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

RHOPHYLAC SUMMARY

Rhophylac® is a sterile Rh_o(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 Rh_o(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 Rh_o(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 Rh_o(D)-negative,
   • the mother is carrying a child whose father is either Rh_o(D)-positive or Rh_o(D) unknown,
   • the baby is either Rh_o(D)-positive or Rh_o(D) unknown, and the mother must not be previously sensitized to the Rh_o(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® Rh_o(D) Immune Globulin Intravenous (Human), is recommended for the suppression of Rh isoimmunization in Rh_o(D)-negative individuals transfused with Rh_o(D)-positive RBCs or blood components containing Rh_o(D)-positive RBCs. Treatment should be initiated within 72 hours of exposure. Treatment should be given (without preceding exchange transfusion) only if the transfused Rh_o(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 Rh_o(D)-positive RBCs.

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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)

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.

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.

Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage [Active, not recruiting]
Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are trying to establish a family. This clinical study will evaluate the effectiveness of intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from secondary recurrent miscarriage. This study will help in providing an answer to the question of whether IVIG is helpful in secondary recurrent miscarriage.

Intravenous Immunoglobulin After Relapse in Vasculitis [Terminated]

Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [Completed]
The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measured by INCAT scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.

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