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The Rhophylac® Promise™ of proven efficacy

homas Hirose, MD, speaks about Rhophylac and Efficacy
 
Dr. Keith Eddleman speaks about the Pharmacokinetic profile of Rhophylac

Efficacy and pharmacokinetics proven in multiple clinical trials of 461 Rh-negative individuals1-3

  • 772 doses of Rhophylac® administered
  • 1 injection guaranteed sufficient protection against sensitization for bleeds of at least 15 mL RBCs
  • All subjects tested negative for antibodies 9-11 months postpartum
  • No differences detected in efficacy or tolerability between IM or IV administration


Results consistent with previously published data for routine antenatal prophylaxis

 

Rhophylac® Documented Efficacy

IV administration

  • Provides less variability in serum concentration
  • May be desirable to avoid potentially slow muscular absorption of IgG, especially in overweight patients2
Rhophylac® Documented Efficacy

References:
1. Miescher S, Spycher MO, Amstutz H, et al. A single recombinant anti-RgD IgG prevents RhD immunization: association of RhD-positive red blood cell clearance rate with polymorphisms in the FcγRIIA genes and FcγIIIA genes. Blood. 2004;103:4028-4035.
2. Bichler J, Schöndorfer G, Pabst G, Andresen I. Pharmacokinetics of anti-D IgG in pregnant RhD-negative women. Br J Obstet Gynaecol. 2003;110:39-45.
3. MacKenzie IZ, Bichler J, Mason GC, et al. Efficacy and safety of a new, chromatographically purified rhesus (D) immunoglobulin. Eur J Obstet Gynecol Repro Biol. 2004;117:154-161.



© CSL Behring 2008. The product information on this site is intended for US residents only.

Important Safety Information

Rhophylac® is indicated for suppression of rhesus (Rh) isoimmunization in:

  • Pregnancy and obstetric conditions in non-sensitized, Rho(D)-negative women with an Rh-incompatible pregnancy, including routine antepartum and postpartum Rh prophylaxis and Rh prophylaxis in cases of obstetric complications, invasive procedures during pregnancy, or obstetric manipulative procedures.
  • Incompatible transfusions in Rho(D)-negative individuals transfused with blood components containing Rho(D)-positive red blood cells.

For suppression of Rh isommunization, Rhophylac® can be administered IM or IV.

Rhophylac® is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products.

Allergic or hypersensitivity reactions may occur with Rhophylac®; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis. Individuals with selective IgA deficiency can develop antibodies to IgA and may develop severe hypersensitivity and anaphylactic reactions. For these individuals, weigh the expected benefits of treatment against the potential risks.

Rhophylac® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

For postpartum use following an Rh-incompatible pregnancy, Rhophylac® should not be given to the newborn infant.

The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac® are nausea, dizziness, headache, injection-site pain, and malaise.

Please see full prescribing information.