About HDN

Hemolytic disease of the newborn (HDN) is a serious medical condition 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
  • Death

View the video below for further information about HDN

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Rh-Sensitization

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

Based on inheritance patterns, approximately 60% of Rh-negative women who become pregnant will have a baby with Rh-positive blood. If preventive measures are not taken, 14% of these women will develop anti-D antibodies within 6 months of delivery or during their next pregnancy. This Rh-sensitization may or may not affect a woman's first child but could create serious problems for subsequent children.1

With appropriate anti-D γ globulin prophylaxis of Rh-negative pregnant and postpartum women, nearly all Rh-negative women can be protected from developing anti-D antibodies that could lead to hemolytic disease in their Rh-positive babies.1

  1. Zipursky A, Paul V. The global burden of Rh disease. Arch Dis Child Fetal Ed. March 2011 Vol 96 No 2: F84-85.
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Important Safety Information

WARNING: INTRAVASCULAR HEMOLYSIS IN ITP
This warning does not apply to Rh (D)-negative patients treated for the suppression of Rh isoimmunization.
Intravascular hemolysis leading to death has been reported in Rh (D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh (D) Immune Globulin Intravenous (Human) products. Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS); acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). Monitor patients for signs and symptoms of intravascular hemolysis in a healthcare setting for at least 8 hours after administration. See full prescribing information for complete boxed warning.

Rhophylac®, Rho(D), Immune Globulin Intravenous (Human), is indicated for suppression of rhesus (Rh) isoimmunization in:

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

For suppression of Rh isoimmunization, Rhophylac can be administered IM or IV. Consider IV administration if reaching the muscle is of concern.

Rhophylac is indicated to raise platelet counts in Rh (D)-positive, non-splenectomized adult patients with chronic immune thrombocytopenic purpura (ITP). For the treatment of ITP, Rhophylac must be administered IV.

Rhophylac is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to Rhophylac or any of its components. Do not administer Rhophylac to the newborn infant of a mother who received Rhophylac postpartum.

Allergic or hypersensitivity reactions may occur with Rhophylac; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis.

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

Suppression of Rh Isoimmunization: The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac (≥0.5% of patients) are nausea, dizziness, headache, injection-site pain, and malaise.

Immune Thrombocytopenic Purpura: The most serious adverse reactions in patients receiving Rh (D) immune globulin have been observed in the treatment of ITP. ITP patients being treated with Rhophylac should be alerted to and monitored for signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and hematuria. Potentially serious complications of intravascular hemolysis include clinically compromising anemia, acute renal insufficiency, and, very rarely, disseminated intravascular coagulation, and death.

The most common adverse reactions observed in the treatment of ITP (>14% of patients) are chills, pyrexia/increased body temperature, headache, and hemolysis. In patients with preexisting anemia, Rhophylac may increase the severity of anemia.

Immunoglobulin administration may transiently interfere with the immune response to live virus vaccines, such as measles, mumps and rubella.

Please see full prescribing information for Rhophylac.

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.


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