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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.

more studies >>

Clinical Trials Related to Rhophylac (Rho D Immune Globulin)

A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) [Completed]
To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects with chronic ITP for.

A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers. [Completed]
The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.

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

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.

Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis [Not yet recruiting]
This is a phase III multi-centre randomised, double blind, placebo controlled trial to assess the role of intravenous immunoglobulin in the treatment of children with encephalitis. The primary objective is to find out whether early use of IVIG treatment improves neurological outcomes of children with encephalitis. 308 children with encephalitis, aged 6 weeks to 16 years will be recruited in 30 hospitals in the United Kingdom. Participants will be randomised to receive two doses of IVIG or matching placebo in addition to other standard treatments, within the first five days of hospital admission. Each participant will be followed up for 12 months. During this period, information on clinical, radiological and laboratory investigations will be collected. Neurological outcomes will be assessed by the use of questionnaires at 6 and 12 months, and a neuropsychological assessment at 12 months.

A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy [Recruiting]
The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an effective treatment for HIV associated myelopathy.

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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