Adult Dosing

Pregnancy and Other Obstetric Conditions

Antenatal prophylaxis

• 1500 Units IM x 1 at 28 wks gestation; followed by another full dose within 72 hrs after delivery

Postpartum prophylaxis

• 1500 Units IM x 1 within 72 hrs after delivery

Threatened abortion

• 1500 Units IM x 1

Miscarriage, abortion, or termination of ectopic pregnancy at or beyond 13 weeks' gestation

• 1500 Units IM x 1

Amniocentesis or abdominal trauma

• 1500 Units IM x 1, if administered at 13-18 wks, repeat full dose at 28 wks and then within 72 hrs postpartum

Excessive fetomaternal hemorrhage

• If large fetomaternal hemorrhage then number of syringes = RBC volume of the fetomaternal hemorrhage divide by 15 mL

Actual or threatened termination of pregnancy upto 12 weeks

• 250 units IM x 1 within 3 hrs or as soon as possible, May give up to 72 hrs

Rh-incompatible transfusion

• Administer with 72 hrs of transfusion
• Calculated dose (No of syringes) = volume of RBCs divided by 15 mL

Suppression of Rh Isoimmunization

Rhophylac

• Antenatal prophylaxis
• 1500 IU IM/IV at 28-30 wks of gestation

• Postpartum prophylaxis
• 1500 IU IM/IV within 72 hours of birth

• Obstetric complications
• 1500 IU IM/IV within 72 hours of complication

• Invasive procedures during pregnancy
• 1500 IU IM/IV within 72 hours of procedure

• Excessive fetomaternal hemorrhage
• 1500 IU IM/IV within 72 hours
• If excess transplacental bleeding is quantified, additional 100 IU/mL fetal RBCs in excess of 15 mL
• If excess transplacental bleeding cannot be quantified additional 1500 IU dose

• Incompatibletransfusions
• 100 IU/2 mL of transfused blood or 100IU/ mL of erythrocyte concentrate

WinRho SDF

• Antenatal prophylaxis
• 1500 IU IM/IV at 28 wks of gestation

• Postpartum prophylaxis
• 600 IU IM/IV within 72 hours of birth

• Threatened abortion
• 1500 IU IM/IV immediately

• Amniocentesis and chorionic villus sampling prior to 34 weeks gestation
• 1500 IU IM/IV immediately

• Amniocentesis and chorionic villus sampling after 34 weeks gestation
• 600 IU IM/IV within 72 hours of procedure

• Incompatible transfusions
• If exposed to Rho(D) Positive Whole Blood: 3000 IU (600 mcg) IV q8 hrs until 45 IU (9 mcg)/mL blood is administered; Alt: 6000 IU (1200 mcg) IM q12 hrs, until 60 IU (12 mcg)/mL blood is administered
• If exposed to Rho(D) Positive Red Blood Cells: 3000 IU (600 mcg) IV q8 hrs until, 90 IU (18 mcg)/mL cell is administered; Alt: 6000 IU (1200 mcg) IM q12 hrs, until 120 IU (24 mcg)/mL cell is administered

Immune thrombocytopenic purpura

Rhophylac

• 250 IU (50 mcg)/kg IV x 1, at a rate of 2 mL/15-60 seconds

WinRho SDF

• Initial dose
• 250 IU (50 mcg)/kg IV as single dose or 2 divided doses
• If Hgb <10 g/dl: 125-200 IU (25-40 mcg)/kg IV

• Subsequent dose
• 125-300 IU (25-60)/kg IV, based on patient’s clinical response (platelet and Hgb levels)
• Hgb 8-10 g/dl: 125-200 IU (25-40 mcg)/kg IV
• Hgb >10 g/dl: 250-300 IU (50-60 mcg)/kg IV
• Hgb <8 g/dl: Alternative treatments should be used

Pediatric Dosing

• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Prevention of isoimmunization in Rho (D) negative mother within 72 hrs after birth of Rho (D) positive infant
• Antepartum prophylaxis at 26 to 28 weeks' gestation in nonsensitized Rho (D) negative women
• Suppression of Rh isoimmunization in nonsensitized Rho (D) negative women, following spontaneous or induced abortion, following ruptured tubal pregnancy, amniocentesis, or abdominal trauma
• Prevention of isoimmunization in Rho (D) negative individuals who have been transfused with Rho (D) positive RBCs or blood components containing RBCs
• Prevention of isoimmunization of Rho (D) negative women at the time of spontaneous or induced abortion of up to 12 weeks [HyperRHO S/ D Mini-Dose]
• To raise platelet counts in Rho (D) positive, nonsplenectomized adult patients with chronic immune thrombocytopenic purpura [Rhophylac, WinRho SDF]

