Rho(D) immune globulin (human).
Each vial contains sufficient anti-Rho(D) (approximately 300 mcg*) to effectively suppress the immunizing potential of 15 mL of Rho(D)-positive red blood cells. The potency is equal to or greater than that of the US Food and Drug Administration Reference Rho(D) immune globulin.
Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose, treated with solvent/detergent, is a sterile solution of immune globulin containing antibodies to Rho(D) for IM administration. It contains no preservative. It is prepared by cold ethanol fractionation from human plasma. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hrs. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. It is then incubated in the final container for 21-28 days at 20-27°C.
The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose has been validated in laboratory studies. Human immunodeficiency virus type I (HIV-1) was chosen as the relevant virus for blood products; bovine viral diarrhea virus (BVDV) was chosen to model hepatitis C virus; pseudorabies virus (PRV) was chosen to model hepatitis B virus and the herpes viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at 2 steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: The precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III. Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.
* A full dose of Rho(D) immune globulin (human) has traditionally been referred to as a "300 mcg" dose and this dosage is employed here for convenience in terminology. It should not be construed as the actual anti-D content. Each full dose of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) must contain at least as much anti-D as 1 mL of the US Reference Rho(D) immune globulin. Studies performed at the FDA have shown that the US Reference contains 880 iu of anti-D per mL. When the conversion factor determined for the International (WHO) Reference Preparation is used, 620 iu/mL is equivalent to 184 mcg/mL of anti-D.
Pharmacology: Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose is used to prevent isoimmunization in the Rho(D)-negative individual exposed to Rho(D)-positive blood as a result of a fetomaternal hemorrhage occurring during a delivery of a Rho(D)-positive infant, abortion (either spontaneous or induced), or following amniocentesis or abdominal trauma. Similarly, immunization resulting in the production of anti-Rho(D) following transfusion of Rh-positive red cells to a Rho(D)-negative recipient may be prevented by administering Rho(D) immune globulin (human).
Rh hemolytic disease of the newborn is the result of the active immunization of a Rho(D)-negative mother by Rho(D)-positive red cells entering the maternal circulation during a previous delivery, abortion, amniocentesis, abdominal trauma, or as a result of red cell transfusion. Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose acts by suppressing the immune response of Rho(D)-negative individuals to Rho(D)-positive red blood cells. The mechanism of action of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose is not fully understood.
The administration of Rho(D) immune globulin (human) within 72 hrs at a full-term delivery of a Rho(D)-positive infant by a Rho(D)-negative mother reduces the incidence of Rh isoimmunization from 12-18% to 19-29%.
The 1-2% treatment failures are probably due to isoimmunization occurring during the latter part of pregnancy or following delivery. Bowman and Pollock have reported that the incidence of isoimmunization can be further reduced from approximately 1.6% to less than 0.5% by administering Rho(D) immune globulin (human) in 2 doses, one antenatal at 28 weeks of gestation and another following delivery.
In a clinical study in 8 healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, rabies immune globulin (human) (BayRab), prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hrs post-injection and persisted through the 21-day study period. These results suggest that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.
Pregnancy and Other Obstetric Conditions: Prevention of Rh hemolytic disease of the newborn by its administration to the Rho(D)-negative mother within 72 hrs after birth of a Rho(D)-positive infant, providing the following criteria are met: The mother must be Rho(D)-negative and must not already be sensitized to the Rho(D) factor; her child must be Rho(D)-positive and should have a negative direct antiglobulin test (see Precautions).
If Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose is administered antepartum, it is essential that the mother receive another dose of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose after delivery of a Rho(D)-positive infant.
If the father can be determined to be Rho(D)-negative, Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose need not be given.
Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose should be administered within 72 hrs to all non-immunized Rho(D)-negative women who have undergone spontaneous or induced abortion, following ruptured tubal pregnancy, amniocentesis or abdominal trauma unless the blood group of the fetus or the father is known to be Rho(D)-negative. If the fetal blood group cannot be determined, one must assume that it is Rho(D)-positive and Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose should be administered to the mother.
Transfusion: Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose may be used to prevent isoimmunization in Rho(D)-negative individuals who have been transfused with Rho(D)-positive red blood cells or blood components containing red blood cells.
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.
Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) is made from human plasma. Products made from human plasma may contain infectious agents eg, viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. All infections thought by a physician possibly to have been transmitted by Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) should be reported by the physician or other healthcare provider to Bayer Corporation.
The physician should discuss the risks and benefits of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) with the patient before prescribing or administering it to the patient.
Never administer Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) IV. Inject only IM. Never administer to the neonate.
Rho(D) immune globulin (human) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.
The attending physician who wishes to administer Rho(D) immune globulin (human) to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunisation against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.
As with all preparations administered by the IM route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.
A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed positive D test result. If there is any doubt about the mother's Rh type, she should be given Rho(D) immune globulin (human). A screening test to detect total red blood cells may be helpful in such cases.
If >15 mL of D-positive fetal red blood cells are present in the mother's circulation, more than a single dose of Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose is required. Failure to recognize this may result in the administration of an inadequate dose.
Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic reactions.
Use in pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated). It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose should be given to a pregnant woman only if clearly needed.
Use in children: Safety and effectiveness in the pediatric population have not been established.
Use in pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated). It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bayrho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) full dose should be given to a pregnant woman only if clearly needed.
Use in children: Safety and effectiveness in the pediatric population have not been established.
Reactions to Rho(D) immune globulin (human) are infrequent in Rho(D)-negative individuals and consist primarily of slight soreness at the site of injection and slight temperature elevation. While sensitization to repeated injections of human immune globulin is extremely rare, it has occurred. Elevated bilirubin levels have been reported in some individuals receiving multiple doses of Rho(D) immune globulin (human) following mismatched transfusions. This is believed to be due to a relatively rapid rate of foreign red cell destruction.
Other antibodies in the Rho(D) immune globulin (human) preparation may interfere with the response to live vaccines eg, measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after Rho(D) immune globulin (human) administration.
Drug/Laboratory Interactions: Babies born of women given Rho(D) immune globulin (human) antepartum may have a weakly positive direct antiglobulin test at birth.
Passively acquired anti-Rho(D) may be detected in maternal serum if antibody screening tests are performed subsequent to ante- or postpartum administration of Rho(D) immune globulin (human).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Store at 2-8°C (36-46°F). Do not freeze.
J06BB01 - anti-D (rh) immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
HyperRho-D (Rho(D) Immune Globulin-Human) (SD Viral Inactivated) inj 300 mcg
1 dose x 1's
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