Engerix B

No

Included as part of the PRECAUTIONS section.

No information provided.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Engerix-B falls into category C. No studies have been conducted in animals, and no well-controlled studies have been done in pregnant women. Engerix-B should only be given to a pregnant woman if clearly needed. 

Engerix-B is given by a healthcare provider as a shot into the muscle in the thigh or upper arm. 

The preferred injection site is the thigh for infants younger than 1 year and the upper arm muscle in older children and adults.

Engerix-B is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur in this setting. However, if overdoes is suspected, seek emergency medical attention. 

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of ENGERIX-B, including yeast, is a contraindication to administration of ENGERIX-B [see Description (11) and How Supplied/Storage and Handling (16)].

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with ENGERIX-B. It is also not known whether ENGERIX-B can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ENGERIX-B should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether ENGERIX-B is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ENGERIX-B is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of ENGERIX-B have been established in all pediatric age groups. Maternally transferred antibodies do not interfere with the active immune response to the vaccine. [See Adverse Reactions (6) and Clinical Studies (14.1, 14.3, 14.4).]

Geriatric Use

Clinical studies of ENGERIX-B used for licensure did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. However, in later studies it has been shown that a diminished antibody response and seroprotective levels can be expected in persons older than 60 years of age.3

Mechanism of Action

Infection with hepatitis B virus can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Chronically infected persons are at increased risk for cirrhosis and hepatocellular carcinoma.

Antibody concentrations ≥10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B virus infection.1 Seroconversion is defined as antibody titers ≥1 mIU/mL.

In the U.S.

• Engerix-B
• Engerix-B Pediatric
• Recombivax HB
• Recombivax HB Pediatric/Adolescent

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Recombivax HB Dialysis Formulation(R):

Predialysis patients: Three doses (40 mcg each), IM, on a 0, 1, and 6 month schedule