Engerix-B Pediatric (Intramuscular)

Hepatitis B vaccine recombinant is used to prevent infection from 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, like hepatitis and cirrhosis, as well as a type of liver cancer called primary hepatocellular carcinoma.

Pregnant women who have hepatitis B infection or are carriers of the hepatitis B virus can pass the disease to their babies at birth. These babies often experience serious long-term health problems from the disease.

Immunization against hepatitis B 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 where hepatitis B is common or who may be at higher risk for hepatitis B virus infection. These adults include:

• Sexually active homosexual and bisexual males, including those with HIV infection.
• Sexually active heterosexual individuals with multiple partners.
• Individuals who may be exposed to the virus through 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.
• Individuals with kidney disease or those who receive blood dialysis for kidney disease.
• Individuals with blood clotting disorders who receive transfusions of clotting-factor concentrates.
• Household and sexual contacts of HBV carriers.
• Individuals 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; individuals adopting or accepting orphans from these areas; and travelers to these areas.
• Individuals who use illegal injection drugs.
• Prisoners.

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

It is very important that you or your child return to your doctor’s office at the correct time for the second and third dose. Make sure to inform 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. Contact your doctor right away if you or your child experience a rash, itching, swelling of the tongue and throat, or difficulty breathing after getting the injection.

Let your doctor know if you or your child are allergic to latex. The needle cover and the rubber plunger of the prefilled syringe have dry natural latex rubber, which can 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 consider the risks of the vaccine compared to the benefits it will provide. Here are some important points to think about:

Allergies

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

Pediatric

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

Geriatric

Studies conducted so far have not shown any specific problems in the elderly that would limit the effectiveness of the hepatitis B vaccine recombinant.

Breast Feeding

Research in women indicates that this medication poses minimal risk to infants when used during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there could be an interaction. In these cases, your doctor might adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this vaccine. The following interactions are important and may not be a complete list.

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

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at the same time as eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect your ability to use this vaccine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Allergy to yeast—This vaccine should not be used in patients with this allergy.

• Bleeding problems (e.g., hemophilia)—Use with caution as there may be an increased risk of bleeding at the injection site.

• Multiple sclerosis—Use with caution as it may worsen this condition.

• Severe illness with a fever—Your dose may need to be postponed.

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

Along with its needed effects, a medication 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 clinician 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
• itchiness, 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 serious)

Some adverse effects may occur that typically do not need medical attention. These side effects may go away during treatment as your body adjusts to the drug. Also, your health care professional may be able to inform you about ways to prevent or lower 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 frequent

• Dizziness
• headache
• soreness at the injection site

Less frequent

• Hard lump, redness, swelling, pain, itchiness, purple spot, tenderness, or warmth at the injection site
• unusual fatigue 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
• itching
• lack of appetite or decreased appetite
• nausea or vomiting
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual sleepiness
• 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 adverse effects not listed may as well 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.