Hyperrho S/d Full Dose

Hyperrho S/d Full Dose

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Questions & Answers

Side Effects & Adverse Reactions

HyperRHO S/D Full 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 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 HYPERRHO S/D FULL DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. 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 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Pregnancy and Other Obstetric Conditions

HyperRHO S/D Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rho(D) negative mother within 72 hours after birth of an Rho(D) positive infant, [12] providing the following criteria are met:

  1. The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) factor.

  2. Her child must be Rho(D) positive, and should have a negative direct antiglobulin test (see PRECAUTIONS).

If HyperRHO S/D Full Dose is administered antepartum, it is essential that the mother receive another dose of HyperRHO S/D Full Dose after delivery of an Rho(D) positive infant.

If the father can be determined to be Rho(D) negative, HyperRHO S/D Full Dose need not be given.

HyperRHO S/D Full Dose should be administered within 72 hours to all nonimmunized 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. [7,8] If the fetal blood group cannot be determined, one must assume that it is Rho(D) positive, [2] and HyperRHO S/D Full Dose should be administered to the mother.

Transfusion

HyperRHO S/D 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. [5,13]

History

There is currently no drug history available for this drug.

Other Information

Rho(D) Immune Globulin (Human) — HyperRHO® S/D Full 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 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. HyperRHO 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. HyperRHO 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 syringe contains sufficient anti-Rho(D) to effectively suppress the immunizing potential of 15 mL of Rho(D) positive red blood cells. [2-4]

The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperRHO 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 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. [18-21]

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.

Hyperrho S/d Full Dose Manufacturers


  • Grifols Usa, Llc
    Hyperrho S/d Full Dose (Rho(D) Immune Globulin (Human)) Solution [Grifols Usa, Llc]

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