Uses of Hepatitis B Vaccine:

• It is used to prevent hepatitis B infection.

What do I need to tell my doctor BEFORE I take Hepatitis B Vaccine?

• If you are allergic to hepatitis B vaccine (recombinant); any part of hepatitis B vaccine (recombinant); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an infection or an illness with a fever.

This is not a list of all drugs or health problems that interact with hepatitis B vaccine (recombinant).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take hepatitis B vaccine (recombinant) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Hepatitis B Vaccine?

For all patients taking hepatitis B vaccine (recombinant):

• Tell all of your health care providers that you take hepatitis B vaccine (recombinant). This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor.
• This medicine may not protect all people who use it. Talk with the doctor.
• This medicine is a vaccine with a virus that is not active. It cannot cause the disease.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take hepatitis B vaccine (recombinant).
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Children:

• If hepatitis B vaccine (recombinant) is being given to your child after birth and your child was born weighing less than 2 kg (4.4 lb), talk with the doctor.
• If your child was born premature, talk with the doctor. Trouble breathing has happened in these children after getting some vaccines.

How is this medicine (Hepatitis B Vaccine) best taken?

Use hepatitis B vaccine (recombinant) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or under the skin.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A burning, numbness, or tingling feeling that is not normal.
• Very bad dizziness or passing out.
• Trouble controlling body movements.
• Change in eyesight.
• High fever.

What are some other side effects of Hepatitis B Vaccine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

For all patients taking hepatitis B vaccine (recombinant):

• Pain, redness, or swelling where the shot was given.
• Feeling dizzy, tired, or weak.
• Headache.
• Mild fever.

Children:

• Feeling fussy.
• Diarrhea.
• Not hungry.
• Runny nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Hepatitis B Vaccine?

• If you need to store hepatitis B vaccine (recombinant) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about hepatitis B vaccine (recombinant), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.