Rhogam Ultra-Filtered (Rho(D) immune globulin)

Preparations of Rho(D) immune globulin for IM use only are commercially available in single-dose prefilled syringes containing a full dose (standard dose) of Rho(D) immune globulin (HyperRHO(R) S/D Full Dose, RhoGAM(R)) or in single-dose prefilled syringes containing a minidose of Rho(D) immune globulin (HyperRHO(R) S/D Mini-Dose, MICRhoGAM(R)). Each single-dose prefilled syringe containing a full dose of Rho(D) immune globulin contains enough anti-Rho(D) (approximately 300 mcg) to suppress the immunization potential of 15 mL of Rho(D)-positive packed red blood cells (RBCs). Each single-dose prefilled syringe of minidose Rho(D) immune globulin contains enough anti-Rho(D) to suppress the immunization potential of 2.5 mL of Rho(D)-positive packed RBCs or the equivalent (5 mL) of whole blood.

Single-dose vials of Rho(D) immune globulin for IV or IM administration (WinRho(R) SDF) containing 1500 units (300 mcg) contain enough anti-Rho(D) to suppress the immunization potential of 17 mL of Rho(D)-positive RBCs. Single-dose prefilled syringes of Rho(D) immune globulin for IV or IM administration (Rhophylac(R)) contain enough anti-Rho(D) (1500 units or 300 mcg) to suppress the immunization potential of at least 15 mL of Rho(D)-positive RBCs.

Rho(D) immune globulin is administered IV or IM. Certain preparations (i.e., HyperRHO(R) S/D Full Dose, HyperRHO(R) S/D Mini-Dose, MICRhoGAM(R), RhoGAM(R)) are for IM injection only and should not be administered IV. Other preparations (i.e., Rhophylac(R), WinRho(R) SDF) may be administered either IV or IM. For indications related to the suppression of Rh isoimmunization, Rho(D) immune globulin may be administered IV or IM; however, when used for the treatment of idiopathic thrombocytopenic purpura (ITP; also known as immune thrombocytopenic purpura), Rho(D) immune globulin must be administered by IV injection. Efficacy of Rho(D) immune globulin for suppression of Rh isoimmunization appears to be similar following IV or IM administration.

For suppression of Rh isoimmunization related to an Rh-incompatible pregnancy, Rho(D) immune globulin is administered to the mother and should not be administered to the infant. Prior to administration of Rho(D) immune globulin, appropriate laboratory tests should be performed to assess the Rh status of the woman and determine whether she was previously sensitized to the Rho(D) antigen. (See Precautions and Contraindications Related to Use for Suppression of Rh Isoimmunization under Cautions: Precautions and Contraindications.)

Solutions of Rho(D) immune globulin should be inspected visually for particulate matter and discoloration prior to administration. Some preparations (Rhophylac(R), WinRho(R) SDF) should be brought to room temperature prior to administration. Vials and prefilled syringes of Rho(D) immune globulin are for single use only and contain no preservatives; any unused solution should be discarded.

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There are no contraindication interactions for this drug.

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There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

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Rho(D) immune globulin is used IM or IV to suppress the active antibody response to Rho(D) and formation of anti-Rho(D) antibodies in unsensitized, Rho(D)-negative women with an Rh-incompatible pregnancy. Rh incompatibility is assumed if the fetus/neonate is either Rho(D)-positive or Rho(D)-unknown or if the father is either Rho(D)-positive or Rho(D)-unknown. The American College of Obstetricians and Gynecologists (ACOG) and other experts recommend routine antenatal prophylaxis with Rho(D) immune globulin at approximately 28 weeks of gestation in all Rho(D)-negative women who have not been previously sensitized to the Rho(D) antigen, unless the father of the fetus is known to be Rho(D)-negative; the recommended timing of this dose is typically at 28 weeks of gestation, but may range from 26 to 30 weeks of gestation. Another dose of Rho(D) immune globulin should be administered within 72 hours after delivery if the neonate is Rho(D)-positive. If the Rho(D) type of an infant born to an Rho(D)-negative mother cannot be determined within this time period, the infant should be assumed to be Rho(D)-positive and a postpartum dose of Rho(D) immune globulin should be administered to the mother at 72 hours after delivery. If Rho(D) immune globulin is administered at any time during pregnancy because of suspected fetal-maternal hemorrhage (e.g., threatened abortion, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, abdominal trauma), a postpartum dose must still be administered to the mother following delivery of an Rho(D)-positive infant. In addition, if Rho(D) immune globulin is administered early in the pregnancy (before 26-28 weeks of gestation), additional antepartum doses should be administered (e.g., at 12-week intervals) to maintain an adequate level of passively acquired anti-Rho(D) antibody throughout the pregnancy.

Clinical studies have shown that administration of Rho(D) immune globulin to the mother within 72 hours after delivery of a full-term infant reduces the incidence of development of active antibody response and formation of anti-Rho(D) from 12-13% to 1-2%. The 1-2% failure rate probably is due to Rh isoimmunization occurring during the latter part of pregnancy or following delivery. The incidence of Rh isoimmunization can be further reduced to about 0.1-0.2% by administering a 2-dose regimen of Rho(D) immune globulin that involves administering an antepartum dose at 28 weeks of gestation in addition to the postpartum dose.

In a study evaluating use of Rho(D) immune globulin for suppression of Rh isoimmunization in unsensitized, Rho(D)-negative pregnant women in cases when the blood type of the father of the fetus was Rho(D)-positive or unknown, Rho(D) immune globulin doses of 600 units (120 mcg) or 1200 units (240 mcg) were given to the mother at 28 weeks of gestation or, alternatively, doses of 1200 units (240 mcg) were given at both 28 and 34 weeks of gestation. A postpartum dose of 600 units (120 mcg) was administered to any of these women who delivered an Rho(D)-positive infant. There was no evidence of Rh isoimmunization in women who received both the antepartum and postpartum doses of Rho(D) immune globulin and who were evaluated for Rh isoimmunization 6 months after delivery.

Animal reproduction studies have not been performed with Rho(D) immune globulin. Available evidence suggests that administration of Rho(D) immune globulin for the suppression of Rh isoimmunization during pregnancy does not have adverse effects on the fetus or future pregnancies and does not adversely affect the reproduction capacity of the mother. Rho(D) immune globulin has not been evaluated systematically in pregnant women with ITP; when treatment is indicated, therapy with corticosteroids and/or immune globulin IV (IGIV) generally is recommended. Infants born to women who received antepartum Rho(D) immune globulin may have a weakly positive direct antiglobulin (Coombs') test at birth.

Rhophylac(R) is used in nursing women for the suppression of Rh isoimmunization; no adverse effects are expected during breastfeeding. Rho(D) immune globulin has not been evaluated in nursing women with ITP. It is not known whether Rho(D) immune globulin is distributed into human milk; because many drugs are distributed into milk, caution is advised when Rho(D) immune globulin is administered to nursing women.

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