Indications Induction of active immunity against hepatitis B virus among people of all ages who are currently or who will be at increased risk of infection with this virus. Routine vaccination is recommended for infants and adolescents. All individuals not receiving the hepatitis B vaccine are recommended to be vaccinated at 11 to 12 yr. In addition, vaccination is recommended in older unvaccinated adolescents at high risk.

Vaccination is also indicated for those at high risk of exposure to or development of hepatitis B virus, such as health care personnel (eg, dentists; dental hygienists; nurses; oral surgeons; health care providers; surgeons; podiatrists; paramedical and ambulence personnel; patients and staff in hemodialysis units and hematology/oncology units; hemodialysis patients and patients with early renal failure before they require hemodialysis; blood bank and plasma fractionation workers; laboratory personnel handling blood, its products, and patients’ specimens; dental, medical, and nursing students); hospital cleaning staff who handle potentially infectious waste; patients requiring frequent or large-volume blood transfusions or clotting factor concentrates; residents and staff of institutions for mentally handicapped; household and other intimate contacts of people with persistent hepatitis B antigenemia; infants born to HBsAg-positive mothers; populations with high incidence of hepatitis B virus (eg, Alaskan Eskimos, Indochinese refugees, Haitian refugees); people at increased risk because of their sexual practices (eg, prostitutes; people who repeatedly contract STDs; homosexually active men; people with multiple sexual partners; international travelers; morticians; embalmers; prisoners; users of illicit injectable drugs; police and fire department personnel who render first aid or medical assistance.

Risk factors for hepatitis C are similar to those for hepatitis B. Consquently, immunization with hepatitis B vaccine is recommended for individuals with chronic hepatitis C.

Revaccination (booster doses): Adults and children with normal immune status: Antibody response lasts 10 yr or more. Hemodialysis patients: Vaccine protection is less complete and may persist only as long as antibody levels remain more than 10 mIU/mL. Vaccinated People who Experience Percutaneous or Needle Exposure to HBsAg-Positive Blood: Serological tests to assess immune status is recommended. If inadequate levels exist, treat with a booster dose of vaccine. Nonresponders: Most people who do not initially respond to the primary series may develop adequate antibody concentrations after revaccination with a fourth or fifth dose or a new complete vaccine series.

 Contraindications Hypersensitivity to yeast or any other component of vaccine.

 Route/Dosage

Adults 20 Yr or Older: Engerix-B: IM 20 mcg at 0, 1, and 6 mo; Recombivax HB: IM 10 mcg at 0, 1, and 6 mo. Children and Adolescents 1 to 19 Yr: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo, alternatively. Adolescents 11 to 15 Yr: Recombivax HB: IM 10 mcg at 0 and 4 to 6 mo. Infants of HBsAg-Positive or -Negative Mothers: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo. Adult Predialysis and Dialysis Patients: Engerix-B: IM 40 mcg at 0, 1, 2, and 6 mo: Recombivax HB: IM 40 mcg at 0, 1, and 6 mo.

Alternate Schedule

Engerix B: Designed for certain populations (eg, neonates born of hepatitis B-infected mothers, others who may have been recently exposed to the virus, certain travelers to high-risk areas). Adults (Older than 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo. Adolescents (11 to 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo, or 20 mcg at 0, 1, 6 mo. Adolescents 11 to 16 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Children (Birth to 10 Yr): IM 10 mcg at 0, 1, 2, 12 mo. Children 5 to 10 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Infants Born of HBsAG-Positive Mothers: IM 10 mcg at 0, 1, 2, and 12 mo. Revaccination: Hemodialysis Patients: A booster dose may be considered for patients undergoing dialysis if anti-HBs level less than 10 mIU/mL 1 to 2 mo after third dose. Other patients (when a booster dose is appropriate) (Engerix-B): Adults and adolescents 11 to 19 yr: IM 20 mcg. Children 10 yr or younger: IM 10 mcg.

 Interactions

Immunosuppressants (including high-dose corticosteroids or radiation therapy): May result in an inadequate response to immunization. Yellow Fever Vaccine: May reduce antibody titer otherwise expected from yellow fever vaccine. Separate these vaccines by 1 mo. Anticoagulants: Use caution when administering to patients receiving anticoagulant therapy because coadministration may increase the immunization drug.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Fatigue; weakness; headache; malaise; dizziness. DERMATOLOGIC: Flushing; angioedema. EENT: Earache; pharyngitis. GI: Nausea; diarrhea. RESPIRATORY: Upper respiratory tract infection. OTHER: Fever; pain; tenderness; pruritus; induration; erythema; ecchymosis; swelling; warmth or nodule formation at injection site; thrombocytopenia.

 Precautions

Pregnancy: Category C. Problems have not been reported and are unlikely. Use if woman is likely to be exposed to hepatitis B virus during or after pregnancy. Lactation: Undetermined. Elderly: Hepatitis B immunogenicity may be reduced in patients older than 40 yr. Hypersensitivity: Anaphylaxis and symptoms of immediate hypersensitivity have occurred within hours of administering vaccine. Immunosuppressed Patients: May require larger doses and may not respond to vaccine. Infection: Delay use of hepatitis B vaccine in presence of serious active infection except when withholding vaccine entails greater risk. Multiple Sclerosis (MS): Although no casual relationship has been established, rare instances of MS exacerbation have been reported following administration of hepatitis vaccines and other vaccines. Severely compromised cardiopulmonary status: Administer vaccine with caution. Unrecognized hepatitis B infection: May be present at time of vaccination and vaccine may not prevent hepatitis B because of long incubation period.

