Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - Last updated 18 April 2017

Indication(s)

1 INDICATIONS AND USAGE HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following: For Intravenous or Intramuscular Administration Only Prevention of Hepatitis B recurrence following Liver Transplantation in HBsAg-positive liver transplant patients (1.1). Postexposure Prophylaxis (1.2) in the following settings: Acute Exposure to Blood Containing HBsAg Perinatal Exposure of Infants Born to HBsAg-positive Mothers Sexual Exposure to HBsAg-positive Persons Household Exposure to Persons with Acute HBV Infection 1.1 Prevention of Hepatitis B recurrence following liver transplant in HBsAg-positive liver transplant patients 1.2 Post-exposure prophylaxis including acute exposure to HBsAg-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc), perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons, and household exposure to persons with acute HBV infection.

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Advisory information

contraindications
4 CONTRAINDICATIONS Individuals known to have anaphylactic or severe systemic reactions to the parenteral administration of human globulin preparations should not receive HepaGam B. Individuals who are deficient in IgA may have the potential to develop anti-IgA antibodies and have an anaphylactoid reaction. HepaGam B contains less than 40 micrograms per milliliter of IgA. For postexposure 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. History of anaphylactic or severe systemic reactions to human globulins (4) IgA deficient individuals may have the potential to develop IgA antibodies and have an anaphylactoid reaction. (4) IM injections may be contraindicated in patients with coagulation disorders. (4)
Adverse reactions
6 ADVERSE REACTIONS The only adverse reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects). The only adverse reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects). (6) To report SUSPECTED ADVERSE REACTIONS, contact Aptevo BioTherapeutics at 1- 844-859-6675 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hepatitis B-Related Liver Transplantation In a clinical trial with 27 liver transplant patients, one adverse drug reaction was reported following the 578 (<1%) HepaGam B infusions. This study utilized the recommended dosing regimen outlined in Table 1 [see Dosage and Administration (2.1)]. The attributed adverse drug reaction of hypotension was reported in one patient. The reaction was associated with a single HepaGam B infusion during the first day post-transplant. The reaction resolved on the same day and did not recur with subsequent HepaGam B infusions. Healthy Volunteer Studies Seventy healthy male and female volunteers received a single dose of HepaGam B intramuscularly in clinical trials6. Only one adverse drug reaction, an episode of nausea, was reported. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of HepaGam B. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postexposure Prophylaxis: Dizziness has been reported in the postmarketing surveillance of HepaGam B for the postexposure prophylaxis indication. Hepatitis B-Related Liver Transplantation: The system organ classification of reported adverse reactions is provided below: Cardiac disorders: Sinus tachycardia Gastrointestinal disorders: Abdominal pain upper Nausea General disorders and administration site conditions: Chills Feeling cold Influenza like illness Pyrexia Immune system disorders: Anaphylactoid reaction Hypersensitivity Investigations: Lipase increased Transaminases increased Musculoskeletal and connective tissue disorders: Back pain Nervous system disorders: Dizziness Headache Respiratory, thoracic and mediastinal disorders: Dyspnoea Skin and subcutaneous tissue disorders: Cold sweat Healthcare professionals should report adverse reactions following the administration of HepaGam B to Aptevo BioTherapeutics at 1- 844-859-6675 or FDA’s MedWatch reporting system at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Prevention of Hepatitis B recurrence following liver transplantation (2.1) HepaGam B is administered intravenously at doses of 20,000 IU (calculated from the measured potency stamped on the vial label) according to the following regimen to attain serum anti-HBs > 500 IU per liter: Regularly monitor serum anti-HBs to allow for treatment adjustments. Anhepatic Phase Week 1 Post-Operative Weeks 2-12 Post-Operative Month 4 onwards First dose Daily from Day 1-7 Every two weeks from Day 14 Monthly Postexposure Prophylaxis (2.2) HepaGam B must be administered intramuscularly only as directed below: Acute Exposure to Blood Containing HBsAg 0.06 milliliter per kilogram Administer as soon as possible after exposure and within 24 hours if possible. Perinatal Exposure of Infants Born to HBsAg-positive Mothers 0.5 milliliter Administer after physiologic stabilization of the infant and preferably within 12 hours of birth. Sexual Exposure to HBsAg-positive Persons 0.06 milliliter per kilogram Administer HepaGam B within 14 days of the last sexual contact or if sexual contact with the infected person will continue. Household Exposure to Persons with Acute HBV Infection 0.5 milliliter Infants < 12 months: Administer HepaGam B + Hepatitis B vaccine if primary caregiver has acute HBV infection. 2.1 Prevention of Hepatitis B recurrence following liver transplantation Administer the first dose of HepaGam B during the grafting of the transplanted liver (the anhepatic phase) with subsequent dosing as recommended in Table 1. Calculate the dosing from the measured potency of the particular lot of HepaGam B as stamped on the vial label. Administer by intravenous infusion (Table 2). Table 1 - HepaGam B Dosing Regimen for HBV-Related Liver Transplant Patients * Each dose should contain 20,000 IU calculated from the measured potency as stamped on the vial label [see Dosage Forms and Strengths (3)]. Anhepatic Phase Week 1 Post-Operative Weeks 2-12 Post-Operative Month 4 onwards First dose Daily from Day 1-7 Every two weeks from Day 14 Monthly Table 2 – HepaGam B Intravenous Infusion Rate Route of Administration Dosage Infusion Rate Intravenous 20,000 IU per dose 2 milliliters per minute. Decrease to 1 milliliter per minute or slower if the patient develops discomfort or infusion-related adverse reactions. HepaGam B dose adjustments may be required in patients who fail to reach anti-HBs levels of 500 International Units per liter within the first week post-liver transplantation1. Patients who have surgical bleeding or abdominal fluid drainage (> 500 milliliters) 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 International Units calculated from the measured potency as stamped on the vial label) intravenously every 6 hours until the target anti-HBs is reached. 2.2 Postexposure Prophylaxis Administer HepaGam B intramuscularly as recommended in Table 3. Table 3 – HepaGam B Dosing Regimen for Postexposure Prophylaxis (Intramuscular) Indication Dosage Instructions Acute Exposure to Blood Containing HBsAg 0.06 milliliter per kilogram Administer HepaGam B as soon as possible after exposure. The value after seven days following exposure is unclear2, 3. For persons who refuse Hepatitis B vaccine or who are known non-responders to vaccine, give a second dose of HepaGam B one month after the first dose2. Perinatal exposure of Infants Born to HBsAg-positive mothers 0.5 milliliter Administer after physiologic stabilization of the infant and preferably within twelve hours of birth. Administer concurrently with Hepatitis B vaccine. Sexual Exposure to HBsAg-Positive Persons 0.06 milliliter per kilogram Administer HepaGam B and Hepatitis B Vaccine series within 14 days of sexual contact or if sexual contact with the infected person will continue. Household Exposure to Person with Acute HBV Infection 0.5 milliliter For infants less than twelve months of age administered concurrently with Hepatitis B Vaccine. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless there is an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Treat such exposures like sexual exposures. HepaGam B may be administered at the same time (but at a different site), or up to one month preceding Hepatitis B vaccination without impairing the active immune response to Hepatitis B vaccine2,3. 2.3 Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid. Do not shake vials during preparation to avoid foaming. The HepaGam B vial is for single use only. HepaGam B contains no preservatives. Promptly use any vial of HepaGam B that has been entered. Do not reuse or save for future use. For intravenous administration, administer HepaGam B through a separate intravenous line using an infusion pump. Use normal saline as the diluent if dilution of HepaGam B is preferred prior to intravenous administration. [see Clinical Trials in Liver Transplant Patients (14.1)] Do not use dextrose (5%) in water (D5W). Use a separate vial, sterile syringe, and needle for each individual patient, to prevent transmission of infectious agents from one person to another.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Pregnancy: No human or animal data. Use only if clearly needed. (8.1) Nursing mothers: Caution should be exercised (8.3) 8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with HepaGam B. It is also not known whether HepaGam B can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HepaGam B should be given to a pregnant woman only if clearly indicated. 8.3 Nursing Mothers It is not known whether HepaGam B is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HepaGam B is administered to a nursing mother. 8.4 Pediatric Use Safety and effectiveness have not been established in pediatric patients. However, for postexposure prophylaxis, the safety and effectiveness of similar hepatitis B immune globulins have been demonstrated in infants and children8. 8.5 Geriatric Use Clinical studies of HepaGam B did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Pregnancy and lactation
8.3 Nursing Mothers It is not known whether HepaGam B is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HepaGam B is administered to a nursing mother.

