HyperRHO Full Dose

Pregnancy And Other Obstetric Conditions

HyperRHO S/D Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rho(D) negative mother within 72 hours after birth of an Rho(D) positive infant,(12) providing the following criteria are met:

1. The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) factor.
2. Her child must be Rho(D) positive, and should have a negative direct antiglobulin test (see PRECAUTIONS).

If HyperRHO S/D Full Dose is administered antepartum, it is essential that the mother receive another dose of HyperRHO S/D Full Dose after delivery of an Rho(D) positive infant.

If the father can be determined to be Rho(D) negative, HyperRHO S/D Full Dose need not be given.

HyperRHO S/D Full Dose should be administered within 72 hours to all nonimmunized Rho(D) negative women who have undergone spontaneous or induced abortion, follow ing ruptured tubal pregnancy, amniocentesis or abdominal trauma unless the blood group of the fetus or the father is known to be Rho(D) negative.(7,8) If the fetal blood group cannot be determined, one must assume that it is Rho(D) positive,(2) and HyperRHO S/D Full Dose should be administered to the mother.

Transfusion

HyperRHO S/D Full Dose may be used to prevent isoimmunization in Rho(D) negative individuals who have been transfused with Rho(D) positive red blood cells or blood components containing red blood cells.(5,13)

No information provided.

The Rh Factor and Your Pregnancy

Information About Pregnancy Protection

The Rh Factor and When It Is Important

The Rh factor is one of many blood group antigens found on the surface of red blood cells. If you have this antigen you are considered Rh positive. If you don't, then you are considered Rh negative. Everyone is either Rh positive or Rh negative. One type is neither better nor worse than the other, only different.

Your Rh factor is important if you are an Rh negative woman and you become pregnant, or if you receive a blood trans fusion.

How the Rh Factor Can Affect Your Future

If you have Rh negative blood, there are two situations that can affect you:

1. If the father of your baby is Rh positive, the baby will probably be Rh positive too. An Rh negative woman carrying an Rh positive baby may have an immune reaction if some of the baby's Rh positive blood cells enter her bloodstream. This immune reaction, called isoimmunization, means your body's defense system recognizes Rh positive blood as foreign from your own and produces “antibodies” to destroy the invading Rh positive blood cells. The passage of blood from the baby to the mother's bloodstream happens most often at delivery, but can also occur during miscarriage, the termination of pregnancy, amnio centesis (test performed to determine fetal health), or due to an injury or trauma. It is important to note that a small number of women develop antibodies to Rh positive blood cells during pregnancy for no apparent reason.

Antibodies to Rh positive blood may not be a problem in first pregnancies; however, the antibodies stay in your blood stream, ready to attack invading Rh positive blood cells, for many years to come. This can lead to problems in future pregnancies by causing miscarriage or a disease known as hemolytic disease of the newborn.

Babies born to Rh positive mothers, regardless of the father's blood type, will usually be free of the dangers of hemolytic disease.

2. Someday it may become necessary for you to receive a blood transfusion. If Rh positive antibodies already reside in your bloodstream due to isoimmun ization and the blood you receive is Rh positive due to error or lifesaving reasons, your Rh positive antibodies will become mobilized and de stroy the donor Rh positive cells. As a result, the transfusion could be unsuccessful and possibly harmful to you.

Hemolytic Disease of the Newborn: A Threat to Your Baby

When an Rh negative woman has Rh positive antibodies in her blood and the baby she is carrying is Rh positive, the antibod ies could possibly enter the baby's bloodstream, attack the baby's red blood cells and cause hemolytic disease of the new born. At birth, the infant suffering from hemolytic disease may be jaundiced and anemic or suffer permanent damage of the brain and central nervous system which may result in mental retardation, hearing loss, or cerebral palsy. Extensive medi cal care can be required, including an exchange transfusion, in which all of the baby's blood is replaced. This usually stops the destruction of the baby's red blood cells and gives the infant a chance to survive.

The risk of hemolytic disease of the newborn is slight with the first baby, but increases with each successive pregnancy.

Preventing Hemolytic Disease

HyperRHO® S/D, Rho(D) Immune Globulin (Human) can pre vent hemolytic disease of the newborn, provided Rh positive antibodies do not already reside in your bloodstream.

