IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
HEPATITIS B VACCINE - INJECTION
COMMON BRAND NAME(S): Engerix-B, Recombivax HB
USES: This medication 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.
HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider. 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. A series of 2 to 4 injections is usually used over a 6- to 12-month period. Your doctor will give you a vaccination schedule, which you must follow closely for best effectiveness. If you have an illness with fever at the time a vaccination is scheduled, your doctor 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 doctor 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.
SIDE EFFECTS: 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 doctor or pharmacist promptly. Fainting right after the injection may occur. Your healthcare provider will usually watch you for 15 minutes after the injection to monitor you for this reaction. Remember that your doctor 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, seek immediate medical attention 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 doctor or pharmacist. Contact your doctor 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 report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before getting hepatitis B vaccine, tell your doctor or pharmacist 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 doctor if you are allergic to latex. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), 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 decreased immune function from other medications (see also Drug Interactions) or other illness (such as HIV, leukemia, lymphoma, other cancer), 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 doctor for more details. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some of the products that may interact with this drug include: chemotherapy, corticosteroids (such as prednisone, dexamethasone), drugs that weaken the immune system (such as cyclosporine, efalizumab, tacrolimus, mycophenolate). 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. This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: 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 doctor 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 doctors. This will prevent unnecessary re-vaccinations.
MISSED DOSE: 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.
STORAGE: Not applicable. This vaccine is given in a doctor's office and will not be stored at home.
Information last revised June 2012. Copyright(c) 2012 First Databank, Inc.