Indications Active immunization of patients 2 yr and older against disease caused by hepatitis A virus.

 Contraindications Hypersensitivity to any component of the vaccine.

 Route/Dosage

Adults 19 yr and older: IM (in the deltoid region) Havrix: 1440 EL.U (1 mL) or Vaqta: 50 U (1 mL) in 2 doses at 0 and 6 to 12 mo later. Children 2 to 18 yr: IM Havrix: 360 EL.U (0.5 mL) in 3 doses at 0, 1, and 6 to 12 mo later or Havrix: 720 EL.U (0.5 mL) in 2 doses at 0 and 6 to 12 mo later or Vaqta: 25 U (0.5 mL) in 2 doses at 0 and 6 to 18 mo later.

 Interactions

Anticoagulants: Since bleeding may occur following IM administration, use with caution. Immunosuppressants: May result in inadequate response to immunization; therefore, additional administration of vaccine may be required. Immune Globulin (IG): Compared with giving hepatitis A vaccine alone, when coadministered with IG, lower antibody titers may be obtained. However, hepatitis A vaccine and IG may be given concurrently using different syringes and different injection sites.

 Adverse Reactions

CNS: Headache; hypertonic episodes; insomnia; photophobia; vertigo; convulsions; encephalopathy; dizziness; neuropathy; myelitis; paresthesia; multiple sclerosis; Guillain-Barré syndrome; somnolence. DERMATOLOGIC: Pruritus; rash; urticaria; erythema multiforme; hyperhydrosis; generalized erythema; dermatitis; angioedema. EENT: Pharyngitis; nasal congestion; eye irritation and itching. GI: Anorexia; nausea; abdominal pain; diarrhea; dysgeusia; vomiting. GU: Menstrual disorder. HEPATIC: Jaundice; hepatitis. RESPIRATORY: Cough; upper respiratory tract infection; bronchial constriction; asthma; wheezing; dyspnea. OTHER: Injection site soreness, pain, pruritus, and rash; tenderness; warmth; induration; redness; swelling; hematoma; ecchymosis; localized edema; arthralgia; myalgia; arm and back pain; stiffness; elevated creatine phosphokinase; fever; malaise; lymphadenopathy; congenital abnormality; syncope; anaphylaxis/anaphylactoid reactions; edema.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established in children younger than 2 yr. Anaphylaxis: There have been rare reports of anaphylaxis and anaphylactoid reactions. Hepatitis: Hepatitis A vaccine will not prevent hepatitis caused by other agents, such as hepatitis B, C, or E virus or other pathogens that infect the liver. Preexisting Infection: Hepatitis A vaccine may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination; in addition, it may not prevent infection in individuals who do not achieve protective antibody titers.

 Administration/Storage

• For IM injection only. Not for IV, SC, or ID administration.
• Vaccination regimen consists of one primary dose and one booster dose. Booster dose is administered 6 to 18 mo after primary dose in patients 2 to 18 yr and 6 to 12 mo after primary dose in patients 19 yr.
• Shake vial or syringe well before use to maintain suspension of the vaccine.
• Examine vial or syringe after shaking. Suspension should be homogeneous and white. Discard if it appears otherwise.
• Use vaccine as supplied; no dilution or reconstitution is necessary.
• After removal of the appropriate volume from the single-dose vial, discard any remaining vaccine.
• Administer IM in deltoid region, or anterolateral thigh in toddlers and older children if deltoid muscle mass is inadequate. Avoid gluteal injection, which may result in less than optimal immune response.
• Record manufacturer’s name and vaccine lot number in patient’s permanent medical record file. Include date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of serious allergic reaction.
• Store vials and syringes in refrigerator. Do not freeze. Discard if vaccine has been frozen because freezing destroys potency.

Alternative vaccination regimen using 360 EL.U strength product in patients 2 to 18 yr

• Three doses administered as primary dose, second dose 1 mo later, and third dose 6 to 12 mo later.

Interchangeability of booster dose

• Products are interchangeable for booster dose (eg, Vaqta can be used for booster dose following primary dose of Havrix). Do not alternate between the 360 EL.U. and 720 EL.U. doses. Booster dose should be same strength as primary dose.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of serious reactions to previous doses of hepatitis A vaccines, anticoagulant therapy, bleeding disorder, and thrombocytopenia.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of moderate or severe acute febrile illness.
• Monitor patient for signs of anaphylaxis or severe allergic reaction. Discontinue therapy and immediately notify health care provider if noted. Be prepared to treat appropriately.

