Select Safety Information

RECOMBIVAX HB is contraindicated in the presence of hypersensitivity to yeast or any component of the vaccine.

Use caution when vaccinating latex-sensitive individuals since the vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber that may cause allergic reactions.

Any serious active infection including febrile illness is reason for delaying use of the vaccine except when in the opinion of the physician, withholding the vaccine entails a greater risk.

Predialysis and dialysis adult patients respond less well to hepatitis B vaccines than do healthy individuals; however, vaccination of adult patients early in the course of their renal disease produces higher seroconversion rates than vaccination after dialysis has been initiated.

In 3 clinical studies involving healthy infants and children receiving 3 doses (5 mcg/0.5 mL) of RECOMBIVAX HB, the most frequent complaints (>1% of injections) included irritability, fever (>101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.

In a group of studies involving healthy adults, the most frequent complaints (>1% of injections) in individuals receiving RECOMBIVAX HB included injection-site reactions, fatigue/weakness, headache, fever (>100°F), malaise, nausea, diarrhea, pharyngitis, and upper respiratory infection.

In a study that compared the 3-dose regimen (5 mcg) with the 2-dose regimen (10 mcg) of the vaccine in adolescents, the overall frequency of adverse reactions was generally similar. For a list of adverse reactions, please read the Prescribing Information.