Rho(D) IMMUNE GLOBULIN (row) RhoGAM, Rhophylac, WinRho SDF Rho(D) IMMUNE GLOBULIN MICRO-DOSE BayRho-D Mini Dose, MICRhoGAM Classifications: biologic response modifier; immunoglobulin; Therapeutic: immunoglobulin Prototype: Immune globulin Pregnancy Category: C |
RhoGAM, MICRhoGAM: 5% solution in prefilled syringes;
Rhophylac: 300 mcg prefilled syringe;
WinRho SDF: 120 mcg, 300 mcg, 1000 mcg vials
Sterile nonpyrogenic gamma globulin solution containing immunoglobulins (IgG) of at least 90% IgG, which provides passive immunity by suppressing active antibody response and formation of anti-Rho(D) in Rh-negative [Rho(D)-negative] individuals previously exposed to Rh-positive [Rho(D)-positive, Du-positive] blood.
Effective for exposure in Rh-negative women when Rh-positive fetal RBCs enter maternal circulation during third stage of labor, fetal-maternal hemorrhage (as early as second trimester), amniocentesis, or other trauma during pregnancy, termination of pregnancy, and following transfusion with Rh-positive RBC, whole blood, or components (platelets, WBC) prepared from Rh-positive blood.
To prevent isoimmunization in Rh-negative individuals exposed to Rh-positive RBC (see above). Rho(D) immune globulin micro-dose is for use only after spontaneous or induced abortion or termination of ectopic pregnancy up to and including 12 wk of gestation. Treatment of idiopathic thrombocytopenia purpura.
Rho(D)-positive patient; person previously immunized against Rho(D) factor, hypersensitivity for thimerosal, severe immune globulin hypersensitivity, bleeding disorders; pregnancy (category C), neonates.
IgA deficiency.
Note: Only WinRho SDF can be given IV. BayRho-D and RhoGAM are available in regular and mini-dose vials. Antepartum ProphylaxisAdult: IM/IV 300 mcg at approximately 28-wk gestation; followed by 1 vial of mini-dose or 120 mcg within 72 h of delivery if infant is Rh-positive Postpartum Prophylaxis Adult: IM/IV 300 mcg preferably within 72 h of delivery if infant is Rh-positive Following Amniocentesis, Miscarriage, Abortion, Ectopic Pregnancy Adult: IM If over 13-wk gestation, 300 mcg, preferably within 3 h but at least within 72 h; if less than 13 wk, give 50 mcg Transfusion Accident Adult: IM/IV 300 mcg for each volume of RBCs infused divided by 15, given within at least 72 h of accident Child: IV Administer 600 mcg q8h until total dose given. Exposure to positive whole blood 9 mcg/mL, exposure to positive RBCs 18 mcg/mL. IM Administer 1200 mcg q12h until total dose given. Exposure to positive whole blood 12 mcg/mL, exposure to positive RBCs 24 mcg/mL. Idiopathic Thrombocytopenia Purpura Adult/Child: IV 50 mcg/kg, then 2560 mcg/kg depending on response |
Note: Each vial of Rho(D) immune globulin contains enough anti-Rho(D) to suppress the immunizing potential of 15 mL Rh-positive packed RBC. Each vial of micro-dose contains enough anti-Rho(D) to suppress the immune response to 2.5 mL of Rh-positive packed RBC.
IntramuscularIntravenous PREPARE: Direct: No dilution is required for products supplied in liquid form. ??Reconstitute powder vials as follows: Add 2.5 mL diluent (provided by manufacturer) to each 600 or 1500 IU vial; add 8.5 mL diluent (provided by manufacturer) to each 5000 IU vial. ??Direct stream of diluent to side of vial, swirl to dissolve, do not shake. Concentration of reconstituted vials: 600 IU yields 240 IU/mL, 1500 IU vial yields 600 IU/mL, and 5000 IU vial yields 588 IU/mL. ADMINISTER: Direct: Give a single dose over 35 min. |
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