Recombivax HB (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, 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 hepatitis B virus can pass the disease to their babies at birth. These babies often experience serious long-term health issues from the disease.

Immunization against hepatitis B disease is recommended for all newborn babies, infants, children, and adolescents up to 19 years old. It is also recommended for adults who live in areas with a high rate of hepatitis B disease or who may be at higher risk of infection from hepatitis B virus. These adults include:

• Sexually active homosexual and bisexual males, including those with HIV infection.
• Sexually active heterosexual individuals with multiple partners.
• People 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 undergo 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 [in the population], such as Alaskan Eskimos, Pacific Islanders, Haitian and Indochinese immigrants, and refugees from areas with a high rate of hepatitis B disease; 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 another authorized health care 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 inform your doctor of 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 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 getting 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 when you receive the shot.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine against the benefits it will provide. For this vaccine, keep the following in mind:

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

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines can be used together even if there might be an interaction. In such cases, your doctor may want to adjust the dose, or other precautions may be needed. When receiving this vaccine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on 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 necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical issues, 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 worsen this condition.

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

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Also, your health care professional may be able to tell you how 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 happen 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.

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.