Generic Name: hepatitis B vaccine

Brand Names: Recombivax HB Pediatric/Adolescent, Recombivax HB Dialysis Formulation, Recombivax HB, Recombivax HB Adult, Recombivax, Engerix-B, Engerix-B Pediatric

What is this medicine?

HEPATITIS B VACCINE (hep uh TAHY tis B vak SEEN) is a vaccine. It is used to prevent from an infection with the hepatitis B virus.

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

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

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

• fever, infection
• heart disease
• hepatitis B infection
• immune system problems
• kidney disease
• an unusual or allergic reaction to vaccines, yeast, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

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 newborn 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?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• medicines that suppress your immune function like adalimumab, anakinra, infliximab
• medicines to treat cancer
• 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 medicine?

See your health care provider for all shots of this vaccine as directed. You must have 3 shots of this vaccine for protection from hepatitis B infection. Tell your doctor right away if you have any serious or unusual side effects after getting this vaccine.

What side effects may I notice from receiving this medicine?

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
• confused, irritated
• fast, irregular heartbeat
• flu-like syndrome
• numb, tingling pain
• seizures
• unusually weak or tired

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
• headache
• 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 medicine?

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.