Engerix-B

ENGERIX-B®
[Hepatitis B Vaccine (Recombinant)]

Engerix-B

DRUG DESCRIPTION

ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a noninfectious recombinant DNA hepatitis B vaccine developed and manufactured by GlaxoSmithKline Biologicals. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. The surface antigen expressed in Saccharomyces cerevisiae cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX-B (hepatitis b vaccine recombinant) result in a product that contains no more than 5% yeast protein. No substances of human origin are used in its manufacture.

ENGERIX-B (hepatitis b vaccine recombinant) is supplied as a sterile suspension for intramuscular administration. The vaccine is ready for use without reconstitution; it must be shaken before administration since a fine white deposit with a clear colorless supernatant may form on storage.

ENGERIX-B (hepatitis b vaccine recombinant) is formulated without preservatives.

Pediatric/Adolescent

Each 0.5-mL dose contains 10 mcg of hepatitis B surface antigen adsorbed on 0.25 mg aluminum as aluminum hydroxide. The pediatric formulation contains sodium chloride (9 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 0.71 mg/mL).

Adult

Each 1-mL adult dose contains 20 mcg of hepatitis B surface antigen adsorbed on 0.5 mg aluminum as aluminum hydroxide. The adult formulation contains sodium chloride (9 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 0.71 mg/mL).

What are the precautions when taking hepatitis b vaccine recombinant (Engerix-B)?

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 Engerix-B »

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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