Pharmacokinetics of anti-D IgG in pregnant RhD-negative women.
OBJECTIVE
To assess the pharmacokinetics of anti-D IgG in pregnant Rhesus D-negative women after intramuscular and intravenous administration of 300 microg of Rhophylac.


METHODS
An open, randomised, multicentre study.


METHODS
Seven gynaecological practices in Germany.


METHODS
Fourteen RhD-negative pregnant women at risk of becoming Rhesus D immunised received study drug at 28th week of pregnancy either by intramuscular or intravenous route.


METHODS
Anti-D IgG concentrations of serum samples obtained up to 11 weeks following antenatal Rhesus D prophylaxis were quantified by flow cytometry.


RESULTS
Mean anti-D IgG concentrations after intravenous and intramuscular administration differed up to seven days post-injection, from two weeks onwards they were comparable to each other. Irrespective of the administration route, anti-D IgG in serum was detectable in all women up to at least nine weeks post-administration.


CONCLUSIONS
The serum concentrations of anti-D IgG measured after administration of Rhophylac were very similar to those obtained with 300 microg of a different anti-D immunoglobulin product.
Bichler
Johann
J
ZLB Bioplasma AG, Berne, Switzerland.
Schöndorfer
Georg
G
Pabst
Günther
G
Andresen
Irmgard
I
D000328:Adult; D005260:Female; D006207:Half-Life; D006801:Humans; D007262:Infusions, Intravenous; D007273:Injections, Intramuscular; D007518:Isoantibodies / Q000097:blood*; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000097:blood*; D012203:Rh Isoimmunization / Q000097:blood*; D018029:Rho(D) Immune Globulin / Q000008:administration & dosage / Q000097:blood*
D007518:Isoantibodies; C061961:RHO(D) antibody; D018029:Rho(D) Immune Globulin