1. West DJ. Clinical experience with hepatitis B vaccines. Am J Infect Control. 1989;17(3):172–180.
2. Centers for Disease Control and Prevention (CDC). A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). Part II: Immunization of adults. MMWR Recomm Rep. 2006;55(RR-16):1–33.
3. Engerix-B® [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2016.
4. Centers for Disease Control and Prevention (CDC). Recommended immunization schedule for children and adolescents aged 18 years or younger, United States, 2017. https://www.cdc.gov/vaccines/schedules/downloads/
child/0-18yrs-child-combined-schedule.pdf. Effective January 1, 2017. Accessed April 20, 2017.
5. Centers for Disease Control and Prevention (CDC). Vaccine Storage & Handling Toolkit. https://www.cdc.gov/vaccines/hcp/admin/storage/
toolkit/storage-handling-toolkit.pdf. Published June 2016. Accessed April 20, 2017.

Indications for RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)]

RECOMBIVAX HB is 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 adult predialysis and dialysis patients 18 years of age and older.

Selected Safety Information for RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)]

Do not administer RECOMBIVAX HB to individuals with a history of severe allergic or hypersensitivity reactions (eg, anaphylaxis) after a previous dose of any hepatitis B-containing vaccine or to any component of RECOMBIVAX HB, including yeast.

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

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. For RECOMBIVAX HB, this assessment should include consideration of the mother’s hepatitis B antigen status and high probability of maternal transmission of hepatitis B virus to infants born to mothers who are HBsAg positive if vaccination is delayed.

Hepatitis B vaccination should be delayed until 1 month of age or hospital discharge in infants weighing <2000 g if the mother is documented to be HBsAg negative at the time of the infant’s birth. Infants weighing <2000 g born to HBsAg positive or HBsAg unknown mothers should receive vaccine and hepatitis B immune globulin (HBIG) in accordance with ACIP recommendations if HBsAg status cannot be determined.

Hepatitis B virus has a long incubation period. RECOMBIVAX HB may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccination.

Vaccination with RECOMBIVAX HB may not protect all individuals.

In healthy infants and children (up to 10 years of age), injection-site reactions and systemic adverse reactions were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In a study that compared the 3-dose regimen (5 mcg) with the 2-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.

In a group of studies involving healthy adults, injection-site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported (≥1% of injections): injection-site reactions, fatigue/weakness, headache, fever, malaise, nausea, diarrhea, pharyngitis, and upper respiratory infection.

Additional adverse reactions have been reported with the use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure.

The vaccination regimen for RECOMBIVAX HB for persons from birth through 19 years of age consists of a series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule.

The vaccination regimen for RECOMBIVAX HB for adolescents 11 through 15 years of age consists of a series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6- month schedule or a series of 2 doses (1.0 mL each) on a 0- and 4- to 6- month schedule.

The vaccination regimen for RECOMBIVAX HB for persons 20 years of age and older consists of a series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule.

The deltoid muscle is the preferred site for intramuscular injection for adults, adolescents and children 1 year of age and older whose deltoid is large enough for intramuscular injection. The anterolateral aspect of the thigh is the preferred site for intramuscular injection for infants younger than 1 year of age. RECOMBIVAX HB should not be administered in the gluteal region, as injections given in the buttocks have resulted in lower seroconversion rates than expected. Consider subcutaneous administration only in persons who are at risk of hemorrhage following intramuscular injections.

Predialysis and Dialysis Adult Patients: The vaccination regimen for RECOMBIVAX HB Dialysis Formulation for adults on predialysis and dialysis consists of a series of 3 doses (1.0 mL each) given on a 0-,1-, and 6-month schedule.

Consider a booster dose or revaccination with RECOMBIVAX HB Dialysis Formulation (blue color code) in predialysis/dialysis patients if the anti-HBs level is less than 10 mIU/mL at 1 to 2 months after the third dose.

The duration of the protective effect on RECOMBIVAX HB in healthy vaccinees is unknown at present and the need for booster doses is not yet defined.

It is 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.

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.

The safety and effectiveness of RECOMBIVAX HB Dialysis Formulation in children have not been established.

Clinical studies of RECOMBIVAX HB did not include sufficient numbers of subjects aged 65 and over 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. In addition, the responses to these vaccines may be lower if the vaccine is administered as a buttock injection.

Predialysis and dialysis adult patients respond less well to hepatitis B vaccines than do healthy individuals; however, vaccination of adult patients early in the course of their renal disease produces higher seroconversion rates than vaccination after dialysis has been initiated.

Refer to recommendations of the Advisory Committee on Immunization Practices (ACIP) and to the package insert for hepatitis B immune globulin (HBIG) for management of persons with known or presumed exposure to the hepatitis B virus (eg, neonates born of infected mothers or persons who experienced percutaneous or permucosal exposure to the virus). When recommended, administer RECOMBIVAX HB and HBIG intramuscularly at separate sites (eg, opposite anterolateral thighs for exposed neonates) as soon as possible after exposure.

Before administering RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)], please read the Prescribing Information.

