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

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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    Contraindicated

      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (6)

              • axicabtagene ciloleucel

                Rho(D) immune globulin, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • brexucabtagene autoleucel

                Rho(D) immune globulin, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • ciltacabtagene autoleucel

                Rho(D) immune globulin, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • idecabtagene vicleucel

                Rho(D) immune globulin, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • lisocabtagene maraleucel

                Rho(D) immune globulin, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tisagenlecleucel

                Rho(D) immune globulin, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (1)

              • efgartigimod alfa

                efgartigimod alfa will decrease the level or effect of Rho(D) immune globulin by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

              Minor (9)

              • adenovirus types 4 and 7 live, oral

                Rho(D) immune globulin decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.

              • BCG vaccine live

                Rho(D) immune globulin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.

              • measles (rubeola) vaccine

                Rho(D) immune globulin decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.

              • measles mumps and rubella vaccine, live

                Rho(D) immune globulin decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.

              • measles, mumps, rubella and varicella vaccine, live

                Rho(D) immune globulin decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.

              • protein a column

                protein a column decreases levels of Rho(D) immune globulin by Other (see comment). Minor/Significance Unknown. Comment: Since Prosorba binds IgG, it could theoretically interfere with the levels and/or effects of pharmacologic immune globulins.

              • rubella vaccine

                Rho(D) immune globulin decreases effects of rubella vaccine by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.

              • smallpox (vaccinia) vaccine, live

                Rho(D) immune globulin decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.

              • varicella virus vaccine live

                Rho(D) immune globulin decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.

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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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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              HyperRHO S/D intramuscular
              -
              1,500 unit (300 mcg) suspension
              Rhophylac injection
              -
              1,500 unit (300 mcg)/2 mL solution
              Rhophylac injection
              -
              1,500 unit (300 mcg)/2 mL solution
              MICRhoGAM Ultra-Filtered PLUS intramuscular
              -
              250 unit (50 mcg) suspension
              MICRhoGAM Ultra-Filtered PLUS intramuscular
              -
              250 unit (50 mcg) suspension
              MICRhoGAM Ultra-Filtered PLUS intramuscular
              -
              250 unit (50 mcg) suspension
              RhoGAM Ultra-Filtered PLUS intramuscular
              -
              1,500 unit (300 mcg) suspension
              RhoGAM Ultra-Filtered PLUS intramuscular
              -
              1,500 unit (300 mcg) suspension
              RhoGAM Ultra-Filtered PLUS intramuscular
              -
              1,500 unit (300 mcg) suspension

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

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              Patient Education
              rho(D) immune globulin injection

              NO MONOGRAPH AVAILABLE AT THIS TIME

              USES: Consult your pharmacist.

              HOW TO USE: Consult your pharmacist.

              SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Consult your pharmacist.

              DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: No monograph available at this time.

              MISSED DOSE: Consult your pharmacist.

              STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

              Information last revised July 2016. Copyright(c) 2022 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.