Updated May 30, 2026, 4:23 PM
Immune globulinsUS FDA Database Verified

Rho (D) immune globulin IV

Brand: Rhophylac, WinRho SDF

(not given)

Pregnancy Category: C

Pharmacological Action

Suppresses immune nonsensitized Rho (D or Du)-negative patients who are exposed to Rho (D or Du)-positive blood

Therapeutic outcome: Absence of Rh factor and transfusion error

Uses

Prevention of isoimmunization in Rh-negative women exposed to Rh-positive blood given after abortions, miscarriages, amniocentesis, chronic idiopathic thrombocytopenic purpura (Rhophylac)

Contraindications

Previous immunization with this product, Rho (D)-positive/Du-positive patient

BLACK BOX WARNING: Hemolysis

Precautions: Pregnancy C

BLACK BOX WARNING: Requires a specialized setting

Dosage & Routes

To reduce risk of Rh isoimmunization antepartum/suppression of Rh isoimmunization postpartum following delivery of full-term infant Adult and adolescent $16 yr: IM/IV (WinRho SDF only) 300 mcg (1500 international units) at 28 wk gestation; if given earlier in pregnancy, give at 12-wk intervals during pregnancy, a 120-mcg (600 international units) dose; IM/IV should be given as soon as possible and preferably within 72 hr of delivery of a confirmed Rho(D)-positive infant, and even if status is unknown give up to 28 days after delivery Known or suspected massive fetomaternal hemorrhage (.15 ml of fetal RBC or .30 ml of fetal whole blood) Adult and adolescent $16 yr: IM/IV (WinRho SDF only) if large fetomaternal hemorrhage is suspected, give IV 9 mcg (45 international units) or IM 12 mcg (60 international units) for every ml of fetal whole blood, give IV 600 mcg (3000 international units) q8 hr or IM 1200 mcg (6000 international units) q12 hr until total dose is given, total dose should be given within 72 hr of exposure Threatened abortion at any stage of pregnancy Adult and adolescent $16 yr: IM/IV (Rhophylac only) 300 mcg (1500 international units) as soon as possible and within 72 hr; IM/IV (WinRho SDF only) 300 mcg (1500 international units) as soon as possible and within 72 hr, repeat dose at 12-wk intervals during pregnancy and 120 mcg (600 international units) as soon as possible after delivery and within 72 hr Following spontaneous abortion, induced termination of pregnancy, aminocentesis, chorionic villus sampling, abdominal trauma, ruptured tubal pregnancy, or percutaneous umbilical cord sampling up to 34 wk gestation Adult and adolescent $16 wk: IM/IV (WinRho SDF only) 300 mcg (1500 international units) within 72 hr, repeat at 12-wk intervals during pregnancy, give 120 mcg (600 international units) as soon as possible and preferably within 72 hr of delivery

Available forms: Rhophylac Pre-Filled Syringes Solution for inj 300 mcg/2 ml; WinRho SDF Liquid for inj; WinRho powder for inj

Implementation - BayRho-D (HyperRHO SD), MICRhoGAM, RhoGAM are given by IM only; do not give IV - WinRho SDF and Rhophylac may be given IM or IV - Inspect for particulate matter; do not use if particulate matter is present -

Reconstitution/dilution: no reconstitution or dilution is needed for BayRho-D (HyperRHO SD), Rhophylac, MICRoGAM, RhoGAM, or the liquid formulation of WinRho SDF - WinRho SDF powder for IV use: if giving IV, reconstitute 600 international units or 1500 international units immediately before use with 2.5 ml of sterile diluent; reconstitute 5000 international units with 8.5 ml sterile diluent; add diluent to vial slowly down the wall of the vial; gently swirl until powder is dissolved; do not shake - WinRho SDF powder for IM use: IV giving IM, reconstitute 600 international units or 1500 international units immediately before use with 1.25 ml of sterile diluent; 5000 international units with 8.5 ml of sterile diluent; add diluent to the vial slowly down the wall of the vial; gently swirl until powder is dissolved; do not shake

IM route: - Use aseptic technique, observe for 20 min after administration - Bring Rhophylac to room temperature before using - Inject into the deltoid muscle of upper arm or anterolateral portion of the upper thigh; do not inject into gluteal muscle - If dose calculated will need multiple vials or syringes, use different sites at the same time

IV route: - Use aseptic technique -

WinRhoSDF: remove entire contents of vial to obtain calculated dose; if partial vial contents are required for dosage calculation, withdraw the entire vial contents to ensure correct calculation; inf correct calculated dose over 3-5 min; do not inf with other fluids or products -

Rhophylac: bring to room temperature; inf by slow IV; observe for 20 min

Adverse Effects

CNS: Lethargy

CV: Hypo/hypertension

INTEG: Irritation at inj site, fever

MISC: Infection, ARDS, anaphylaxis, pulmonary edema, DIC

MS: Myalgia

Pharmacokinetics

Absorption: Well absorbed

Distribution: Unknown

Metabolism: Unknown

Excretion: Unknown

Half-life: Unknown

Pharmacodynamics

Onset: Rapid

Peak: Unknown

Duration: Unknown

Interactions

Drug classifications Live virus vaccines (measles, mumps, rubella): decreased antibody response to vaccine

Nursing Considerations

Assessment - Assess for allergies, reactions to immunizations; previous immunization with this product - Intravascular hemolysis: assess for back pain, chills, hemoglobinuria, renal insufficiency; usually when WinRho SDF is given in those with immune thrombocytopenia purpura - Obtain type and cross-match of mother's blood and of neonate's cord blood; neonate must be Rho(D)-positive, mother must be Rho(D)-negative and (Du)-negative, medication should be given if there is a doubt

Patient/family education - Teach patient how product works; that product must be given after subsequent deliveries if subsequent babies are Rh-positive - Intravascular hemolysis: Teach patient to report immediately: shaking, fever, chills, dark urine, swelling of hand or feet, back pain, SOB

Evaluation

Positive therapeutic outcome: Prevention of Rho(D) sensitization in transfusion error; Prevention of erythroblastosis fetalis in subsequent Rho(D)-positive neonates

Reference

Mosby's Drug Guide; Davis Drug Guide

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