Human Anti-D Immunoglobulin (Rho(D) immune globulin)

Indications

Human Anti-D Immunoglobulin (Rho(D) immune globulin) is used for: Suppression of Rhesus (Rh) Isoimmunization, Immune Thrombocytopenic Purpura (ITP)

Adult Dose

Intravenous (IV) or Intramuscular (IM) Rh-incompatible Pregnancy Administer to Mother Routine antepartum prophylaxis: 300 mcg (1500 IU) IV or IM between weeks 28-30 of pregnancy Postpartum prophylaxis (required only if the newborn is Rh(D)-positive, or of unknown status): 300 mcg (1500 IU) IV or IM within 72 hours of birth Obstetric complications/invasive procedures: 300 mcg (1500 IU) IV or IM within 72 hours of complication/procedure Excessive fetomaternal hemorrhage (>15 mL fetal RBCs) within 72 hours of complication: 300 mcg plus: 20 mcg per mL (100 IU) RhD-positive fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified, or An additional 300 mcg if excess transplacental bleeding cannot be quantified Incompatible transfusions 20 mcg per 2 mL (100 IU) transfused Rh(D)- positive whole blood or per 1 mL Rh(D)-positive RBCs within 72 hours of exposure Intravenous (IV) Immune Thrombocytopenic Purpura (ITP) 50 mcg per kg body weight 2 mL per 15 to 60 seconds

Child Dose

Renal Dose

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

Contra Indications

History of anaphylactic or severe systemic reaction to human immune globulin products IgA deficient patients with antibodies against IgA and a history of hypersensitivity to Human Anti-D Immunoglobulin or any of its components Do not administer to the newborn infant of the mother that received Human Anti-D Immunoglobulin postpartum

Precautions

Intravascular hemolysis leading to death has been reported in Rh(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh(D) Immune Globulin Intravenous (Human) products. Intravascular hemolysis can lead to clinically compromising anemia and multisystem organ failure including acute respiratory distress syndrome (ARDS), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). Hypersensitivity: Severe hypersensitivity and anaphylactic reactions may occur. Transmissible Infectious Agents: Potential of viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Intravascular Hemolysis in ITP Treatment: Monitor patients for signs and symptoms and perform confirmatory laboratory tests. Pre-existing Anemia in ITP Treatment: Human Anti-D Immunoglobulin may increase the severity of anemia. Monitoring Parameters Monitor patients in a healthcare setting for signs and symptoms of intravascular hemolysis for at least 8 hours after administration. Monitor patients for signs and symptoms and perform confirmatory laboratory tests.

Pregnancy-Lactation

Risk Summary Animal reproduction studies have not been conducted with Human Anti-D Immunoglobulin. Suppression of Rh Isoimmunization Human Anti-D Immunoglobulin is used in pregnant women for the suppression of Rh isoimmunization. When administered to pregnant women in a clinical trial to evaluate Human Anti-D Immunoglobulin for suppression of Rh isoimmunization following dosing regimens similar to Human Anti-D Immunoglobulin was not shown to harm the fetus or newborn. In general, anti-D immunoglobulins have been shown to not harm the fetus or affect future pregnancies or reproduction capacity when given to pregnant Rh(D)-negative women for suppression of Rh isoimmunization. ITP Human Anti-D Immunoglobulin has not been evaluated in pregnant women with ITP. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Lactation Risk Summary There is no information regarding the presence of Human Anti-D Immunoglobulin in human milk, the effect on the breastfed infant, and the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Human Anti-D Immunoglobulin and any potential adverse effects on the breastfed child from Human Anti-D Immunoglobulin or from the underlying maternal condition. Suppression of Rh Isoimmunization Human Anti-D Immunoglobulin is used in nursing mothers for the suppression of Rh isoimmunization. ITP Human Anti-D Immunoglobulin has not been evaluated in nursing mothers with ITP.

Interactions

May interfere with the immune response to live measles vaccine, live mumps vaccine, live rubella vaccine and live varicella vaccine, therefore these vaccines should be given at least 3 wk before or 3 mth after the admin of the immunoglobulins. Contraindicated (0) Serious (6) axicabtagene ciloleucel brexucabtagene autoleucel ciltacabtagene autoleucel idecabtagene vicleucel lisocabtagene maraleucel tisagenlecleucel

Adverse Effects

Side effects of Human Anti-D Immunoglobulin (Rho(D) immune globulin) : Frequency Not Defined Tenderness Allergic reaction Urticaria Angioedema Rare elevation in total bilirubin secondary to rapid RBC destruction when given following transfusion mismatch

Mechanism of Action

Suppression of Rh Isoimmunization The mechanism by which Rh(D) immune globulin suppresses immunization to Rh(D)-positive RBCs is not completely known. In a clinical study of Rh(D)-negative healthy male volunteers, both the intravenous and intramuscular administration of a 1500 IU (300 mcg) dose of Human Anti-D Immunoglobulin 24 hours after injection of 15 mL of Rh(D)-positive RBCs resulted in an effective clearance of Rh(D)-positive RBCs. On average, 99% of injected RBCs were cleared within 12 hours following intravenous administration and within 144 hours following intramuscular administration. ITP Human Anti-D Immunoglobulin has been shown to increase platelet counts and to reduce bleeding in nonsplenectomized Rh(D)-positive subjects with chronic ITP. The mechanism of action is thought to involve the formation of Rh(D) immune globulin RBC complexes, which are preferentially removed by the reticuloendothelial system, particularly the spleen. This results in Fc receptor blockade, thus sparing antibody-coated platelets.