|Rho(D) IMMUNE GLOBULIN
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
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
Route & Dosage
Note: Only WinRho SDF can be given IV. BayRho-D and RhoGAM are available in regular and mini-dose vials. Antepartum Prophylaxis
Adult: 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
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
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
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.
- Make sure that lot numbers of drug used for the cross-match and the drug to be administered are the same.
- Administer Rho(D) immune globulin via IM to the mother only; not to the infant.
- Use the deltoid muscle. Give in divided doses at different sites, all at once or at intervals, as long as the entire dose
is given within 72 h after delivery or termination of pregnancy.
- Reconstitute with 1.25 mL of NS (using the same method to dissolve as for IV). Give immediately after reconstitution.
- Keep epinephrine immediately available; systemic allergic reactions sometimes occur.
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.
- Refrigerate commercially prepared solutions, although it may remain stable up to 30 d at room temperature according to manufacturers.
Discard solutions that have been frozen. Store powder at 2°8° C (36°46° F) unless otherwise
directed; avoid freezing.
Adverse Effects (≥1%)Body as a Whole:
Injection site irritation, slight fever, myalgia, lethargy.
May interfere with immune response
to live virus vaccine
; should delay use of live virus vaccines
for 3 mo after administration
of Rho(D) immune globulin.
2 h IV
, 510 d IM. Half-Life:
Assessment & Drug Effects
- Obtain history of systemic allergic reactions to human immune globulin preparations prior to drug administration.
- Send sample of newborn's cord blood to laboratory for cross-match and typing immediately after delivery and before administration
of Rho(D) immune globulin. Confirm that mother is Rho(D) and Du-negative. Infant must be Rh-positive.
Patient & Family Education
- Be aware that administration of Rho(D) immune globulin (antibody) prevents hemolytic disease of the newborn in a subsequent pregnancy.