HEPAGAMb Dosing and Administration

vial

Measured, effective dosing

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

Dosage volume is consistent with published protocols^1,2

The FDA approval of HepaGam B^® [Hepatitis B Immune Globulin Intravenous (Human)] for the prevention of hepatitis B recurrence following liver transplantation 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

Dosing Calculation Example

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.

Convenient Dosing

At 2 mL/minute, the infusion of HepaGam B takes less than 20 minutes per patient¹*

HepaGam B Dosing Schedule¹

*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.

Important Risk Information

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.

Please see accompanying full Prescribing Information for full prescribing details.

References: 1. HepaGam B Prescribing Information, December 2008. 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: 1189-119.5