 Administration/Storage

• Shake well before use to maintain suspension of the vaccine.
• Administer IM in deltoid muscle in adults. In infants and young children administer IM in anterolateral thigh. Avoid gluteal injection into buttock, which may result in less than optimal immune response.
• May administer vaccine SC in patients who are at risk of hemorrhage following IM injection (eg, people with hemophilia or thalassemia). However, SC route may produce less than optimal response and may lead to increased incidence of local reactions.
• Always record manufacturer’s name and vaccine lot number in patient’s permanent record file along with date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of laryngospasms.
• Use vaccine as supplied. No dilution or reconstitution is necessary. Note that vaccine is slightly opaque, white suspension.
• Refrigerate vials. Do not freeze. Freezing destroys potency.

 Assessment/Interventions

• Obtain complete history, including drug history and any known allergies.
• Review patient’s medical history for history of serious adverse reactions to previous dose of hepatitis B vaccine.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of serious active infection.
• Monitor for hypersensitivity or anaphylaxis. Always have epinephrine available to counteract any possible reactions.

 Patient/Family Education

• Instruct patient or parent to complete the series of injections for vaccine to be effective.
• Provide patient or parent with immunization history record and record of this immunization in patient’s medical records.
• Instruct patient or parent to use antipyretics for fever or analgesics (eg, acetaminophen) for local pain.
• Inform patient or parent of immunization schedule.

Indications for Drugs ::

 Action Induces specific antibodies against hepatitis B virus.

 Indications Induction of active immunity against hepatitis B virus among people of all ages who are currently or who will be at increased risk of infection with this virus. Routine vaccination is recommended for infants and adolescents. All individuals not receiving the hepatitis B vaccine are recommended to be vaccinated at 11 to 12 yr. In addition, vaccination is recommended in older unvaccinated adolescents at high risk.

Vaccination is also indicated for those at high risk of exposure to or development of hepatitis B virus, such as health care personnel (eg, dentists; dental hygienists; nurses; oral surgeons; health care providers; surgeons; podiatrists; paramedical and ambulence personnel; patients and staff in hemodialysis units and hematology/oncology units; hemodialysis patients and patients with early renal failure before they require hemodialysis; blood bank and plasma fractionation workers; laboratory personnel handling blood, its products, and patients’ specimens; dental, medical, and nursing students); hospital cleaning staff who handle potentially infectious waste; patients requiring frequent or large-volume blood transfusions or clotting factor concentrates; residents and staff of institutions for mentally handicapped; household and other intimate contacts of people with persistent hepatitis B antigenemia; infants born to HBsAg-positive mothers; populations with high incidence of hepatitis B virus (eg, Alaskan Eskimos, Indochinese refugees, Haitian refugees); people at increased risk because of their sexual practices (eg, prostitutes; people who repeatedly contract STDs; homosexually active men; people with multiple sexual partners; international travelers; morticians; embalmers; prisoners; users of illicit injectable drugs; police and fire department personnel who render first aid or medical assistance.

Risk factors for hepatitis C are similar to those for hepatitis B. Consquently, immunization with hepatitis B vaccine is recommended for individuals with chronic hepatitis C.

Revaccination (booster doses): Adults and children with normal immune status: Antibody response lasts 10 yr or more. Hemodialysis patients: Vaccine protection is less complete and may persist only as long as antibody levels remain more than 10 mIU/mL. Vaccinated People who Experience Percutaneous or Needle Exposure to HBsAg-Positive Blood: Serological tests to assess immune status is recommended. If inadequate levels exist, treat with a booster dose of vaccine. Nonresponders: Most people who do not initially respond to the primary series may develop adequate antibody concentrations after revaccination with a fourth or fifth dose or a new complete vaccine series.

 Contraindications Hypersensitivity to yeast or any other component of vaccine.

 Route/Dosage

Adults 20 Yr or Older: Engerix-B: IM 20 mcg at 0, 1, and 6 mo; Recombivax HB: IM 10 mcg at 0, 1, and 6 mo. Children and Adolescents 1 to 19 Yr: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo, alternatively. Adolescents 11 to 15 Yr: Recombivax HB: IM 10 mcg at 0 and 4 to 6 mo. Infants of HBsAg-Positive or -Negative Mothers: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo. Adult Predialysis and Dialysis Patients: Engerix-B: IM 40 mcg at 0, 1, 2, and 6 mo: Recombivax HB: IM 40 mcg at 0, 1, and 6 mo.

Alternate Schedule

Engerix B: Designed for certain populations (eg, neonates born of hepatitis B-infected mothers, others who may have been recently exposed to the virus, certain travelers to high-risk areas). Adults (Older than 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo. Adolescents (11 to 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo, or 20 mcg at 0, 1, 6 mo. Adolescents 11 to 16 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Children (Birth to 10 Yr): IM 10 mcg at 0, 1, 2, 12 mo. Children 5 to 10 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Infants Born of HBsAG-Positive Mothers: IM 10 mcg at 0, 1, 2, and 12 mo. Revaccination: Hemodialysis Patients: A booster dose may be considered for patients undergoing dialysis if anti-HBs level less than 10 mIU/mL 1 to 2 mo after third dose. Other patients (when a booster dose is appropriate) (Engerix-B): Adults and adolescents 11 to 19 yr: IM 20 mcg. Children 10 yr or younger: IM 10 mcg.

