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USP DI Vol. II - RH O(D) IMMUNE GLOBULIN (Systemic)

RH O(D) IMMUNE GLOBULIN (Systemic)


Some commonly used brand names are:

In the U.S.?

  • BayRho-D Full Dose
  • BayRho-D Mini-Dose
  • MICRhoGAM
  • RhoGAM
  • WinRho SDF

In Canada?

  • BayRho-D Full Dose
  • WinRho SDF

Other commonly used names are anti-D gammaglobulin; anti-D (Rh o) immunoglobulin; anti-Rh immunoglobulin; anti-Rh o(D); D(Rh o) immune globulin; RhD immune globulin; Rh immune globulin; Rh-IG;and Rh o(D) immune human globulin.


Category

  • Immunizing agent, passive
  • platelet count stimulator (systemic)

Description

Rh o(D) immuneglobulin is used to prevent your body from interacting with any of your baby'sblood that may get into your blood system while you are pregnant or duringthe delivery of your baby. If your blood type is Rh o(D) negative and your baby's blood type is Rh o(D) positive, your body may produce a defense (antibodies) againstRh o(D) positive blood. These antibodies usuallywill not cause a problem if this is your first pregnancy, unless you havehad a blood transfusion in the past and have already developed these antibodies.However, if you have other Rh o(D) positivebabies in the future, these antibodies may try to destroy the blood of thefuture babies. If this occurs, it is a very serious condition. Babies bornwith this condition may need to have their blood replaced.

Rh o(D) immune globulin can be used to treatimmune thrombocytopenic purpura, a type of blood disorder. This medicine maybe helpful to prevent excessive bleeding.

Rh o(D) immune globulin may also be usedif you have recently received a transfusion that contained Rh o(D) positive blood and your blood type is Rh o(D) negative.

Rh o(D) immune globulin is to be administeredonly by or under the supervision of your doctor or other health care professional.It is available in the following dosage form:

    Parenteral
  • Injection (U.S. and Canada)


Before Using This Medicine

In deciding to use a medicine,the risks of using the medicine must be weighed against the good it will do.This is a decision you and your doctor will make. For Rh o(D) immune globulin, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to Rh o(D) immune globulinor any other kind of human immune globulin. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals. However, this medicine has been used in pregnantwomen and has not been shown to cause birth defects or other problems.

Breast-feeding?Rh o(D) immune globulinhas not been reported to cause problems in nursing babies.

Children?Studies on this medicine have been done only in adultpatients and there is no specific information comparing use of Rh o(D) immune globulin in children with use in other age groups.

Other medical problems?The presence of other medical problems may affectthe use of Rh o(D) immune globulin. Make sureyou tell your doctor if you have any other medical problems, especially:

  • Immunoglobulin A (IgA) deficiencies?Rh o(D) immune globulin may cause an allergic reaction to occur
  • Rh o(D) positive patients with immunethrombocytopenic purpura, ITP (a type of blood disorder)?Should be monitoredfor anemia and kidney problems

Proper Use of This Medicine

Dosing?The dose of Rh o(D) immune globulinwill be different for different patients. The following information includesonly the average dose of Rh o(D) immune globulin.

  • For injection dosage form:
    • To prevent your body from producing antibodies against Rh o(D) positive blood:
      • Adults and children?One or more injections, depending on howmuch Rh o(D) positive blood has gotten intoyour blood system. The medicine may be used during your pregnancy, within72 hours after your baby is born, at the end of an incomplete pregnancy (abortion,miscarriage), or after a transfusion. The medicine is usually injected intoa muscle, although it may be injected into a vein.
    • To help prevent excessive bleeding in patients with immune thrombocytopenicpurpura, ITP (a type of blood disorder):
      • Adults and children?One or more injections, depending on factorsin your blood. The medicine is injected into a vein.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention. Check with your doctorif any of the following side effects occur:

Rare

Bloody urine; decreased frequency ofurination or amount of urine; increased blood pressure; increased thirst; lossof appetite; lower back pain; nausea or vomiting; pale skin; swelling of face, fingers, or lower legs; troubledbreathing; unusual bleeding or bruising; unusual tiredness or weakness; weightgain

The following sideeffects may occur and usually do not need medical attention. However, checkwith your doctor if either of the following side effects continue or are bothersome:

Less common

Fever; soreness at the place of injection

Other side effects not listed above mayalso occur in some patients. If you notice any other effects, check with yourdoctor.


Developed: 08/31/1994
Revised: 01/21/2004