Recombivax

Recombivax

INDICATIONS

RECOMBIVAX (hepatitis b vaccine (recombinant)) HB is indicated for vaccination against infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX (hepatitis b vaccine (recombinant)) HB Dialysis Formulation is indicated for vaccination of adult predialysis and dialysis patients against infection caused by all known subtypes of hepatitis B virus.

Vaccination with RECOMBIVAX (hepatitis b vaccine (recombinant)) HB is recommended for:

  1. Infants including those born to HBsAg positive mothers (high-risk infants).
  2. Children born after November 21, 1991.30
  3. Adolescents (see CLINICAL PHARMACOLOGY).
  4. Other persons of all ages in areas of high prevalence or those who are or may be at increased risk of infection with hepatitis B virus, such as:30
  • Health Care Personnel
    • Dentists and oral surgeons.
    • Physicians and surgeons.
    • Nurses.
    • Paramedical personnel and custodial staff who may be exposed to the virus via blood or other patient specimens.
    • Dental hygienists and dental nurses.
    • Laboratory personnel handling blood, blood products, and other patient specimens.
    • Dental, medical and nursing students.
  • Selected Patients and Patient Contacts
    • Staff in hemodialysis units and hematology/oncology units.
    • Hemodialysis patients and patients with early renal failure before they require hemodialysis.
    • Patients requiring frequent and/or large volume blood transfusions or clotting factor concentrates (e.g., persons with hemophilia, thalassemia).
    • Individuals with hepatitis C virus infection.35
    • Clients (residents) and staff of institutions for the mentally handicapped.
    • Classroom contacts of deinstitutionalized mentally handicapped persons who have persistent hepatitis B surface antigenemia and who show aggressive behavior.
    • Household and other intimate contacts of persons with persistent hepatitis B surface antigenemia.
  • Sub-populations with a known high incidence of the disease, such as:
    • Alaskan Natives.
    • Pacific Islanders.
    • Refugees from areas where hepatitis B virus infection is endemic.
    • Adoptees from countries where hepatitis B virus infection is endemic.
  • International Travelers
  • Military Personnel identified as being at increased risk
  • Morticians and Embalmers
  • Blood bank and plasma fractionation workers
  • Persons at Increased Risk of the Disease Due to Their Sexual Practices, such as:
    • Persons who have heterosexual activity with multiple partners.
    • Persons who repeatedly contract sexually transmitted diseases.
    • Homosexual and bisexual adolescent and adult men.
    • Female prostitutes.
  • Prisoners
  • Injection drug users

Neither dosage strength will prevent hepatitis caused by other agents, such as hepatitis A virus, hepatitis C virus, hepatitis E virus or other viruses known to infect the liver.

Revaccination

See CLINICAL PHARMACOLOGY.

Use with Other Vaccines

Results from clinical studies indicate that RECOMBIVAX (hepatitis b vaccine (recombinant)) HB can be administered concomitantly with DTP (Diphtheria, Tetanus and whole cell Pertussis), OPV (oral Poliomyelitis vaccine), M-M-R* II (Measles, Mumps, and Rubella Virus Vaccine Live), Liquid PedvaxHIB* [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] or a booster dose of DTaP [Diphtheria, Tetanus, acellular Pertussis], using separate sites and syringes for injectable vaccines. No impairment of immune response to individually tested vaccine antigens was demonstrated.

The type, frequency and severity of adverse experiences observed in these studies with RECOMBIVAX (hepatitis b vaccine (recombinant)) HB were similar to those seen when the other vaccines were given alone.

In addition, an HBsAg-containing product, COMVAX* [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine], was given concomitantly with Eipv (enhanced inactivated Poliovirus vaccine) or VARIVAX* [Varicella Virus Vaccine Live (Oka/Merck)], using separate sites and syringes for injectable vaccines. No impairment of immune response to these individually tested vaccine antigens was demonstrated. No serious vaccine-related adverse events were reported.

COMVAX has also been administered concomitantly with the primary series of DTaP to a limited number of infants. No serious vaccine-related adverse events were reported.10

Separate sites and syringes should be used for simultaneous administration of injectable vaccines.

DOSAGE AND ADMINISTRATION

Do not inject intravenously or intradermally.

RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) DIALYSIS FORMULATION [(40 mcg/mL) (WITHOUT PRESERVATIVE)] IS INTENDED ONLY FOR ADULT PREDIALYSIS/DIALYSIS PATIENTS.RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) PEDIATRIC/ADOLESCENT (WITHOUT PRESERVATIVE) and ADULT FORMULATIONS (WITHOUT PRESERVATIVE) ARE NOT INTENDED FOR USE IN PREDIALYSIS/DIALYSIS PATIENTS.

Three-Dose Regimen

The vaccination regimen for each population consists of 3 doses of vaccine given according to the following schedule:

First dose: at elected date

Second dose: 1 month later

Third dose: 6 months after the first dose

For infants born of mothers who are HBsAg positive or mothers of unknown HBsAg status, treatment recommendations are described in the subsection titled: Guidelines for Treatment of Infants Born of HBsAg Positive Mothers or Mothers of Unknown HBsAg Status.

Two-Dose Regimen - Adolescents (11 through 15 years of age)

An alternate two-dose regimen is available for routine vaccination of adolescents (11 through 15 years of age). The regimen consists of two doses of vaccine (10 mcg) given according to the following schedule:

First injection: at elected date

Second injection: 4-6 months later

Table 1 summarizes the dose and formulation of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB for specific populations, regardless of the risk of infection with hepatitis B virus.

Table 1

Group Dose/Regimen Formulation Color Code
Infants, Children and Adolescents
0-19 years of age
5 mcg (0.5 mL)
3 x 5 mcg
Pediatric/Adolescent Yellow
Adolescents
11 through 15 years of age
10 mcg** (1.0 mL)
2 x 10 mcg
Adult Green
Adults
≥ 20 years of age
10 mcg** (1.0 mL)
3 x 10 mcg
Adult Green
Predialysis and Dialysis Patients† 40 mcg (1.0 mL)
3 x 40 mcg
Dialysis Blue
** If the suggested formulation is not available, the appropriate dosage can be achieved from another formulation provided that the total volume of vaccine administered does not exceed 1 mL. However, the Dialysis Formulation may be used only for adult predialysis/dialysis patients.
* Adolescents (11 through 15 years of age) may receive either regimen: the 3 x 5 mcg (Pediatric/Adolescent Formulation) or the 2 x 10 mcg (Adult Formulation).
† See also recommendations for revaccination of predialysis and dialysis patients in DOSAGE AND ADMINISTRATION, Revaccination.

RECOMBIVAX (hepatitis b vaccine (recombinant)) HB is for intramuscular injection. The deltoid muscleis the preferred site for intramuscular injection in adults. Data suggest that injections given in the buttocks frequently are given into fatty tissue instead of into muscle. Such injections have resulted in a lower seroconversion rate than was expected. The anterolateral thighis the recommended site for intramuscular injection in infants and young children.

For persons at risk of hemorrhage following intramuscular injection, RECOMBIVAX (hepatitis b vaccine (recombinant)) HB may be administered subcutaneously. However, when other aluminum-adsorbed vaccines have been administered subcutaneously, an increased incidence of local reactions including subcutaneous nodules has been observed. Therefore, subcutaneous administration should be used only in persons (e.g., hemophiliacs) who are at risk of hemorrhage following intramuscular injections.

The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used.

For All Formulations: Since none of the formulations contain a preservative, once the single-dose vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.

Shake well before use. Thorough agitation at the time of administration is necessary to maintain suspension of the vaccine.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. After thorough agitation, the vaccine is a slightly opaque, white suspension.

Withdraw the recommended dose from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.

It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis and other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.

Injection must be accomplished with a needle long enough to ensure intramuscular deposition of the vaccine.

Guidelines for Treatment of Infants Born of HBsAg Positive Mothers or Mothers of Unknown HbsAg Status

Each infant should receive three 5 mcg doses of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB irrespective of the mother's HBsAg status (see Table 1). The ACIP recommends that if the mother is determined to be HbsAg positive within 7 days of delivery, the infant also should be given a dose of HBIG (0.5 mL) immediately. The first dose of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB may be given at the same time as HBIG, but it should be administered in the opposite anterolateral thigh.7

Revaccination

The duration of the protective effect of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB in healthy vaccinees is unknown at present and the need for booster doses is not yet defined (see CLINICAL PHARMACOLOGY).

