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Rh o (D) Immune Globulin (Human) -- Hyper RHO ™ S/D Full Dose treated with solvent/detergent is a sterile solution of immune globulin containing antibodies to Rh o (D) for intramuscular administration; it contains no preservative. Hyper RHO S/D Full Dose 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 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. Hyper RHO S/D 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. Hyper RHO S/D Full Dose is then incubated in the final container for 21-28 days at 20-27°C.
The potency is equal to or greater than 1500 IU. Each single dose vial or syringe contains sufficient anti-Rh o (D) to effectively suppress the immunizing potential of 15 mL of Rh o (D) positive red blood cells. 2-4
The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for Hyper RHO S/D Full Dose has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (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 two 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.
HyperRHO S/D Full Dose is used to prevent isoimmunization in the Rh o (D) negative individual exposed to Rh o (D) positive blood as a result of a fetomaternal hemorrhage occurring during a delivery of an Rh o (D) positive infant, abortion (either spontaneous or induced), or following amniocentesis or abdominal trauma. Similarly, immunization resulting in the production of anti-Rh o (D) following transfusion of Rh positive red cells to an Rh o (D) negative recipient may be prevented by administering Rh o (D) Immune Globulin (Human). 5,6
Rh hemolytic disease of the newborn is the result of the active immunization of an Rh o (D) negative mother by Rh o (D) positive red cells entering the maternal circulation during a previous delivery, abortion, amniocentesis, abdominal trauma, or as a result of red cell transfusion. 7,8 Hyper RHO S/D Full Dose acts by suppressing the immune response of Rh o (D) negative individuals to Rh o (D) positive red blood cells. The mechanism of action of Hyper RHO S/D Full Dose is not fully understood.
The administration of Rh o (D) Immune Globulin (Human) within 72 hours of a full-term delivery of an Rh o (D) positive infant by an Rh o (D) negative mother reduces the incidence of Rh isoimmunization from 12%-13% to 1%-2%. 9
The 1%-2% treatment failures are probably due to isoimmunization occurring during the latter part of pregnancy or following delivery. 10 Bowman and Pollock 11 have reported that the incidence of isoimmunization can be further reduced from approximately 1.6% to less than 0.1% by administering Rh o (D) Immune Globulin (Human) in two doses, one antenatal at 28 weeks' gestation and another following delivery.
In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), Hyper RAB ™ S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours 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.
Hyper RHO S/D Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rh o (D) negative mother within 72 hours after birth of an Rh o (D) positive infant, 12 providing the following criteria are met:
If Hyper RHO S/D Full Dose is administered antepartum, it is essential that the mother receive another dose of Hyper RHO S/D Full Dose after delivery of an Rh o (D) positive infant.
If the father can be determined to be Rh o (D) negative, Hyper RHO S/D Full Dose need not be given.
Hyper RHO S/D Full Dose should be administered within 72 hours to all nonimmunized Rh o (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 Rh o (D) negative. 7,8 If the fetal blood group cannot be determined, one must assume that it is Rh o (D) positive, 2 and Hyper RHO S/D Full Dose should be administered to the mother.
Hyper RHO S/D Full Dose may be used to prevent isoimmunization in Rh o (D) negative individuals who have been transfused with Rh o (D) positive red blood cells or blood components containing red blood cells. 5,13
None known.
HyperRHO S/D Full Dose is made from human plasma. Products made from human plasma may contain infectious agents, such as 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 this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. [1-800-520-2807].
The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.
NEVER ADMINISTER HYPER RHO S/D FULL DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. NEVER ADMINISTER TO THE NEONATE.
Rh o (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 Rh o (D) Immune Globulin (Human) to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization 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 intramuscular 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 field positive D u test result. If there is any doubt about the mother's Rh type, she should be given Rh o (D) Immune Globulin (Human). A screening test to detect fetal red blood cells may be helpful in such cases.
If more than 15 mL of D-positive fetal red blood cells are present in the mother's circulation, more than a single dose of Hyper RHO S/D 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.
Other antibodies in the Rh o (D) Immune Globulin (Human) preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after Rh o (D) Immune Globulin (Human) administration.