 Interactions

Immunosuppressants (including high-dose corticosteroids or radiation therapy): May result in an inadequate response to immunization. Yellow Fever Vaccine: May reduce antibody titer otherwise expected from yellow fever vaccine. Separate these vaccines by 1 mo. Anticoagulants: Use caution when administering to patients receiving anticoagulant therapy because coadministration may increase the immunization drug.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Fatigue; weakness; headache; malaise; dizziness. DERMATOLOGIC: Flushing; angioedema. EENT: Earache; pharyngitis. GI: Nausea; diarrhea. RESPIRATORY: Upper respiratory tract infection. OTHER: Fever; pain; tenderness; pruritus; induration; erythema; ecchymosis; swelling; warmth or nodule formation at injection site; thrombocytopenia.

 Precautions

Pregnancy: Category C. Problems have not been reported and are unlikely. Use if woman is likely to be exposed to hepatitis B virus during or after pregnancy. Lactation: Undetermined. Elderly: Hepatitis B immunogenicity may be reduced in patients older than 40 yr. Hypersensitivity: Anaphylaxis and symptoms of immediate hypersensitivity have occurred within hours of administering vaccine. Immunosuppressed Patients: May require larger doses and may not respond to vaccine. Infection: Delay use of hepatitis B vaccine in presence of serious active infection except when withholding vaccine entails greater risk. Multiple Sclerosis (MS): Although no casual relationship has been established, rare instances of MS exacerbation have been reported following administration of hepatitis vaccines and other vaccines. Severely compromised cardiopulmonary status: Administer vaccine with caution. Unrecognized hepatitis B infection: May be present at time of vaccination and vaccine may not prevent hepatitis B because of long incubation period.

 Administration/Storage

• Shake well before use to maintain suspension of the vaccine.
• Administer IM in deltoid muscle in adults. In infants and young children administer IM in anterolateral thigh. Avoid gluteal injection into buttock, which may result in less than optimal immune response.
• May administer vaccine SC in patients who are at risk of hemorrhage following IM injection (eg, people with hemophilia or thalassemia). However, SC route may produce less than optimal response and may lead to increased incidence of local reactions.
• Always record manufacturer’s name and vaccine lot number in patient’s permanent record file along with date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of laryngospasms.
• Use vaccine as supplied. No dilution or reconstitution is necessary. Note that vaccine is slightly opaque, white suspension.
• Refrigerate vials. Do not freeze. Freezing destroys potency.

 Assessment/Interventions

• Obtain complete history, including drug history and any known allergies.
• Review patient’s medical history for history of serious adverse reactions to previous dose of hepatitis B vaccine.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of serious active infection.
• Monitor for hypersensitivity or anaphylaxis. Always have epinephrine available to counteract any possible reactions.

 Patient/Family Education

• Instruct patient or parent to complete the series of injections for vaccine to be effective.
• Provide patient or parent with immunization history record and record of this immunization in patient’s medical records.
• Instruct patient or parent to use antipyretics for fever or analgesics (eg, acetaminophen) for local pain.
• Inform patient or parent of immunization schedule.

Drug Dose ::

 Action Induces specific antibodies against hepatitis B virus.

 Indications Induction of active immunity against hepatitis B virus among people of all ages who are currently or who will be at increased risk of infection with this virus. Routine vaccination is recommended for infants and adolescents. All individuals not receiving the hepatitis B vaccine are recommended to be vaccinated at 11 to 12 yr. In addition, vaccination is recommended in older unvaccinated adolescents at high risk.

Vaccination is also indicated for those at high risk of exposure to or development of hepatitis B virus, such as health care personnel (eg, dentists; dental hygienists; nurses; oral surgeons; health care providers; surgeons; podiatrists; paramedical and ambulence personnel; patients and staff in hemodialysis units and hematology/oncology units; hemodialysis patients and patients with early renal failure before they require hemodialysis; blood bank and plasma fractionation workers; laboratory personnel handling blood, its products, and patients’ specimens; dental, medical, and nursing students); hospital cleaning staff who handle potentially infectious waste; patients requiring frequent or large-volume blood transfusions or clotting factor concentrates; residents and staff of institutions for mentally handicapped; household and other intimate contacts of people with persistent hepatitis B antigenemia; infants born to HBsAg-positive mothers; populations with high incidence of hepatitis B virus (eg, Alaskan Eskimos, Indochinese refugees, Haitian refugees); people at increased risk because of their sexual practices (eg, prostitutes; people who repeatedly contract STDs; homosexually active men; people with multiple sexual partners; international travelers; morticians; embalmers; prisoners; users of illicit injectable drugs; police and fire department personnel who render first aid or medical assistance.

Risk factors for hepatitis C are similar to those for hepatitis B. Consquently, immunization with hepatitis B vaccine is recommended for individuals with chronic hepatitis C.

