Heplisav-B (PF)

This vaccine is used to help prevent infection from the hepatitis B virus. Hepatitis B infection can cause serious problems including liver failure, persistent hepatitis B infection, cirrhosis, and liver cancer. Preventing infection can prevent these problems.

Hepatitis B vaccine is a genetically engineered (man-made in the laboratory) piece of the virus. It does not contain live virus, so you cannot get hepatitis from the vaccine. This vaccine works by helping the body produce immunity (through antibody production) that will prevent you from getting infection from hepatitis B virus. Hepatitis B vaccine does not protect you from other virus infections (such as HIV virus which causes AIDS; hepatitis A, hepatitis C or hepatitis E; HPV virus which causes genital warts and other problems).

The vaccine is recommended for people of all ages, especially those at an increased risk of getting the infection. Those at an increased risk include health care personnel, laboratory workers who handle blood and patient specimens, police, fire and emergency medical personnel who give first aid treatment, hemophiliacs, dialysis patients, people who live with or spend much time with people with persistent hepatitis B infections, people with multiple sex partners, men who have sex with men, sex workers, injection drug abusers, and people traveling to high-risk areas.

Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.

This vaccine is usually given by injection into a muscle (shoulder or thigh) by a health care professional. Injection under the skin may be used if you have a bleeding disorder.

Your health care professional will give you a vaccination schedule (usually a series of 2 to 4 injections), which you must follow closely for best effectiveness. If you have an illness with fever at the time a vaccination is scheduled, your health care professional may choose to delay the injection until you are better.

The dosage and vaccination schedule is based on your age, medical condition, risk of hepatitis B exposure, and the brand of vaccine used.

If you are receiving the first hepatitis B vaccine injection at a time when your health care professional feels you may have been exposed to hepatitis B, you will also receive an injection of hepatitis B immune globulin (HBIG). HBIG is a dose of antibodies against the virus and will immediately help protect you from developing an infection. These antibodies only last a few months. For long-term protection, it is important to follow your vaccination schedule for the hepatitis B vaccine exactly.

Pain/soreness/redness/swelling at the injection site, fever, headache, tiredness, sore throat, nausea, diarrhea, loss of appetite, and dizziness may occur. If any of these effects persist or worsen, tell your health care professional promptly.

Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.

Remember that your health care professional has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.

Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

Before you receive this vaccine, tell the health care professional if you are allergic to it; or to yeast; or other vaccines; or if you have any other allergies. Some vials and prefilled syringes may use latex rubber stoppers or plungers. Tell your health care professional if you are allergic to latex. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your health care professional for more details.

Before using this vaccine, tell your health care professional your medical history, especially of: current illness with fever.

If you are a hemodialysis patient, you may not respond as well to the vaccine and will need to have hepatitis B antibody levels checked yearly. If antibodies drop too low over time, you may be given another dose of vaccine (often called a booster shot).

If you have immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment), your body may not make enough antibodies to protect you from hepatitis B infection. Antibody levels may be checked after the vaccine series.

The elderly may not make as many antibodies to the vaccine. Talk to your health care professional for more details.

During pregnancy, this vaccine should be used only when clearly needed. Discuss the risks and benefits with your health care professional.

It is unknown if this vaccine passes into breast milk. Consult your health care professional before breast-feeding.

Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this vaccine include: drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone).

Other vaccines may be given at the same time as hepatitis B vaccine, but should be given with separate syringes and at different injection sites.

Not applicable.

It is important to receive each vaccination as scheduled. Be sure to ask when each dose should be received and make a note on a calendar to help you remember.

As with any vaccine, this vaccine may not fully protect everyone who receives it.

Laboratory and/or medical tests (such as hepatitis B antibody levels) may be performed periodically for some patients at risk of a poor response to the vaccine. Consult your health care professional for more details.

Keep vaccine records for yourself and all of your children, and after your children are grown provide their records to them and their health care professionals. This will prevent unnecessary re-vaccinations.