TM Owner Merck & Co.
Recombivax HB 10mcg/mL Injection
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Indications & Clinical Uses
- Recombivax HB 10 mcg/mL is a recombinant hepatitis B vaccine containing purified hepatitis B surface antigen (HBsAg) produced in yeast cells, used for active immunisation against infection caused by all known subtypes of hepatitis B virus.
- It is approved for individuals of all ages, from newborns through adults, usually given as a three-dose primary series at 0, 1 and 6 months; a separate higher-strength 40 mcg/mL dialysis formulation is used on an accelerated schedule in predialysis and dialysis patients aged 18 years and older.
- Recombivax HB does not treat existing hepatitis B infection and gives no protection against hepatitis A, C or E.
- It is given only by a healthcare provider as an intramuscular injection and is never self-administered.
- Merck & Co., through its subsidiary Merck Sharp & Dohme LLC, holds the current US label.
Side Effects
- The most frequently reported reactions to Recombivax HB are injection-site soreness, redness and swelling, seen in up to 17% of adult recipients, along with systemic effects such as fatigue, headache and mild fever in around 15% of adults; in infants and children, irritability, reduced appetite, drowsiness, fever and mild diarrhoea are most common.
- The current US label carries no boxed warning.
- Rare but serious reactions include anaphylaxis, which can occur even after a previous dose of any hepatitis B-containing vaccine, and fainting (syncope), sometimes causing falls and injury, particularly in adolescents.
- Seek urgent medical help for hives, facial or throat swelling, wheezing or difficulty breathing after vaccination, and ask the vaccinator about sitting for 15 minutes afterward to reduce fainting risk.
Precautions & Warnings
- Recombivax HB must not be given to anyone with a history of severe allergic reaction (anaphylaxis) to a previous dose of any hepatitis B vaccine or to any component, including yeast, or to latex if present in the vial stopper of the presentation used.
- Vaccination should be postponed during moderate or severe acute illness.
- Premature infants weighing under 2000 g may have a reduced immune response and need individualised timing, and very premature infants should be monitored for apnoea for 48-72 hours after the first dose.
- The vaccine may not prevent hepatitis B if given during an already-established, unrecognised infection, and it does not protect against hepatitis caused by other agents.
- Because this is a clinician-administered injection, there is no home-storage or missed-dose responsibility for the patient; the vaccination schedule is tracked by the healthcare provider.
Avoid Interactions
- Recombivax HB must never be mixed with any other vaccine in the same syringe or vial; each vaccine is given as a separate injection at a separate site.
- It can be given at the same visit as hepatitis B immune globulin (HBIG) for post-exposure or newborn perinatal prophylaxis, using separate injection sites.
- Medicines and conditions that suppress the immune system, including corticosteroids, chemotherapy or other immunosuppressive therapy, may lower the antibody response to Recombivax HB, so timing should be discussed with the prescriber.
- Tell your healthcare provider about all vaccines, medicines, supplements and any bleeding disorder before each dose, since intramuscular injections need extra care in people who bruise or bleed easily.
References
Frequently Asked Questions
Recombivax HB is a recombinant hepatitis B vaccine that protects against infection with all known hepatitis B virus subtypes. It's approved for people of all ages, usually given as three intramuscular doses at 0, 1 and 6 months. It doesn't treat existing hepatitis B and won't prevent hepatitis A, C or E.
A healthcare provider gives Recombivax HB (hepatitis B vaccine) as an intramuscular injection, usually in the upper arm or thigh. Adults and older children typically receive a 10 mcg dose; dialysis patients aged 18 and over get a separate 40 mcg formulation. It is never self-injected at home.
The most common effects are soreness, redness or swelling where Recombivax HB is injected, plus tiredness, headache or mild fever, affecting up to 1 in 6 adults. Infants may become irritable or feed poorly. Seek urgent care for hives, facial swelling, breathing difficulty or fainting after the shot.
Avoid Recombivax HB if you've had a severe allergic reaction (anaphylaxis) to a previous hepatitis B vaccine dose or to any ingredient, including yeast. Vaccination is usually postponed during moderate or severe acute illness. Tell your provider about all medicines, other vaccines and any immune-suppressing treatment beforehand.
Yes. Recombivax HB is stored by the clinic or pharmacy at 2°C to 8°C and must never be frozen, since freezing destroys its potency. As a clinician-given vaccine, you don't need to store or handle it at home; your provider manages storage and timing of each dose.
Recombivax HB can be given to premature infants, but those weighing under 2000 g may have a weaker immune response, so timing needs individual assessment by the provider. Very premature infants are monitored for apnoea (breathing pauses) for 48 to 72 hours after their first dose.
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