Havrix is a hepatitis A vaccine. Hepatitis is a serious disease caused by a virus. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.

Havrix vaccine is used to help prevent this disease in adults.

Havrix 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.

Like any vaccine, Havrix may not provide protection from disease in every person.

You should not receive Havrix if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A, or if you are allergic to neomycin.

Vaccination with Havrix vaccine is recommended for all adults who travel in certain areas of the world where hepatitis A is a common disease.

Other risk factors for hepatitis include: being a homosexual male; having chronic liver disease; using intravenous (IV) drugs; receiving treatment for hemophilia or other bleeding disorders; working in a research laboratory or around animals (especially monkeys) where you may be exposed to the hepatitis A virus; or being in an area where there has been an outbreak of hepatitis A.

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

Before taking this medicine

Havrix vaccine will not protect against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect against hepatitis A if you are already infected with the virus, even without showing symptoms.

You should not receive Havrix if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A, or if you are allergic to neomycin.

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

• an allergy to latex rubber; or

• a weak immune system (caused by disease or by using certain medicine).

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

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that Havrix could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with hepatitis A.

It is not known if hepatitis A vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Havrix is not FDA-approved for use by anyone younger than 12 months old.

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

You will most likely receive 2 separate injections of Havrix at 6 to 12 months apart, depending on your exposure or risk of infection.

To prevent hepatitis A while traveling, you should receive Havrix at least 2 weeks before your trip. Your healthcare provider will determine the best dosing schedule for your situation.

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 use.

Usual Adult Dose for Hepatitis A Prophylaxis:

Havrix: 1 mL IM followed by a 1 mL booster dose 6 to 12 months following primary immunization.

Primary immunization is recommended at least 2 weeks before expected exposure to hepatitis A virus.

Immune globulin may be administered with the vaccine (at a different injection site) to patients requiring immediate prophylaxis or postexposure prophylaxis.

Havrix vaccine will not protect against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect against hepatitis A if you are already infected with the virus, even without showing symptoms.

You should not receive Havrix if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A, or if you are allergic to neomycin.

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

• an allergy to latex rubber; or

• a weak immune system (caused by disease or by using certain medicine).

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

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that Havrix could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with hepatitis A.

It is not known if hepatitis A vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Havrix is not FDA-approved for use by anyone younger than 12 months old.

Contact your doctor if you 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 to receive all recommended doses of Havrix or you may not be fully protected against disease.

An overdose of Havrix is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

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 Havrix. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with hepatitis A is much more dangerous to your health than receiving Havrix. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Call your doctor at once if you have:

• extreme drowsiness, fainting; or

• high fever (within a few hours or a few days after the vaccine).

Common Havrix side effects may include:

• low fever, general ill feeling;

• nausea, loss of appetite;

• headache; or

• swelling, tenderness, redness, warmth, or a hard lump where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

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

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

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

• medications to treat cancer, ppsoriasis, rheumatoid arthritis, or other autoimmune disorders;

• radiation; or

• medicines to treat or prevent organ transplant rejection.

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.

This list is not complete. Other drugs may interact with hepatitis A vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.