hepatitis B vaccine

Generic Name: hepatitis B vaccine (HEP a TYE tis)
Brand Name: Engerix-B, Engerix-B Pediatric, Recombivax HB Adult, Recombivax HB Dialysis Formulation, Recombivax HB Pediatric/Adolescent, ...show all 11 brand names

What is hepatitis B vaccine?

Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The hepatitis B vaccine is used to help prevent this disease.

This vaccine works by exposing you to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis B vaccine is recommended for all adults and children who are at risk of getting hepatitis B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has chronic hepatitis B infection.

Like any vaccine, the hepatitis B vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

Hepatitis B vaccine will not protect you against infection with hepatitis A, C, and E, or other viruses that affect the liver. It will also not protect you from hepatitis B if you are already infected with the virus, even if you do not yet show symptoms.

Vaccination with hepatitis B vaccine is recommended for all adults and children who are at risk of getting hepatitis B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has chronic hepatitis B infection.

The hepatitis B vaccine is given in a series of shots. The booster shots are sometimes given 1 month and 6 months after the first shot. If you have a high risk of hepatitis B infection, you may be given an additional booster 2 months after the first shot.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

Hepatitis B vaccine will not protect you against infection with hepatitis A, C, and E, or other viruses that affect the liver. It will also not protect you from hepatitis B if you are already infected with the virus, even if you do not yet show symptoms.

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis B, or if you are allergic to baker's yeast. You also should not receive this vaccine if you have received cancer chemotherapy or radiation treatment in the past 3 months.

Before receiving this vaccine, tell the doctor if you have:

  • multiple sclerosis;

  • kidney disease (or if you are on dialysis);

  • a bleeding or blood clotting disorder such as hemophilia or easy bruising;

  • a history of seizures;

  • a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);

  • an allergy to latex rubber;

  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or

  • if you are taking a blood thinner such as warfarin (Coumadin).

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether hepatitis B vaccine passes into breast milk or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

How is this vaccine given?

The vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.

The hepatitis B vaccine is given in a series of shots. The booster shots are sometimes given 1 month and 6 months after the first shot. If you have a high risk of hepatitis B infection, you may be given an additional booster 2 months after the first shot.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

What happens if I miss a dose?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

There are no restrictions on food, beverages, or activity before or after receiving this vaccine, unless your doctor has told you otherwise.

This vaccine side effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  • fussiness, irritability, crying for an hour or longer;

  • fast or pounding heartbeats; or

  • easy bruising or bleeding.

Less serious side effects include:

  • redness, pain, swelling, or a lump where the shot was given;

  • headache, dizziness;

  • low fever;

  • joint pain, body aches;

  • tired feeling; or

  • nausea, vomiting, stomach pain, constipation, diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Hepatitis B vaccine Dosing Information

Usual Adult Dose for Hepatitis B Prophylaxis:

Engerix-B: 1 mL (20 mcg) IM for 3 doses at 0, 1, and 6 months.
Alternate dose (with recent exposure to the virus or certain travelers to high-risk areas): 1 mL IM for 4 doses at 0, 1, 2, and 12 months.

Recombivax-HB: 1 mL (10 mcg) IM for 3 doses at 0, 1, and 6 months.

Postexposure prophylaxis: Hepatitis B immune globulin should be given as soon as possible after exposure (preferably within 24 hours) along with a dose of hepatitis B vaccine (at a separate site) within 7 days of exposure at 1 and 6 months.

Usual Pediatric Dose for Hepatitis B Prophylaxis:

Engerix-B:
Infants born of HBsAg positive mothers: 0.5 mL (10 mcg) IM at 0, 1 and 6 months.
Alternate dose: 0.5 mL (10 mcg) IM at 0, 1, 2, and 12 months. Hepatitis B immune globulin should be given at the same time as the first dose of vaccine (in the opposite thigh).

Infants born of HBsAg negative mothers: 0.5 mL (10 mcg) IM at 0, 1, and 6 months.

0 to 19 years: 0.5 mL (10 mcg) IM at 0, 1, and 6 months.

Alternate dose:
0 to 10 years (with recent exposure to the virus or certain travelers to high-risk areas): 0.5 mL (10 mcg) IM at 0, 1, 2, and 12 months.
5 to 16 years: 0.5 mL (10 mcg) IM at 0, 12, and 24 months.
11 years or older (with recent exposure to the virus or certain travelers to high-risk areas): 1 mL (20 mcg) IM at 0, 1, 2, and 12 months.


Recombivax HB:
Infants born of HBsAg positive mothers: 0.5 mL (5 mcg) IM at 0, 1, and 6 months. Hepatitis B immune globulin should be given at the same time as the first dose of vaccine (in the opposite thigh).

Infants born of HBsAg negative mothers: 0.5 mL (5 mcg) IM at 0, 1, and 6 months.

0 to 19 years: 0.5 mL (5 mcg) at 0, 1, and 6 months.

Alternate dose:
11 to 15 years: 1 mL (10 mcg) at 0 and 4 to 6 months.

What other drugs will affect hepatitis B vaccine?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have received drugs or treatments in the past 2 weeks that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;

  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.08. Revision Date: 2009-04-12, 4:39:12 PM.

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