Twinrix

TWINRIX®
[Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine]

DRUG DESCRIPTION

TWINRIX® [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] is a sterile bivalent vaccine containing the antigenic components used in producing HAVRIX® (Hepatitis A Vaccine, Inactivated) and ENGERIX-B® [Hepatitis B Vaccine (Recombinant)]. TWINRIX (hepatitis a inactivated & hepatitis b recombinant vaccine) is a sterile suspension of inactivated hepatitis A virus (strain HM175) propagated in MRC-5 cells, and combined with purified surface antigen of the hepatitis B virus. The purified hepatitis B surface antigen (HBsAg) is obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus, in synthetic media containing inorganic salts, amino acids, dextrose, and vitamins. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation.

A 1.0-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, 5.0 mg 2-phenoxyethanol as a preservative, sodium chloride, phosphate buffer, polysorbate 20, Water for Injection, traces of formalin (not more than 0.1 mg), a trace amount of thimerosal (<1 mcg mercury) from the manufacturing process, and residual MRC-5 cellular proteins (not more than 2.5 mcg). Neomycin sulfate, an aminoglycoside antibiotic, is included in the cell growth media; only trace amounts (not more than 20 ng) remain following purification. The manufacturing procedures used to manufacture TWINRIX (hepatitis a inactivated & hepatitis b recombinant vaccine) result in a product that contains no more than 5% yeast protein.

TWINRIX (hepatitis a inactivated & hepatitis b recombinant vaccine) is supplied as a sterile suspension for intramuscular administration. The vaccine is ready for use without reconstitution; it must be well shaken before administration to obtain a homogeneous, turbid, white suspension.

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...

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What are the precautions when taking hepatitis a inactivated & hepatitis b (recombinant) vaccine (Twinrix)?

Before getting hepatitis A/hepatitis B vaccine, tell your doctor or pharmacist 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 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 A or B antibody levels checked yearly. If antibodies drop too low over time, you may be given another dose of...

Read All Potential Precautions of Twinrix »

Last reviewed on RxList: 4/30/2007
This monograph has been modified to include the generic and brand name in many instances.

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