About HDN

Hemolytic disease of the newborn (HDN) occurs when the mother is Rh negative and the father is Rh positive, potentially creating an Rh-positive baby. It is crucial for the mother to receive immune globulin treatment in a timely manner because once she is sensitized, it can no longer help.1,2 

It's important to know that even if the body produces these antibodies, it may not cause HDN. However, if these antibodies enter the baby's bloodstream, they can attack the baby's red blood cells and lead to HDN—Rh disease. HDN rarely develops in the first baby, but future Rh-positive babies may be at risk if the mother is sensitized.1,4

If HDN develops, it could become serious. A baby born with HDN may develop jaundice or anemia or may have permanent damage to the brain and central nervous system. HDN can also lead to mental handicaps, hearing loss, or cerebral palsy. The baby may also need an exchange transfusion to replace his or her blood.1,4

 

Download the American College of Obstetricians and Gynecologists (ACOG) guidelines for more information on treating HDN.

QUICK FACTS

  • In the United States, the frequency of Rh-negative status varies; it's about 17% in Caucasian people, less in African Americans, approximately 7% in non-Hispanics, and a very low incidence of 1.7% in the Asian population2
  • Once a mother is sensitized, she can no longer receive immune globulin treatment for HDN; this is why it is crucial to have an Rh immune globulin such as HyperRHO S/D administered before the mother is exposed to Rh-positive red blood cells2,4
  • An Rh-negative woman must be treated with an Rh immune globulin during each pregnancy5
  • If an estimated 4 million births occur each year, approximately 4000 of those infants will develop HDN2,3

Learn more about other Hypermunes.

HyperRHO® S/D Mini-Dose (RhO[D] immune globulin [human]) is recommended to prevent the isoimmunization of RhO(D) negative women at the time of spontaneous or induced abortion of up to 12 weeks' gestation provided the following criteria are met:

  1. The mother must be RhO(D) negative and must not already be sensitized to the RhO(D) antigen.
  2. The father is not known to be RhO(D) negative.
  3. Gestation is not more than 12 weeks at termination.

HyperRHO S/D Mini-Dose is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

NEVER ADMINISTER HYPERRHO S/D MINI-DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. ADMINISTER ONLY TO WOMEN POSTABORTION OR POSTMISCARRIAGE OF UP TO 12 WEEKS' GESTATION. NEVER ADMINISTER TO THE NEONATE.

HyperRHO S/D Mini-Dose should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin preparations.

The attending physician who wishes to administer HyperRHO S/D Mini-Dose to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic symptoms.

Other antibodies in the HyperRHO S/D Mini-Dose preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after HyperRHO S/D Mini-Dose administration.

Animal reproduction studies have not been conducted with HyperRHO S/D Mini-Dose. It is also not known whether HyperRHO S/D Mini-Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperRHO S/D Mini-Dose is not indicated for use during pregnancy and it should be administered only postabortion or postmiscarriage.

Safety and effectiveness in the pediatric population have not been established.

Reactions to HyperRHO S/D Mini-Dose are infrequent in RhO(D) negative individuals and consist primarily of slight soreness at the site of injection and slight temperature elevation. While sensitization to repeated injections of human globulin is extremely rare, it has occurred.

Please see full Prescribing Information for HyperRHO S/D Mini-Dose.

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.


HyperRHO® S/D Full Dose (RhO[D] immune globulin [human]) is indicated for prevention of Rh hemolytic disease of the newborn (HDN) and the prevention of isoimmunization in RhO(D) negative individuals who have been transfused with RhO(D) positive red blood cells.

HyperRHO S/D Full Dose is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Never administer HyperRHO S/D Full Dose intravenously. Inject only intramuscularly. Never administer to the neonate.

RhO(D) immune globulin (human) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field positive DU test result. If there is any doubt about the mother's Rh type, she should be given RhO(D) immune globulin (human). A screening test to detect fetal red blood cells may be helpful in such cases.

If more than 15 mL of D-positive red blood cells are present in the mother's circulation, more than a single dose of HyperRHO S/D Full Dose is required. Failure to recognize this may result in the administration of an inadequate dose.

Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic symptoms.

Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after RhO(D) immune globulin (human) administration.

HyperRHO S/D Full Dose should be given in pregnant women only if clearly needed because animal reproduction studies have not been conducted.

Reactions to RhO(D) immune globulin (human) are infrequent in RhO(D)-negative individuals and consist primarily of slight soreness at the site of injection and slight temperature elevation. While sensitization to repeated injections of human immunoglobulin is extremely rare, it has occurred.

Elevated bilirubin levels have been reported in some individuals receiving multiple doses of RhO(D) immune globulin (human) following mismatched transfusions. This is believed to be due to a relatively rapid rate of foreign red cell destruction.

Please see full Prescribing Information for HyperRHO S/D Full Dose.

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.


References:

  1. American College of Obstetricians and Gynecologists. The Rh factor: how it can affect your pregnancy. http://www.acog.org/Patients/FAQs/The-Rh-Factor-How-It-Can-Affect-Your-Pregnancy. Published February 2018. Accessed November 6, 2019.
  2. Hirose TG, Mays DA. The safety of RhIG in the prevention of haemolytic disease of the newborn. J Obstet Gynaecol. 2007;27(6):545-557.
  3. Curtin SC, Abma JC, Kost K. 2010 pregnancy rates among U.S. women. National Center for Health Statistics website. https://www.cdc.gov/nchs/data/hestat/pregnancy/2010_pregnancy_rates.htm. Updated December 6, 2015. Accessed November 6, 2019.
  4. HyperRHO S/D Full Dose (RhO[D] immune globulin [human]) Prescribing Information. Grifols.
  5. ACOG Practice Bulletin No. 181: prevention of Rh D alloimmunization. Obstet Gynecol. 2017;130(2):e57-e70.