Revaccination (booster doses): Adults and children with normal immune status: Antibody response lasts 10 yr or more. Hemodialysis patients: Vaccine protection is less complete and may persist only as long as antibody levels remain more than 10 mIU/mL. Vaccinated People who Experience Percutaneous or Needle Exposure to HBsAg-Positive Blood: Serological tests to assess immune status is recommended. If inadequate levels exist, treat with a booster dose of vaccine. Nonresponders: Most people who do not initially respond to the primary series may develop adequate antibody concentrations after revaccination with a fourth or fifth dose or a new complete vaccine series.

 Contraindications Hypersensitivity to yeast or any other component of vaccine.

 Route/Dosage

Adults 20 Yr or Older: Engerix-B: IM 20 mcg at 0, 1, and 6 mo; Recombivax HB: IM 10 mcg at 0, 1, and 6 mo. Children and Adolescents 1 to 19 Yr: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo, alternatively. Adolescents 11 to 15 Yr: Recombivax HB: IM 10 mcg at 0 and 4 to 6 mo. Infants of HBsAg-Positive or -Negative Mothers: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo. Adult Predialysis and Dialysis Patients: Engerix-B: IM 40 mcg at 0, 1, 2, and 6 mo: Recombivax HB: IM 40 mcg at 0, 1, and 6 mo.

Alternate Schedule

Engerix B: Designed for certain populations (eg, neonates born of hepatitis B-infected mothers, others who may have been recently exposed to the virus, certain travelers to high-risk areas). Adults (Older than 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo. Adolescents (11 to 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo, or 20 mcg at 0, 1, 6 mo. Adolescents 11 to 16 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Children (Birth to 10 Yr): IM 10 mcg at 0, 1, 2, 12 mo. Children 5 to 10 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Infants Born of HBsAG-Positive Mothers: IM 10 mcg at 0, 1, 2, and 12 mo. Revaccination: Hemodialysis Patients: A booster dose may be considered for patients undergoing dialysis if anti-HBs level less than 10 mIU/mL 1 to 2 mo after third dose. Other patients (when a booster dose is appropriate) (Engerix-B): Adults and adolescents 11 to 19 yr: IM 20 mcg. Children 10 yr or younger: IM 10 mcg.

 Interactions

Immunosuppressants (including high-dose corticosteroids or radiation therapy): May result in an inadequate response to immunization. Yellow Fever Vaccine: May reduce antibody titer otherwise expected from yellow fever vaccine. Separate these vaccines by 1 mo. Anticoagulants: Use caution when administering to patients receiving anticoagulant therapy because coadministration may increase the immunization drug.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Fatigue; weakness; headache; malaise; dizziness. DERMATOLOGIC: Flushing; angioedema. EENT: Earache; pharyngitis. GI: Nausea; diarrhea. RESPIRATORY: Upper respiratory tract infection. OTHER: Fever; pain; tenderness; pruritus; induration; erythema; ecchymosis; swelling; warmth or nodule formation at injection site; thrombocytopenia.

 Precautions

Pregnancy: Category C. Problems have not been reported and are unlikely. Use if woman is likely to be exposed to hepatitis B virus during or after pregnancy. Lactation: Undetermined. Elderly: Hepatitis B immunogenicity may be reduced in patients older than 40 yr. Hypersensitivity: Anaphylaxis and symptoms of immediate hypersensitivity have occurred within hours of administering vaccine. Immunosuppressed Patients: May require larger doses and may not respond to vaccine. Infection: Delay use of hepatitis B vaccine in presence of serious active infection except when withholding vaccine entails greater risk. Multiple Sclerosis (MS): Although no casual relationship has been established, rare instances of MS exacerbation have been reported following administration of hepatitis vaccines and other vaccines. Severely compromised cardiopulmonary status: Administer vaccine with caution. Unrecognized hepatitis B infection: May be present at time of vaccination and vaccine may not prevent hepatitis B because of long incubation period.

 Administration/Storage

• Shake well before use to maintain suspension of the vaccine.
• Administer IM in deltoid muscle in adults. In infants and young children administer IM in anterolateral thigh. Avoid gluteal injection into buttock, which may result in less than optimal immune response.
• May administer vaccine SC in patients who are at risk of hemorrhage following IM injection (eg, people with hemophilia or thalassemia). However, SC route may produce less than optimal response and may lead to increased incidence of local reactions.
• Always record manufacturer’s name and vaccine lot number in patient’s permanent record file along with date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of laryngospasms.
• Use vaccine as supplied. No dilution or reconstitution is necessary. Note that vaccine is slightly opaque, white suspension.
• Refrigerate vials. Do not freeze. Freezing destroys potency.

 Assessment/Interventions

• Obtain complete history, including drug history and any known allergies.
• Review patient’s medical history for history of serious adverse reactions to previous dose of hepatitis B vaccine.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of serious active infection.
• Monitor for hypersensitivity or anaphylaxis. Always have epinephrine available to counteract any possible reactions.

 Patient/Family Education

• Instruct patient or parent to complete the series of injections for vaccine to be effective.
• Provide patient or parent with immunization history record and record of this immunization in patient’s medical records.
• Instruct patient or parent to use antipyretics for fever or analgesics (eg, acetaminophen) for local pain.
• Inform patient or parent of immunization schedule.

Contraindication ::

 Action Induces specific antibodies against hepatitis B virus.

