RhoGAM and MICRhoGAM Rho(D) Immune Globulin (Human) are sterile solutions containing immunoglobulin G (IgG) anti-D (anti-Rh) for use in preventing Rh immunization. They are manufactured from human plasma containing anti-D.
RhoGAM Ultra-Filtered PLUS (HUMAN IMMUNOGLOBULIN G) is indicated for the following:
1.1. Pregnancy and other obstetrical conditions
For administration to Rh-negative women not previously sensitized to the Rho(D) factor, unless the father or baby are conclusively Rh-negative.
1.2. Transfusion of Rh-incompatible blood or blood products
- Delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby
- Antepartum prophylaxis at 26 to 28 weeks gestation
- Antepartum fetal-maternal hemorrhage (suspected or proven) as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma
- Actual or threatened pregnancy loss at any stage of gestation
- Ectopic pregnancy
- Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (e.g., red blood cells, platelet concentrates, granulocyte concentrates)
Clinical Trials Related to Rhogam Ultra-Filtered Plus (Rho(d) Immune Globulin Human)
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 Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency [Recruiting]
The main objective is to determine the efficacy of Gammaplex by measuring the number of
serious acute bacterial infections during treatment with Gammaplex over a 12 month period.
The secondary objectives are to assess the safety and tolerability of Gammaplex and to
compare the data collected from adult subjects with PID from the GMX01 study
Page last updated: 2009-12-16