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About HDN

Hemolytic disease of the newborn (HDN) is a serious medical condition that is caused by incompatibility between the blood of an Rh-negative pregnant woman and her Rh-positive fetus. HDN develops in the fetus when the IgG antibodies produced by the mother pass through the placenta and attack the red blood cells (RBCs) in the fetal circulation. Although HDN does not affect the mother, it can have serious consequences for her baby, such as:

  • Anemia
  • Jaundice
  • Brain damage
  • Heart failure
  • Mortality

Of the 500,000 Rh-negative women who are pregnant each year, approximately 60% will have an Rh-positive baby.

Evolution of Preventive Treatment

Before the introduction of anti-D products such as Rhophylac®, babies who developed HDN in utero or at birth were at high risk for experiencing serious consequences.

Rh-Sensitization

Certain conditions can trigger the baby's blood cells to enter the mother's bloodstream, triggering the mother's immune system to develop antibodies against the antigens in the Rh-positive blood. This is called Rh-sensitization.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.