Pharmacokinetics of anti-D IgG in pregnant RhD-negative women.
Author(s): Bichler J, Schondorfer G, Pabst G, Andresen I
Affiliation(s): ZLB Bioplasma AG, Berne, Switzerland.
Publication date & source: 2003-01, BJOG., 110(1):39-45.
Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial
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. DESIGN: An open, randomised, multicentre study. SETTING: Seven gynaecological practices in Germany. SAMPLE: 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. MAIN OUTCOME MEASURES: 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.