Immune GlobulinRhophylac (Rho[D] Immune Globulin Intravenous [Human])
Manufacturer: ZLB Bioplasma AG
Drug Approval Classification: Biologics License Application (Approval Date: 2/12/04)
Indication: Rhophylac (Rho[D] Immune Globulin Intravenous [Human]) is indicated for:
Clinical Summary: Rhophylac was studied in 2 clinical trials in 446 Rho(D)-negative pregnant women. In both studies, Rho(D)-negative women received Rhophylac 1500 IU intravenously or intramuscularly in the 28th week of pregnancy. Mothers who gave birth to a Rho(D)-positive child received a further dose of Rhophylac 1500 IU within 72 hours after the birth. Eight out of 14 pregnant women gave birth to a Rho(D)-positive child. The antibody tests performed 6 to 8 months later yielded negative results for all mothers, suggesting that no Rho(D) immunization occurred.
Of the 432 women who received Rhophylac 1500 IU (300 mcg) in the 28th week of pregnancy, 270 women delivered Rho(D)-positive children. None of those women developed antibodies against the Rho(D) antigen as assessed by the absence of anti-D antibodies.
Adverse Effects: Injection-site pain and tenderness were observed in clinical trials. Mild and transient fever, malaise, headache, cutaneous reactions, and chills occur occasionally.
Medscape Pharmacists. 2004;5(1) © 2004 Medscape
Cite this: March 2004 - Medscape - Apr 06, 2004.