A booster dose or revaccination with RECOMBIVAX (hepatitis b vaccine (recombinant)) HB Dialysis Formulation (blue color code) may be considered in predialysis/dialysis patients if the anti-HBs level is less than 10 mIU/mL 1 to 2 months after the third dose.23 The ACIP recommends that the need for booster doses of vaccine should be assessed by annual antibody testing and a booster dose given when antibody levels decline to < 10 mIU/mL.30

Known or Presumed Exposure to HBsAg

There are no prospective studies directly testing the efficacy of a combination of HBIG and RECOMBIVAX (hepatitis b vaccine (recombinant)) HB in preventing clinical hepatitis B following percutaneous, ocular or mucous membrane exposure to hepatitis B virus. However, since most persons with such exposures (e.g., health-care workers) are candidates for RECOMBIVAX (hepatitis b vaccine (recombinant)) HB and since combined HBIG plus vaccine is more efficacious than HBIG alone in perinatal exposures, the following guidelines are recommended for persons who have been exposed to hepatitis B virus such as through (1) percutaneous (needlestick), ocular, mucous membrane exposure to blood known or presumed to contain HBsAg, (2) human bites by known or presumed HBsAg carriers, that penetrate the skin, or (3) following intimate sexual contact with known or presumed HBsAg carriers.

HBIG (0.06 mL/kg) should be given intramuscularly as soon as possible after exposure and within 24 hours if possible. RECOMBIVAX (hepatitis b vaccine (recombinant)) HB (see dosage recommendation) should be given intramuscularly at a separate site within 7 days of exposure and second and third doses given one and six months, respectively, after the first dose.

Prefilled Syringe Use with and without Needle Guard (Safety) Device

Prefilled Syringe with Needle Guard (Safety) Device

Instructions for using the prefilled single-dose syringes preassembled with needle guard device

Prefilled Syringe with Needle Guard (Safety) Device - Illustration

NOTE: Please use the enclosed needle for administration. If a different needle is chosen, it should fit securely on the syringe and be no longer than 1 inch to ensure proper functioning of the needle guard device. Two detachable labels are provided which can be removed after the needle is guarded.

At any of the following steps, avoid contact with the Trigger Fingers to keep from activating the safety device prematurely.

Remove Syringe Tip Cap and Needle Cap. Attach Luer Needle by pressing both Anti-Rotation Tabs to secure syringe and by twisting the Luer Needle in a clockwise direction until secured to the syringe. Remove Needle Sheath. Administer injection per standard protocol as stated above under DOSAGE AND ADMINISTRATION. Depress the Plunger while grasping the Finger Flange until the entire dose has been given. The Needle Guard Device will NOT activate to cover and protect the needle unless the ENTIRE dose has been given. While the Plunger is still depressed, remove needle from the vaccine recipient. Slowly release the Plunger and allow syringe to move up until the entire needle is guarded. For documentation of vaccination, remove detachable labels by pulling slowly on them. Dispose in approved sharps container.

Prefilled Syringe without Needle Guard (Safety) Device

This package does not contain a needle guard (safety device) or a needle. Shake well before use. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.

HOW SUPPLIED

PEDIATRIC/ADOLESCENT FORMULATION (PRESERVATIVE FREE)

Vials

No. 4980 - RECOMBIVAX (hepatitis b vaccine (recombinant)) HB for use in infants, children, and adolescents is supplied as 5 mcg/0.5 mL of HBsAg in a 0.5 mL single-dose vial, color coded with a yellow cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons stating “Preservative Free”, NDC 0006-4980-00.

No. 4981 - RECOMBIVAX (hepatitis b vaccine (recombinant)) HB for use in infants, children, and adolescents is supplied as 5 mcg/0.5 mL of HBsAg in a 0.5 mL single-dose vial, in a box of 10 single-dose vials, color coded with a yellow cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons stating “Preservative Free”, NDC 0006-4981-00.

Syringes

No. 4093 - RECOMBIVAX (hepatitis b vaccine (recombinant)) HB for use in infants, children and adolescents is supplied as 5 mcg/0.5 mL of HBsAg in a prefilled single-dose Luer Lock syringe, preassembled with UltraSafe Passive®** delivery system in a box of 6 single-dose, prefilled syringes color coded with a yellow plunger rod and stripe on the peel-off syringe labels and cartons and an orange banner on the cartons stating “Preservative Free.” Six one-inch 23 gauge needles are provided separately in the package. NDC 0006-4093-06.

