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Rhogam Drug Description
RhoGAM®
Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
DRUG DESCRIPTION



What are the possible side effects of Rho(D) IG?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

fever, chills, or shaking;
urinating less than normal;
a change in color of your urine;
sudden weight gain, swelling in your hands, feet, or ankles;
back pain; or
shortness of breath.

Less serious side...
Read All Potential Side Effects for Rhogam »




RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are
sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (approximately 300 μg or 1500 IU)* to suppress
the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3
A single dose of MICRhoGAM contains sufficient anti-D (approximately 50
μg or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive
red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house
reference standard, the potency of which is established relative to the US/WHO/EP
Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER
Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).
All donors are carefully screened by history and laboratory testing to reduce
the risk of transmitting blood-borne pathogens from infected donors. Fractionation
of the plasma is performed by a modification of the cold alcohol procedure that
has been shown to significantly lower viral titers.4 Following fractionation,
an additional viral-clearance filtration step is incorporated into the manufacturing
process. This filtration step removes viruses via a size-exclusion mechanism
utilizing a patented Viresolve† 180 ultrafiltration membrane with
defined pore-size distribution of 12-18 nanometers. The ultrafiltration step
utilizes tangential flow filtration to permit filtration of IgG while effectively
retarding enveloped and non-enveloped viruses above the pore-size distribution
cutoff. The filter is inert to the product. Non-enveloped viruses are known
to be resistant to chemical and physical inactivation.5,6 Laboratory
spiking studies have shown that the cumulative viral removal capability of the
RhoGAM/MICRhoGAM manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis
B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4
The donor selection process, the fractionation process and the Viresolve
ultrafiltration step are designed to increase product safety by reducing the
risk of transmission of enveloped and non-enveloped viruses. Rho(D)
Immune Globulin (Human) intended for intramuscular use and prepared by cold
alcohol fractionation has not been reported to transmit hepatitis or other infectious
diseases.7
The safety of Rho(D) Immune Globulin (Human) has been further shown
in an empirical study of viral marker rates in female blood donors in the United
States.8 This study revealed that Rh-negative donors, of whom an
estimated 55-60% had received Rho(D) Immune Globulin (Human) for
pregnancy-related indications, had prevalence and incidence viral marker rates
similar to those of Rh-positive female donors who had not received Rho(D)
Immune Globulin (Human). However, even after the fractionation and virus-filtration
steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived
product.
The final product contains approximately 5 ±1% gamma globulin, 2.9 mg/mL sodium
chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically
less than 15 μg per dose, are present.9 The pH range is 6.20-6.55.
The product contains no preservative and utilizes a latex-free delivery system.

REFERENCES
*The anti-D content of RhoGAM/MICRhoGAM is expressed as μg per dose or as
International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.1

†Viresolve is a trademark of Millipore Corporation.
1. Gunson HH, Bowell PJ, Kirkwood TBL. Collaborative study to
recalibrate the International Reference Preparation of anti-D immunoglobulin.
J Clin Pathol 1980;33:249-53.
2. Pollack W, Ascari WQ, Kochesky RJ, O'Connor RR, Ho TY, Tripodi
D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size
of antigenic stimulus. Transfusion 1971;11:333-39.
3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies
on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive
blood. Transfusion 1971;11:340-44.
4. Data on file at Ortho-Clinical Diagnostics, Inc.
5. Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood
products. Vox Sang 1997;72:1-10.
6. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia
N, Ciavarella N, Emerson SU, Purcell RH. Transmission of hepatitis A to patients
with hemophilia by Factor VIII concentrates treated with organic solvent and
detergent to inactivate viruses. Ann Intern Med 1994;120:1-7.
7. Tabor E. The epidemiology of virus transmission by plasma
derivatives: clinical studies verifying the lack of transmission of hepatitis
B and C viruses and HIV type 1. Transfusion 1999;39:1160-68.
8. Watanabe KK, Busch MP, Schreiber GB, Zuck TF. Evaluation
of the safety of Rh Immunoglobulin by monitoring viral markers among Rh-negative
female blood donors. Vox Sang 2000;8:1-6.
9. Data on file at Ortho-Clinical Diagnostics, Inc.Last reviewed on RxList: 5/8/2008




Rhogam Drug Description
RhoGAM®
Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
DRUG DESCRIPTION



What are the possible side effects of Rho(D) IG?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

fever, chills, or shaking;
urinating less than normal;
a change in color of your urine;
sudden weight gain, swelling in your hands, feet, or ankles;
back pain; or
shortness of breath.

