Rho(D) Immune Globulin
Encyclopedia
Rho 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 antigen
s, 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.
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.
. 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. Rho(D) immune globulin may trigger an allergic reaction, and there is the possibility of transmission of Creutzfeldt-Jakob disease
as a residual risk.
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. It is also given after antenatal pathological events that are likely to cause a feto-maternal hemorrhage.
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
. 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.
) and Rhesonativ (Octapharma).
RhesuGam (NBI)
Antibody
An antibody, also known as an immunoglobulin, is a large Y-shaped protein used by the immune system to identify and neutralize foreign objects such as bacteria and viruses. The antibody recognizes a unique part of the foreign target, termed an antigen...
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 antigen
Antigen
An antigen is a foreign molecule that, when introduced into the body, triggers the production of an antibody by the immune system. The immune system will then kill or neutralize the antigen that is recognized as a foreign and potentially harmful invader. These invaders can be molecules such as...
s, which can cause rhesus disease in the current or in subsequent pregnancies. With the widespread use of Rho(D) Immune Globulin, Rh disease
Rh disease
Rh disease is one of the causes of hemolytic disease of the newborn...
of the fetus
Fetus
A fetus is a developing mammal or other viviparous vertebrate after the embryonic stage and before birth.In humans, the fetal stage of prenatal development starts at the beginning of the 11th week in gestational age, which is the 9th week after fertilization.-Etymology and spelling variations:The...
and newborn has almost disappeared.
History
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.In 1996 ZLB Bioplasma (part of CSL Behring
CSL Behring
CSL Behring is one of the world's leading plasma protein biotherapeutics companies, specializing in the manufacture of therapies for the treatment of rare and serious diseases...
) was given approval to sell Rhophylac in Europe, and in 2004 Rhophylac was approved in the United States.
Manufacturing and viral transmission
Rho(D) Immune Globulin is a derivative of human plasmaBlood plasma
Blood plasma is the straw-colored liquid component of blood in which the blood cells in whole blood are normally suspended. It makes up about 55% of the total blood volume. It is the intravascular fluid part of extracellular fluid...
. 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. Rho(D) immune globulin may trigger an allergic reaction, and there is the possibility of transmission of Creutzfeldt-Jakob disease
Creutzfeldt-Jakob disease
Creutzfeldt–Jakob disease or CJD is a degenerative neurological disorder that is incurable and invariably fatal. CJD is at times called a human form of mad cow disease, given that bovine spongiform encephalopathy is believed to be the cause of variant Creutzfeldt–Jakob disease in humans.CJD...
as a residual risk.
Use
The medication has an FDA Pregnancy CategoryPregnancy category
The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites that are present in breast...
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. It is also given after antenatal pathological events that are likely to cause a feto-maternal hemorrhage.
Infused Rho(D) has also been used with some success in treating chronic idiopathic thrombocytopenic purpura
Idiopathic thrombocytopenic purpura
Idiopathic thrombocytopenic purpura is the condition of having an abnormally low platelet count of no known cause . As most incidents of ITP appear to be related to the production of antibodies against platelets, immune thrombocytopenic purpura or immune thrombocytopenia are terms also used to...
in Rh-positive patients who have not been splenectomized
Splenectomy
A splenectomy is a surgical procedure that partially or completely removes the spleen.-Indications:The spleen, similar in structure to a large lymph node, acts as a blood filter. Current knowledge of its purpose includes the removal of old red blood cells and platelets, and the detection and fight...
. The mechanism in this case appears to be mainly due to blockade of the reticuloendothelial system
Reticuloendothelial system
"Reticuloendothelial system" is an older term for the mononuclear phagocyte system. The mononuclear phagocyte system consists primarily of monocytes and macrophages. The spleen is the largest unit of the mononuclear phagocyte system. The monocyte is formed in the bone marrow and transported by the...
, namely by saturating Fcγ receptors
Fc receptor
An Fc receptor is a protein found on the surface of certain cells - including natural killer cells, macrophages, neutrophils, and mast cells - that contribute to the protective functions of the immune system....
in the spleen which are responsible for platelet destruction.
Brand names
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 (BaxterBaxter International
Baxter International Inc. , is an American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions...
) and Rhesonativ (Octapharma).
RhesuGam (NBI)