Engerix-B

Engerix-B is a vaccine used for the prevention of infection caused by all known subtypes of hepatitis B virus.

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

Common side effects of Engerix-B include soreness, redness, and swelling at the injection site.

Engerix-B is a vaccine used for the prevention of infection caused by all known subtypes of hepatitis B virus.

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

Persons From Birth Through 19 Years of Age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule.

Persons 20 Years of Age and Older: A series of 3 doses (1 mL each) given on a 0-, 1-, and 6-month schedule.

Adults on Hemodialysis: A series of 4 doses (2 mL each) given as a single 2-mL dose or (two) 1-mL doses on a 0-, 1-, 2-, and 6-month schedule.

The need for booster doses should be assessed by annual antibody testing. 

Serious side effects have been reported with Engerix-B including the following:

• Allergic reactions. Tell your healthcare provider about any signs or symptoms of  allergic reactions, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• Latex. The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
• Fainting. Fainting can occur in association with administration of Engerix-B.
• Infants weighing less than 2,000 grams. Hepatitis B vaccine should be deferred for infants weighing <2,000 g if the mother is documented to be HBsAg negative at the time of the infant’s birth.
• Premature infants may temporarily stop breathing. Breathing issues have been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Engerix-B, to infants born prematurely should be based on consideration of the infant’s medical status, and the potential benefits and possible risks of vaccination.
• Moderate or severe illness. To avoid confusion when diagnosing between illness and possible vaccine adverse effects, vaccination with Engerix-B should be postponed in persons with moderate or severe illness associated with fever unless they are at immediate risk of hepatitis A or hepatitis B infection.
• Multiple sclerosis. Results from 2 clinical studies indicate that there is no association between hepatitis B vaccination and the development of multiple sclerosis, and that vaccination with hepatitis B vaccine does not appear to increase the short-term risk of relapse in multiple sclerosis.
• Limitations of vaccine effectiveness. Vaccination with Engerix-B may not protect all individuals.
• Altered immunocompetence. If Engerix-B is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

Do not get Engerix-B if you or your child had a 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.

Side effects reported with Engerix-B include:

• soreness, redness, and swelling at the injection site
• fatigue
• dizziness
• headache
• fever

This is not a complete list of Engerix-B side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to VAERS at 1-800-822-7967.

No drug interaction have been determined by the manufacturer for Engerix-B. Theoretically, immunosuppressant therapy may diminish the immune response to Engerix-B. You should tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported. 

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. 

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if Engerix-B crosses into human milk. Because some vaccines can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this vaccine, caution should be exercised when Engerix-B is administered to a nursing woman.