Less serious side...
Read All Potential Side Effects for Rhogam »




RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are
sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (approximately 300 μg or 1500 IU)* to suppress
the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3
A single dose of MICRhoGAM contains sufficient anti-D (approximately 50
μg or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive
red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house
reference standard, the potency of which is established relative to the US/WHO/EP
Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER
Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).
All donors are carefully screened by history and laboratory testing to reduce
the risk of transmitting blood-borne pathogens from infected donors. Fractionation
of the plasma is performed by a modification of the cold alcohol procedure that
has been shown to significantly lower viral titers.4 Following fractionation,
an additional viral-clearance filtration step is incorporated into the manufacturing
process. This filtration step removes viruses via a size-exclusion mechanism
utilizing a patented Viresolve† 180 ultrafiltration membrane with
defined pore-size distribution of 12-18 nanometers. The ultrafiltration step
utilizes tangential flow filtration to permit filtration of IgG while effectively
retarding enveloped and non-enveloped viruses above the pore-size distribution
cutoff. The filter is inert to the product. Non-enveloped viruses are known
to be resistant to chemical and physical inactivation.5,6 Laboratory
spiking studies have shown that the cumulative viral removal capability of the
RhoGAM/MICRhoGAM manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis
B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4
The donor selection process, the fractionation process and the Viresolve
ultrafiltration step are designed to increase product safety by reducing the
risk of transmission of enveloped and non-enveloped viruses. Rho(D)
Immune Globulin (Human) intended for intramuscular use and prepared by cold
alcohol fractionation has not been reported to transmit hepatitis or other infectious
diseases.7
The safety of Rho(D) Immune Globulin (Human) has been further shown
in an empirical study of viral marker rates in female blood donors in the United
States.8 This study revealed that Rh-negative donors, of whom an
estimated 55-60% had received Rho(D) Immune Globulin (Human) for
pregnancy-related indications, had prevalence and incidence viral marker rates
similar to those of Rh-positive female donors who had not received Rho(D)
Immune Globulin (Human). However, even after the fractionation and virus-filtration
steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived
product.
The final product contains approximately 5 ±1% gamma globulin, 2.9 mg/mL sodium
chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically
less than 15 μg per dose, are present.9 The pH range is 6.20-6.55.
The product contains no preservative and utilizes a latex-free delivery system.

REFERENCES
*The anti-D content of RhoGAM/MICRhoGAM is expressed as μg per dose or as
International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.1

†Viresolve is a trademark of Millipore Corporation.
1. Gunson HH, Bowell PJ, Kirkwood TBL. Collaborative study to
recalibrate the International Reference Preparation of anti-D immunoglobulin.
J Clin Pathol 1980;33:249-53.
2. Pollack W, Ascari WQ, Kochesky RJ, O'Connor RR, Ho TY, Tripodi
D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size
of antigenic stimulus. Transfusion 1971;11:333-39.
3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies
on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive
blood. Transfusion 1971;11:340-44.
4. Data on file at Ortho-Clinical Diagnostics, Inc.
5. Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood
products. Vox Sang 1997;72:1-10.
6. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia
N, Ciavarella N, Emerson SU, Purcell RH. Transmission of hepatitis A to patients
with hemophilia by Factor VIII concentrates treated with organic solvent and
detergent to inactivate viruses. Ann Intern Med 1994;120:1-7.
7. Tabor E. The epidemiology of virus transmission by plasma
derivatives: clinical studies verifying the lack of transmission of hepatitis
B and C viruses and HIV type 1. Transfusion 1999;39:1160-68.
8. Watanabe KK, Busch MP, Schreiber GB, Zuck TF. Evaluation
of the safety of Rh Immunoglobulin by monitoring viral markers among Rh-negative
female blood donors. Vox Sang 2000;8:1-6.
9. Data on file at Ortho-Clinical Diagnostics, Inc.Last reviewed on RxList: 5/8/2008




Rhogam Drug Description
RhoGAM®
Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
DRUG DESCRIPTION



What are the possible side effects of Rho(D) IG?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

fever, chills, or shaking;
urinating less than normal;
a change in color of your urine;
sudden weight gain, swelling in your hands, feet, or ankles;
back pain; or
shortness of breath.

