WINRHO SDF SUMMARY
Rho(D) Immune Globulin Intravenous (Human) (Rho(D) IGIV) - WinRho SDF® - is a sterile, freeze-dried gamma globulin (IgG) fraction containing antibodies to the Rho(D) antigen (D antigen).
WinRho SDF®, Rho(D) Immune Globulin Intravenous (Human), is indicated for the following:
Treatment of ITP
WinRho SDF®, Rho(D) Immune Globulin Intravenous (Human), is recommended for the treatment of non-splenectomized, Rho(D) positive
children with chronic or acute ITP,
adults with chronic ITP, or
children and adults with ITP secondary to HIV infection
in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage. The safety and efficacy of WinRho have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients.
Suppression of Rh Isoimmunization
PREGNANCY AND OTHER OBSTETRIC CONDITIONS
WinRho SDF® is recommended for the suppression of Rh isoimmunization in non-sensitized, Rho(D) negative (D-negative) women within 72 hours after spontaneous or induced abortions, amniocentesis, chorionic villus sampling, ruptured tubal pregnancy, abdominal trauma or transplacental hemorrhage or in the normal course of pregnancy unless the blood type of the fetus or father is known to be Rho(D) negative. In the case of maternal bleeding due to threatened abortion, WinRho SDF® should be administered as soon as possible. Suppression of Rh isoimmunization reduces the likelihood of hemolytic disease in an Rho(D) positive fetus in present and future pregnancies.
The criteria for an Rh-incompatible pregnancy requiring administration of WinRho SDF® at 28 weeks gestation and within 72 hours after delivery are:
the mother must be Rho(D) negative,
the mother is carrying a child whose father is either Rho(D) positive or Rho(D) unknown,
the baby is either Rho(D) positive or Rho(D) unknown, and
the mother must not be previously sensitized to the Rho(D) factor.
WinRho SDF®, Rho(D) Immune Globulin Intravenous (Human), is recommended for the suppression of Rh isoimmunization in Rho(D) negative female children and female adults in their childbearing years transfused with Rho(D) positive RBCs or blood components containing Rho(D) positive RBCs. Treatment should be initiated within 72 hours of exposure. Treatment should be given (without preceding exchange transfusion) only if the transfused Rho(D) positive blood represents less than 20% of the total circulating red cells. A 300 Âµg (1,500 IU) dose will suppress the immunizing potential of approximately 17 mL of Rho(D) positive RBCs.
Published Studies Related to Winrho SDF (Rho D Immune Globulin)
Anti-D (WinRho SD) treatment of children with chronic autoimmune thrombocytopenic purpura stimulates transient cytokine/chemokine production. [2002.03]
Intravenous anti-D is often used in the treatment of autoimmune thrombocytopenic purpura (AITP), but little is known about its mechanisms of action. To investigate anti-D's potential in vivo mechanism(s) of action, a small group (N = 7) of children with chronic AITP was studied...
Neurodevelopmental disorders, maternal Rh-negativity, and Rho(D) immune globulins: a multi-center assessment. [2008.04]
BACKGROUND: Many formulations of Thimerosal (49.55% mercury by weight)-containing Rho(D) immune globulins (TCRs) were routinely administered to Rh-negative mothers in the US prior to 2002. OBJECTIVES: It was hypothesized: (1) if prenatal Rho(D)-immune globulin preparation exposure was a risk factor for neurodevelopmental disorders (NDs) then more children with NDs would have Rh-negative mothers compared to controls; and (2) if Thimerosal in the Rho(D)-immune globulin preparations was the ingredient associated with NDs, following the removal of Thimerosal from all manufactured Rho(D)-immune globulin preparations from 2002 in the US the frequency of maternal Rh-negativity among children with NDs should be similar to control populations... CONCLUSION: This study associates TCR exposure with some NDs in children.
Efficacy and safety of intravenous anti-D immunoglobulin (Rhophylac) in chronic immune thrombocytopenic purpura. [2007.08]
OBJECTIVES: This Phase III study examined the efficacy and safety of Rhophylac (CSL Behring AG, Bern, Switzerland), a highly pure, liquid-stable anti-D preparation, in chronic immune thrombocytopenic purpura (ITP)... CONCLUSION: rhophylac is well tolerated and efficacious in chronic itp.
A prospective study of thimerosal-containing Rho(D)-immune globulin administration as a risk factor for autistic disorders. [2007.05]
BACKGROUND: This study evaluated the relationship between prenatal mercury exposure from thimerosal (49.55% mercury by weight)-containing Rho(D)-immune globulins (TCRs) and autism spectrum disorders (ASDs)... CONCLUSION: The results provide insights into the potential role prenatal mercury exposure may play in some children with ASDs.
