Hepatitis A, Inactivated, and Hepatitis B Recombinant Vaccine,

What are other names for this medicine?

Generic and brand names: hepatitis A, inactivated, and hepatitis B recombinant vaccine, injection; Twinrix

What is this medicine used for?

This medicine is given by injection (shots) to prevent diseases caused by hepatitis A and B viruses (HAV and HBV).

This vaccine does not prevent hepatitis C or hepatitis E or other diseases known to infect the liver.

Adults at risk for HAV and HBV infection include:

• workers who handle live viruses, human waste, or sewage
• health care workers and public safety workers who might be exposed to infected blood or body fluids
• people infected with HIV
• people who get blood transfusions or dialysis
• people who have unprotected sex with an infected person
• people who inject illegal drugs
• people who live in or are traveling to areas where hepatitis A and B virus are common, such as Africa, parts of South America, and most of the Middle East, South and Southeast Asia.

What should my health care provider know before I take this medicine?

Before receiving this medicine, tell your health care provider if you have liver disease or a weakened immune system.

If you are severely ill at the time the shot is scheduled, wait until you recover before getting this vaccine. If you have a mild cold or mild upper respiratory infection with or without fever, you may still be able to get your shot. Talk to your health care provider about this.

Females of childbearing age: Tell your health care provider if you are pregnant or plan to become pregnant. Do not breast-feed while receiving this medicine without your health care provider's approval.

How do I use it?

This vaccine must be given by shots into a large muscle in the upper arm. Shots in the buttocks are less effective. You will get 3 doses of vaccine as follows:

• first dose
• 2nd dose one month later
• 3rd dose 6 months after the first dose.

You must receive all 3 shots for the vaccine to be effective.

Shots of this vaccine will not be effective if you already have hepatitis A or B virus infection.

What should I watch out for?

This medicine is recommended for use by adults and children over 18 years of age.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your health care provider if you have any side effects that continue or get worse.

Life threatening (Report these to your health care provider right away. If you cannot reach your health care provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest, trouble breathing, swelling of the tongue and throat).

Other: Irritation at the spot where the shot was given, sweating, weakness, flushing, fever, headache, abdominal pain, vomiting, loss of appetite, upper respiratory infection.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your health care provider if you are taking:

• blood thinners such as warfarin (Coumadin)
• cyclosporine (Sandimmune, Gengraf, Neoral)
• prednisone (Deltasone, Orasone).

Keep a list of all your medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. Be sure that you tell all health care providers who treat you about all the products you are taking.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your health care provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.