Storage and Handling for RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)]

Condition on Arrival

  • Should not be frozen; refrigerate on arrival.

Storage and Handling

  • Store vaccine vials and syringes at 2°C to 8°C (36°F to 46°F); storage above or below the recommended temperature may reduce potency.
  • DO NOT FREEZE since freezing destroys potency.

Preparation

  • Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly opaque, white suspension before withdrawal and use.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Discard if the suspension does not appear homogeneous or if extraneous particulate matter remains or if discoloration is observed.

General Tips

  • If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage and call the Merck Vaccine Customer Center at 877.VAX.MERCK (877.829.6372).
  • Rotate stock so that the shortest-dated vaccine is used first.5
  • Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.5
  • It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.
  • All vaccines must be discarded after the expiration date; expired or damaged Vaccines for Children vaccines must be returned to your State Immunization Program.5
  • For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Helpline at 800.MERCK.90 (800.637.2590), Monday through Friday, 8:00 AM to 7:00 PM ET.

Indications for RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)]

RECOMBIVAX HB is 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 adult predialysis and dialysis patients 18 years of age and older.

Selected Safety Information for RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)]

Do not administer RECOMBIVAX HB to individuals with a history of severe allergic or hypersensitivity reactions (eg, anaphylaxis) after a previous dose of any hepatitis B-containing vaccine or to any component of RECOMBIVAX HB, including yeast.

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

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. For RECOMBIVAX HB, this assessment should include consideration of the mother’s hepatitis B antigen status and high probability of maternal transmission of hepatitis B virus to infants born to mothers who are HBsAg positive if vaccination is delayed.

Hepatitis B vaccination should be delayed until 1 month of age or hospital discharge in infants weighing <2000 g if the mother is documented to be HBsAg negative at the time of the infant’s birth. Infants weighing <2000 g born to HBsAg positive or HBsAg unknown mothers should receive vaccine and hepatitis B immune globulin (HBIG) in accordance with ACIP recommendations if HBsAg status cannot be determined.

Hepatitis B virus has a long incubation period. RECOMBIVAX HB may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccination.

Vaccination with RECOMBIVAX HB may not protect all individuals.

In healthy infants and children (up to 10 years of age), injection-site reactions and systemic adverse reactions were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In a study that compared the 3-dose regimen (5 mcg) with the 2-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.

In a group of studies involving healthy adults, injection-site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported (≥1% of injections): injection-site reactions, fatigue/weakness, headache, fever, malaise, nausea, diarrhea, pharyngitis, and upper respiratory infection.

Additional adverse reactions have been reported with the use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure.

The vaccination regimen for RECOMBIVAX HB for persons from birth through 19 years of age consists of a series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule.

The vaccination regimen for RECOMBIVAX HB for adolescents 11 through 15 years of age consists of a series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6- month schedule or a series of 2 doses (1.0 mL each) on a 0- and 4- to 6- month schedule.

The vaccination regimen for RECOMBIVAX HB for persons 20 years of age and older consists of a series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule.

The deltoid muscle is the preferred site for intramuscular injection for adults, adolescents and children 1 year of age and older whose deltoid is large enough for intramuscular injection. The anterolateral aspect of the thigh is the preferred site for intramuscular injection for infants younger than 1 year of age. RECOMBIVAX HB should not be administered in the gluteal region, as injections given in the buttocks have resulted in lower seroconversion rates than expected. Consider subcutaneous administration only in persons who are at risk of hemorrhage following intramuscular injections.

Predialysis and Dialysis Adult Patients: The vaccination regimen for RECOMBIVAX HB Dialysis Formulation for adults on predialysis and dialysis consists of a series of 3 doses (1.0 mL each) given on a 0-,1-, and 6-month schedule.

Consider a booster dose or revaccination with RECOMBIVAX HB Dialysis Formulation (blue color code) in predialysis/dialysis patients if the anti-HBs level is less than 10 mIU/mL at 1 to 2 months after the third dose.

The duration of the protective effect on RECOMBIVAX HB in healthy vaccinees is unknown at present and the need for booster doses is not yet defined.

It is 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.

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.

The safety and effectiveness of RECOMBIVAX HB Dialysis Formulation in children have not been established.

Clinical studies of RECOMBIVAX HB did not include sufficient numbers of subjects aged 65 and over 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. In addition, the responses to these vaccines may be lower if the vaccine is administered as a buttock injection.

Predialysis and dialysis adult patients respond less well to hepatitis B vaccines than do healthy individuals; however, vaccination of adult patients early in the course of their renal disease produces higher seroconversion rates than vaccination after dialysis has been initiated.

Refer to recommendations of the Advisory Committee on Immunization Practices (ACIP) and to the package insert for hepatitis B immune globulin (HBIG) for management of persons with known or presumed exposure to the hepatitis B virus (eg, neonates born of infected mothers or persons who experienced percutaneous or permucosal exposure to the virus). When recommended, administer RECOMBIVAX HB and HBIG intramuscularly at separate sites (eg, opposite anterolateral thighs for exposed neonates) as soon as possible after exposure.

Before administering RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)], please read the Prescribing Information.

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