Less serious side...
Read All Potential Side Effects for Rhogam »




RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are
sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (approximately 300 μg or 1500 IU)* to suppress
the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3
A single dose of MICRhoGAM contains sufficient anti-D (approximately 50
μg or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive
red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house
reference standard, the potency of which is established relative to the US/WHO/EP
Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER
Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).
All donors are carefully screened by history and laboratory testing to reduce
the risk of transmitting blood-borne pathogens from infected donors. Fractionation
of the plasma is performed by a modification of the cold alcohol procedure that
has been shown to significantly lower viral titers.4 Following fractionation,
an additional viral-clearance filtration step is incorporated into the manufacturing
process. This filtration step removes viruses via a size-exclusion mechanism
utilizing a patented Viresolve† 180 ultrafiltration membrane with
defined pore-size distribution of 12-18 nanometers. The ultrafiltration step
utilizes tangential flow filtration to permit filtration of IgG while effectively
retarding enveloped and non-enveloped viruses above the pore-size distribution
cutoff. The filter is inert to the product. Non-enveloped viruses are known
to be resistant to chemical and physical inactivation.5,6 Laboratory
spiking studies have shown that the cumulative viral removal capability of the
RhoGAM/MICRhoGAM manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis
B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4
The donor selection process, the fractionation process and the Viresolve
ultrafiltration step are designed to increase product safety by reducing the
risk of transmission of enveloped and non-enveloped viruses. Rho(D)
Immune Globulin (Human) intended for intramuscular use and prepared by cold
alcohol fractionation has not been reported to transmit hepatitis or other infectious
diseases.7
The safety of Rho(D) Immune Globulin (Human) has been further shown
in an empirical study of viral marker rates in female blood donors in the United
States.8 This study revealed that Rh-negative donors, of whom an
estimated 55-60% had received Rho(D) Immune Globulin (Human) for
pregnancy-related indications, had prevalence and incidence viral marker rates
similar to those of Rh-positive female donors who had not received Rho(D)
Immune Globulin (Human). However, even after the fractionation and virus-filtration
steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived
product.
The final product contains approximately 5 ±1% gamma globulin, 2.9 mg/mL sodium
chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically
less than 15 μg per dose, are present.9 The pH range is 6.20-6.55.
The product contains no preservative and utilizes a latex-free delivery system.

REFERENCES
*The anti-D content of RhoGAM/MICRhoGAM is expressed as μg per dose or as
International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.1

†Viresolve is a trademark of Millipore Corporation.
1. Gunson HH, Bowell PJ, Kirkwood TBL. Collaborative study to
recalibrate the International Reference Preparation of anti-D immunoglobulin.
J Clin Pathol 1980;33:249-53.
2. Pollack W, Ascari WQ, Kochesky RJ, O'Connor RR, Ho TY, Tripodi
D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size
of antigenic stimulus. Transfusion 1971;11:333-39.
3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies
on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive
blood. Transfusion 1971;11:340-44.
4. Data on file at Ortho-Clinical Diagnostics, Inc.
5. Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood
products. Vox Sang 1997;72:1-10.
6. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia
N, Ciavarella N, Emerson SU, Purcell RH. Transmission of hepatitis A to patients
with hemophilia by Factor VIII concentrates treated with organic solvent and
detergent to inactivate viruses. Ann Intern Med 1994;120:1-7.
7. Tabor E. The epidemiology of virus transmission by plasma
derivatives: clinical studies verifying the lack of transmission of hepatitis
B and C viruses and HIV type 1. Transfusion 1999;39:1160-68.
8. Watanabe KK, Busch MP, Schreiber GB, Zuck TF. Evaluation
of the safety of Rh Immunoglobulin by monitoring viral markers among Rh-negative
female blood donors. Vox Sang 2000;8:1-6.
9. Data on file at Ortho-Clinical Diagnostics, Inc.Last reviewed on RxList: 5/8/2008




Rhogam Drug Description
RhoGAM®
Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
DRUG DESCRIPTION



What are the possible side effects of Rho(D) IG?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

fever, chills, or shaking;
urinating less than normal;
a change in color of your urine;
sudden weight gain, swelling in your hands, feet, or ankles;
back pain; or
shortness of breath.

