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General Product Questions What is HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)]? HepaGam B is a sterile solution of purified gamma globulin (IgG) fraction of human plasma containing antibodies to hepatitis B surface antigen (anti-HBs). HepaGam B is manufactured from human plasma collected from healthy, screened donors with high titers of anti-HBs which is purified by an anion-exchange column chromatography method.Is HepaGam B a new hepatitis B vaccine? No, HepaGam B is not a vaccine. HepaGam B is an immune globulin fraction that contains antibodies to hepatitis B surface antigen (anti-HBs). HepaGam B provides passive immunization (i.e. short-term protection) for individuals exposed to the hepatitis B virus, by binding to the surface antigen and reducing the rate of hepatitis B infection. This short-term immunity can protect against hepatitis B while long-term immunity is built through vaccination.What is the protein concentration of HepaGam B? The protein concentration is 5% (50 mg/mL). For more information regarding the formulation, please see the Description (section11) of HepaGam B Full Prescribing Information.What is the potency of a vial of HepaGam B? The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 IU/mL, with a potency of 550 IU/mL targeted at manufacture. As with all immune globulins, the potency of HepaGam B varies from lot to lot. The measured potency of each lot is stamped on the vial label (see Dosage Forms and Strength (3.1) of the HepaGam B Full Prescribing Information).How is HepaGam B administered? For Prevention of Hepatitis B recurrence following Liver Transplantation – HepaGam B [Hepatitis B Immune Globulin Intravenous (Human)], is indicated for the prevention of hepatitis B recurrence following liver transplantation, in HBsAg-positive liver transplant patients. HepaGam B should be administered intravenously for this indication.For Post-exposure Prophylaxis – HepaGam B is indicated for the treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection. HepaGam B is indicated for intramuscular use only for the post-exposure prophylaxis indication. Why are there 2 potencies on a vial of HepaGam B (> 312 IU/mL and actual potency e.g. 550 IU/mL)? When immune globulins such as HepaGam B are manufactured, the manufacturer indicates on the vial the minimum potency that the vial will contain at the time the vial expires (expiry date), which is usually 2–3 years from the time of manufacture. For instance, if a vial of HBIg expresses the potency as > 312 IU/mL, this means that two to three years from the date of manufacturing there is guaranteed to be greater than 312 IU/mL of anti-HBs in that vial.In order to make this guarantee, manufacturers will add additional antibodies to that vial and this is referred to as “overfill”. HepaGam B, for instance has a shelf life of 3 years presently and Cangene Corporation guarantees that 3 years from the date of manufacturing that vial will contain greater than 312 IU anti-HBs/mL. In order to ensure that claim is always met within the variability of the anti-HB assay, each vial is overfilled to a target potency of 550 IU/mL. The actual measured potency of the lot is stamped on each vial. Dosing for the prevention of hepatitis B recurrence following liver transplantation should be calculated from the measured potency of the particular lot of HepaGam B as stamped on the vial label. back to top Indications and Dosage What is HepaGam B indicated to treat? For Prevention of Hepatitis B recurrence following Liver Transplantation – HepaGam B [Hepatitis B Immune Globulin Intravenous (Human)], is indicated for the prevention of hepatitis B recurrence following liver transplantation, in HBsAg-positive liver transplant patients. HepaGam B should be administered intravenously for this indication.For Post-exposure Prophylaxis – HepaGam B is indicated for the treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg positive persons and household exposure to persons with acute HBV infection in the following settings:
When should HepaGam B be administered? The answer depends on the indication:For Prevention of Hepatitis B recurrence following Liver Transplantation: For the prevention of hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients, HepaGam B is administered intravenously according to a set dosing regimen designed to attain serum levels of antibodies to hepatitis B surface antigen (anti-HBs) greater than 500 IU/L. Based upon a HepaGam B clinical trial, patients should receive 20,000 IU/dose [see Clinical Trials in Liver Transplant Patients (14.1) of the HepaGam B Full Prescribing Information]. The volume of each 20,000 IU dose should be calculated from the measured potency of the particular lot of HepaGam B as stamped on the vial label. The first dose should be administered concurrently with the grafting of the transplanted liver (the anhepatic phase) with subsequent dosing as recommended in the table below. HepaGam B Dosing Regimen HepaGam B dose adjustments may be required in patients who fail to reach anti-HBs levels of 500 IU/L within the first week post-liver transplantation. Patients who have surgical bleeding or abdominal fluid drainage (> 500 mL) or patients who undergo plasmapheresis are particularly susceptible to extensive loss of circulated