[Hepatitis A & Hepatitis B (Recombinant) Vaccine] Intramuscular Administration
TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] is a bivalent vaccine containing the antigenic components used in producing HAVRIX® (Hepatitis A Vaccine) and ENGERIX-B® [Hepatitis B Vaccine (Recombinant)]. TWINRIX is a sterile suspension for intramuscular administration that contains inactivated hepatitis A virus (strain HM175) and noninfectious hepatitis B virus surface antigen (HBsAg). The hepatitis A virus is propagated in MRC-5 human diploid cells and inactivated with formalin. The purified HBsAg is obtained by culturing genetically engineered Saccharomyces cerevisiae yeast cells, which carry the surface antigen gene of the hepatitis B virus. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation.
A 1-mL dose of vaccine contains 720 ELISA Units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum in the form of aluminum phosphate and aluminum hydroxide as adjuvants, amino acids, sodium chloride, phosphate buffer, polysorbate 20, and Water for Injection. From the manufacturing process each 1-mL dose of TWINRIX also contains residual formalin (not more than 0.1 mg), MRC-5 cellular proteins (not more than 2.5 mcg), neomycin sulfate (an aminoglycoside antibiotic included in the cell growth media; not more than 20 ng) and yeast protein (no more than 5%).
TWINRIX is available in vials and prefilled syringes. The tip caps of the prefilled syringes may contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.
TWINRIX is formulated without preservatives.
What are the possible side effects of this vaccine (Twinrix)?
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 A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help...
What are the precautions when taking hepatitis a inactivated & hepatitis b (recombinant) vaccine (Twinrix)?
Before getting hepatitis A/hepatitis B vaccine, tell your health care professional if you are allergic to it; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex rubber, yeast, neomycin, formalin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this vaccine, tell your health care professional 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 A or B antibody levels checked yearly. If antibodies drop too low over time, you may be given another...
Last reviewed on RxList: 11/2/2015
This monograph has been modified to include the generic and brand name in many instances.
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