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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RHOPHYLAC 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]

Neurodevelopmental disorders, maternal Rh-negativity, and Rho(D) immune globulins: a multi-center assessment. [2008.04]

Efficacy and safety of intravenous anti-D immunoglobulin (Rhophylac) in chronic immune thrombocytopenic purpura. [2007.08]

A prospective study of thimerosal-containing Rho(D)-immune globulin administration as a risk factor for autistic disorders. [2007.05]

Non-evidence-based use of Rho(D) immune globulin for threatened abortion by family practice and obstetric faculty physicians. [2002.11]

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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]

Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage [Recruiting]

Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage [Active, not recruiting]

Intravenous Immunoglobulin After Relapse in Vasculitis [Terminated]

Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [Completed]

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