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Bayrho-D (Rho-D Immune Globulin Human) - Warnings and Precautions

 
 



WARNINGS

BayRho-D Full Dose is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Bayer Corporation [1-888-765-3203].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

NEVER ADMINISTER BAYRHO-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.

The attending physician who wishes to administer Rho(D) Immune Globulin (Human) 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.

PRECAUTIONS

GENERAL

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 fetal red blood cells are present in the mother's circulation, more than a single dose of BayRho-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 reactions.

DRUG INTERACTIONS

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

DRUG/LABORATORY INTERACTIONS

Babies born of women given Rho(D) Immune Globulin (Human) antepartum may have a weakly positive direct antiglobulin test at birth.

Passively acquired anti-Rho(D) may be detected in maternal serum if antibody screening tests are performed subsequent to antepartum or postpartum administration of Rho(D) Immune Globulin (Human).

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with BayRho-D Full Dose. It is also not known whether BayRho-D Full Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. BayRho-D Full Dose should be given to a pregnant woman only if clearly needed.

PEDIATRIC USE

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

CAUTION

Rx only

U.S. federal law prohibits dispensing without prescription.

Page last updated: 2006-03-15

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