anti-HBs. In these cases, the dosing regimen should be increased to a half-dose (10,000 IU calculated from the measured potency as stamped on the vial label) intravenously every 6 hours until the target anti-HBs is reached. For Post-exposure Prophylaxis: Indication: Acute exposure to blood containing HBsAgDose: An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours if possible. See the HepaGam B Full Prescribing Information for additional information. Indication: Prophylaxis of infants born to mothers who are positive for HBsAg with or without HBeAg Dose: Infants born to mothers known to be HBsAg-positive should receive 0.5 mL of HepaGam B after physiologic stabilization of the infant and preferably within 12 hours of birth. A Hepatitis B vaccine series should be initiated simultaneously, if not contraindicated, with the first dose of the vaccine given concurrently with HepaGam B, but at a different site. Subsequent doses of the vaccine should be administered in accordance with the recommendations of the manufacturer. See the HepaGam B Full Prescribing Information for additional information. Indication: Sexual exposure to HBsAg-positive persons Dose: All susceptible persons whose sexual partners have acute hepatitis B infection should receive a single dose of HepaGam B (0.06 mL/kg) and should begin a Hepatitis B vaccine series, if not contraindicated, within 14 days of the last sexual contact or if sexual contact with the infected person will continue. Administering the vaccine concurrently with Hepatitis B Immune Globulin (Human) may improve the efficacy of post-exposure treatment. The vaccine has the added advantage of conferring long-lasting protection. See the HepaGam B Full Prescribing Information for additional information. Indication: Household exposure to persons with acute hepatitis B virus (HBV) infection Dose: Prophylaxis of an infant less than 12 months of age with 0.5 mL HepaGam B and a Hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless they had an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive Hepatitis B vaccine. See the HepaGam B Full Prescribing Information for additional information. Is there an upper volume limit of a HepaGam B dose? For Prevention of Hepatitis B recurrence following Liver Transplantation – No. However, HepaGam B should be prepared for intravenous administration under aseptic conditions. HepaGam B should be administered through a separate intravenous line using an intravenous administration set via infusion pump.The rate of administration should be set at 2 mL per minute. The rate of infusion should be decreased to 1 mL per minute or slower if the patient develops discomfort, infusion-related adverse events or there is concern about the speed of infusion. What is the preferred site for injecting HepaGam B? For Prevention of Hepatitis B recurrence following Liver Transplantation – HepaGam B should be prepared for intravenous administration under aseptic conditions. HepaGam B should be administered through a separate intravenous line using an intravenous administration set via infusion pump.For Post-exposure Prophylaxis – The preferred sites for intramuscular injections are the anterolateral aspect of the upper thigh and the deltoid muscle of the upper arm. If the buttock is used due to the volume to be injected, the central region should be avoided; only the upper, outer quadrant should be used, and the needle should be directed anterior (i.e. not inferior or perpendicular to the skin) to minimize the possibility of involvement with the sciatic nerve. back to top Efficacy How quickly does HepaGam B provide protection? Peak concentrations of HepaGam B in the serum are observed 4–5 days after administration and elimination half-life is 22–25 days.back to top Safety What are the most common adverse reactions associated with HepaGam B? The most common expected adverse drug reactions for intravenous immune globulins like HepaGam B are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain. In a clinical trial in liver transplant patients, 2 adverse drug reactions of tremor and hypotension were reported in 2 of 14 patients who received intravenous infusions of HepaGam B. In studies with healthy volunteers, only 1 adverse drug reaction of nausea was reported in the 70 adult subjects who received an intramuscular administration of HepaGam B. Although no anaphylactic reactions have been reported following HepaGam B administration, anaphylactic reactions have been reported following the administration of other immune globulin products on rare occasions [see Warnings and Precautions (5.2) of the HepaGam B Full Prescribing Information]. To report SUSPECTED ADVERSE REACTIONS, contact Cangene Corporation at 1-800-768-2304 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchWhat warnings, precautions and contraindications are associated with the use of HepaGam B? Contraindications: Individuals known to have anaphylactic or severe systematic reactions associated with the parenteral administration of human globulin preparations should not receive HepaGam B [Hepatitis B Immune Globulin Intravenous (Human)], or any other human immune globulin. HepaGam B contains less than 40 micrograms/mL of IgA. