Efficacy and safety of a new, chromatographically purified rhesus (D) immunoglobulin.
OBJECTIVE
To study the efficacy, safety, and tolerability of the 300 microg dose of a new chromatographically produced rhesus immunoglobulin (Rhophylac 300) for ante- and postnatal rhesus prophylaxis.


METHODS
In an open-label multi-centre study, rhesus D (RhD)-negative women were randomly allocated to receive Rhophylac 300 either intravenously or intramuscularly at the 28th week of gestation and within 72 h after delivery of an RhD-positive child. Serum samples were obtained prior to the antenatal dose and 6-11.5 months after delivery of an RhD-positive child and tested by the indirect antiglobulin test and papain test for anti-D. Safety parameters were assessed in all women who were treated with the study drug.


RESULTS
Four hundred and thirty two women received the study drug antenatally. No differences were detected in efficacy or tolerability between intravenous and intramuscular administration. Of the 261 women who delivered an RhD-positive child and received rhesus prophylaxis according to the protocol, 248 women returned for follow-up investigations. None of them had detectable anti-D at their last visit. There were no serious adverse events, no cases of infectious disease transmission nor clinically relevant changes in laboratory safety values and vital signs attributable to the study drug.


CONCLUSIONS
The results suggest that Rhophylac 300 given intravenously or intramuscularly is safe and efficacious in preventing rhesus (D) immunisation.
MacKenzie
Ian Z
IZ
John Radcliffe Hospital, Women's Centre, Oxford, UK. ray.anson@obstetrics-gynaecology.oxford.ac.uk
Bichler
Johann
J
Mason
Gerald C
GC
Lunan
C Burnett
CB
Stewart
Peter
P
Al-Azzawi
Farook
F
De Bono
Martin
M
Watson
Neale
N
Andresen
Irmgard
I
D000293:Adolescent; D000328:Adult; D002845:Chromatography; D004334:Drug Administration Schedule; D004899:Erythroblastosis, Fetal / Q000276:immunology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage*; D007273:Injections, Intramuscular; D007275:Injections, Intravenous; D011247:Pregnancy; D011256:Pregnancy Outcome; D012204:Rh-Hr Blood-Group System / Q000276:immunology*; D018029:Rho(D) Immune Globulin / Q000008:administration & dosage*; D016896:Treatment Outcome; D006113:United Kingdom; D014481:United States
D007136:Immunoglobulins; D012204:Rh-Hr Blood-Group System; D018029:Rho(D) Immune Globulin