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Dosage: Pregnancy and Other Obstetric Conditions: For postpartum prophylaxis, administer 1 vial or syringe preferably within 72 hrs of delivery. Although a lesser degree of protection is afforded if Rh antibody is administered beyond the 72-hr period, Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose may still be given. Full-term deliveries can vary in their dosage requirements depending on the magnitude of the fetomaternal hemorrhage. One 300-mcg vial or syringe provides sufficient antibody to prevent Rh sensitization if the volume of red blood cells that has entered the circulation is ≤15 mL. In instances where a large (>30 mL of whole blood or 15 mL red blood cells) fetomaternal hemorrhage is suspected, a fetal red cell count by an approved laboratory technique (eg, modified Kleihauer-Beikse acid elution stain technique) should be performed to determine the dosage of immune globulin required. The red blood cell volume of the calculated fetomaternal hemorrhage is divided by 15 mL to obtain the number of vials or syringes of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose for administration. If >15 mL of red cells is suspected or if the dose calculation results in a fraction, administer the next higher whole number of vials or syringes (eg, if 1.4, give 2 vials or 2 syringes).
For antenatal prophylaxis, one 300-mcg vial or syringe is administered at approximately 28 weeks of gestation. This must be followed by another 300 mcg dose, preferably within 72 hrs following delivery, if the infant is Rh-positive.
Following threatened abortion at any stage of gestation with continuation of pregnancy, it is recommended that 300 mcg be given. If >15 mL of red cells is suspected due to fetomaternal hemorrhage, the same dose modification as for postpartum prophylaxis applies.
Following miscarriage, abortion or termination of ectopic pregnancy at or beyond 13 weeks of gestation, it is recommended that 300 mcg be given. If >15 mL of red cells is suspected due to fetomaternal hemorrhage, the same dose modification as for postpartum prophylaxis applies. If pregnancy is terminated prior to 13 weeks of gestation, where licensed, a single dose of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) mini-dose (approximately 50 mcg) may be used instead of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose.
Following amniocentesis at either 15-18 weeks of gestation or during the 3rd trimester, or following abdominal trauma in the 2nd or 3rd trimester, it is recommended that 300 mcg of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose be administered. If there is a fetomaternal hemorrhage in excess of 16 mL of red cells, the same dose modification as for postpartum prophylaxis applies.
If abdominal trauma, amniocentesis or other adverse event requires the administration of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose at 13-19 weeks of gestation, another 300-mcg dose should be given at 26-28 weeks. To maintain protection throughout pregnancy, the level of passively acquired anti-Rho(D) should not be allowed to fall below the level required to prevent an immune response to Rh-positive red cells. The half-life of IgG is 23-26 days. In any case, a dose of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose should be given within 72 hrs after delivery if the baby is Rh-positive. If delivery occurs within 3 weeks after the last dose, the postpartum dose may be withheld unless there is a fetomaternal hemorrhage in excess of 15 mL of red blood cells.
Transfusion: In the case of a transfusion of Rho(D)-positive red cells to a Rho(D)-negative recipient, the volume of Rh-positive whole blood administered is multiplied by the hematocrit of the donor unit giving the volume of red blood cells transfused. The volume of red blood cells is divided by 15 mL which provides the number of vials or syringes of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose to be administered.
If the dose calculated results in a fraction, the next higher whole number of vials or syringes should be administered (eg, if 1.4, give 2 vials or 2 syringes). Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose should be administered within 72 hrs after an incompatible transfusion, but preferably as soon as possible.
Administration: Do not inject IV. Do not inject to neonate. Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose is administered IM, preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. The gluteal region should not be used routinely as an injection site because of the risk of injury to the sciatic nerve. If the gluteal region is used, the central region must be avoided; only the upper, outer quadrant should be used.
Single Vial or Syringe Dose: Inject entire contents of the vial or syringe into the individual IM.
Multiple Vial or Syringe Dose: Calculate the number of vials or syringes of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose to be given (see Dosage).
The total volume of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose can be given in divided doses at different sites at one time or the total dose may be divided and injected at intervals, provided the total dosage is given within 72 hrs of the fetomaternal hemorrhage or transfusion. Using sterile technique, inject the entire contents of the calculated number of vials or syringes IM into the patient.
Directions for Syringe Use: Remove the pre-filled syringe from the package. Lift syringe by barrel, not by plunger. Twist the plunger rod clockwise until the threads are seated. With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel. Remove the needle shield and expel air bubbles. Proceed with hypodermic needle procedure. Aspirate prior to injection to confirm that the needle is not in a vein or artery. Inject the medication. Withdraw the needle and destroy it.