 Indications Induction of active immunity against hepatitis B virus among people of all ages who are currently or who will be at increased risk of infection with this virus. Routine vaccination is recommended for infants and adolescents. All individuals not receiving the hepatitis B vaccine are recommended to be vaccinated at 11 to 12 yr. In addition, vaccination is recommended in older unvaccinated adolescents at high risk.

Vaccination is also indicated for those at high risk of exposure to or development of hepatitis B virus, such as health care personnel (eg, dentists; dental hygienists; nurses; oral surgeons; health care providers; surgeons; podiatrists; paramedical and ambulence personnel; patients and staff in hemodialysis units and hematology/oncology units; hemodialysis patients and patients with early renal failure before they require hemodialysis; blood bank and plasma fractionation workers; laboratory personnel handling blood, its products, and patients’ specimens; dental, medical, and nursing students); hospital cleaning staff who handle potentially infectious waste; patients requiring frequent or large-volume blood transfusions or clotting factor concentrates; residents and staff of institutions for mentally handicapped; household and other intimate contacts of people with persistent hepatitis B antigenemia; infants born to HBsAg-positive mothers; populations with high incidence of hepatitis B virus (eg, Alaskan Eskimos, Indochinese refugees, Haitian refugees); people at increased risk because of their sexual practices (eg, prostitutes; people who repeatedly contract STDs; homosexually active men; people with multiple sexual partners; international travelers; morticians; embalmers; prisoners; users of illicit injectable drugs; police and fire department personnel who render first aid or medical assistance.

Risk factors for hepatitis C are similar to those for hepatitis B. Consquently, immunization with hepatitis B vaccine is recommended for individuals with chronic hepatitis C.

Revaccination (booster doses): Adults and children with normal immune status: Antibody response lasts 10 yr or more. Hemodialysis patients: Vaccine protection is less complete and may persist only as long as antibody levels remain more than 10 mIU/mL. Vaccinated People who Experience Percutaneous or Needle Exposure to HBsAg-Positive Blood: Serological tests to assess immune status is recommended. If inadequate levels exist, treat with a booster dose of vaccine. Nonresponders: Most people who do not initially respond to the primary series may develop adequate antibody concentrations after revaccination with a fourth or fifth dose or a new complete vaccine series.

 Contraindications Hypersensitivity to yeast or any other component of vaccine.

 Route/Dosage

Adults 20 Yr or Older: Engerix-B: IM 20 mcg at 0, 1, and 6 mo; Recombivax HB: IM 10 mcg at 0, 1, and 6 mo. Children and Adolescents 1 to 19 Yr: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo, alternatively. Adolescents 11 to 15 Yr: Recombivax HB: IM 10 mcg at 0 and 4 to 6 mo. Infants of HBsAg-Positive or -Negative Mothers: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo. Adult Predialysis and Dialysis Patients: Engerix-B: IM 40 mcg at 0, 1, 2, and 6 mo: Recombivax HB: IM 40 mcg at 0, 1, and 6 mo.

Alternate Schedule

Engerix B: Designed for certain populations (eg, neonates born of hepatitis B-infected mothers, others who may have been recently exposed to the virus, certain travelers to high-risk areas). Adults (Older than 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo. Adolescents (11 to 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo, or 20 mcg at 0, 1, 6 mo. Adolescents 11 to 16 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Children (Birth to 10 Yr): IM 10 mcg at 0, 1, 2, 12 mo. Children 5 to 10 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Infants Born of HBsAG-Positive Mothers: IM 10 mcg at 0, 1, 2, and 12 mo. Revaccination: Hemodialysis Patients: A booster dose may be considered for patients undergoing dialysis if anti-HBs level less than 10 mIU/mL 1 to 2 mo after third dose. Other patients (when a booster dose is appropriate) (Engerix-B): Adults and adolescents 11 to 19 yr: IM 20 mcg. Children 10 yr or younger: IM 10 mcg.

 Interactions

Immunosuppressants (including high-dose corticosteroids or radiation therapy): May result in an inadequate response to immunization. Yellow Fever Vaccine: May reduce antibody titer otherwise expected from yellow fever vaccine. Separate these vaccines by 1 mo. Anticoagulants: Use caution when administering to patients receiving anticoagulant therapy because coadministration may increase the immunization drug.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Fatigue; weakness; headache; malaise; dizziness. DERMATOLOGIC: Flushing; angioedema. EENT: Earache; pharyngitis. GI: Nausea; diarrhea. RESPIRATORY: Upper respiratory tract infection. OTHER: Fever; pain; tenderness; pruritus; induration; erythema; ecchymosis; swelling; warmth or nodule formation at injection site; thrombocytopenia.

 Precautions

Pregnancy: Category C. Problems have not been reported and are unlikely. Use if woman is likely to be exposed to hepatitis B virus during or after pregnancy. Lactation: Undetermined. Elderly: Hepatitis B immunogenicity may be reduced in patients older than 40 yr. Hypersensitivity: Anaphylaxis and symptoms of immediate hypersensitivity have occurred within hours of administering vaccine. Immunosuppressed Patients: May require larger doses and may not respond to vaccine. Infection: Delay use of hepatitis B vaccine in presence of serious active infection except when withholding vaccine entails greater risk. Multiple Sclerosis (MS): Although no casual relationship has been established, rare instances of MS exacerbation have been reported following administration of hepatitis vaccines and other vaccines. Severely compromised cardiopulmonary status: Administer vaccine with caution. Unrecognized hepatitis B infection: May be present at time of vaccination and vaccine may not prevent hepatitis B because of long incubation period.

