"The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes"...
Patients who receive immune globulin therapy for the first time, who are switched from another brand of immune globulin, or who have not received immune globulin therapy within the preceding eight weeks may be at risk for developing reactions including fever, chills, nausea, and vomiting. On rare occasions, these reactions may lead to shock. Such patients should be monitored for these reactions in a clinical setting during the initial administration of Vivaglobin® Immune Globulin Subcutaneous (Human).
If anaphylactic or anaphylactoid reactions are suspected, discontinue administration immediately. Treat any acute anaphylactoid reactions as medically appropriate.
Vivaglobin® is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Because Vivaglobin® is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the CJD agent. The risk that such plasma-derived 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 during manufacture (see DESCRIPTION section for virus reduction measures). Stringent procedures utilized at plasma collection centers, plasma-testing laboratories and fractionation facilities are designed to reduce the risk of virus transmission. The primary virus reduction steps of the Vivaglobin® (immune globulin subcutaneous (human)) manufacturing process are pasteurization (heat treatment of the aqueous solution at 60°C for 10 hours) and ethanol - fatty alcohol / pH precipitation. Additional purification procedures used in the manufacture of Vivaglobin® (immune globulin subcutaneous (human)) also potentially provide virus reduction. Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus, the risk of transmission of infectious agents cannot be totally eliminated. Any infections thought by a physician to have been possibly transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 1-800-504-5434 (in the US and Canada). The physician should discuss the risks and benefits of this product with the patient.
During clinical trials, no cases of infection due to hepatitis A, B, or C virus, parvovirus B19, or HIV were reported with the use of Vivaglobin® (immune globulin subcutaneous (human)) .
Administer Vivaglobin® Immune Globulin Subcutaneous (Human), subcutaneously. Do not administer this product intravenously. The recommended infusion rate and amount per injection site stated under DOSAGE AND ADMINISTRATION should be followed. When initiating therapy with Vivaglobin® (immune globulin subcutaneous (human)) , patients should be monitored for any adverse events during and after the infusion.
After injection of immunoglobulins, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, D may cause a positive direct or indirect antiglobulin (Coombs') test.
Pregnancy Category C
Animal reproduction studies have not been conducted with Vivaglobin® Immune Globulin Subcutaneous (Human). It is also not known whether Vivaglobin® (immune globulin subcutaneous (human)) can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Vivaglobin® (immune globulin subcutaneous (human)) should be given to a pregnant woman only if clearly needed.
Vivaglobin® (immune globulin subcutaneous (human)) was evaluated in 6 children and 4 adolescents in the US and Canada study and in 16 children and 6 adolescents in the non-IND study. There were no apparent differences in the safety and efficacy profiles as compared to adult subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. The safety and efficacy of Vivaglobin® (immune globulin subcutaneous (human)) was not studied in pediatric subjects under two years of age.
The clinical study of Vivaglobin® Immune Globulin Subcutaneous (Human), did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/3/2009
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