Human rho(d) immune globulin

RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients. RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) indicated for: Suppression of Rhesus (Rh) Isoimmunization in: Pregnancy and obstetric conditions in non-sensitized, Rh(D)-negative women with an Rh-incompatible pregnancy, including: Routine antepartum and postpartum Rh prophylaxis Rh prophylaxis in obstetric complications or invasive procedures Incompatible transfusions in Rh(D)-negative individuals transfused with blood components containing Rh(D)-positive red blood cells (RBCs) Immune Thrombocytopenic Purpura (ITP). Raising platelet counts in Rh(D)-positive, non-splenectomized adults with chronic ITP.

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 RHOPHYLAC 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 RHOPHYLAC has been shown to increase platelet counts and to reduce bleeding in non-splenectomized Rh(D)-positive subjects with chronic ITP.

Observe patients for at least 20 minutes following administration of RHOPHYLAC. DO NOT confuse micrograms (mcg) with International Units (IU) when calculating the dose. Miscalculations could result in overdose or underdose Suppression of Rh Isoimmunization (IV or IM administration only) Indication Timing Dose A 1500 IU (300 mcg) dose will suppress the immunizing potential of ≤15 mL of Rh(D)-positive RBCs. 1 (1 mcg = 5 IU) Rh-incompatible Pregnancy: mcg IU Routine antepartum prophylaxis Week 28-30 of pregnancy 300 mcg 1500 IU Postpartum prophylaxis (required only if the newborn is Rh(D)-positive, or of unknown status) Within 72 hours of birth 300 mcg The dose must be increased if the patient is exposed to >15 mL of Rh(D)-positive RBCs, in this case, follow the dosing guidelines for excessive fetomaternal hemorrhage. 1500 IU Obstetric complications/invasive procedures Within 72 hours of…

RHOPHYLAC is contraindicated in: patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin, IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to RHOPHYLAC or any of its components, the newborn infant of a mother that received RHOPHYLAC postpartum. 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 RHOPHYLAC or any of its components. Do not administer to the newborn infant of the mother that received RHOPHYLAC postpartum.

Boxed warning (intravascular hemolysis in itp): This warning does not apply to Rh(D)-negative patients treated for the suppression of Rh isoimmunization. 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. 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: RHOPHYLAC may increase the severity of anemia.

The most serious adverse reactions in patients receiving Rh(D) Immune Globulin Intravenous (Human) have been observed in the treatment of ITP and include intravascular hemolysis, clinically compromising anemia, acute renal insufficiency, and, very rarely, DIC and death. 2 The most common adverse reactions observed with the use of RHOPHYLAC for suppression of Rh isoimmunization (≥0.5% of subjects) are nausea, dizziness, headache, injection-site pain, and malaise. The most common adverse reactions observed in the treatment of ITP (>14% of subjects) are chills, pyrexia/increased body temperature, and headache. Hemolysis (manifested by an increase in bilirubin, a decrease in hemoglobin, or a decrease in haptoglobin) was also observed. Suppression of Rh Isoimmunization: Most common adverse reactions in ≥0.5% of subjects are nausea, dizziness, headache, injection-site pain, and malaise.

Immunoglobulin administration may transiently interfere with the immune response to live virus vaccines, such as measles, mumps and rubella. Live Virus Vaccines Passive transfer of antibodies may transiently impair the immune response to live attenuated virus vaccines such as measles, mumps, rubella, and varicella. Do not immunize with live vaccines within 3 months after the final dose of RHOPHYLAC. If RHOPHYLAC is administered within 14 days after administration of a live vaccine, the immune response to the vaccination may be inhibited. 3

Store at 2 to 8°C (36 to 46°F) for a shelf life of 36 months from the date of manufacture, as indicated by the expiration date printed on the outer carton and syringe label.