In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB, Hepatitis B Immune Globulin (Human), should be given only if the expected benefits outweigh the potential risks.
Nabi-HB is made from human plasma. Products made from human plasma may contain infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. 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 (hepatitis b vaccine recombinant) 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 (hepatitis b vaccine recombinant) 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® Biopharmaceuticals at 1-800-458-4244. The physician should discuss the risks and benefits of this product with the patient.
Nabi-HB, 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. 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 anterior (i.e., not inferior or perpendicular to the skin) to minimize the possibility of involvement with the sciatic nerve22.
The 50 healthy volunteers who received Nabi-HB (hepatitis b vaccine recombinant) in pharmacokinetic studies were followed for 84 days for possible development of anti-HCV antibodies. No subject seroconverted.
Pregnancy Category C
Animal reproduction studies have not been conducted with Nabi-HB (hepatitis b vaccine recombinant) . It is also not known whether Nabi-HB (hepatitis b vaccine recombinant) can cause fetal harm when administered to a pregnant woman or can affect a woman's ability to conceive. Nabi-HB (hepatitis b vaccine recombinant) should be given to a pregnant woman only if clearly indicated.
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 (hepatitis b vaccine recombinant) is administered to a nursing mother.
Safety and effectiveness in the pediatric population have not been established for Nabi-HB (hepatitis b vaccine recombinant) . However, the safety and effectiveness of similar hepatitis B immune globulins have been demonstrated in infants and children12.
Clinical studies of Nabi-HB (hepatitis b vaccine recombinant) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
12. Centers for Disease Control: Recommendations for protection against viral hepatitis. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1985; 34(22):313-335.
22. Centers for Disease Control: General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1994; 43:1-38.
Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.
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