Interactions

7 DRUG INTERACTIONS Efficacy of live attenuated virus vaccines may be impaired by immune globulin administration; revaccination may be necessary. (7.1) Antibodies in HepaGam B may interfere with some serological tests. (7.2) Maltose in HepaGam B may interfere with non-glucose specific blood glucose testing systems. (7.3) 7.1 Live Attenuated Virus Vaccines Immune globulin administration may impair the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella2,3,7. Vaccination with live virus vaccines should be deferred until approximately three months after administration of HepaGam B, Hepatitis B Immune Globulin Intravenous (Human). Persons who received HepaGam B less than 14 days after live virus vaccination should be revaccinated 3 months after the administration of the immune globulin, unless serologic test results indicate that antibodies were produced2,3. There are no available data on drug interactions of HepaGam B with other medications. 7.2 Drug-Laboratory Interactions: Serological Testing Antibodies present in HepaGam B may interfere with some serological tests. After administration of immune globulins like HepaGam B, a transitory increase of passively transferred antibodies in the patient’s blood may result in misleading positive results in serological testing (e.g. Coombs' test). 7.3 Drug-Laboratory Interactions: Blood Glucose Testing HepaGam B contains maltose which can interfere with certain types of blood glucose monitoring systems. [See Warnings and Precautions (5.2 ).] 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 product information of the blood glucose testing system, including that of the test strips, should be carefully reviewed to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system to determine if the system is appropriate for use with maltose-containing parenteral products.

More information

Category Value
Authorisation number BLA125035
Agency product number XII270YC6M
Orphan designation No
Product NDC 70504-0052,70504-0051
Date Last Revised 03-02-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Aptevo BioTherapeutics LLC