No

Immune Globulin

Prevention of Rh isoimmunization in nonsensitized Rh_o(D) antigen-negative women within 72 hours after spontaneous or induced abortion, amniocentesis, chorionic villus sampling, ruptured tubal pregnancy, abdominal trauma, transplacental hemorrhage, or in the normal course of pregnancy unless the blood type of the fetus or father is known to be Rh_o(D) antigen-negative.

Suppression of Rh isoimmunization in Rh_o(D) antigen-negative female children and female adults in their childbearing years transfused with Rh_o(D) antigen-positive RBCs or blood components containing Rh_o(D) antigen-positive RBCs

Treatment of idiopathic thrombocytopenic purpura (ITP) in nonsplenectomized Rh_o(D) antigen-positive patients

C

Hypersensitivity to immune globulin or any component, IgA deficiency

Anaphylactic hypersensitivity reactions can occur; studies indicate that there is no discernible risk of transmitting HIV or hepatitis B; do not administer by S.C. route; use only the I.V. route when treating ITP

1% to 10%:

Hematologic: Hemolysis (Hgb decrease of >2 g/dL in 5% to 10% of ITP patients)

Local: Slight edema and pain at the injection site

No symptoms are likely, however, high doses have been associated with a mild, transient hemolytic anemia

Treatment is supportive

Increased toxicity: Live virus, vaccines (measles, mumps, rubella); do not administer within 3 months after administration of these vaccines

Store at 2°C to 8°C; do not freeze; if not used immediately, store the product at room temperature for 4 hours; do not freeze the reconstituted product; use within 4 hours; discard unused portions

The Rh_o(D) antigen is responsible for most cases of Rh sensitization, which occurs when Rh-positive fetal RBCs enter the maternal circulation of an Rh-negative woman. Injection of anti-D globulin results in opsonization of the fetal RBCs, which are then phagocytized in the spleen, preventing immunization of the mother. Injection of anti-D into an Rh-positive patient with ITP coats the patient's own D-positive RBCs with antibody and, as they are cleared by the spleen, they saturate the capacity of the spleen to clear antibody-coated cells, sparing antibody-coated platelets. Other proposed mechanisms involve the generation of cytokines following the interaction between antibody-coated RBCs and macrophages.

Time to peak serum concentration: I.V.: 2 hours; I.M.: 5-10 days

Half-life: I.V.: 24 days; I.M.: 30 days

Prevention of Rh isoimmunization: I.V.: 1500 units (300 mcg) at 28 weeks gestation or immediately after amniocentesis if before 34 weeks gestation or after chorionic villus sampling; repeat this dose every 12 weeks during the pregnancy. Administer 600 units (120 mcg) at delivery (within 72 hours) and after invasive intrauterine procedures such as abortion, amniocentesis, or any other manipulation if at >34 weeks gestation. Note: If the Rh status of the baby is not known at 72 hours, administer Rh_o(D) immune globulin to the mother at 72 hours after delivery. If >72 hours have elapsed, do not withhold Rh_o(D) immune globulin, but administer as soon as possible, up to 28 days after delivery.

I.M.: Reconstitute vial with 1.25 mL and administer as above

Transfusion: Administer within 72 hours after exposure for treatment of incompatible blood transfusions or massive fetal hemorrhage as follows:

I.V.: 3000 units (600 mcg) every 8 hours until the total dose is administered (45 units [9 mcg] of Rh-positive blood/mL blood; 90 units [18 mcg] Rh-positive red cells/mL cells)

I.M.: 6000 units [1200 mcg] every 12 hours until the total dose is administered (60 units [12 mcg] of Rh-positive blood/mL blood; 120 units [24 mcg] Rh-positive red cells/mL cells)

Treatment of ITP: I.V.: Initial: 25-50 mcg/kg depending on the patient's Hgb concentration; maintenance: 25-60 mcg/kg depending on the clinical response

May be given I.V. or I.M. for the suppression of Rh isoimmunization; I.V. only for the treatment of ITP.

Increasing the time of infusion from 1-3 minutes to 15-20 minutes may also help; pretreatment with acetaminophen, diphenhydramine, or prednisone can prevent the fever/chill reaction

Injection: 600 units [120 mcg], 1500 units [300 mcg] with 2.5 mL diluent

Freiberg A and Mauger D, "Efficacy, Safety, and Dose Response of Intravenous Anti-D Immune Globulin (WinRho SDF) for the Treatment of Idiopathic Thrombocytopenic Purpura in Children," Semin Hematol, 1998, 35(1 Suppl 1):23-7.

Hartwell EA, "Use of Rh Immune Globulin: ASCP Practice Parameter. American Society of Clinical Pathologists," Am J Clin Pathol, 1998, 110(3):281-92.

Hong F, Ruiz R, Price H, et al, "Safety Profile of WinRho Anti-D," Semin Hematol, 1998, 35(1 Suppl 1):9-13.

Simpson KN, Coughlin CM, Eron J, et al, "Idiopathic Thrombocytopenia Purpura: Treatment Patterns and an Analysis of Cost Associated With Intravenous Immunoglobulin and Anti-D Therapy," Semin Hematol, 1998, 35(1 Suppl 1):58-64.

Ware RE and Zimmerman SA, "Anti-D: Mechanisms of Action," Semin Hematol, 1998, 35(1 Suppl 1):14-22.