Rh Blood Incompatibility Can Complicate Pregnancies1

According to the American Congress of Obstetricians and Gynecologists (ACOG), proper treatment with an Rh immune globulin, such as HyperRHO® S/D (RhO(D) immune globulin [human]), can prevent Rh sensitization in unsensitized Rh-negative women.1

For more information on Rh factor and hemolytic disease of the newborn (HDN), please visit the National Center for Biotechnology Information.

Development of hemolytic disease

Maternal-fetal RhO(D) blood type incompatibility occurs when the mother is Rh negative and the father is Rh positive, potentially creating an Rh-positive baby. The mother's body will create antibodies against the baby's Rh-positive blood. The risk to the first fetus is only slight because the mother's body hasn't necessarily developed the antibodies to the Rh-positive blood by the time the first baby is born. Unfortunately, subsequent pregnancies carry greater risk, as the body has had sufficient time to build up immunity. This creates a progressively higher risk of HDN. Once the mother is sensitized, she is no longer eligible to receive RhO(D) immune globulin treatment, which makes it crucial for the mother to receive immune globulin treatment in a timely manner.1

Immediate Protection

HyperRHO S/D contains high titers of RhO(D) immune globulin antibodies. This optimizes protection and reduces the potentially life-threatening risk of HDN.2

Antenatal prophylaxis calls for administering HyperRHO S/D Full Dose in 2 doses—1 antenatal dose at 28 weeks' gestation and another dose within 72 hours of a full-term delivery, which provides the critical protection needed to combat the potential risks associated with HDN. For women undergoing spontaneous or induced abortion of up to 12 weeks' gestation, HyperRHO S/D Mini-Dose should be administered within 3 hours or as soon as possible following the abortion.2,3




Safety Is a Priority2

  • HyperRHO S/D is mercury (thimerosal) free and latex free
  • HyperRHO S/D has Food and Drug Administration (FDA) labeling for removal of pathogenic prions that may cause transmissible spongiform encephalopathies in humans; HyperRHO S/D also has 4 steps for virus removal and inactivation5

    • Studies of the HyperRHO S/D manufacturing process demonstrated that TSE clearance is achieved during the Pooled Plasma to Effluent III Fraction Process (6.7 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed
  • HyperRHO S/D offers tamper-evident packaging and incorporates UltraSafe® Needle Guards to help protect the healthcare professional from needlestick injuries
  • Because HyperRHO S/D 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 that can cause disease. There is also the possibility that unknown infectious agents may be present in such products

Dosing Recommendations2

HyperRHO Dosing Recomendations

Product Information2,3

HyperRHO Product Information

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 HyperRHO S/D Mini-Dose full Prescribing Information for complete prescribing details.

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 HyperRHO S/D Full Dose full Prescribing Information for complete prescribing details.

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.