- Rho(D) immune globulin
Rho(D) Immune Globulin is a medicine given by intramuscular injection which is used to prevent the immunological condition known as
Rhesus disease(or hemolytic disease of newborn). The medicine is a solution of IgGanti-D (anti-RhD) antibodies which bind to, and lead to the destruction of, fetal Rh D positive red blood cellsthat 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 diseaseof the fetusand newbornhas almost disappeared. It can also be used in the treatment of idiopathic thrombocytopenic purpurain Rhesus positive patients.
The first Rho(D) Immune Globulin treatment "RhoGAM" was introduced by Ortho-Clinical Diagnostics, a subsidiary holding of
Johnson and Johnson, and first administered on May 29, 1968. [ [https://www2.vaxserve.com/views/PDF/RhoGAM%20Ultra-Filtered%20Plus%20Package%20Insert%207-07.pdf RhoGAM product label, includes clinical trial data and prescribing information] ]
In 1996 ZLB Bioplasma, which is part of
CSL Behringand has been producing plasma-based products since 1949, was given approval to sell Rhophylac in Europe, and in 2004 Rhophylac was approved in the United States. [ [http://www.rhophylac.com/AboutHDN/evolution.asp History of HDN Treatment] ]
It has been estimated that with the use of Rho(D) Immune Globulin treatment,
perinatal mortalityof about 10,000 cases per year in the US alone is avoided.
Manufacturing and Viral Transmission
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 the
FDAapproved ChromaPlus™ process used to make Rhophylac®. [ [http://www.rhophylac.com/About/chromaplus.asp ChromaPlus™ Manufacturing Process] ] Rho(D) immune globulin may trigger an allergic reaction, and there is the possibility of transmission of Creutzfeldt-Jakob diseaseas a residual risk. [ [http://www.jnj.com/innovations/new_features/RhoGAM.htm RhoGAM Ultra-Filtered PLUS Rho(D) Immune Globulin (Human) Information Site] ]
The medication has a
Food and Drug Administration(FDA) Pregnancy Category C. It is given by intramuscular injection as part of modern routine antenatalcare at about 28 weeks of pregnancy, and within 72 hours after childbirth. [cite web |url =http://www.nice.org.uk/guidance/TA41/?c=91520 |title = Pregnancy - routine anti-D prophylaxis for RhD-negative women |publisher = NICE |month = May |year = 2002] It is also given after antenatal pathological events that are likely to cause a feto-maternal hemorrhage. [cite web |url = http://www.rcog.org.uk/index.asp?PageID=1972 |title = Use of Anti-D Immunoglobulin for Rh Prophylaxis | publisher = Royal College of Obstetricians and Gynaecologists| |month = May |year = 2002]
Anti-D is also a relatively new method to treat
idiopathic thrombocytopenic purpurapatients who are Rh+. However, is not recommended for post-splenectomy patients. [See http://www.winrho.com/isi.html for efficacy and safety data on WinRho anti-D.]
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).
Rhesus blood group system
* [http://www.pptaglobal.org/esourcedocs/December%202001.pdf/ Profile on Dr. Crispen]
* [http://www.rhophylac.com Rhophylac Product Website]
* [http://www.rhogam.com Rhogam Product Website]
* [http://www.jnj.com/innovations/new_features/RhoGAM.htm Product information]
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