Hepatitis B vaccine prevents infection by hepatitis B virus by allowing your body to produce its own protection (antibodies) against the disease. Hepatitis B virus is a major cause of serious liver diseases such as hepatitis, cirrhosis, and liver cancer. Hepatitis B vaccine is recommended for persons of all ages, especially those at increased risk of infection with hepatitis B virus. These include:

• adolescents
• adults and children who have immigrated to Canada from areas where there is a high prevalence of hepatitis B
• blood bank workers
• children in childcare settings in which there is a hepatitis B virus-infected child
• children under 7 years of age whose families have moved to Canada from high-risk areas and were exposed to hepatitis B carriers
• emergency service workers (police, firefighters)
• health care personnel
• infants born to mothers with hepatitis B
• military personnel
• morticians and embalmers
• patients and patient contacts in certain hospital clinics (e.g., dialysis, cancer) or psychiatric institutions
• people requiring frequent or large-volume blood transfusions or other blood products
• people travelling to high-risk areas
• people who engage in high-risk sexual activity
• prisoners
• users of illicit injectable drugs

Your doctor may have suggested this vaccine for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are receiving this vaccine, speak to your doctor.

The dose varies according to age and dosing schedule. Hepatitis B vaccine should be used only by or under the supervision of a doctor. A qualified health professional will inject the hepatitis B vaccine.

The dose of hepatitis B vaccine is injected into a muscle (preferably the upper, outer arm for adults and the thigh for infants and children) with 3 doses that are at least 1 month apart. A two-dose regimen is available for adolescents (11 to 15 years of age) where the second dose is given 4 to 6 months after the first.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. Other dosing schedules are sometimes used. It is very important to keep doctor appointments so that this medication may be used according to recommended schedules. Add all vaccines you receive to your immunization record.

This vaccine is stored in the refrigerator and protected from light until it is used. It should be kept out of the reach of children, and it must not be allowed to freeze or it will have to be discarded.

Engerix®-B
Each 1 mL adult dose contains 20 µg of hepatitis B surface antigen adsorbed onto 0.5 mg of aluminum hydroxide. Nonmedicinal ingredients: aluminum hydroxide, disodium phosphate dihydrate, sodium chloride, sodium dihydrogen phosphate dihydrate, and water for injection. The vaccine is a slightly opaque, white, sterile suspension. A slow settling of the white aluminum hydroxide may occur during storage leaving a clear, colourless, supernatant liquid. Thimerosal-free

Engerix®-B Pediatric Dose
Each 0.5 mL pediatric dose contains 10 µg of hepatitis B surface antigen adsorbed onto 0.25 mg of aluminum hydroxide. Nonmedicinal ingredients: aluminum hydroxide, disodium phosphate dihydrate, sodium chloride, sodium dihydrogen phosphate dihydrate, and water for injection. The vaccine is a slightly opaque, white, sterile suspension. A slow settling of the white aluminum hydroxide may occur during storage leaving a clear, colourless, supernatant liquid. Thimerosal-free.

Hepatitis B vaccine should not be used by anyone who is allergic to hepatitis B vaccine or to any of the ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• diarrhea
• dizziness
• drowsiness
• fever of 37.7°C (100°F) or higher
• hard lump, redness, swelling, pain, itching, purple spot, tenderness, or warmth at the place of injection
• headache
• loss of appetite
• muscle aches
• nausea
• soreness where the vaccine was injected
• unusual tiredness or weakness
• vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• aches or pain in joints
• fever
• flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
• irritability
• muscle weakness or numbness or tingling of arms and legs
• skin rash or welts (may occur days or weeks after receiving the vaccine)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• difficulty breathing or swallowing
• hives
• itching, especially hands or feet
• reddening of skin, especially around ears
• swelling of eyes, face, or inside of nose
• unusual tiredness or weakness (sudden and severe)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you receive this medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Hemodialysis: People undergoing hemodialysis have a reduced immune response to the hepatitis B vaccine. Additional and higher doses of the vaccine may be required.  Discuss any concerns you have with your doctor.

Immune deficiency or suppression: People with immunodeficiency or those receiving immunosuppressive therapy (e.g., some medications used for the treatment of cancer or for transplant recipients) may require higher doses and may not respond as well as healthy individuals.

Infection: The vaccine should be delayed for people with serious infections, unless in the opinion of the doctor there is a greater risk associated with not giving the vaccine.

Vaccine protection: As with any vaccine, this vaccine may not protect 100% of people who receive it. (NOTE: Hepatitis B vaccine may not prevent hepatitis in people who were infected with the virus prior to receiving the vaccine.)

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while receiving this medication, contact your doctor immediately.

Breast-feeding: It is not known if the vaccine passes into breast milk. If you are a breast-feeding mother and are receiving this vaccine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: This vaccine can be used in babies and children.

There may be an interaction between hepatitis B vaccine and any of the following:

• medications that suppress the immune system:
• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• medications used to treat conditions such as cancer, inflammatory bowel disease, multiple sclerosis, psoriasis, rheumatoid arthritis, or medications used after a transplant

         If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.