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Hepatitis B Vaccine (Recombinant) is a sterile suspension available in the following:

• 0.5 mL (5 mcg) Pediatric/Adolescent Formulation single-dose vials and prefilled syringes
• 1 mL (10 mcg) Adult Formulation single-dose vials and prefilled syringes
• Hepatitis B Vaccine (Recombinant) Dialysis Formulation is a sterile suspension available in the following presentation: 1 mL (40 mcg) single-dose vials

Hepatitis B Vaccine (Recombinant) is a vaccine and is used to prevent hepatitis B.

Hepatitis B Vaccine (Recombinant) is an inactivated vaccine that protects you from hepatitis B caused by the hepatitis B virus. The vaccine helps your body’s immune system make antibodies that will attack the virus if it ever infects you.

The exact dose of Hepatitis B Vaccine (Recombinant) you’ll receive depends on the brand and formulation you get, your age, and medical conditions. Hepatitis B Vaccine (Recombinant) is typically given as a 3-dose series, with 1 injection into the muscle at months 0, 1, and 6. Hepatitis B Vaccine (Recombinant) is given as an injection into the thigh muscle for babies up to 1 year of age and into the shoulder muscle for adults and older children.

Hepatitis B Vaccine (Recombinant) is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. Severe allergic or hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any
component of Hepatitis B Vaccine (Recombinant), including yeast.

Common side effects of Hepatitis B Vaccine (Recombinant):

• Feeling irritated
• Fever
• Diarrhea
• Fatigue/weakness
• Poor appetite
• Nasal symptoms (runny nose, congestion, sneezing, itching)
• Soreness at injection site
• Fatigue
• Dizziness
• Headache
• Fever

Serious side effects are rare with Hepatitis B Vaccine (Recombinant). Contact your healthcare provider immediately if you experience any of the following.

• Serious allergic reactions: hives, rash, shaking, itching, nausea, flushing, dizziness, shortness of breath, chest pain

The following medications may interact with Hepatitis B Vaccine (Recombinant):

• Do not mix Hepatitis B Vaccine (Recombinant) with any other vaccine in the same syringe or vial

Various FDA-approved generic manufacturers

There are no adequate and well-controlled studies designed to evaluate Hepatitis B Vaccine (Recombinant) in pregnant women. It should only be used during pregnancy if the benefit to you is worth the possible risk to your baby.

• Recombivax HB