HEPAGAMb

HepaGam B^® [Hepatitis B Immune Globulin Intravenous (Human)] is manufactured with high levels of anti-HBs and is administered as an intravenous infusion¹

Short, convenient infusion–– less than 20 minutes¹*

Significant, clinically proven reduction in HBV recurrence and demonstrated survival benefit²

Only 2 adverse drug reactions related to HepaGam B––tremor and hypotension––occurred in the pivotal liver transplant clinical study¹

No thimerosol or mercury-derived preservatives¹

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.

*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.

References: 1. HepaGam B Prescribing Information, December 2008. 2. 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.