Recombivax

Last updated on RxList: 4/12/2021

What is Recombivax and how is it used?

Recombivax is a prescription medicine used as a vaccine as a prophylaxis to Hepatitis B. Recombivax may be used alone or with other medications.

Recombivax belongs to a class of drugs called Vaccines, Inactivated, Viral.

What are the possible side effects of Recombivax?

Recombivax may cause serious side effects including:

  • fainting,
  • dizziness,
  • lightheadedness,
  • vision changes,
  • numbness or tingling, and
  • seizures

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Recombivax include:

  • pain, soreness, redness, and swelling at the injection site,
  • fever,
  • headache,
  • tiredness,
  • sore throat,
  • nausea,
  • diarrhea,
  • loss of appetite, and
  • dizziness

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

These are not all the possible side effects of Recombivax. For more information, ask your doctor or pharmacist.

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

DESCRIPTION

RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is a sterile suspension of non-infectious subunit viral vaccine derived from HBsAg produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories.

The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. Each dose contains less than 1% yeast protein. The vaccine produced by the Merck method has been shown to be comparable to the plasma-derived vaccine in terms of animal potency (mouse, monkey, and chimpanzee) and protective efficacy (chimpanzee and human).

The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products.

RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations. [See HOW SUPPLIED/Storage and Handling]

Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen.

Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen.

Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of hepatitis B surface antigen.

All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains < 15 mcg/mL residual formaldehyde. The vaccine is of the adw subtype.