• Hypersensitivity to any of the ingredients of the product
• Rh-positive individuals
• Autoimmune hemolytic anemia [WinRho SDF]
• Pre-existing hemolysis [WinRho SDF]
• Risk for hemolysis [WinRho SDF]
• IgA deficient with antibodies against IgA [WinRho SDF]
• In infants for the suppression of isoimmunization, Rho (D)[WinRho SDF]

• WinRho SDF and Rhophylac can cause intravascular hemolysis leading to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS) and death in patients treated for immune thrombocytopenic purpura (ITP)
• Other serious complications such as severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported
• Closely monitor ITP patients treated with WinRho SDF for at least 8 hrs after administration in a health care setting. After administration, perform dipstick urinalysis at baseline, 2 hrs, 4 hrs and prior to the end of the monitoring period
• Alert patients of and monitor them for the signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria. If present or suspected, perform post-treatment laboratory tests including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect). Absence of these signs and symptoms within 8 hrs does not indicate that IVH cannot occur subsequently

Renal Dose Adjustment

• IM
• Renal impairment: Dose adjustments not defined

• IV
• Renal impairment: Use caution; may require infusion rate reduction

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Rho (D) immune globulin is prepared from human plasma; hence there is a chance of transmission of viral infections including viral hepatitis and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent. However, because of plasma donor screening and viral inactivation and removal properties, the incidence of viral transmission is low
• Discuss the potential risks and benefits of this product with the patient before prescribing or administering it
• Do not administer HyperRHO S/ D Full Dose, HyperRHO S/ D Mini-Dose, MicRhoGAM, RhoGAM intravenously, inject only intramuscularly. Never administer to neonates
• Can cause systemic allergic reactions, use cautiously in patients with history of prior systemic allergic reactions. Epinephrine should be readily available for acute anaphylatic reactions
• Weigh the benefit of immunization against the possible risk of hypersensitivity in persons with isolated immunoglobulin A (IgA) deficiency, as they are at high risk of developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA
• Bleeding may occur following IM administration in individuals with thrombocytopenia or a bleeding disorder or in those receiving anticoagulant therapy
• A weak mixed field positive D test result is observed if there is large fetomaternal hemorrhage in late pregnancy or post delivery. Administer Rho (D) immune globulin (Human) if there is doubt about the mother's Rh type. In such cases, screening test to detect fetal red blood cells may be helpful [HyperRHO S/D Full Dose]
• More than a single dose is required if there is more than 15 mL of D positive fetal red blood in mother's circulation. Failure to recognize this may result in inadequate dose [HyperRHO S/D Full Dose]
• Blood typing, the antibody screening test, and the direct antiglobulin (Coombs’) test may be affected by administration of Rho(D) immune globulin. These tests in the newborn infant are also affected when administered antepartum to the mother
• Can contain antibodies to other Rh antigens (e.g., anti-C antibodies) that can be detected by sensitive serological tests following administration [Rhophylac]
• Clinically compromising anemia, acute renal insufficiency, and very rarely disseminated intravascular coagulation (DIC) and death has been reported due to intravascular hemolysis in patients treated for ITP [US Black Box Warning] [Rhophylac, WinRho SDF]
• Closely monitor ITP patients treated with WinRho SDF/Rhophylac for signs and/or symptoms of intravascular hemolysis and its complications. Perform confirmatory laboratory tests (plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin), if IVH occurs or suspected [US Black Box Warning]
• Transfused, Rh0(D)-negative packed RBCs if patients develops hemolysis with clinically compromising anemia, to avoid exacerbating ongoing hemolysis
• The safety in the treatment of ITP patients with pre-existing anemia has not been established. Weigh the benefit against the potential risk of increasing the severity of the anemia [WinRho SDF/Rhophylac]
• WinRho SDF contains maltose, hence can give falsely high blood glucose levels in certain types of blood glucose testing systems. Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels
• Administer WinRho SDF® at the minimum infusion rate practicable in patients at risk of renal dysfunction or failure
• Thrombotic events have been reported with WinRho® SDF and other immunoglobulin IV. Patients with history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known/suspected hyperviscosity are at higher risk
• Monitor blood viscosity of high risk patients at baseline and if patient is judged to be at risk of developing thrombotic events, administer WinRho SDF at the minimum rate of infusion practicable
• WinRho SDF for treatment of ITP can cause decrease in hemoglobin levels (extravascular hemolysis). Administer a reduced dose in patients with lower than normal hemoglobin and use alternate treatment in patients with hemoglobin levels that are less than 8 g/dL
• Transfusion-related acute lung injury characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever has been reported with immune globulin IV treatment within 1-6 hrs following treatment. Manage these patients using oxygen therapy with adequate ventilatory support

