| Clinical data | |
|---|---|
| Pregnancy cat. | C |
| Legal status | ? |
| Routes | intramuscular injection |
| Identifiers | |
| ATC code | J06BB01 |
| Chemical data | |
| Formula | ? |
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Rho(D) Immune Globulin is a medicine given by intramuscular injection that is used to prevent the immunological condition known as Rhesus disease (or hemolytic disease of newborn). The medicine is a solution of IgG anti-D (anti-RhD) antibodies that bind to, and lead to the destruction of, fetal Rh D positive red blood cells that have passed from the fetal circulation to the maternal circulation. Therefore, in a Rhesus negative mother it can prevent sensitization of the maternal immune system to Rh D antigens, which can cause rhesus disease in the current or in subsequent pregnancies. With the widespread use of Rho(D) Immune Globulin, Rh disease of the fetus and newborn has almost disappeared.
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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, 1968 to a woman in Teaneck, NJ.[1]
In 1996 ZLB Bioplasma (part of CSL Behring) was given approval to sell Rhophylac in Europe, and in 2004 Rhophylac was approved in the United States.[2]
Rho(D) Immune Globulin is a derivative of human plasma. In the manufacturing process steps are taken to eliminate bacterial and viral contamination. The most common way anti-D products are manufactured is by a form of the Cohn cold ethanol fractionation method developed in the 1950s. Variations of the Cohn method developed in the 1950s may not completely clear aggregates of immunoglobulins, which can cause problems for patients if administered intravenously, and is a primary reason why most anti-Ds are for intramuscular use only. A non-Cohn manufacturing variation is ChromaPlus process approved by the U.S. Food and Drug Administration (FDA) that is used to make Rhophylac.[3] Rho(D) immune globulin may trigger an allergic reaction, and there is the possibility of transmission of Creutzfeldt-Jakob disease as a residual risk.[4]
The medication has an FDA Pregnancy Category C. It is given by intramuscular injection as part of modern routine antenatal care at about 28 weeks of pregnancy, and within 72 hours after childbirth.[5] It is also given after antenatal pathological events that are likely to cause a feto-maternal hemorrhage.[6]
Infused Rho(D) has also been used with some success in treating chronic idiopathic thrombocytopenic purpura in Rh-positive patients who have not been splenectomized.[7] The mechanism in this case appears to be mainly due to blockade of the reticuloendothelial system, namely by saturating Fcγ receptors in the spleen which are responsible for platelet destruction[8].
Rhophylac manufactured by CSL Limited. RhoGAM and MICRhoGam are brand names of Johnson and Johnson. Other brand names are: BayRHo-D, Gamulin Rh, HypRho-D Mini-Dose, Mini-Gamulin Rh, WinRho SDF (Cangene), Partobulin SDF (Baxter) and Rhesonativ (Octapharma). RhesuGam (NBI)
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