No. 4093 - RECOMBIVAX (hepatitis b vaccine (recombinant)) HB for use in infants, children and adolescents is supplied as 5 mcg/0.5 mL of HBsAg in a carton of 6 prefilled single-dose Luer Lock syringes with tip caps, color coded with a yellow plunger rod and stripe on the peel-off syringe labels and cartons and an orange banner on the cartons stating “Preservative Free.” NDC 0006-4093-09.

ADULT FORMULATION (PRESERVATIVE FREE)

Vials

No. 4995 - RECOMBIVAX (hepatitis b vaccine (recombinant)) HB for use in adults and adolescents (11 through 15 years of age) is supplied as 10 mcg/mL of HBsAg in a 1 mL single-dose vial, color coded with a green cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons stating “Preservative Free”, NDC 0006-4995-00.

No. 4995 - RECOMBIVAX (hepatitis b vaccine (recombinant)) HB for use in adults and adolescents (11 through 15 years of age) is supplied as 10 mcg/mL of HBsAg in a 1 mL single-dose vial, in a box of 10 single-dose vials, color coded with a green cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons stating “Preservative Free”, NDC 0006-4995-41.

Syringes

No. 4094 - RECOMBIVAX (hepatitis b vaccine (recombinant)) HB for use in adults and adolescents (11 through 15 years of age) is supplied as 10 mcg/1.0 mL HBsAg in a single-dose prefilled Luer Lock syringe, preassembled with UltraSafe Passive® delivery system, color coded with a green plunger rod and stripe on the peel-off syringe labels and cartons and an orange banner on the cartons stating “Preservative Free.” A one-inch 23 gauge needle is provided separately in the package. NDC 0006-4094-31.

No. 4094 - RECOMBIVAX (hepatitis b vaccine (recombinant)) HB for use in adults and adolescents (11 through 15 years of age) is supplied as 10 mcg/1.0 mL HBsAg in a single-dose prefilled Luer Lock syringe, preassembled with UltraSafe Passive® delivery system in a box of 6 single-dose, prefilled syringes color coded with a green plunger rod and stripe on the peel-off syringe labels and cartons and an orange banner on the cartons stating “Preservative Free.” Six one-inch 23 gauge needles are provided separately in the package. NDC 0006-4094-06.

No. 4094 - RECOMBIVAX (hepatitis b vaccine (recombinant)) HB for use in adults and adolescents (11 through 15 years of age) is supplied as 10 mcg/1.0 mL HBsAg in a carton of 6 single-dose prefilled Luer Lock syringes with tip caps, color coded with a green plunger rod and stripe on the peel-off syringe labels and cartons and an orange banner on the carton stating “Preservative Free.” NDC 0006-4094-09.

DIALYSIS FORMULATION (PRESERVATIVE FREE)

Vials

No. 4992 - RECOMBIVAX (hepatitis b vaccine (recombinant)) HB Dialysis Formulation is supplied as 40 mcg/mL of HBsAg in a 1 mL single-dose vial, color coded with a blue cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons stating “Preservative Free”, NDC 0006-4992-00.

Storage

Store vials and syringes at 2-8°C (36-46°F). Storage above or below the recommended temperature may reduce potency.

Do not freeze since freezing destroys potency.

REFERENCES

** UltraSafe Passive® delivery system is a Trademark of Safety Syringes, Inc.

7. Recommendations of the Immunization Practices Advisory Committee (ACIP): Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination, MMWR 40(RR-13): 1-25, November 22, 1991.

10. Data on file at Merck Research Laboratories.

23. Recommendations of the Immunization Practices Advisory Committee (ACIP): Update on Hepatitis B Prevention, MMWR 36(23): 353-366, June 19, 1987.

30. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Hepatitis B Virus Infection: A Comprehensive Strategy to Eliminate Transmission in the United States, 1996 update, MMWR (draft January 13, 1996).

33. WHO Bulletin, Expanded Programme on Immunization, Hepatitis B Vaccine - Making Global Progress. October, 1996.

35. National Institutes of Health, National Institutes of Health Consensus Development Conference Panel Statement: Management of Hepatitis C, Hepatology, 26(Suppl. 1): 2S-10S, 1997.

Issued December 2007. Merck & Co Inc., Whitehouse Station, NJ 08889, USA. FDA rev date: 5/15/2007

Last reviewed on RxList: 9/2/2008
This monograph has been modified to include the generic and brand name in many instances.

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