Rho(D) immune globulin (Rx)

Brand and Other Names:RhoGAM, Gamulin Rh, more...HypRho D, MicRhoGAM, Rhesonativ, HyperRHO, Rhophylac, WinRho SDF
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

50 mcg

300 mcg

1,500 Units/2 mL

1,500 Units/1.3 mL

2,500 Units/2.2 mL

5,000 Units/4.4 mL

15,000 Units/13 mL

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Administer to Mother to Prevent Hemolytic Disease in Newborn

Antepartum: 1500 IU~300 mcg IV/IM at 28-30 weeks of gestation

Postpartum: 1500 IU IV/IM within 72 hr

If both given risk reduced to 0.1%

If unable to give within 72 hr, give within 28 days; do not withhold

If >15 mL of Rho+ fetal RBC present in mother's circulation, multiple 1500 IU doses are required

Obstetric Conditions (Abortion/Miscarriage)

1500 IU IV/IM x1 within 72 hr

HyperRHO/MicRhoGAM: If abortion within 13 weeks give 250 IU/50 mcg (minidose)

Immune Thrombocytopenic Purpura (Nonsplenectomized Rho(D)-Positive Patients)

Initial, Hgb >10 g/dL: 250 IU/kg IV once 

Initial, Hgb <10 g/dL: 125-200 IU/kg IV once

Additional doses: 125-300 IU/kg IV PRN

Infuse IV over 3-5 min

If unresponsive to intital dose and Hgb <8 g/dL, use an alternate treatment

Incompatible Transfusions

WinRho SDF

  • Exposure to Rh(D) positive whole blood
  • IM: 12 mcg (60 IU)/mL blood
  • IV: 9 mcg (45 IU)/mL blood

Rhophylac

  • 20 mcg (100 IU)/2 mL blood (or 1 mL erythrocyte concentrate) IV/IM

Safety & efficacy not established; but given at doses proportionate with adult dose in childhood ITP

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Interactions

Interaction Checker

and Rho(D) immune globulin

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            Adverse Effects

            Frequency Not Defined

            Tenderness

            Allergic reaction

            Urticaria

            Angioedema

            Rare elevation in total bilirubin secondary to rapid RBC destruction when given following transfusion mismatch

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            Warnings

            Black Box Warnings

            Intravascular Hemolysis (IVH) with WinRho SDF

            • Intravascular hemolysis (IVH) leading to death has been reported in patients treated for ITP with WinRho SDF
            • IVH can lead to clinically compromising anemia and multisystem organ failure including acute respiratory distress syndrome (ARDS)
            • Serious complications, including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported
            • Monitor closely in health care setting for at least 8 hr after administration
            • Perform dipstick urinalysis at baseline, 2 hr, and 4 hr after administration and prior to end of the monitoring period
            • Alert patients to signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria
            • Absence signs and/or symptoms of IVH within 8 hr do not indicate IVH cannot occur subsequently
            • Post-treatment laboratory tests should be performed if IVH suspected and include plasma hemoglobin, urinalysis, haptoglobin, LDH, and plasma bilirubin (direct and indirect)

            Contraindications

            Hemolytic Disease

            • Rho(D)+
            • Rho(D) negative women who are Rh immunized
            • Hypersensitivity to immune globulins

            Immune Thrombocytopenic Purpura

            • Rho(D) negative individuals
            • Splenectomized individuals
            • Hypersensitivity to plasma products
            • Autoimmune hemolytic anemia
            • Pre-existing hemolysis or high risk for hemolysis
            • Do not use WinRho SDF in patients with IgA deficency with antibioies against IgA

            Cautions

            NEVER GIVE TO NEONATE

            Do not administer IM for ITP

            WinRho SDF: risk of rare but potentially fatal intravascular hemolysis in ITP pts

            Maltose-containing IVIG products (eg WinRho SDF) may give false highs in certain glucose-testing systems

            Avoid live vaccines for 3 mth

            IgA deficiency

            Avoid gluteal IM if possible, if not inject only in upper outer quadrant

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk, no adverse effects reported

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Anti-Rho(D) immune globulins from human donors

            Pharmacokinetics

            Peak Plasma Time: 5-10 d (IM); 2 hr (IV)

            Peak Plasma Concentration: 18-19 ng/mL (IM); 36-48 ng/mL (IV)

            Half-Life: 24-30 days

            Vd: 8.59 L (IM)

            Bioavailability: 69% (IM)

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            Administration

            IM

            Administer to mother, not to infant

            Administer into the deltoid muscle or upper outer side of the thigh

            Do not use gluteal region as routine inj site (risk of injury to sciatic nerves), however if necessary, use only the upper, outer quadrant of gluteal muscle

            The plunger of the syringe should be drawn back before injection to ensure that the needle is not in a blood vessel

            If blood or any unusual discoloration is present in the syringe, withdraw needle &discard syringe; administer new dose of Rho(D) IGIM at a different site using a new syringe & needle

            Do not adminster RhoD IGIM by IV; however, RhoD IGIV may be administered IM

            Do NOT administer IM for ITP treatment

            WinRho SDF: dilute 600 IU & 1500 IU in 1.25 mL supplied diluent(s); for 5000 IU vial, use 8.5 mL

            IV

            For Rh suppression, administer to mother & not infant

            Reconstitute vial contents with appropriate volume of NS by injecting supplied diluent (NS) slowly onto the inside wall of the vial & swirl vial gently until the lyophilized pellet has dissolved

            Do not shake vial. Inspect for particulate matter and discoloration prior to administration

            For 600 IU or 1500 IU vials, use 2.5 mL diluent; for 5000 IU vial, use 8.5 mL

            Do not administer with other drugs

            Administer direct injection Rhophylac at 2 mL/15-60 sec; WinRho SDF 1500 IU/5-15 sec

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            Formulary

            FormularyPatient Discounts

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            Tier Description
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.