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Convenient dosing with high levels of anti-HBs

Convenient dosing with high levels of anti-HBs

Measured dosing

  • A potency of 550 IU/mL of anti-HBs is targeted at the time of manufacture1

Measured potency: The only HBIg with actual potency stamped on each vial

For prevention of HBV recurrence following liver transplantation:
HepaGam B® combines a convenient infusion with precise dosing

HepaGam B® is the only HBIg for the prevention of HBV recurrence following liver transplantation in HBsAg-positive patients that offers:

  • Infusion times for a 20,000 IU (35 mL) dose

    • At 2 mL/minute, the infusion of HepaGam B® takes as little as 20 minutes per patient1*
    • ~45 minutes for a dose diluted with 50 mL of Normal Saline and infused at a rate of 2 mL per minute2

HepaGam B® Dosing Regimen for HBV-Related Liver Transplant Patients

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 protocols1,2

  • 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

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.1

Dosing Calculation Example

Recommended Dose of HepaGam B®

Potency

Calculation

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

575 IU/mL
(stamped actual potency)

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

20,000 ÷ 575 = 34 mL
34 ÷ 5 = 6.8 (7 vials)

Do NOT use the measured potency on the vial of HepaGam B® to calculate a 10,000 IU dose. This will result in significant underdosing as compared to published protocols.

*Based on a 20,000 IU dose with a total infusion volume of 35 mL at a rate of 2 mL per minute; volume of the dose will vary based on potency. The infusion rate should be decreased to 1 mL per minute or slower if the patient develops discomfort, infusion-related adverse events or if there is concern about the speed of infusion.1

For HBV post-exposure prophylaxis in the following settings1:

HepaGam B® Dosing Regimen for Post-exposure Prophylaxis (Intramuscular)

Indication

Dosing

Instructions

Acute Exposure to Blood Containing HBsAg

0.06 mL/kg

Administer HepaGam B® as soon as possible after exposure. The value after seven days following exposure is unclear.

For persons who refuse Hepatitis B vaccine or who are known non-responders to vaccine, give a second dose of HepaGam® one month after the first dose.

Perinatal Exposure of Infants Born to HBsAg-Positive Mothers

0.5 mL

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 mL/kg

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 mL

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.

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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 Risk 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 (877) 437-2426.

Please see full Prescribing Information for full prescribing details.

References: 1. HepaGam B® [package insert]. Aptevo Therapeutics, Inc., Berwyn, PA; August 2016. 2. 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.