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylactoid reaction. The physician must weigh the potential benefit of treatment with HepaGam B against the potential for hypersensitivity reactions.For post-exposure prophylaxis indications, HepaGam B must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B should be given only if the expected benefits outweigh the potential risks. General Warnings: HepaGam B is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob disease agent. The risk that such products can 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. The HepaGam B manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton® X-100) that is effective in inactivating known enveloped viruses such as HBV, HCV, and HIV. HepaGam B is filtered using a Planova™ 20N Virus Filter that is effective in reducing the levels of some enveloped and non-enveloped viruses. These two processes are designed to increase product safety. 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. ALL infections thought by a physician to have been transmitted by this product should be reported by the physician or other healthcare provider to medical affairs at 1-800-768-2304. The physician should discuss the risks and benefits of this product with the patient. Anaphylactic Precautions: Although allergic reactions have not been reported following HepaGam B administration [see Adverse Reactions (6.2) of the HepaGam B Full Prescribing Information], the product should be administered only in a setting where appropriate equipment and personnel trained in the management of acute anaphylaxis are available. If hypotension or anaphylaxis occurs, the administration of HepaGam B should be discontinued immediately and supportive care given as needed. Interference with Blood Glucose Testing: The maltose contained in HepaGam B can interfere with some types of blood glucose monitoring systems, i.e., those based on the glucose dehydrogenase pyrroloquinequinone (GDH-PQQ) method. This interference can result in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia. Cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated results. Monitoring: Serum anti-HBs Levels: Liver transplant patients should be monitored regularly for serum anti-HBs levels using a quantitative assay [see Dosage and Administration (2.1) of the HepaGam B Full Prescribing Information]. Infusion Reactions: Certain adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under (Dosage and Administration (2.1) of the HepaGam B Full Prescribing Information) must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period and immediately following an infusion. Pregnancy Category C: It is not known whether HepaGam B can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HepaGam B should be given to a pregnant woman only if clearly indicated. Does HepaGam B contain thimerosal, a mercury-derived preservative? No. HepaGam B does not contain any preservatives.Does the HepaGam B vial stopper contain latex? No, HepaGam B stoppers do not contain latex. All excipients, raw materials and components used to manufacture HepaGam B are latex-free.What viral inactivation steps are included in the HepaGam B manufacturing process? The manufacturing process contains two steps implemented specifically for virus clearance. The solvent/detergent step (using tri-n-butyl phosphate and Triton® X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV. Virus filtration, using a Planova™ 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small, non-enveloped viruses.back to top Storage How is HepaGam B stored? HepaGam B is stored at 36 to 46 °F (2 to 8 °C). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration; if these are seen, vials should not be used. During preparation, do not shake vials; avoid foaming. Use HepaGam B within six hours after the vial has been entered. Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately due to the risk of contamination.Can you freeze HepaGam B? No.back to top Ordering Information How do I order HepaGam B? You may call 1-877-HepaGam B (437-2426) Press option 1 for Customer ServicePress option 2 for Reimbursement SupportPress option 3 for Medical AffairsPress option 4 to Report an Adverse Event |
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HepaGam B [Hepatitis B Immune Globulin Intravenous (Human)] is a sterile solution of gamma globulin (IgG) made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Individuals known to have severe, potentially life-threatening reaction to human globulin preparations should not receive HepaGam B or any other immune globulin (human). Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have severe, potentially life-threatening allergic reactions. The maltose contained in HepaGam B can interfere with some types of blood glucose monitoring systems. Only testing systems that are glucose-specific should be used in patients receiving HepaGam B. This interference can result in falsely elevated glucose readings that can lead to untreated hypoglycemia or to inappropriate insulin administration, resulting in life-threatening hypoglycemia. The most common expected adverse drug reactions for immune globulins like HepaGam B are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain. For post-exposure prophylaxis indications, HepaGam B must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B should be given only if the expected benefits outweigh the potential risks. |
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