Less serious side...
Read All Potential Side Effects for Rhogam »




RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are
sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (approximately 300 μg or 1500 IU)* to suppress
the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3
A single dose of MICRhoGAM contains sufficient anti-D (approximately 50
μg or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive
red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house
reference standard, the potency of which is established relative to the US/WHO/EP
Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER
Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).
All donors are carefully screened by history and laboratory testing to reduce
the risk of transmitting blood-borne pathogens from infected donors. Fractionation
of the plasma is performed by a modification of the cold alcohol procedure that
has been shown to significantly lower viral titers.4 Following fractionation,
an additional viral-clearance filtration step is incorporated into the manufacturing
process. This filtration step removes viruses via a size-exclusion mechanism
utilizing a patented Viresolve† 180 ultrafiltration membrane with
defined pore-size distribution of 12-18 nanometers. The ultrafiltration step
utilizes tangential flow filtration to permit filtration of IgG while effectively
retarding enveloped and non-enveloped viruses above the pore-size distribution
cutoff. The filter is inert to the product. Non-enveloped viruses are known
to be resistant to chemical and physical inactivation.5,6 Laboratory
spiking studies have shown that the cumulative viral removal capability of the
RhoGAM/MICRhoGAM manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis
B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4
The donor selection process, the fractionation process and the Viresolve
ultrafiltration step are designed to increase product safety by reducing the
risk of transmission of enveloped and non-enveloped viruses. Rho(D)
Immune Globulin (Human) intended for intramuscular use and prepared by cold
alcohol fractionation has not been reported to transmit hepatitis or other infectious
diseases.7
The safety of Rho(D) Immune Globulin (Human) has been further shown
in an empirical study of viral marker rates in female blood donors in the United
States.8 This study revealed that Rh-negative donors, of whom an
estimated 55-60% had received Rho(D) Immune Globulin (Human) for
pregnancy-related indications, had prevalence and incidence viral marker rates
similar to those of Rh-positive female donors who had not received Rho(D)
Immune Globulin (Human). However, even after the fractionation and virus-filtration
steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived
product.
The final product contains approximately 5 ±1% gamma globulin, 2.9 mg/mL sodium
chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically
less than 15 μg per dose, are present.9 The pH range is 6.20-6.55.
The product contains no preservative and utilizes a latex-free delivery system.

REFERENCES
*The anti-D content of RhoGAM/MICRhoGAM is expressed as μg per dose or as
International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.1

†Viresolve is a trademark of Millipore Corporation.
1. Gunson HH, Bowell PJ, Kirkwood TBL. Collaborative study to
recalibrate the International Reference Preparation of anti-D immunoglobulin.
J Clin Pathol 1980;33:249-53.
2. Pollack W, Ascari WQ, Kochesky RJ, O'Connor RR, Ho TY, Tripodi
D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size
of antigenic stimulus. Transfusion 1971;11:333-39.
3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies
on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive
blood. Transfusion 1971;11:340-44.
4. Data on file at Ortho-Clinical Diagnostics, Inc.
5. Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood
products. Vox Sang 1997;72:1-10.
6. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia
N, Ciavarella N, Emerson SU, Purcell RH. Transmission of hepatitis A to patients
with hemophilia by Factor VIII concentrates treated with organic solvent and
detergent to inactivate viruses. Ann Intern Med 1994;120:1-7.
7. Tabor E. The epidemiology of virus transmission by plasma
derivatives: clinical studies verifying the lack of transmission of hepatitis
B and C viruses and HIV type 1. Transfusion 1999;39:1160-68.
8. Watanabe KK, Busch MP, Schreiber GB, Zuck TF. Evaluation
of the safety of Rh Immunoglobulin by monitoring viral markers among Rh-negative
female blood donors. Vox Sang 2000;8:1-6.
9. Data on file at Ortho-Clinical Diagnostics, Inc.Last reviewed on RxList: 5/8/2008