 Administration/Storage

• Shake well before use to maintain suspension of the vaccine.
• Administer IM in deltoid muscle in adults. In infants and young children administer IM in anterolateral thigh. Avoid gluteal injection into buttock, which may result in less than optimal immune response.
• May administer vaccine SC in patients who are at risk of hemorrhage following IM injection (eg, people with hemophilia or thalassemia). However, SC route may produce less than optimal response and may lead to increased incidence of local reactions.
• Always record manufacturer’s name and vaccine lot number in patient’s permanent record file along with date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of laryngospasms.
• Use vaccine as supplied. No dilution or reconstitution is necessary. Note that vaccine is slightly opaque, white suspension.
• Refrigerate vials. Do not freeze. Freezing destroys potency.

 Assessment/Interventions

• Obtain complete history, including drug history and any known allergies.
• Review patient’s medical history for history of serious adverse reactions to previous dose of hepatitis B vaccine.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of serious active infection.
• Monitor for hypersensitivity or anaphylaxis. Always have epinephrine available to counteract any possible reactions.

 Patient/Family Education

• Instruct patient or parent to complete the series of injections for vaccine to be effective.
• Provide patient or parent with immunization history record and record of this immunization in patient’s medical records.
• Instruct patient or parent to use antipyretics for fever or analgesics (eg, acetaminophen) for local pain.
• Inform patient or parent of immunization schedule.

Drug Precautions ::

 Action Induces specific antibodies against hepatitis B virus.

 Indications Induction of active immunity against hepatitis B virus among people of all ages who are currently or who will be at increased risk of infection with this virus. Routine vaccination is recommended for infants and adolescents. All individuals not receiving the hepatitis B vaccine are recommended to be vaccinated at 11 to 12 yr. In addition, vaccination is recommended in older unvaccinated adolescents at high risk.

Vaccination is also indicated for those at high risk of exposure to or development of hepatitis B virus, such as health care personnel (eg, dentists; dental hygienists; nurses; oral surgeons; health care providers; surgeons; podiatrists; paramedical and ambulence personnel; patients and staff in hemodialysis units and hematology/oncology units; hemodialysis patients and patients with early renal failure before they require hemodialysis; blood bank and plasma fractionation workers; laboratory personnel handling blood, its products, and patients’ specimens; dental, medical, and nursing students); hospital cleaning staff who handle potentially infectious waste; patients requiring frequent or large-volume blood transfusions or clotting factor concentrates; residents and staff of institutions for mentally handicapped; household and other intimate contacts of people with persistent hepatitis B antigenemia; infants born to HBsAg-positive mothers; populations with high incidence of hepatitis B virus (eg, Alaskan Eskimos, Indochinese refugees, Haitian refugees); people at increased risk because of their sexual practices (eg, prostitutes; people who repeatedly contract STDs; homosexually active men; people with multiple sexual partners; international travelers; morticians; embalmers; prisoners; users of illicit injectable drugs; police and fire department personnel who render first aid or medical assistance.

Risk factors for hepatitis C are similar to those for hepatitis B. Consquently, immunization with hepatitis B vaccine is recommended for individuals with chronic hepatitis C.

Revaccination (booster doses): Adults and children with normal immune status: Antibody response lasts 10 yr or more. Hemodialysis patients: Vaccine protection is less complete and may persist only as long as antibody levels remain more than 10 mIU/mL. Vaccinated People who Experience Percutaneous or Needle Exposure to HBsAg-Positive Blood: Serological tests to assess immune status is recommended. If inadequate levels exist, treat with a booster dose of vaccine. Nonresponders: Most people who do not initially respond to the primary series may develop adequate antibody concentrations after revaccination with a fourth or fifth dose or a new complete vaccine series.

 Contraindications Hypersensitivity to yeast or any other component of vaccine.

 Route/Dosage

Adults 20 Yr or Older: Engerix-B: IM 20 mcg at 0, 1, and 6 mo; Recombivax HB: IM 10 mcg at 0, 1, and 6 mo. Children and Adolescents 1 to 19 Yr: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo, alternatively. Adolescents 11 to 15 Yr: Recombivax HB: IM 10 mcg at 0 and 4 to 6 mo. Infants of HBsAg-Positive or -Negative Mothers: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo. Adult Predialysis and Dialysis Patients: Engerix-B: IM 40 mcg at 0, 1, 2, and 6 mo: Recombivax HB: IM 40 mcg at 0, 1, and 6 mo.

Alternate Schedule

Engerix B: Designed for certain populations (eg, neonates born of hepatitis B-infected mothers, others who may have been recently exposed to the virus, certain travelers to high-risk areas). Adults (Older than 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo. Adolescents (11 to 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo, or 20 mcg at 0, 1, 6 mo. Adolescents 11 to 16 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Children (Birth to 10 Yr): IM 10 mcg at 0, 1, 2, 12 mo. Children 5 to 10 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Infants Born of HBsAG-Positive Mothers: IM 10 mcg at 0, 1, 2, and 12 mo. Revaccination: Hemodialysis Patients: A booster dose may be considered for patients undergoing dialysis if anti-HBs level less than 10 mIU/mL 1 to 2 mo after third dose. Other patients (when a booster dose is appropriate) (Engerix-B): Adults and adolescents 11 to 19 yr: IM 20 mcg. Children 10 yr or younger: IM 10 mcg.

