go :) meanwhile, I am putting some reviews on the site, so people will not get an empty site at the launch....