Seventy-six male and female volunteers received Nabi-HB^TM, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials. 20 The number of patients with reactions related to the administration of Nabi-HB^TM included local reactions such as pain 9 (12%), ache 2 (3%), erythema 2 (3%), heat1( 1%), and burning 2 (3%) at the injection site, as well as systemic reactions such as headache 20 (26%), malaise 4 (5%), nausea 4 (5%), diarrhea 2 (3%) and myalgia 4 (5%). The majority of reactions were reported as mild. The following adverse events were reported once each in pharmacokinetics trials and were probably related to Nabi-HB^TM: chills, fatigue, lightheadedness, abdominal cramping, and retching. There were no serious adverse events.

No anaphylactic reactions with Nabi-HB^TM have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins.²³

Vaccination with live virus vaccines should be deferred until approximately three months after administration of Nabi-HB^TM, Hepatitis B Immune Globulin (Human). It may be necessary to revaccinate persons who received Nabi-HB^TM shortly after live virus vaccination.

There are no available data on concomitant use of Nabi-HB^TM and other drugs; therefore, Nabi-HB^TM should not be mixed with other drugs.

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