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An important component of a regimen to prevent HBV recurrence1

An important component of a regimen to prevent HBV recurrence1

HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)] is approved by the FDA, based on a pivotal clinical study, to prevent HBV recurrence following liver transplantation in HBsAg-positive patients2-4

  • A significantly lower rate of HBV recurrence following liver transplantation (8.3% vs 85.7% for historical controls (p<.001))2

    • Recurrence was defined as the development of detectable serum HBsAg and/or HBeAg between Days 28 and 365 following liver transplant (LT)5

 

 

Proportion of patients with HBV recurrence

Survival advantage documented in secondary end-point analysis5

  • HepaGam B® has shown a one-year survival benefit (96% vs. 43% for retrospective control patients)2

Two adverse reactions were observed in clinical trial subjects
who received HepaGam B®—hypotension and nausea2

For more information on Adverse Events, please see the full Prescribing Information.

Clinical trial in liver transplant patients2

The effectiveness of HepaGam B® in the prevention of hepatitis B recurrence following liver transplantation was studied in a multi-center, open-labeled, superiority study involving HBsAg-positive/HBeAg-negative liver transplant patients. The study arms included:

  • An active treatment group (n=27) enrolled to receive HepaGam B® starting during transplant and continuing over the course of a year

  • A retrospective untreated control group (n=14) of historical patients with data gathered by chart review

HepaGam B® Dosing Regimen for HBV-Related Liver Transplant Patients (Intravenous)2

Anhepatic Phase

Week 1 Post-Operative

Week 2-12 Post-Operative

Month 4 Onwards

First dose

Daily from Day 1-7

Every two weeks from Day 14

Monthly

Dosage volume is consistent with published protocols2,6

  • The FDA approval of HepaGam B® for the prevention of hepatitis B recurrence following liver transplantation in HBsAg-positive patients is based on the dose of 20,000 IU used in the pivotal clinical trial

    • Total dose should be calculated based on the measured potency stamped on each 5 mL vial label. This provides a dose that is consistent with published protocols. Please note this dosing guidance is specific to HepaGam B®.

HepaGam B® Intravenous Infusion Rate‡

Route of Administration

Dosage

Infusion Rate

Intravenous

20,000 IU per dose

2 mL/minute

Decrease to 1 mL/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 transplantation. 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

Dosing Calculation Example

Recommended Dose of HepaGam B®

Potency

Calculation

Based on the 20,000 IU dose in the FDA-approved labeling

571 IU/mL
(stamped actual potency)

Target dose ÷ measured potency = number of mL
mL ÷ mL/vial = number of vials

20,000 IU ÷ 571 IU/mL = 35 mL
35 mL ÷ 5 mL/vial = 7 vials*

*Round up to nearest full vial

Total dose should be calculated based on the measured potency stamped on each 5 mL vial label. This provides a dose that is consistent with published protocols. Please note this guidance is specific to HepaGam B®.


SELECTED IMPORTANT SAFETY INFORMATION

HepaGam B® 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-Jacob disease (CJD) agent.


References: 1. Terrault NA. Prophylaxis in HBV-infected liver transplant patients: end of the HBIG era? Am J Gastroenterol. 2013;108:949-951. 2. HepaGam B® [Prescribing Information]. 3. HyperHEP B S/D Prescribing Information. Research Triangle Park, NC: Grifols Therapeutics Inc.; September 2012. 4. Nabi-HB Prescribing Information. Boca Raton, FL: Biotest Pharmaceuticals Corporation; 2008. 5. Terrault NA, Kilic M, Karademir S, et al. HepaGam B after liver transplant in patients with Hepatitis B virus. US Gastroenterol Rev. 2007;2:39-45. 6. Shouval D, Samuel D. Hepatitis B immune globulin to prevent hepatitis B virus graft reinfection following liver transplantation: a concise review. Hepatology. 2000;32:1189-1195.
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Indications and Important Safety Information for HepaGam B®

Indications

HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)] is an intravenous immune globulin indicated for the following:

  • Prevention of Hepatitis B recurrence following liver transplant in HBsAg-positive liver transplant patients

  • 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.

Important Safety Information

CONTRAINDICATIONS: 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.

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.

WARNINGS and PRECAUTIONS: 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-Jacob disease (CJD) agent.

Thrombotic events have been reported in association with the use of immune globulins. Patients at risk include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known/suspected hyperviscosity.

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.

Liver transplant patients should be monitored regularly for serum anti-HBs antibody levels.

Certain adverse drug reactions may be related to the rate of infusion. The recommended infusion rate must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period and immediately following an infusion.

The most common adverse drug reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects).

For product inquiries about HepaGam B®, call (866)-966-2655.

Please see full Prescribing Information for full prescribing details.