Engerix-B Hepatitis B Vaccine

Engerix-B Vaccine

Engerix-B is a vaccine against Hepatitis B that is given in a series of 3 shots. The most common side effects are fatigue and soreness where the shot was given.

What is Engerix-B?

Engerix-B® is a recombinant Hepatitis B vaccine. It protects against liver infections caused by the Hepatitis B virus (HBV). Engerix-B was approved by the FDA in 1989 and it is made by GlaxoSmithKline.

How is Engerix-B given?

Engerix-B is administered by intramuscular injection. The preferred injection site is the thigh for infants under 12 months old, or the deltoid muscle of the upper arm in older children and adults.

How many shots do I need?

Engerix-B is usually given in a 3-shot series, but a 4-shot series (with the fourth shot given 12 months after the first) is recommended for newborns of mothers who are infected with Hepatitis B, people who were recently exposed to the virus, and travelers to high-risk areas.

Newborn babies, children, and teenagers up to 19 years old receive a series of three shots (0.5-mL each), given on a 0-month, 1-month, and 6-month schedule. For example, the second shot is given 1 month after the first shot, and the third shot is given six months after the first.

Adults over 20 years old receive a series of three shots (1-mL each), on a 0-month, 1-month, and 6-month immunization schedule.

Adults on hemodialysis receive a series of four shots (2-mL each), given as a single 2-mL dose or two 1-mL doses on a 1-month, 1-month, 2-month, and 6-month immunization schedule. Booster shots may be needed if antibody levels decline below 10-mIU/mL.

Who should NOT get Engerix-B?

Engerix-B is not for anyone who experienced a severe allergic reaction (e.g. anaphylaxis) after a previous Hepatitis B vaccine, or any component in Engerix-B, including yeast. The tip caps of the prefilled syringes contain rubber latex that may cause allergic reactions.

What are the most common side effects of Engerix-B?

The most commonly reported side effects of Engerix-B were injection-site soreness (22%) and fatigue (14%). Up to 10% of patients experienced fever over 100ºF, injection-site swelling, redness, or lump. Less than 1% of patients experienced other side effects, such as:

  • Abdominal pain/cramps
  • Agitation
  • Back pain
  • Chills
  • Constipation
  • Diarrhea
  • Enlarged lymph nodes
  • Fatigue
  • Feeling unwell
  • Flu-like symptoms
  • Flushing
  • Hypotension (low blood pressure)
  • Irritability
  • Insomnia
  • Joint pain
  • Loss of appetite
  • Lymphadenopathy
  • Malaise
  • Myalgia
  • Muscle aches
  • Nausea
  • Rash
  • Sleepiness
  • Stiffness in the arm, shoulder, or neck
  • Sweating
  • Tingling
  • Upper respiratory tract illness
  • Vomiting

What are severe side effects of Engerix-B?

Premature babies have developed apnea (temporarily stop breathing) after receiving Engerix-B. Decisions about when to administer the vaccine to premature infants should be based on consideration of the infant’s medical status, and potential risks and benefits of the vaccine.

SIRVA (Shoulder Injury Related to Vaccine Administration) is a side effect that occurs when the needle damages tendons, ligaments, or the bursa in the shoulder. It can cause chronic shoulder pain, limited range of motion, and disability. It is not caused by nerve damage.

What other side effects have been reported?

  • Abnormal liver function tests
  • Allergic reaction
  • Anaphylaxis
  • Apnea (temporarily stop breathing)
  • Arthritis
  • Asthma-like symptoms
  • Bell’s palsy
  • Bronchospasm
  • Conjunctivitis
  • Earache
  • Eczema
  • Encephalitis
  • Encephalopathy
  • Erythema multiforme
  • Erythema nodosum
  • Facial paralysis
  • Fainting
  • Fever
  • Guillain-Barre Syndrome
  • Hair loss
  • Heart palpitations
  • Herpes zoster
  • Hypersensitivity syndrome
  • Hypoesthesia
  • Indigestion (dyspepsia)
  • Injection-site reaction
  • Keratitis
  • Lichen planus
  • Migraine headache
  • Meningitis (brain inflammation)
  • Multiple sclerosis
  • Muscular weakness
  • Neuritis
  • Neuropathy
  • Numbness
  • Optic neuritis
  • Paralysis
  • Paresis
  • Seizures
  • Serum sickness-like symptoms
  • Stevens-Johnson Syndrome
  • Tinnitus
  • Transverse myelitis
  • Vasculitis
  • Vertigo
  • Visual disturbances

What ingredients are in Engerix-B?

Each 0.5-mL pediatric dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide.

Each 1-mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.

Engerix-B contains the following excipients: Sodium chloride (9 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL), sodium dihydrogen phosphate dihydrate (0.71-mg/mL).

Does Engerix-B have thimerosal?

No. Engerix-B is formulated without preservatives.

Where can I get more information?

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