RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
The indications are the following:
PREGNANCY AND OTHER OBSTETRICAL CONDITIONS IN RH-NEGATIVE WOMEN, UNLESS THE FATHER OR BABY ARE CONCLUSIVELY RH NEGATIVE
Pregnancy/delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby
Abortion/threatened abortion at any stage of gestation
Antepartum fetal-maternal hemorrhage (suspected or proven) resulting from antepartum hemorrhage (e.g., placenta previa), amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma
Transfusion of Rh incompatible blood or blood products
Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (e.g., red cells, platelet concentrates, granulocyte concentrates)
Published Studies Related to Rhogam (IgG Anti-D)
Dual inhibition of the epidermal growth factor receptor with cetuximab, an IgG1 monoclonal antibody, and gefitinib, a tyrosine kinase inhibitor, in patients with refractory non-small cell lung cancer (NSCLC): a phase I study. [2008.03]
PURPOSE: To determine the optimal doses of the antiepidermal growth factor receptor (anti-EGFR) monoclonal antibody cetuximab and the EGFR tyrosine kinase inhibitor gefitinib when administered as a combination for patients with advanced/metastatic non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy... CONCLUSION: Dual EGFR inhibition with cetuximab and gefitinib is feasible; the combination can be safely administered and may have modest activity in advanced/metastatic NSCLC. Cetuximab 250 mg/m(2) weekly IV and gefitinib 250 mg/d PO is the recommended phase II dose, although the potential for late-onset hypomagnesemia warrants close monitoring of patients receiving this combined dosage.
Kinetics of the immune response following pneumococcal PD conjugate vaccination. [2007.03.01]
Primary vaccination with pneumococcal protein D conjugate vaccine in the first year of life induced clear ELISA and OPA responses, which varied considerably for the different serotypes. Antibody levels declined following primary vaccination but were restored (except for serotype 3) to above post-primary levels by booster vaccination in the second year of life.
Pharmacokinetics of anti-D IgG in pregnant RhD-negative women. [2003.01]
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... 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.
IgG-mediated immunosuppression is not dependent on erythrocyte clearance or immunological evasion: implications for the mechanism of action of anti-D in the prevention of haemolytic disease of the newborn? [2007.10]
Haemolytic disease of the newborn (HDN) can be prevented by the passive administration of anti-D to the mother... These data indicate that removal of opsonized erythrocytes by phagocytic cells does not prevent their immunological recognition and suggest that antigen clearance may not be the predominant mechanism of anti-erythrocyte action in downregulating the humoral immune response.
Binding kinetics, uptake and intracellular accumulation of F105, an anti-gp120 human IgG1kappa monoclonal antibody, in HIV-1 infected cells. [2007.01]
The use of targeting moieties is a new and exciting field of scientific research for facilitating the specific delivery of therapeutic agents in HIV-infected patients. The interaction of a potential targeting moiety with its ligand is a crucial factor in the evaluation of a targeted approach for chemotherapeutic intervention.
Clinical Trials Related to Rhogam (IgG Anti-D)
Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage [Recruiting]
The investigators want to test whether infusions of intravenous immunoglobulin - a blood
product known to modify immune responses - in early pregnancy will increase the chance of a
subsequent live birth in women with three or more miscarriages after a birth and a total of
at least four miscarriages. This will be done in a trial where 82 patients will be randomly
allocated to infusions with intravenous immunoglobulin or placebo during pregnancy.
Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency [Recruiting]
The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and
tolerability of subcutaneously (SC; under the skin) administered GAMUNEX®-C compared to
intravenously (IV; through the vein) administered GAMUNEX®-C in subjects 2-16 years of age
with Primary Immunodeficiency.
Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria [Recruiting]
Solar urticaria is a rare but debilitating disease that can severely impact the quality of
life, restricting outdoor activities. Treatment, based on sun protection and anti-histaminic
drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization
or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic
urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7
patients, to dramatically improve 71% of patients. In an open-label prospective multicenter
study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10
patients affected with severe and refractory solar urticaria.
Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases [Not yet recruiting]
Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration.
Octagam 5% is currently registered in more than 60 countries. This study will evaluate the
efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary
A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency [Active, not recruiting]
This study will investigate the pharmacokinetics (PK), safety and tolerability of GAMUNEX
administered subcutaneously (SC) in subjects with Primary Immune Deficiency (PID). Gamunex
is a ready to use 10% solution Immunoglobulin G (IgG) currently approved for intravenous (IV)
administration for the treatment of PID. The goal is to demonstrate based on PK evaluation
that Gamunex administered SC with an appropriate dose conversion factor will achieve a
steady-state AUC of plasma IgG to be non-inferior to that achieved by the corresponding dose
utilizing IV Gamunex therapy.