Rhogam Drug Description
RhoGAM®
Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
DRUG DESCRIPTION



What are the possible side effects of Rho(D) IG?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

fever, chills, or shaking;
urinating less than normal;
a change in color of your urine;
sudden weight gain, swelling in your hands, feet, or ankles;
back pain; or
shortness of breath.

Less serious side...
Read All Potential Side Effects for Rhogam »




RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are
sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (approximately 300 μg or 1500 IU)* to suppress
the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3
A single dose of MICRhoGAM contains sufficient anti-D (approximately 50
μg or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive
red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house
reference standard, the potency of which is established relative to the US/WHO/EP
Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER
Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).
All donors are carefully screened by history and laboratory testing to reduce
the risk of transmitting blood-borne pathogens from infected donors. Fractionation
of the plasma is performed by a modification of the cold alcohol procedure that
has been shown to significantly lower viral titers.4 Following fractionation,
an additional viral-clearance filtration step is incorporated into the manufacturing
process. This filtration step removes viruses via a size-exclusion mechanism
utilizing a patented Viresolve† 180 ultrafiltration membrane with
defined pore-size distribution of 12-18 nanometers. The ultrafiltration step
utilizes tangential flow filtration to permit filtration of IgG while effectively
retarding enveloped and non-enveloped viruses above the pore-size distribution
cutoff. The filter is inert to the product. Non-enveloped viruses are known
to be resistant to chemical and physical inactivation.5,6 Laboratory
spiking studies have shown that the cumulative viral removal capability of the
RhoGAM/MICRhoGAM manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis
B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4
The donor selection process, the fractionation process and the Viresolve
ultrafiltration step are designed to increase product safety by reducing the
risk of transmission of enveloped and non-enveloped viruses. Rho(D)
Immune Globulin (Human) intended for intramuscular use and prepared by cold
alcohol fractionation has not been reported to transmit hepatitis or other infectious
diseases.7
The safety of Rho(D) Immune Globulin (Human) has been further shown
in an empirical study of viral marker rates in female blood donors in the United
States.8 This study revealed that Rh-negative donors, of whom an
estimated 55-60% had received Rho(D) Immune Globulin (Human) for
pregnancy-related indications, had prevalence and incidence viral marker rates
similar to those of Rh-positive female donors who had not received Rho(D)
Immune Globulin (Human). However, even after the fractionation and virus-filtration
steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived
product.
The final product contains approximately 5 ±1% gamma globulin, 2.9 mg/mL sodium
chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically
less than 15 μg per dose, are present.9 The pH range is 6.20-6.55.
The product contains no preservative and utilizes a latex-free delivery system.

REFERENCES
*The anti-D content of RhoGAM/MICRhoGAM is expressed as μg per dose or as
International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.1

†Viresolve is a trademark of Millipore Corporation.
1. Gunson HH, Bowell PJ, Kirkwood TBL. Collaborative study to
recalibrate the International Reference Preparation of anti-D immunoglobulin.
J Clin Pathol 1980;33:249-53.
2. Pollack W, Ascari WQ, Kochesky RJ, O'Connor RR, Ho TY, Tripodi
D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size
of antigenic stimulus. Transfusion 1971;11:333-39.
3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies
on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive
blood. Transfusion 1971;11:340-44.
4. Data on file at Ortho-Clinical Diagnostics, Inc.
5. Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood
products. Vox Sang 1997;72:1-10.
6. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia
N, Ciavarella N, Emerson SU, Purcell RH. Transmission of hepatitis A to patients
with hemophilia by Factor VIII concentrates treated with organic solvent and
detergent to inactivate viruses. Ann Intern Med 1994;120:1-7.
7. Tabor E. The epidemiology of virus transmission by plasma
derivatives: clinical studies verifying the lack of transmission of hepatitis
B and C viruses and HIV type 1. Transfusion 1999;39:1160-68.
8. Watanabe KK, Busch MP, Schreiber GB, Zuck TF. Evaluation
of the safety of Rh Immunoglobulin by monitoring viral markers among Rh-negative
female blood donors. Vox Sang 2000;8:1-6.
9. Data on file at Ortho-Clinical Diagnostics, Inc.Last reviewed on RxList: 5/8/2008