 Interactions

Immunosuppressants (including high-dose corticosteroids or radiation therapy): May result in an inadequate response to immunization. Yellow Fever Vaccine: May reduce antibody titer otherwise expected from yellow fever vaccine. Separate these vaccines by 1 mo. Anticoagulants: Use caution when administering to patients receiving anticoagulant therapy because coadministration may increase the immunization drug.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Fatigue; weakness; headache; malaise; dizziness. DERMATOLOGIC: Flushing; angioedema. EENT: Earache; pharyngitis. GI: Nausea; diarrhea. RESPIRATORY: Upper respiratory tract infection. OTHER: Fever; pain; tenderness; pruritus; induration; erythema; ecchymosis; swelling; warmth or nodule formation at injection site; thrombocytopenia.

 Precautions

Pregnancy: Category C. Problems have not been reported and are unlikely. Use if woman is likely to be exposed to hepatitis B virus during or after pregnancy. Lactation: Undetermined. Elderly: Hepatitis B immunogenicity may be reduced in patients older than 40 yr. Hypersensitivity: Anaphylaxis and symptoms of immediate hypersensitivity have occurred within hours of administering vaccine. Immunosuppressed Patients: May require larger doses and may not respond to vaccine. Infection: Delay use of hepatitis B vaccine in presence of serious active infection except when withholding vaccine entails greater risk. Multiple Sclerosis (MS): Although no casual relationship has been established, rare instances of MS exacerbation have been reported following administration of hepatitis vaccines and other vaccines. Severely compromised cardiopulmonary status: Administer vaccine with caution. Unrecognized hepatitis B infection: May be present at time of vaccination and vaccine may not prevent hepatitis B because of long incubation period.

 Administration/Storage

• Shake well before use to maintain suspension of the vaccine.
• Administer IM in deltoid muscle in adults. In infants and young children administer IM in anterolateral thigh. Avoid gluteal injection into buttock, which may result in less than optimal immune response.
• May administer vaccine SC in patients who are at risk of hemorrhage following IM injection (eg, people with hemophilia or thalassemia). However, SC route may produce less than optimal response and may lead to increased incidence of local reactions.
• Always record manufacturer’s name and vaccine lot number in patient’s permanent record file along with date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of laryngospasms.
• Use vaccine as supplied. No dilution or reconstitution is necessary. Note that vaccine is slightly opaque, white suspension.
• Refrigerate vials. Do not freeze. Freezing destroys potency.

 Assessment/Interventions

• Obtain complete history, including drug history and any known allergies.
• Review patient’s medical history for history of serious adverse reactions to previous dose of hepatitis B vaccine.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of serious active infection.
• Monitor for hypersensitivity or anaphylaxis. Always have epinephrine available to counteract any possible reactions.

 Patient/Family Education

• Instruct patient or parent to complete the series of injections for vaccine to be effective.
• Provide patient or parent with immunization history record and record of this immunization in patient’s medical records.
• Instruct patient or parent to use antipyretics for fever or analgesics (eg, acetaminophen) for local pain.
• Inform patient or parent of immunization schedule.

Drug Side Effects ::

 Action Induces specific antibodies against hepatitis B virus.

 Indications Induction of active immunity against hepatitis B virus among people of all ages who are currently or who will be at increased risk of infection with this virus. Routine vaccination is recommended for infants and adolescents. All individuals not receiving the hepatitis B vaccine are recommended to be vaccinated at 11 to 12 yr. In addition, vaccination is recommended in older unvaccinated adolescents at high risk.

Vaccination is also indicated for those at high risk of exposure to or development of hepatitis B virus, such as health care personnel (eg, dentists; dental hygienists; nurses; oral surgeons; health care providers; surgeons; podiatrists; paramedical and ambulence personnel; patients and staff in hemodialysis units and hematology/oncology units; hemodialysis patients and patients with early renal failure before they require hemodialysis; blood bank and plasma fractionation workers; laboratory personnel handling blood, its products, and patients’ specimens; dental, medical, and nursing students); hospital cleaning staff who handle potentially infectious waste; patients requiring frequent or large-volume blood transfusions or clotting factor concentrates; residents and staff of institutions for mentally handicapped; household and other intimate contacts of people with persistent hepatitis B antigenemia; infants born to HBsAg-positive mothers; populations with high incidence of hepatitis B virus (eg, Alaskan Eskimos, Indochinese refugees, Haitian refugees); people at increased risk because of their sexual practices (eg, prostitutes; people who repeatedly contract STDs; homosexually active men; people with multiple sexual partners; international travelers; morticians; embalmers; prisoners; users of illicit injectable drugs; police and fire department personnel who render first aid or medical assistance.

Risk factors for hepatitis C are similar to those for hepatitis B. Consquently, immunization with hepatitis B vaccine is recommended for individuals with chronic hepatitis C.

Revaccination (booster doses): Adults and children with normal immune status: Antibody response lasts 10 yr or more. Hemodialysis patients: Vaccine protection is less complete and may persist only as long as antibody levels remain more than 10 mIU/mL. Vaccinated People who Experience Percutaneous or Needle Exposure to HBsAg-Positive Blood: Serological tests to assess immune status is recommended. If inadequate levels exist, treat with a booster dose of vaccine. Nonresponders: Most people who do not initially respond to the primary series may develop adequate antibody concentrations after revaccination with a fourth or fifth dose or a new complete vaccine series.