HyperRHO S/D is a specially prepared gamma globulin with a high level of preformed antibodies against Rh positive blood cells. The injection of HyperRHO S/D destroys any Rh positive blood cells that may have entered the mother's bloodstream and prevents the mother's immune system from producing Rh positive antibodies; thus protecting the baby from developing hemolytic disease.

HyperRHO S/D Full Dose — When Prescribed

Pregnancy and Other Obstetric Conditions Pertaining to Rh Negative Women

HyperRHO S/D Full Dose is administered during pregnancy if you fall into a high-risk category. For example, you are at risk of producing Rh positive antibodies if you have an amniocentesis procedure performed, or if you have a miscarriage or other termination of pregnancy at or beyond 13 weeks' gestation.

Laboratory findings have shown that some Rh negative women develop Rh positive antibodies during the last weeks of pregnancy even without an antibody-stimulating event. As a preventive measure, your physician will probably recommend the first injection of HyperRHO S/D Full Dose at the 28th week of pregnancy.

In both of the above situations, if the blood type of the father or baby can be determined to be Rh negative, an injection of HyperRHO S/D is not required.

Another injection of HyperRHO S/D Full Dose is administered within 72 hours of delivery of an Rh positive baby.

Blood Transfusion

HyperRHO S/D Full Dose may be used to prevent isoimmunization in Rh negative individuals who have been transfused with Rh positive red blood cells or blood components containing red blood cells.

HyperRHO S/D Mini-Dose — When Prescribed

A single dose of HyperRHO S/D Mini-Dose may be prescribed for an Rh negative woman instead of HyperRHO S/D Full Dose in the event of miscarriage or other termination of pregnancy occurring prior to 13 weeks' gestation. HyperRHO S/D Mini-Dose is not required if the blood type of the father or fetus can be determined to be Rh negative.

Will You Need HyperRHO S/D Again?

HyperRHO S/D provides protection only if you have not already produced Rh positive antibodies. Women who have developed antibodies through previous pregnancy, miscarriage, other ter mination of pregnancy, or blood transfusion cannot be protected by HyperRHO S/D. This is why with each pregnancy it is important to have HyperRHO S/D injections within the prescribed time period.

Reactions to HyperRHO S/D

You may feel a temporary soreness at the site of the injection. You may also have a slight and temporary change in body tem perature. In very rare instances, an allergic type of reaction can occur, for which your physician will take appropriate measures.

Delivering a Sound, Healthy Baby

Your physician can answer any questions you may have about receiving a HyperRHO S/D injection to prevent hemolytic disease of the newborn. If you know that you are Rh negative and you are pregnant, you should discuss your situation with your phy sician. Today, with HyperRHO S/D, hemolytic disease of the newborn can be reduced to its lowest possible rate of incidence.

Development of Hemolytic Disease

1. Rh positive (+) father. Rh negative (–) mother.

2. Pregnancy: Rh– mother is carrying Rh+ baby.

3. The passage of Rh+ blood from the baby to the mother's bloodstream happens most often at delivery, but can also occur during miscarriage, other termination of pregnancy, amniocentesis, or due to injury or trauma.

4. Rh+ antibodies stay in your blood stream, ready to attack invading Rh+ blood cells, for many years to come.

5. Next pregnancy, mother's Rh+ anti bodies enter baby's Rh+ bloodstream, attacking baby's blood cells and caus ing hemolytic disease of the newborn.

How HyperRHO S/D Immune Globulin

Can Prevent Hemolytic Disease

1. You will probably be given two injections of HyperRHO S/D Full Dose, one at the 28th week of your pregnancy and another within 72 hours of delivery, miscarriage or other termination of pregnancy. A single injection of HyperRHO S/D Mini-Dose may be prescribed instead of HyperRHO S/D Full Dose in the event of miscarriage or other termination of pregnancy occurring prior to 13 weeks' gestation.

2. HyperRHO S/D immunization prevents formation of mother's own Rh+ antibodies. Mother's bloodstream remains free of Rh+ antibodies.

3. Next pregnancy, baby develops normally. HyperRHO S/D should be administered following delivery, miscarriage, or other termination of pregnancy to continue protection if baby is Rh+.

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 immune globulin 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.

Read the entire FDA prescribing information for HyperRHO Full Dose (Rho(D) Immune Globulin (Human) for Injection)