ADMA Biologics Announces Poster Presentation Highlighting Pharmacoeconomic Burden of HIV and HBV Infection in Sexual Assault Patients at the 2021 Academy of Managed Care Pharmacy Virtual Annual Meeting - Seite 2
Additional Important Safety Information about Nabi-HB
Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB [Hepatitis B Immune Globulin (Human)] or any other human immune globulin. Individuals who are deficient in IgA have the potential to develop antibodies against IgA and anaphylactic reactions. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB 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 carry a risk of transmitting infectious agents (e.g., viruses) and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Nabi-HB [Hepatitis B Immune Globulin (Human)], must be administered only intramuscularly for post-exposure prophylaxis. Vaccination with live virus vaccines (e.g., MMR) should be deferred until approximately three months after administration of Nabi-HB. The most common adverse reactions associated with Nabi-HB in clinical trials were erythema and ache at the injection site as well as systemic reactions such as headache, myalgia, malaise, nausea and vomiting. No anaphylactic reactions with Nabi-HB have been reported. Please see the full Prescribing Information for Nabi-HB [Hepatitis B Immune Globulin (Human)].
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
Warnings and Precautions:
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 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 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 Biotest Pharmaceuticals at 1-800-458-4244. The physician should discuss the risks and benefits of this product with the patient.