Other reviews about Rhogam on wordpress

Friday Terror Watch: Rhogam
  by aliasmother
I should really call this "Friday Pissed-Off Watch," because this time it's personal.  Really personal.  And not at all funny. There's a unique situation that some women, myself included, […]


RhoGAM update: Let's all exhale
  by aliasmother
Okie-dokie.  I've had some time to poke around and weigh the evidence.  Never one to want to throw red meat to the overreactive wolves, I wanted to make […]


Rhogam...
  by shraders
Rhogam shots...good or bad during pregnancy?  Click here to check out some very interesting information about Rhogam vaccines in Rh- women during pregnancy.  Until about 2001, each Rhogam […]


A Rhogam fairytale
  by thecarrawayseed
I may have previously mentioned this, but I discovered reasonably early in pregnancy that my blood type is O-, and not long after that, we learned Devin is […]


Rhogam Me!
  by fromasesameseed
Operation Rhogam shot is complete. Let me just say this, and I by no means intend to insult Jordan Hospital or anyone born/given birth there. I am really glad I […]


Rh Factor - The Truth About Rh & Pregnancy
  by theCmom
(Rh Factor or Rhogam - click here for an updated post)  and for an explanation of what Rh means, click here - A friend of mine did alot of research […]


From Rhogam to Rabies
  by jmliz
Today was rather busy, with classes all morning, a big shopping trip to a Target-like store here to stock up this afternoon, followed by a doctor's appointment for […]


Rhogam shot scare
  by Mrs. Velvetcake
I knew my blood type was X- negative.   One long ago summer, I was stuck with jury duty.  To cut time and also miss the chance of being […]


Rh Factor - RhoGam - 28 weeks
  by theCmom
Rh Factor. Rhogam. Testing. Rh - Negative...   If you have not read my post about explaining the Rh Factor and whether or not you need to get the […]


Rh factor and Rhogam.
  by yourdailydoula
I get asked what being "Rh positive" means a lot. It's rather complicated with different blood types and all but the basics of it are simple enough. When you […]



Other reviews about Rhogam on web:

Official site from Ortho-Clinical Diagnostics. Includes patient and prescribing information. The Official RhoGAM® Brand Site


The first Rho(D) Immune Globulin treatment "RhoGAM" was introduced by Ortho-Clinical Diagnostics, a subsidiary holding of Johnson and Johnson, and was first administered on May 29 ... Rho(D) immune globulin - Wikipedia, the free encyclopedia


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


Learn about the RhoGAM shot, its side effects, and the concerns over thimerosal. Find information about RhoGAM injuries and thimerosal RhoGAM FYI - RhoGAM injection and RhoGAM side effects


All about RhoGAM. View complete and up to date RhoGAM information - part of the Drugs.com trusted medication database. RhoGAM Facts and Comparisons at Drugs.com


What does it mean to be Rh-negative? What does “Rh” stand for? Why do I need RhoGAM ® Ultra-Filtered PLUS? What kind of problems might I have during pregnancy because I’m Rh ... The Official RhoGAM® Site – Frequently asked questions


Online Medical Dictionary and glossary with medical definitions Rhogam definition - Medical Dictionary definitions of popular ...


Physician reviewed RhoGAM (injectable) patient information - includes RhoGAM description, dosage and directions. RhoGAM (injectable) medical facts from Drugs.com


Rhogam and Pregnancy Stealth Mercury Assault By Stephen C. Marini, D.C., PhC There have been far too many moms at my seminars the last 3 months reacting with alarm, surprise and ... Rhogam


RhoGAM is an immune globulin injection given after a birth or miscarriage to women who are Rh negative in order to prevent later pregnancy complications. RhoGAM Definition - Rho(D) Immune Globulin Glossary Definition





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