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 Schedules for Persons Aged 0 Through 18 Years – United States, 2016. http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Effective 1 January 2016. Accessed March 8, 2016.
5. Centers for Disease Control and Prevention (CDC). National Center for Immunization and Respiratory Diseases. Vaccine Storage & Handling Toolkit. http://www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf. Published May 2014. Accessed March 8, 2016.

Indication

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.

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.

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.

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

Adult/Dialysis Product Information

Adult Immunogenicity

High immunogenicity in adults

In healthy adultsa ≥20 years of age after the recommended 3-dose series in clinical trials

High immunogenicity in adults High immunogenicity in adults

Post-dose 2

Post-dose 3

Seroprotection ratesb in healthy adults of all ages after the recommended 3-dose series of 10 mcg/1.0 mL administered at 0, 1, and 6 months, as demonstrated in clinical studies [n=1,240–1,873].1

Adapted from West 1989.1

aDialysis and predialysis patients should receive dialysis formulation (40 mcg/1.0 mL).2

bSeroprotection is defined by the ACIP as an anti-HBs level ≥10 mIU/mL.2

ACIP=Advisory Committee on Immunization Practices;
anti-HBs=antibody to hepatitis B surface antigen.

Dialysis Immunogenicity

In clinical studies (n=28–44), RECOMBIVAX HB provided seroprotectiona in 86% of adult predialysis and dialysis patients after the recommended 3-dose series of 40 mcg/1.0 mL at 0, 1, and 6 months1
Dialysis Immunogenicity Dialysis Immunogenicity

percent seroprotection

Adapted from West, 19891
aSeroprotection is defined by the ACIP as an anti-HBs level ≥10 mlU/mL.2

ACIP=Advisory Committee on Immunization Practices;
anti-HBs=antibody to hepatitis B surface antigen.

Adult & Dialysis Dosing

Dosing schedule for RECOMBIVAX HB
Group Dose Schedule Injections
Adults ≥20 years of age 10 mcg (1.0 mL) 0, 1, 6 months 3
Predialysis and dialysis patients 40 mcg (1.0 mL)a 0, 1, 6 months 3
Dosing schedule for Engerix-B®3,b
Group Dose Schedule Injections
Adults ≥20 years of age 20 mcg (1.0 mL) 0, 1, 6 months 3
Adults on hemodialysis 40 mcg (2.0 mL)c 0, 1, 2, 6 months 4–8

aRECOMBIVAX HB Dialysis Formulation is available in 1-mL (40 mcg/1.0 mL) single-dose vials.
bEngerix-B is a registered trademark of GlaxoSmithKline.
cFor adults on hemodialysis, Engerix-B, available in 1-mL (20 mcg/1.0 mL) single-dose vials or prefilled syringes, can be given as a single 2-mL dose or as two 1-mL doses.

Indication

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.

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.

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.

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

VACC-1175001-0001 02/17