Recombivax HB

Recombivax HB is a vaccine used for the prevention of infection caused by all known subtypes of hepatitis B virus. 

Recombivax HB is a vaccine given as a shot in the upper arm or thigh.

Common side effects of Recombivax HB include soreness, redness, swelling, warmth, and itching at the injection site. 

Recombivax HB is a vaccine used for the prevention of infection caused by all known subtypes of hepatitis B virus.

Recombivax HB is approved for use in individuals of all ages.

Recombivax HB Dialysis Formulation is approved for use in predialysis and dialysis patients 18 years of age and older.

Recombivax HB is a vaccine given as a shot in the upper arm or thigh.

The recommended vaccination schedules for Recombivax HB are the following:

• Persons from birth through 19 years of age: A series of 3 doses (0.5 ml) given on a 0, 1, and 6 month schedule.
• Adolescents 11 through 15 years of age: A series of either 3 doses (0.5 ml) given on a 0, 1, and 6 month schedule or a series of 2 doses (1.0 mL) on a 0 and 4 to 6 month schedule.
• Persons 20 years of age and older: A series of 3 doses (1.0 mL each) given on a 0, 1, and 6 month schedule.
• Recombivax HB Dialysis Formulation Adults on predialysis or dialysis: A series of 3 doses (1.0 mL each) given on a 0, 1, and 6 month schedule.

Serious side effects have been reported with Recombivax HB including the following:

• temporary absence of breathing (apnea) following vaccination (intramuscular route) in some infants born prematurely. Giving Recombivax HB to infants born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination.

The vial stopper, the syringe plunger stopper, and tip cap contain dry natural latex rubber which may cause allergic reactions in latex-sensitive individuals

Do not take Recombivax HB if you or your child have severe allergic or hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of Recombivax HB, including yeast.

Serious side effects have been reported for Recombivax HB. See "Recombivax HB Precautions" section.

Common side effects of Recombivax HB in infants and children include:

• soreness, redness, swelling, warmth, and itching at the injection site
• irritability
• fever
• diarrhea
• fatigue/weakness
• diminished appetite
• stuffy nose (rhinitis)

Common side effects of Recombivax HB in adults include:

• soreness, redness, swelling, warmth, and itching at the injection site
• fatigue/weakness
• headache
• fever 
• generally not feeling well (malaise)
• diarrhea
• sore throat (pharyngitis)
• upper respiratory infection

​This is not a complete list of Recombivax HB side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Recombivax HB may be administered at the same time with HBIG. The first dose of Recombivax HB may be given at the same time as HBIG, but the injections should be administered at different sites.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications and vaccines based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Recombivax HB falls into category C. No studies have been done in animals, and no well controlled studies have been done in pregnant women. Recombivax HB should be given to a pregnant women only if clearly needed. 

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if Recombivax HB crosses into human milk. Because some vaccines can cross into human milk and becuase of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. You and your doctor will need to decide if the benefits outweigh the risk of using Recombivax HB.