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Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM (rhod immune globulin human) ®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
RhoGAM (rhod immune globulin human) ® and MICRhoGAM (rhod immune globulin human) ® 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 (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 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 (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. 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.
*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.
Additional Rhogam Information
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