Cautions: Use cautiously in

• Renal impairment [WinRho SDF]
• History of hypersensitivity to human immunoglobulin preparations
• Bleeding disorders
• Anemia [IV]
• Risk of thrombosis [IV]

Supplemental Patient Information

• Instruct patients being treated ITP to immediately report symptoms of intravascular hemolysis including back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath to their physicians

Pregnancy Category:C

Breastfeeding: Rho (D) immune globulin is rich in IgG antibodies against erythrocyte antigen Rho (D) which is a normal component of breastmilk. Frequent use of Rho (D) immune globulin is not associated with any adverse events in breastfed infants, hence no special precaution is required. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 Aug 2011). As per manufacturer's data no undesirable effects on a nursing infant are expected when used in nursing mothers for the suppression of Rh isoimmunization. Safety in nursing mothers with ITP has not been evaluated [Rhophylac].

• CV: Intravascular hemolysis (IVH), hypertension, hypotension, vasodilation
• CNS: Headache, asthenia, dizziness, hyperkinesia, malaise, somnolence
• DERM: Pruritus, rash, sweating
• GI: Abdominal pain, diarrhea, nausea, vomiting
• HEMA: Extravascular hemolysis, anemia, DIC, hemoglobinemia, intravascular hemolysis
• LABTESTABS: Increased bilirubin, creatinine, and LDH; decreased Hgb and haptoglobin
• LOCAL: Pain at the injection site, induration, redness, swelling, warmth
• MUSC: Arthralgia, back pain, myalgia
• RESP: Acute respiratory distress syndrome, dyspnea, transfusion-related acute lung injury
• GU: Acute renal insufficiency, hemoglobinuria
• MISC: Chills, pyrexia/increased body temperature, pallor, allergic or anaphylactic reactions

• Immunoglobulin; prevents the formation of Rho(D) antibody in Rho(D) negative individuals exposed to Rho(D) antigen, increases platelet count in patients with ITP
• Metabolism: Unknown
• Excretion: Unknown
• Half-life
• RhoGAM: 93.9 days
• Rhophylac: 18+/-5 days (IM); 16+/-4 days (IV)
• WinRho SDF: 30 days (IM); 24 days (IV)

US Trade Name(s)

• HyperRHO S/ D Full Dose
• HyperRHO S/ D Mini-Dose
• MicRhoGAM
• RhoGAM
• Rhophylac
• WinRho SDF

US Availability

HyperRHO S/ D Full Dose, RhoGAM, Rhophylac

• INJ: 1500 U (Prefilled syringe)

HyperRHO S/ D Mini-Dose, MicRhoGAM

• INJ: 250 U (Prefilled syringe)

WinRho SDF

• INJ: 600 U/vial
• INJ: 1500 U/vial
• INJ: 5000 U/vial

Canadian Trade Name(s)

• WinRho SDF

Canadian Availability

WinRho SDF

• INJ: 600 U/vial
• INJ: 1500 U/vial
• INJ: 2500 U/vial
• INJ: 5000 U/vial
• INJ: 15000 U/vial
• PWDR for INJ: 600 U/vial
• PWDR for INJ: 1500 U/vial
• PWDR for INJ: 5000 U/vial

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• WinRho SDF

Australian Availability

rh(D) immunoglobulin-VF (generic)

• INJ: 250 U/vial
• INJ: 625 U/vial

WinRho SDF

• PWDR for INJ: 600 U/vial

[Outline]

Immunologic

Immunoglobulins