In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB^TM, Hepatitis B Immune Globulin (Human), should be given only if the expected benefits outweigh the potential risks.

Nabi-HB^TM is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products can transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections, and by inactivating and/or reducing certain viruses. The Nabi-HB^TM manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton^®X-100) that is effective in inactivating known enveloped viruses such as HBV, HCV, and HIV. Nabi-HB^TM is filtered using a Planova^®35 nm Virus Filter that is effective in reducing the levels of some enveloped and non-enveloped viruses. These two processes are designed to increase product safety. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health care provider to Nabi at 1-800-458-4244. The physician should discuss the risks and benefits of this product with the patient.

Nabi-HB^TM, Hepatitis B Immune Globulin (Human), must be administered only intramuscularly for post exposure prophylaxis. The preferred sites for intramuscular injections are the anterolateral aspect of the upper thigh and the deltoid muscle of the upper arm. If the buttock is used due to the volume to be injected, the central region should be avoided; only the upper, outer quadrant should be used, and the needle should be directed anteriorly (i.e., not interiorly or perpendicular to the skin) to minimize the possibility of involvement with the sciatic nerve.²²

Drug Interactions

See DRUG INTERACTIONS section.

Pregnancy Category C

Animal reproduction studies have not been conducted with Nabi-HB^TM. It is also not known whether Nabi-HB^TM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nabi-HB^TM should be given to a pregnant woman only if clearly indicated.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nabi-HB^TM is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established for Nabi-HB^TM. However, the safety and effectiveness of similar Hepatitis B immune globulins have been demonstrated in infants and children.¹²

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