Babies born of women given Rh o (D) Immune Globulin (Human) antepartum may have a weakly positive direct antiglobulin test at birth.
Passively acquired anti-Rh o (D) may be detected in maternal serum if antibody screening tests are performed subsequent to antepartum or postpartum administration of Rh o (D) Immune Globulin (Human).
Animal reproduction studies have not been conducted with Hyper RHO S/D Full Dose. It is also not known whether Hyper RHO S/D Full Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyper RHO S/D Full Dose should be given to a pregnant woman only if clearly needed.
Safety and effectiveness in the pediatric population have not been established.
Reactions to Rh o (D) Immune Globulin (Human) are infrequent in Rh o (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 Rh o (D) Immune Globulin (Human) following mismatched transfusions. This is believed to be due to a relatively rapid rate of foreign red cell destruction.
NEVER ADMINISTER RH O (D) IMMUNE GLOBULIN (HUMAN) -- HYPERRHO™ S/D FULL DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. NEVER ADMINISTER TO THE NEONATE.
If abdominal trauma, amniocentesis, or other adverse event requires the administration of Hyper RHO S/D Full Dose at 13 to 18 weeks' gestation, another full dose should be given at 26 to 28 weeks. To maintain protection throughout pregnancy, the level of passively acquired anti-Rh o (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 to 26 days. In any case, a Hyper RHO S/D Full Dose should be given within 72 hours 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. 16
In the case of a transfusion of Rh o (D) positive red cells to an Rh o (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 Hyper RHO S/D 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 (e.g., if 1.4, give 2 vials or 2 syringes). Hyper RHO S/D Full Dose should be administered within 72 hours after an incompatible transfusion, but preferably as soon as possible.
DO NOT INJECT INTRAVENOUSLY. DO NOT INJECT NEONATE. Hyper RHO S/D Full Dose is administered intramuscularly , 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. 17
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Hyper RHO S/D Full Dose is supplied with a syringe and an attached UltraSafe® Needle Guard for your protection and convenience. Please follow instructions below for proper use of syringe and UltraSafe® Needle Guard.
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A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hyper RHO S/D Full Dose is available in individual and multiple-pack single dose syringes with attached needles and vials.
| NDC Number | Size |
| 13533-631-02 | Syringe |
Store at 2-8°C (36-46°F). Do not freeze.
CAUTION
Rx only
U.S. federal law prohibits dispensing without prescription.
Talecris Biotherapeutics, Inc.
Research Triangle Park, NC 27709 USA 08907644
U.S. License No. 1716 (Rev. January 2005)
Information About
Pregnancy Protection
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The Rh Factor and When It Is Important
The Rh factor is one of many blood group antigens found on the surface of red blood cells. If you have this antigen you are considered Rh positive. If you don't, then you are considered Rh negative. Everyone is either Rh positive or Rh negative. One type is neither better nor worse than the other, only different.
Your Rh factor is important if you are an Rh negative woman and you become pregnant, or if you receive a blood transfusion.
How the Rh Factor Can Affect Your Future
If you have Rh negative blood, there are two situations that can affect you:
Hemolytic Disease of the Newborn: A Threat to Your Baby
When an Rh negative woman has Rh positive antibodies in her blood and the baby she is carrying is Rh positive, the antibodies could possibly enter the baby's bloodstream, attack the baby's red blood cells and cause hemolytic disease of the newborn. At birth, the infant suffering from hemolytic disease may be jaundiced and anemic or suffer permanent damage of the brain and central nervous system which may result in mental retardation, hearing loss, or cerebral palsy. Extensive medical care can be required, including an exchange transfusion, in which all of the baby's blood is replaced. This usually stops the destruction of the baby's red blood cells and gives the infant a chance to survive.
The risk of hemolytic disease of the newborn is slight with the first baby, but increases with each successive pregnancy.
Hyper RHO ™ S/D, Rh o (D) Immune Globulin (Human) can prevent hemolytic disease of the newborn, provided Rh positive antibodies do not already reside in your bloodstream.
Hyper RHO S/D is a specially prepared gamma globulin with a high level of preformed antibodies against Rh positive blood cells. The injection of Hyper RHO S/D destroys any Rh positive blood cells that may have entered the mother's bloodstream and prevents the mother's immune system from producing Rh positive antibodies; thus protecting the baby from developing hemolytic disease.
