Recombivax HB: Hepatitis B Vaccine (Recombinant): patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB.

See full insert sheet at this link at the Natural News Reference website.

RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant)

Suspension for intramuscular injection

Initial U.S. Approval: 1983

INGREDIENTS AND EXCIPIENTS

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 (16).]

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.

INDICATIONS AND USAGE

RECOMBIVAX HB is a vaccine indicated for 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. (1)

DOSAGE AND ADMINISTRATION

– Persons from birth through 19 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule. (2.1)

– Adolescents 11 through 15 years of age: A series of either 3 doses (0.5 mL each) 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). (2.1)

– 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. (2.1) 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. (2.1)

DOSAGE FORMS AND STRENGTHS

RECOMBIVAX HB is a sterile suspension available in the following presentations:

– 0.5 mL (5 mcg) Pediatric/Adolescent Formulation single-dose vials and prefilled syringes (3, 11, 16)

1 mL (10 mcg) Adult Formulation single-dose vials and prefilled syringes (3, 11, 16) RECOMBIVAX HB Dialysis Formulation is a sterile suspension available in the following presentation:

– 1 mL (40 mcg) single-dose vials (3, 11, 16)

CONTRAINDICATIONS

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. (4, 11)

WARNINGS AND PRECAUTIONS

The vial stopper, the syringe plunger stopper, and tip cap contain dry natural latex rubber which may cause allergic reactions in latexsensitive individuals. (5.1)

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including 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. (5.2)

ADVERSE REACTIONS

In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. (6.1) In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877- 888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

DRUG INTERACTIONS

Do not mix RECOMBIVAX HB with any other vaccine in the same syringe or vial. ( 7.1)

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with the vaccine. It is also not known whether the vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether the vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when the vaccine is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of RECOMBIVAX HB have been established in all pediatric age groups. Maternally transferred antibodies do not interfere with the active immune response to the vaccine. [See Adverse Reactions (6.1) and Clinical Studies (14.1 and 14.2).] The safety and effectiveness of RECOMBIVAX HB Dialysis Formulation in children have not been established.

Geriatric Use

Clinical studies of RECOMBIVAX HB used for licensure did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. However, in later studies it has been shown that a diminished antibody response can be expected in persons older than 60 years of age.

Safety and effectiveness of RECOMBIVAX HB have not been established in pregnant women and nursing mothers. RECOMBIVAX HB should only be given to a pregnant woman if clearly needed. (8.1, 8.3)

Revised: XX/XXXX

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM110114.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Recombivax-HB-Hepatitis-B-Vaccine-Recombinant.pdf