Pronunciation:

hep-a-TYE-tis B VAX-een re-KOM-bin-ant

Brand Names:

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

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

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

Hepatitis B vaccine recombinant is made without any human blood or blood products or any other substances of human origin. 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 are carriers of hepatitis B virus can give the disease to their babies when they are born. These babies often suffer 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 who live in areas that have a high rate of hepatitis B disease or who may be at increased risk of infection from 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 by means of blood, blood products, or human bites, such as health care 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 who have kidney disease or 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 high risk of HBV infection [in the population], such as Alaskan Eskimos, Pacific Islanders, Haitian and Indochinese immigrants, and refugees from areas that have a high rate of hepatitis B disease; persons accepting orphans or adoptees 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 health care professional.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hepatitis B vaccine recombinant in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hepatitis B vaccine recombinant in the elderly.

Breast-feeding—

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

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

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

• Bleeding problems (e.g., hemophilia)—Use with caution. May have an increased risk of bleeding at the injection site.

• Multiple sclerosis—Use with caution. May make this condition worse.

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

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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 notify your doctor of any unwanted effects that occur after you or your child receive this vaccine.

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

Side Effects of This Medicine:

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

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

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 tiredness or weakness (sudden and severe)

Some side effects may occur that usually do not need 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. Check 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

Dizziness

headache

soreness at the injection site

Less common

Hard lump, redness, swelling, pain, itching, 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 (mild), sore throat, runny nose, or fever (mild)

increased sweating

itching

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 also occur in some patients. If you notice any other effects, check with your healthcare professional.

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