HyperRHO S/D Full Dose -- When Prescribed
Pregnancy and Other Obstetric Conditions Pertaining to Rh Negative Women
Hyper RHO S/D Full Dose is administered during pregnancy if you fall into a high-risk category. For example, you are at risk of producing Rh positive antibodies if you have an amniocentesis procedure performed, or if you have a miscarriage or other termination of pregnancy at or beyond 13 weeks' gestation.
Laboratory findings have shown that some Rh negative women develop Rh positive antibodies during the last weeks of pregnancy even without an antibody-stimulating event. As a preventive measure, your physician will probably recommend the first injection of Hyper RHO S/D Full Dose at the 28th week of pregnancy.
In both of the above situations, if the blood type of the father or baby can be determined to be Rh negative, an injection of Hyper RHO S/D is not required.
Another injection of Hyper RHO S/D Full Dose is administered within 72 hours of delivery of an Rh positive baby.
Hyper RHO S/D Full Dose may be used to prevent isoimmunization in Rh negative individuals who have been transfused with Rh positive red blood cells or blood components containing red blood cells.
HyperRHO S/D Mini-Dose -- When Prescribed
A single dose of Hyper RHO S/D Mini-Dose may be prescribed for an Rh negative woman instead of Hyper RHO S/D Full Dose in the event of miscarriage or other termination of pregnancy occurring prior to 13 weeks' gestation. Hyper RHO S/D Mini-Dose is not required if the blood type of the father or fetus can be determined to be Rh negative.
Will You Need HyperRHO S/D Again?
Hyper RHO S/D provides protection only if you have not already produced Rh positive antibodies. Women who have developed antibodies through previous pregnancy, miscarriage, other termination of pregnancy, or blood transfusion cannot be protected by Hyper RHO S/D. This is why with each pregnancy it is important to have Hyper RHO S/D injections within the prescribed time period.
Reactions to HyperRHO S/D
You may feel a temporary soreness at the site of the injection. You may also have a slight and temporary change in body temperature. In very rare instances, an allergic type of reaction can occur, for which your physician will take appropriate measures.
Delivering a Sound, Healthy Baby
Your physician can answer any questions you may have about receiving a Hyper RHO S/D injection to prevent hemolytic disease of the newborn. If you know that you are Rh negative and you are pregnant, you should discuss your situation with your physician. Today, with Hyper RHO S/D, hemolytic disease of the newborn can be reduced to its lowest possible rate of incidence.
08907644 (Rev. January 2005)
Talecris Biotherapeutics, Inc.
Research Triangle Park, NC 27709 USA
U.S. License No. 1716
Development of Hemolytic Disease
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Rh positive ( + ) father.
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2
Pregnancy: Rh- mother is carrying Rh + baby.
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3
The passage of Rh + blood from the baby to the mother's bloodstream happens most often at delivery, but can also occur during miscarriage, other termination of pregnancy, amniocentesis, or due to injury or trauma.
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4
Rh + antibodies stay in your bloodstream, ready to attack invading Rh + blood cells, for many years to come.
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5
Next pregnancy, mother's Rh + antibodies enter baby's Rh + bloodstream, attacking baby's blood cells and causing hemolytic disease of the newborn.
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How How HyperRHO S/D Immune Globulin Can Prevent Hemolytic Disease
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You will probably be given two injections of Hyper RHO S/D Full Dose, one at the 28th week of your pregnancy and another within 72 hours of delivery, miscarriage or other termination of pregnancy. A single injection of Hyper RHO S/D Mini-Dose may be prescribed instead of Hyper RHO S/D Full Dose in the event of miscarriage or other termination of pregnancy occurring prior to 13 weeks' gestation.
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2
Hyper RHO S/D immunization prevents formation of mother's own Rh + antibodies. Mother's bloodstream remains free of Rh + antibodies.
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3
Next pregnancy, baby develops normally. Hyper RHO S/D should be administered following delivery, miscarriage, or other termination of pregnancy to continue protection if baby is Rh + .
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