DESCRIPTION
Rho(D) Immune Globulin (Human) �" HyperRHO® S/D Mini-Dose treated with solvent/ detergent is a colorless to pale yellow or pink sterile solution of immune globulin containing antibodies to Rho(D) for intramuscular administration; it is preservative-free, in a latex-free delivery system. HyperRHO S/D Mini-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. HyperRHO S/D Mini-Dose is then incubated in the final container for 21�"28 days at 20�"27°C. HyperRHO S/D Mini-Dose is formulated as a 15�"18% protein solution at a pH of 6.4�"7.2 in 0.21�"0.32 M glycine. One dose of HyperRHO S/D Mini-Dose contains not less than one-sixth the quantity of Rho(D) antibody contained in one standard dose of Rho(D) Immune Globulin (Human), and it will suppress the immunizing potential of 2.5 mL of Rho(D) positive packed red blood cells or the equivalent of whole blood (5 mL). The quantity of Rho(D) antibody in HyperRHO S/D Mini-Dose is not less than 250 IU (50 mcg).
The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperRHO S/D Mini-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 Human Herpes viruses and other large enveloped DNA 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.
Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [11-14]
Studies of the HyperRHO S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.
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CLINICAL PHARMACOLOGY
Rh sensitization may occur in nonsensitized Rho(D) negative women following transplacental hemorrhage resulting from spontaneous or induced abortions. [1-2] The risk of sensitization is higher in women undergoing induced abortions than in those aborting spontaneously. [1-3]
HyperRHO S/D Mini-Dose is used to prevent the formation of anti-Rho(D) antibody in Rho(D) negative women who are exposed to the Rho(D) antigen at the time of spontaneous or induced abortion (up to 12 weeks’ gestation). [3-5] HyperRHO S/D Mini-Dose suppresses the stimulation of active immunity by Rho(D) positive fetal erythrocytes that may enter the maternal circulation at the time of termination of the pregnancy.
The amount of anti-Rho(D) in HyperRHO S/D Mini-Dose has been shown to effectively prevent maternal isosensitization to the Rho(D) antigens following spontaneous or induced abortion occurring up to the 12th week of gestation. [6-8] After the 12th week of gestation, a standard dose of HyperRHO S/D Full Dose is indicated.
In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), HyperRAB® 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.
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INDICATIONS AND USAGE
HyperRHO S/D Mini-Dose is recommended to prevent the isoimmunization of Rho(D) negative women at the time of spontaneous or induced abortion of up to 12 weeks’ gestation provided the following criteria are met:
The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) antigen.
The father is not known to be Rho(D) negative.
Gestation is not more than 12 weeks at termination.
Note: Rho(D) Immune Globulin (Human) prophylaxis is not indicated if the fetus or father can be determined to be Rh negative. If the Rh status of the fetus is unknown, the fetus must be assumed to be Rho(D) positive, and HyperRHO S/D Mini-Dose should be administered to the mother.
FOR ABORTIONS OR MISCARRIAGES OCCURRING AFTER 12 WEEKS’ GESTATION, A STANDARD DOSE OF Rho(D) IMMUNE GLOBULIN (HUMAN) IS INDICATED.
HyperRHO S/D Mini-Dose should be administered within 3 hours or as soon as possible after spontaneous passage or surgical removal of the products of conception. However, if HyperRHO S/D Mini-Dose is not given within this time period, consideration should still be given to its administration since clinical studies in male volunteers have demonstrated the effectiveness of Rho(D) Immune Globulin (Human) in preventing isoimmunization as long as 72 hours after infusion of Rho(D) positive red cells. [9]
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CONTRAINDICATIONS
None known.
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WARNINGS
HyperRHO S/D Mini-Dose is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent 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 Grifols Therapeutics LLC [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 HYPERRHO S/D MINI-DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. ADMINISTER ONLY TO WOMEN POSTABORTION OR POSTMISCARRIAGE OF UP TO 12 WEEKS’ GESTATION. NEVER ADMINISTER TO THE NEONATE.
HyperRHO S/D Mini-Dose should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin preparations.
The attending physician who wishes to administer HyperRHO S/D Mini-Dose 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.
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PRECAUTIONS
General
Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic symptoms.
Drug Interactions
Other antibodies in the HyperRHO S/D Mini-Dose 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 HyperRHO S/D Mini-Dose administration.
Pregnancy
Animal reproduction studies have not been conducted with HyperRHO S/D Mini-Dose. It is also not known whether HyperRHO S/D Mini-Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
It should be again noted, however, that HyperRHO S/D Mini-Dose is not indicated for use during pregnancy and it should be administered only postabortion or postmiscarriage.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established.
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ADVERSE REACTIONS
Reactions to HyperRHO S/D Mini-Dose 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 globulin is extremely rare, it has occurred.
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DOSAGE AND ADMINISTRATION
NEVER ADMINISTER HYPERRHO S/D MINI-DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. ADMINISTER ONLY TO WOMEN POSTABORTION OR POSTMISCARRIAGE OF UP TO 12 WEEKS’ GESTATION. NEVER ADMINISTER TO THE NEONATE.
One syringe of HyperRHO S/D Mini-Dose provides sufficient antibody to prevent Rh sensitization to 2.5 mL Rho(D) positive packed red cells or the equivalent (5 mL) of whole blood. This dose is sufficient to provide protection against maternal Rh sensitization for women undergoing spontaneous or induced abortion of up to 12 weeks’ gestation.
Rho(D) Immune Globulin (Human) �" HyperRHO® S/D Mini-Dose (250 IU; 50 mcg) should be administered within 3 hours or as soon as possible following spontaneous or induced abortion. If prompt administration is not possible, HyperRHO S/D Mini-Dose should be given within 72 hours following termination of the pregnancy.
HyperRHO S/D Mini-Dose is administered intramuscularly, preferably in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve. [10]
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HyperRHO S/D Mini-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.
Directions for Syringe Usage
Remove the prefilled 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. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.]
Proceed with hypodermic needle puncture.
Aspirate prior to injection to confirm that the needle is not in a vein or artery.
Inject the medication.
Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B)
Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C)
digrams-a-b-c
A number of factors 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.
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HOW SUPPLIED
HyperRHO S/D Mini-Dose package contains 10 single dose syringes. HyperRHO S/D Mini-Dose is preservative-free, in a latex-free delivery system.
NDC Number Size
13533-661-06 Syringe (10 pack)
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STORAGE
Store at 2�"8°C (36�"46°F). Do not freeze.
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CAUTION
Rx only
U.S. federal law prohibits dispensing without prescription.
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