Non-evidence-based use of Rho(D) immune globulin for threatened abortion by family practice and obstetric faculty physicians. [2002.11]
OBJECTIVE: To examine the practice patterns and differences between faculty members in obstetrics and gynecology (OB/G) and family practice (FP) residency programs in administering Rho(D) immune globulin (RhIG) for threatened abortion... CONCLUSION: Most FP and OB/G residency faculty report using RhIG in threatened abortion. The practice has become part of the medical culture despite the lack of supporting evidence and should be revaluated in that light.
Clinical Trials Related to Winrho SDF (Rho D Immune Globulin)
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.
Intravenous Immunoglobulin After Relapse in Vasculitis [Terminated]
Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease [Active, not recruiting]
The overall goal of this double-blind Phase II study is to evaluate the safety, efficacy and
biological mechanisms of action of Intravenous Immunoglobulin (IVIg) in the treatment of mild
to moderate stage Alzheimer's disease (AD). IVIg contains antibodies against the amyloid beta
protein that is the central component of the AD senile plaque. It is hypothesized that IVIg
treatment will reduce the levels of beta amyloid in the brain and improve cognitive abilities
relative to placebo. A total of 24 patients with mild to moderate AD capable of giving
informed consent will be randomly assigned to receive either IVIg (16 patients)or saline
placebo (8 patients) for six months. This study includes comparison of four dosing regimens
of IVIg. Cognitive, behavioral and functional measures will be collected at baseline, three
months and six months of treatment and after a six-week washout period. Plasma samples will
be collected before and after infusions. Subjects will undergo a lumbar puncture before and
after the six months of treatment for cerebrospinal fluid (CSF) biomarker analyses. In
addition, Positron Emission Tomography (PET) imaging substudies will be performed at two time
points during the study. Following the initial 6 month placebo-controlled period, all
participants have the opportunity to receive IVIg for an additional 6 month period.
Treatment of Childhood Onset Psychiatric Disorders With Intravenous Immunoglobulin (IVIg) [Completed]
Recent research studies of early onset-obsessive compulsive disorder (OCD) and Tourette's
syndrome have questioned whether autoimmunity could play a role in the development of these
conditions. As a result, there has been an increased interest in the field of research on
the potential involvement of autoimmunity in other psychiatric conditions like
Autoimmune conditions occur when the normal immune system of the body begins working against
itself. The immune system recognizes cells as foreign and begins to attack them.
There are several similarities between autoimmune diseases and schizophrenia. Genetics play
some role in the development of both diseases. Both conditions show a similar course, and
both conditions tend to show worsening of symptoms when exposed to stress.
Previous research studies have shown intravenous immunoglobulin to be safe and effective when
used in neurologic diseases involving the immune system. Presently the NIMH is testing the
effectiveness of IVIg in OCD and Tourette's syndrome.
Intravenous Immunoglobulin IVIg is a medication that has been used to treat diseases like
Kawasaki disease, systemic juvenile rheumatoid arthritis, lupus nephritis, and idiopathic
thrombocytopenic purpura. The drug modifies the body's natural immune reactions.
This research study is a 13-week trial of intravenous immunoglobulin (IVIg) on patients
suffering from childhood-onset schizophrenia, who have failed to respond to other therapies.
Efficacy of High-Dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease [Recruiting]
The use of intravenous immunoglobulin G (IVIG) therapy has been reported in
hyperbilirubinemia of Rh hemolytic disease but we don't have enough evidences for it. Human
Immunoglobulin is considered an alternative to delay the hemolytic process and consequently
reduce the number of exchange transfusions and transfusions of red cells concentrate, thus
diminishing the risk of transmitting transfusional therapies-related diseases. OBJECTIVE: To
determine the effect of IVIG in decreasing the incidence and severity of neonatal immune
hemolytic jaundice due to Rh hemolytic disease reducing the need for exchange transfusion
as a primary goal in these babies. METHODS: This will be a randomized, double blind,
clinical trial involving all newborns with risk of significant hyperbilirubinemia due to
direct Coombs-positive Rh hemolytic disease. The primary goal will be need for exchange
transfusion and others are: incidence of late anemia, kernicterus and deafness Babies were
randomly assigned into two groups: group 1 (study group) received phototherapy plus IVIG (500
mg/kg); and group 2 (control group) received phototherapy and normal saline solution (10
ml/Kg) in the first 6 hours of life. Exchange transfusion was carried out in any group if at
any time the bilirubin level reached 340 micromol/l (20 mg/dl) or more, or rose by 8. 5
micromol/l per h (0. 5 mg/dl per h) in group 2. Adverse effects will be related in two
groups. Parents informed consent will be asked in pre-natal time.
Reports of Suspected Winrho SDF (Rho D Immune Globulin) Side Effects
Haemoglobin Decreased (6),
Chest Pain (4),
Blood Lactate Dehydrogenase Increased (4),
Abdominal Pain (3), more >>
Page last updated: 2008-08-11