- 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. For a list of
adverse reactions, please read the Prescribing
Information.
- 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.
- 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.
RECOMBIVAX
HB has simple dosing schedules for individuals 0 to
19 years
of age.
Dosing schedules for RECOMBIVAX
HB
| Group |
Dose |
Schedule |
Injections |
Recommended
0–19 years of age
|
5 mcg/0.5 mL |
0, 1, 6 months |
3 |
Alternate
11–15 years of age
|
10 mcg/1.0 mL |
0, 4–6 months |
2 |
|
Dosing
schedules for Engerix-Ba,1
| Group |
Dose |
Schedule |
Injections |
Recommended
0 –19 years of ageb |
10 mcg/0.5 mL |
0, 1, 6 months |
3 |
Alternate
Adolescents 11–19 years of age |
20 mcg/1.0 mL |
0, 1, 6 months |
3 |
Alternate/high
risk
Infants born to HBsAg-positive mothersc
Children 0 –10 years of agec
Adolescents 11–19 years of aged |
10 mcg/0.5 mL
10 mcg/0.5 mL
20 mcg/1.0 mL |
0, 1, 2, 12 months
0, 1, 2, 12 months
0, 1, 2, 12 months |
4
4
4 |
Alternate/extended
schedule
Children 5 –10 years of aged
Adolescents 11–16 years of aged |
10 mcg/0.5 mL
10 mcg/0.5 mL |
0, 12, 24 months
0, 12, 24 months |
3
3 |
|
| |
Adapted from
Prescribing Information for Engerix-B, 2006.1
|
| a |
Engerix-B is
a registered trademark of GlaxoSmithKline Biologicals,
S.A. |
| b |
Infants born
to HBsAg-negative mothers or HBsAg-positive mothers,
children 0 to 10 years of age, and adolescents 11–19
years of age |
| c |
This schedule
is designed for certain populations (eg, neonates born
to hepatitis B-infected mothers, others who have or might
have been recently exposed to the virus, or certain travelers
to high-risk areas). On this alternate schedule, an additional
dose at 12 months is recommended for prolonged maintenance
of protective titers. |
| d |
For children
and adolescents for whom an extended administration schedule
is acceptable based on risk of exposure. |
- 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.
Reference:
1. GlaxoSmithKline Biologicals S.A. Engerix-B® Prescribing
Information, December 2006, EB:L37, Available at: http://us.gsk.com/products/assets/us_engerixb.pdf.
Accessed November 4, 2007.
RECOMBIVAX HB is a registered trademark of Merck & Co.,
Inc.
|
