Bayrho-D (Rho-D Immune Globulin Human) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Other antibodies in the Rh_o(D) Immune Globulin (Human) 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 Rh_o(D) Immune Globulin (Human) administration.

CONTRAINDICATIONS

None known.

REFERENCES

1. Gunson HH, Bowell PJ, Kirkwood TBL: Collaborative study to recalibrate the International Reference Preparation of Anti-D Immunoglobulin. J Clin Pathol 33:249-53, 1980.
2. Rh_o(D) immune globulin (human). Med Lett Drugs Ther 16(1):3-4, 1974.
3. Pollack W, Ascari WQ, Kochesky RJ, et al: Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size of antigenic stimulus. Transfusion 11(6):333-9, 1971.
4. Unpublished data in files of Bayer Corporation.
5. Pollack W, Ascari WQ, Crispen JF, et al: Studies on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive blood. Transfusion 11 (6):340-4, 1971.
6. Keith LG, Houser GH: Anti-Rh immune globulin after a massive transfusion accident. Transfusion 11(3):176, 1971.
7. The selective use of Rh_o(D) immune globulin (RhIG). ACOG Tech Bull 61, 1981.
8. Current uses of Rh_o immune globulin and detection of antibodies. ACOG Tech Bull 35, 1976.
9. Pollack W: Rh hemolytic disease of the newborn; its cause and prevention. Prog Clin Biol Res 70:185-203, 1981.
10. Bowman JM, Chown B, Lewis M, et al: Rh isoimmunization during pregnancy: antenatal prophylaxis. Can Med Assoc J 118(6):623-7, 1978.
11. Bowman JM, Pollock JM: Antenatal prophylaxis of Rh isoimmunization: 28-weeks'-gestation service program. Can Med Assoc J 118(6):627-30, 1978.
12. Ascari WQ, Allen AE, Baker WJ, et al: Rh_o(D) immune globulin (human): evaluation in women at risk of Rh immunization. JAMA 205(1):1-4, 1968.
13. Prevention of Rh sensitization. WHO Tech Rep Ser 468:25, 1971.
14. Samson D, Mollison PL: Effect on primary Rh immunization of delayed administration of anti-Rh. Immunology 28:349-57, 1975.
15. Finn R, Harper DT, Stallings, SA, et al: Transplacental hemorrhage. Transfusion 3(2):114-24, 1963.
16. Garraty G (ed.): Hemolytic disease of the newborn. Arlington, VA, American Association of Blood Banks, 1984, p 78.
17. Recommendations of the Immunization Practices Advisory Committee (ACIP): General recommendations on immunization. MMWR 38(13):205-14; 219-27, 1989.

Bayer Corporation

Pharmaceutical Division

Elkhart, IN 46515 USA

U.S. License No. 8 14-7631-003

(Rev. October 2000)

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 transfusion.

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, amniocentesis (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 bloodstream, 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 isoimmunization and the blood you receive is Rh positive due to error or lifesaving reasons, your Rh positive antibodies will become mobilized and destroy 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 antibodies could possibly enter the baby's bloodstream, attack the baby's red blood cells and cause hemolytic disease of the newborn. 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 medical 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

BayRho-D®, Rh_o(D) Immune Globulin (Human) can prevent hemolytic disease of the newborn, provided Rh positive antibodies do not already reside in your bloodstream.

BayRho-D is a specially prepared gamma globulin with a high level of preformed antibodies against Rh positive blood cells. The injection of BayRho-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.

BayRho-D Full Dose -- When Prescribed

Pregnancy and Other Obstetric Conditions Pertaining to Rh Negative Women

BayRho-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 BayRho-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 BayRho-D is not required.

Another injection of BayRho-D Full Dose is administered within 72 hours of delivery of an Rh positive baby.

Blood Transfusion

BayRho-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.

BayRho-D Mini-Dose -- When Prescribed

A single dose of BayRho-D Mini-Dose may be prescribed for an Rh negative woman instead of BayRho-D Full Dose in the event of miscarriage or other termination of pregnancy occurring prior to 13 weeks' gestation. BayRho-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 BayRho-D Again?

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

Reactions to BayRho-D

You may feel a temporary soreness at the site of the injection. You may also have a slight and temporary change in body temperature. 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 BayRho-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 physician. Today, with BayRho-D, hemolytic disease of the newborn can be reduced to its lowest possible rate of incidence.

14-7631-003 (Rev. October 2000)

Bayer Corporation

Pharmaceutical Division

Elkhart, IN 46515 USA

U.S. License No. 8

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 bloodstream, ready to attack invading Rh + blood cells, for many years to come.

5

Next pregnancy, mother's Rh + antibodies enter baby's Rh + bloodstream, attacking baby's blood cells and causing hemolytic disease of the newborn.

How BayRho-D Immune Globulin Can Prevent Hemolytic Disease

1

You will probably be given two injections of BayRho-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 BayRho-D Mini-Dose may be prescribed instead of BayRho-D Full Dose in the event of miscarriage or other termination of pregnancy occurring prior to 13 weeks' gestation.

2

BayRho-D immunization prevents formation of mother's own Rh + antibodies. Mother's bloodstream remains free of Rh + antibodies.

3

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