Hepatitis A Vaccine, Inactivated suspension for injection

What is this medication?

HEPATITIS A VACCINE (hep uh TAHY tis A VAK seen) is a vaccine to protect from an infection with the hepatitis A virus. This vaccine does not contain the live virus. It will not cause a hepatitis infection. This vaccine is also used with immunoglobulin to prevent infection in people who have been exposed to hepatitis A.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Havrix, Havrix Pediatric, Vaqta

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

•bleeding disorder

•fever or infection

•heart disease

•immune system problems

•an unusual or allergic reaction to hepatitis A vaccine, latex, neomycin, other medicines, foods, dyes, or preservatives

•pregnant or trying to get pregnant

•breast-feeding

How should I use this medication?

This vaccine is for injection into a muscle. It is given by a health care professional.

A copy of Vaccine Information Statements will be given before each vaccination. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 months of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medication?

•medicines to treat cancer

•medicines that suppress your immune function like adalimumab, anakinra, etanercept, infliximab

•steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

See your health care provider for a booster shot of this vaccine as directed. Tell your doctor right away if you have any serious or unusual side effects after getting this vaccine.

You will not have protection from the hepatitis A virus for at least 8 to 10 days after your first injection. The length of time you will have protection from hepatitis A virus infection is not known. Check with your doctor if you have questions about your immunity. See your doctor before you travel out of the country.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

•breathing problems

•seizures

•yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

•diarrhea

•fever

•loss of appetite

•muscle pain

•nausea

•pain, redness, swelling or irritation at site where injected

•tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.