RECOMBIVAX HB is indicated for vaccination
against infection caused by all known subtypes of
hepatitis
B virus.
Select Safety
Information
- RECOMBIVAX HB is contraindicated
in the presence of hypersensitivity to yeast or any
component of the vaccine.
- 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.
- 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 study that compared the three-dose regimen (5
mcg) with the two-dose regimen (10 mcg) of the vaccine in adolescents, the
overall frequency of adverse reactions was generally similar.
- 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.
- Predialysis and Dialysis Patients: The vaccination
regimen for RECOMBIVAX HB
Dialysis Formulation consists of three 40 mcg doses of
vaccine given according to the following schedule: 1st
dose at elected date; 2nd dose 1 month later; 3rd dose
6 months after the first dose.
- A booster dose or revaccination with RECOMBIVAX
HB Dialysis Formulation may be considered in predialysis/dialysis
patients if the anti-HBs level is less than 10 mIU/mL.
- Because of the long incubation period for hepatitis
B, it is possible for unrecognized infection to be present
at the time the vaccine is given. The vaccine may not
prevent hepatitis B in such patients.
- As with any vaccine, vaccination with RECOMBIVAX HB
may not result in seroprotection of all vaccinees.
- Before administering RECOMBIVAX
HB, please read the Prescribing
Information.
Dosing options
for hepatitis B vaccination with RECOMBIVAX HB
| Group |
Dose |
Schedule |
Injections |
More information |
| 0–19 years of age |
5 mcg/0.5 mL |
0, 1, 6
months |
3 |
Click
Here |
| 11–15 years of age |
10 mcg/1.0 mL |
0, 4–6
months |
2 |
Click
Here |
Adults > 20 years
of age |
10 mcg/1.0 mL |
0, 1, 6
months |
3 |
Click
Here |
Predialysis and
dialysis patients |
40 mcg/1.0 mL |
0, 1, 6
months |
3 |
Click
Here |
|
RECOMBIVAX HB is a registered trademark of Merck & Co.,
Inc.
|
