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Rhophylac (Rho D Immune Globulin Intravenous (Human)) - Summary

 
 



RHOPHYLAC SUMMARY

Rhophylac® is a sterile Rho(D) Immune Globulin Intravenous (Human) solution in a prefilled, ready to use syringe for either intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 µg) of IgG antibodies to Rho(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh-positive red blood cells1. The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard2.

Rhophylac® is indicated for the following:

PREGNANCY AND OBSTETRICAL CONDITIONS

Rhophylac® is recommended:

  1. for the suppression of Rh isoimmunization in non-sensitized Rho(D)-negative (D-negative) women.
    The criteria for an Rh-incompatible pregnancy requiring administration of Rhophylac® at 28 to 30 weeks of 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.
  2. for Rhesus prophylaxis in case of obstetric complications, e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage.
  3. for Rhesus prophylaxis in case of invasive procedures during pregnancy, e.g., amniocentesis, chorionic biopsy or obstetric manipulative procedures, e.g., external version, or abdominal trauma.

INCOMPATIBLE TRANSFUSIONS

Rhophylac® Rho(D) Immune Globulin Intravenous (Human), is recommended for the suppression of Rh isoimmunization in Rho(D)-negative individuals 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 1500 IU (300 µg) dose will suppress the immunizing potential of approximately 15 mL of Rho(D)-positive RBCs.


See all Rhophylac indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Rhophylac (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.

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Clinical Trials Related to Rhophylac (Rho D Immune Globulin)

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.

Evaluating the Effectiveness of Intravenous Immunoglobulin Therapy in Autoimmune Autonomic Ganglionopathy [Not yet recruiting]
The purpose of the study is to see if administering intravenous immune globulin (IVIG) (putting immune globulin directly into your blood) helps to improve the symptoms of orthostatic hypotension (sudden fall in blood pressure when a person stands up) and quality of life in men and women who have autoimmune autonomic ganglionopathy (AAG).

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.

Intravenous Immunoglobulins in Complex-regional Pain Syndrome [Not yet recruiting]
The purpose of this study is to determine whether intravenous immunoglobulins are effective in the treatment of complex-regional pain syndrome.

more trials >>

Reports of Suspected Rhophylac (Rho D Immune Globulin) Side Effects

Maternal Exposure During Pregnancy (7)Drug Ineffective (5)Malaise (5)Foetal-Maternal Haemorrhage (3)Body Temperature Increased (3)Pyrexia (3)Feeling Cold (3)Rhesus Antibodies (3)Abdominal Pain (2)Somnolence (2)more >>


Page last updated: 2008-08-11

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