Hepatitis b vaccine (Intramuscular)

Hepatitis B vaccine recombinant is used to prevent infection by the hepatitis B virus. The vaccine helps your body create its own protection (antibodies) against the disease.

Hepatitis B vaccine recombinant is made without any human blood or blood products or any other substances from humans. It cannot give you the hepatitis B virus (HBV) or the human immunodeficiency virus (HIV).

HBV infection is a major cause of serious liver diseases, such as hepatitis and cirrhosis, and a type of liver cancer called primary hepatocellular carcinoma.

Pregnant women who have hepatitis B infection or carry the hepatitis B virus can pass the disease to their babies at birth. These babies often experience serious long-term illnesses from the disease.

Immunization against hepatitis B disease is recommended for all newborn babies, infants, children, and adolescents up to 19 years of age. It is also recommended for adults living in areas with a high rate of hepatitis B disease or those at increased risk of infection from the hepatitis B virus. These adults include:

• Sexually active homosexual and bisexual males, including those with HIV infection.
• Sexually active heterosexual persons with multiple partners.
• Persons who may be exposed to the virus through blood, blood products, or human bites, such as healthcare workers, employees in medical facilities, patients and staff of live-in facilities and daycare programs for the developmentally disabled, morticians and embalmers, police and fire department personnel, and military personnel.
• Persons with kidney disease or those who undergo blood dialysis for kidney disease.
• Persons with blood clotting disorders who receive transfusions of clotting-factor concentrates.
• Household and sexual contacts of HBV carriers.
• Persons in areas with a high risk of HBV infection, such as Alaskan Eskimos, Pacific Islanders, Haitian and Indochinese immigrants, and refugees from areas with a high rate of hepatitis B disease; persons adopting or accepting orphans from these areas; and travelers to these areas.
• Persons who use illegal injection drugs.
• Prisoners.

This vaccine is available only from your doctor or other authorized healthcare professional.

It is very important that you or your child return to your doctor’s office at the right time for the second and third dose. Be sure to tell your doctor about any side effects that happen after you or your child receive this vaccine.

This vaccine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble breathing after the injection.

Tell your doctor if you or your child are allergic to latex. The needle cover and the rubber plunger of the prefilled syringe contain dry natural latex rubber, which may cause an allergic reaction in people with a latex allergy.

This vaccine may not protect you against hepatitis B infection if you are already infected with the virus at the time you receive the shot.

In deciding to use a vaccine, you and your doctor need to think about the risks of the vaccine compared to the benefits it provides. Here are some important things to consider for this vaccine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems that would limit the use of hepatitis B vaccine recombinant in children.

Geriatric

Studies done so far have not shown any specific problems that would limit the use of hepatitis B vaccine recombinant in older adults.

Breast Feeding

Research in women suggests that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if there might be an interaction. In those cases, your doctor may adjust the dose or take other precautions. When receiving this vaccine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how well this vaccine works. Make sure to inform your doctor about any other medical problems you have, especially:

• Allergy to yeast—Should not be used in patients with this condition.

• Bleeding problems (e.g., hemophilia)—Use with caution. There may be a higher risk of bleeding at the injection site.

• Multiple sclerosis—Use with caution. This condition may worsen.

• Severe illness with a fever—Your dose may need to be given at a later time.

• Weak immune system from a disease or medicine—This vaccine may not work as well in patients with this condition.

Along with its needed effects, a drug may cause some unwanted effects. Although not all of these adverse effects may occur, if they do occur they may need medical attention.

Check with your physician or nurse right away if any of the following adverse effects occur:

More frequent

• Fever of 37.7 degrees C (100 degrees F) or higher

Rare

• Aches or pain in the joints, fever, or skin rash or welts (may occur days or weeks after receiving the vaccine)
• blurred vision or other vision changes
• confusion
• difficulty with breathing or swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives
• itching, especially of the feet or hands
• muscle weakness
• numbness or tingling of the arms and legs
• reddening of the skin, especially around the ears
• sweating
• swelling of the eyes, face, or inside of the nose
• unusual fatigue or weakness (sudden and severe)

Some side effects may occur that typically do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Verify with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Light-headedness
• headache
• soreness at the injection site

Less frequent

• Hard lump, redness, swelling, pain, itchiness, purple spot, tenderness, or warmth at the injection site
• unusual tiredness or weakness

Rare

• Aches or pain in the muscles
• agitation
• back pain or stiffness or pain in neck or shoulder
• chills
• constipation
• diarrhea
• difficulty with moving
• feeling of warmth
• general feeling of discomfort or illness
• headache (slight), sore throat, runny nose, or fever (slight)
• increased sweating
• itchiness
• lack of appetite or decreased appetite
• nausea or vomiting
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual drowsiness
• sleeplessness
• stomach cramps or pain
• sudden redness of skin
• swelling of glands in the armpit or neck
• trouble with sleeping
• unable to sleep
• welts
• weight loss

Other side effects not listed may additionally occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your physician for medical guidance about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Engerix-B
• Engerix-B Pediatric
• Recombivax HB
• Recombivax HB Pediatric/Adolescent

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot into one of your muscles. If you have bleeding problems such as hemophilia, the vaccine may be given as a shot under your skin.

This vaccine is usually given as 3 doses. After the first dose, two more doses are given 1 month and 6 months after the first dose, unless your doctor tells you otherwise.