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 IgG
anti-D (anti-RhD) antibodies
which 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
has almost disappeared. It can also be used in the treatment of idiopathic thrombocytopenic purpura
in 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
In 1996 ZLB Bioplasma, which is part of CSL Behring and 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.
It has been estimated that with the use of Rho(D) Immune Globulin treatment, perinatal mortality of 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 FDA
approved ChromaPlus™ process 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.
The medication has a Food and Drug Administration
(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. It is also given after antenatal pathological events that are likely to cause a feto-maternal hemorrhage.
Anti-D is also a relatively new method to treat idiopathic thrombocytopenic purpura patients who are Rh+. However, is not recommended for post-splenectomy patients.
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).