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H-Big Side Effects, and Drug Interactions - Hepatitis B Immune Globulin (Human)

H-Big Side Effects, and Drug Interactions - Hepatitis B Immune Globulin (Human)

SIDE EFFECTS

Seventy-six male and female volunteers received Nabi-HBTM, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials. 20 The number of patients with reactions related to the administration of Nabi-HBTM 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-HBTM: chills, fatigue, lightheadedness, abdominal cramping, and retching. There were no serious adverse events.

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

DRUG INTERACTIONS

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

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

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