RECOMBIVAX HB* Hepatitis B Vaccine (Recombinant) is a non-infectious subunit
viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast
cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned
into yeast, and the vaccine for hepatitis B is produced from cultures of this
recombinant yeast strain according to methods developed in the Merck Research
Laboratories.
The antigen is harvested and purified from fermentation cultures of a recombinant
strain of the yeast Saccharomyces cerevisiae containing the gene for
the adw subtype of HBsAg. The fermentation process involves growth of
Saccharomyces cerevisiae on a complex fermentation medium which consists
of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts.
The HBsAg protein is released from the yeast cells by cell disruption and purified
by a series of physical and chemical methods. The purified protein is treated
in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate
sulfate. The vaccine contains no detectable yeast DNA but may contain not more
than 1% yeast protein. The vaccine produced by the Merck method has been shown
to be comparable to the plasma-derived vaccine in terms of animal potency (mouse,
monkey, and chimpanzee) and protective efficacy (chimpanzee and human).
The vaccine against hepatitis B, prepared from recombinant yeast cultures,
is free of association with human blood or blood products.
Each lot of hepatitis B vaccine is tested for sterility.
RECOMBIVAX (hepatitis b vaccine recombinant) HB is a sterile suspension for intramuscular injection. However,
for persons at risk of hemorrhage following intramuscular injection, the vaccine
may be administered subcutaneously. (See DOSAGE AND ADMINISTRATION).
RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations.
(See HOW SUPPLIED.)
Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL:
each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen.
Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose
contains 10 mcg of hepatitis B surface antigen.
Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose
contains 40 mcg of hepatitis B surface antigen.
All formulations contain approximately 0.5 mg of aluminum (provided as amorphous
aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide)
per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed
onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate
sulfate) per mL of vaccine. The vaccine is of the adw subtype. RECOMBIVAX (hepatitis b vaccine recombinant)
HB is indicated for vaccination of persons at risk of infection from hepatitis
B virus including all known subtypes. RECOMBIVAX (hepatitis b vaccine recombinant) HB Dialysis Formulation is
indicated for vaccination of adult predialysis and dialysis patients against
infection caused by all known subtypes of hepatitis B virus.
What are the possible side effects of this vaccine (Engerix-B, Engerix-B Pediatric, Recombivax HB Adult, Recombivax HB Dialysis Formulation, Recombivax HB Pediatric/Adolescent)?
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with hepatitis B is much more dangerous to your health than receiving the vaccine to protect against it....
Read All Potential Side Effects and See Pictures of Recombivax »
What are the precautions when taking hepatitis b vaccine (recombinant) (Recombivax)?
Before getting hepatitis B vaccine, tell your doctor or pharmacist if you are allergic to it; or to yeast; or other vaccines; or if you have any other allergies. Some vials and prefilled syringes may use latex rubber stoppers or plungers. Tell your doctor if you are allergic to latex. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.
If you are a hemodialysis patient, you may not respond as well to the vaccine and will need to have hepatitis B antibody levels checked yearly. If...
Read All Potential Precautions of Recombivax »
* Registered trademark of MERCK & CO., Inc. COPYRIGHT © 1998 MERCK
& CO., Inc. All rights reserved
What are the possible side effects of this vaccine (Engerix-B, Engerix-B Pediatric, Recombivax HB Adult, Recombivax HB Dialysis Formulation, Recombivax HB Pediatric/Adolescent)?
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with hepatitis B is much more dangerous to your health than receiving the vaccine to protect against it....
Read All Potential Side Effects and See Pictures of Recombivax »
What are the precautions when taking hepatitis b vaccine (recombinant) (Recombivax)?
Before getting hepatitis B vaccine, tell your doctor or pharmacist if you are allergic to it; or to yeast; or other vaccines; or if you have any other allergies. Some vials and prefilled syringes may use latex rubber stoppers or plungers. Tell your doctor if you are allergic to latex. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.
If you are a hemodialysis patient, you may not respond as well to the vaccine and will need to have hepatitis B antibody levels checked yearly. If...
Read All Potential Precautions of Recombivax »
Last reviewed on RxList: 9/2/2008
This monograph has been modified to include the generic and brand name in many instances.