 Contraindications Hypersensitivity to yeast or any other component of vaccine.

 Route/Dosage

Adults 20 Yr or Older: Engerix-B: IM 20 mcg at 0, 1, and 6 mo; Recombivax HB: IM 10 mcg at 0, 1, and 6 mo. Children and Adolescents 1 to 19 Yr: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo, alternatively. Adolescents 11 to 15 Yr: Recombivax HB: IM 10 mcg at 0 and 4 to 6 mo. Infants of HBsAg-Positive or -Negative Mothers: Engerix-B: IM 10 mcg at 0, 1, and 6 mo; Recombivax HB: IM 5 mcg at 0, 1, and 6 mo. Adult Predialysis and Dialysis Patients: Engerix-B: IM 40 mcg at 0, 1, 2, and 6 mo: Recombivax HB: IM 40 mcg at 0, 1, and 6 mo.

Alternate Schedule

Engerix B: Designed for certain populations (eg, neonates born of hepatitis B-infected mothers, others who may have been recently exposed to the virus, certain travelers to high-risk areas). Adults (Older than 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo. Adolescents (11 to 19 Yr): IM 20 mcg at 0, 1, 2, 12 mo, or 20 mcg at 0, 1, 6 mo. Adolescents 11 to 16 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Children (Birth to 10 Yr): IM 10 mcg at 0, 1, 2, 12 mo. Children 5 to 10 Yr (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure): IM 10 mcg at 0, 12, and 24 mo. Infants Born of HBsAG-Positive Mothers: IM 10 mcg at 0, 1, 2, and 12 mo. Revaccination: Hemodialysis Patients: A booster dose may be considered for patients undergoing dialysis if anti-HBs level less than 10 mIU/mL 1 to 2 mo after third dose. Other patients (when a booster dose is appropriate) (Engerix-B): Adults and adolescents 11 to 19 yr: IM 20 mcg. Children 10 yr or younger: IM 10 mcg.

 Interactions

Immunosuppressants (including high-dose corticosteroids or radiation therapy): May result in an inadequate response to immunization. Yellow Fever Vaccine: May reduce antibody titer otherwise expected from yellow fever vaccine. Separate these vaccines by 1 mo. Anticoagulants: Use caution when administering to patients receiving anticoagulant therapy because coadministration may increase the immunization drug.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Fatigue; weakness; headache; malaise; dizziness. DERMATOLOGIC: Flushing; angioedema. EENT: Earache; pharyngitis. GI: Nausea; diarrhea. RESPIRATORY: Upper respiratory tract infection. OTHER: Fever; pain; tenderness; pruritus; induration; erythema; ecchymosis; swelling; warmth or nodule formation at injection site; thrombocytopenia.

 Precautions

Pregnancy: Category C. Problems have not been reported and are unlikely. Use if woman is likely to be exposed to hepatitis B virus during or after pregnancy. Lactation: Undetermined. Elderly: Hepatitis B immunogenicity may be reduced in patients older than 40 yr. Hypersensitivity: Anaphylaxis and symptoms of immediate hypersensitivity have occurred within hours of administering vaccine. Immunosuppressed Patients: May require larger doses and may not respond to vaccine. Infection: Delay use of hepatitis B vaccine in presence of serious active infection except when withholding vaccine entails greater risk. Multiple Sclerosis (MS): Although no casual relationship has been established, rare instances of MS exacerbation have been reported following administration of hepatitis vaccines and other vaccines. Severely compromised cardiopulmonary status: Administer vaccine with caution. Unrecognized hepatitis B infection: May be present at time of vaccination and vaccine may not prevent hepatitis B because of long incubation period.

 Administration/Storage

• Shake well before use to maintain suspension of the vaccine.
• Administer IM in deltoid muscle in adults. In infants and young children administer IM in anterolateral thigh. Avoid gluteal injection into buttock, which may result in less than optimal immune response.
• May administer vaccine SC in patients who are at risk of hemorrhage following IM injection (eg, people with hemophilia or thalassemia). However, SC route may produce less than optimal response and may lead to increased incidence of local reactions.
• Always record manufacturer’s name and vaccine lot number in patient’s permanent record file along with date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of laryngospasms.
• Use vaccine as supplied. No dilution or reconstitution is necessary. Note that vaccine is slightly opaque, white suspension.
• Refrigerate vials. Do not freeze. Freezing destroys potency.

 Assessment/Interventions

• Obtain complete history, including drug history and any known allergies.
• Review patient’s medical history for history of serious adverse reactions to previous dose of hepatitis B vaccine.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of serious active infection.
• Monitor for hypersensitivity or anaphylaxis. Always have epinephrine available to counteract any possible reactions.

 Patient/Family Education

• Instruct patient or parent to complete the series of injections for vaccine to be effective.
• Provide patient or parent with immunization history record and record of this immunization in patient’s medical records.
• Instruct patient or parent to use antipyretics for fever or analgesics (eg, acetaminophen) for local pain.
• Inform patient or parent of immunization schedule.

Drug Mode of Action ::  

 Action Induces specific antibodies against hepatitis B virus.