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RhoGAM (rhod immune globulin human) ® and MICRhoGAM (rhod immune globulin human) ® Rh_o(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 (rhod immune globulin human) 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 (rhod immune globulin human) 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 (rhod immune globulin human) in-house reference standard, the potency of which is established relative to the US/WHO/EP Standard Anti-D Immunoglobulin Rh_o(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 (rhod immune globulin human) /MICRhoGAM (rhod immune globulin human) 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. Rh_o(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 Rh_o(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 Rh_o(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 Rh_o(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 (rhod immune globulin human) /MICRhoGAM (rhod immune globulin human) 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
This monograph has been modified to include the generic and brand name in many instances.