Missed boster dose

• If booster dose is missed, administer as soon as possible. Do not restart the series. Delaying booster dose does not reduce final effectiveness of vaccine but may allow protective effect of primary dose to drop below protective levels until booster is administered.

 Patient/Family Education

• Explain name, action, and potential side effects of vaccine.
• Advise patient that hepatitis A vaccine does not protect from other causes of food and waterborne diseases and to continue taking all necessary precautions to avoid contact with, or ingestion of, contaminated food and water.
• Review immunization schedule and advise patient that for vaccine to provide long-term protection, the booster dose needs to be administered as scheduled.
• Provide patient with immunization history record.
• Advise patient to use otc analgesics (eg, acetaminophen or ibuprofen) for fever or pain or discomfort at injection site.
• Advise patient to notify health care provider if bothersome side effects last more than 24 hr.

Indications for Drugs ::

 Action Provides active immunization.

 Indications Active immunization of patients 2 yr and older against disease caused by hepatitis A virus.

 Contraindications Hypersensitivity to any component of the vaccine.

 Route/Dosage

Adults 19 yr and older: IM (in the deltoid region) Havrix: 1440 EL.U (1 mL) or Vaqta: 50 U (1 mL) in 2 doses at 0 and 6 to 12 mo later. Children 2 to 18 yr: IM Havrix: 360 EL.U (0.5 mL) in 3 doses at 0, 1, and 6 to 12 mo later or Havrix: 720 EL.U (0.5 mL) in 2 doses at 0 and 6 to 12 mo later or Vaqta: 25 U (0.5 mL) in 2 doses at 0 and 6 to 18 mo later.

 Interactions

Anticoagulants: Since bleeding may occur following IM administration, use with caution. Immunosuppressants: May result in inadequate response to immunization; therefore, additional administration of vaccine may be required. Immune Globulin (IG): Compared with giving hepatitis A vaccine alone, when coadministered with IG, lower antibody titers may be obtained. However, hepatitis A vaccine and IG may be given concurrently using different syringes and different injection sites.

 Adverse Reactions

CNS: Headache; hypertonic episodes; insomnia; photophobia; vertigo; convulsions; encephalopathy; dizziness; neuropathy; myelitis; paresthesia; multiple sclerosis; Guillain-Barré syndrome; somnolence. DERMATOLOGIC: Pruritus; rash; urticaria; erythema multiforme; hyperhydrosis; generalized erythema; dermatitis; angioedema. EENT: Pharyngitis; nasal congestion; eye irritation and itching. GI: Anorexia; nausea; abdominal pain; diarrhea; dysgeusia; vomiting. GU: Menstrual disorder. HEPATIC: Jaundice; hepatitis. RESPIRATORY: Cough; upper respiratory tract infection; bronchial constriction; asthma; wheezing; dyspnea. OTHER: Injection site soreness, pain, pruritus, and rash; tenderness; warmth; induration; redness; swelling; hematoma; ecchymosis; localized edema; arthralgia; myalgia; arm and back pain; stiffness; elevated creatine phosphokinase; fever; malaise; lymphadenopathy; congenital abnormality; syncope; anaphylaxis/anaphylactoid reactions; edema.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established in children younger than 2 yr. Anaphylaxis: There have been rare reports of anaphylaxis and anaphylactoid reactions. Hepatitis: Hepatitis A vaccine will not prevent hepatitis caused by other agents, such as hepatitis B, C, or E virus or other pathogens that infect the liver. Preexisting Infection: Hepatitis A vaccine may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination; in addition, it may not prevent infection in individuals who do not achieve protective antibody titers.

 Administration/Storage

• For IM injection only. Not for IV, SC, or ID administration.
• Vaccination regimen consists of one primary dose and one booster dose. Booster dose is administered 6 to 18 mo after primary dose in patients 2 to 18 yr and 6 to 12 mo after primary dose in patients 19 yr.
• Shake vial or syringe well before use to maintain suspension of the vaccine.
• Examine vial or syringe after shaking. Suspension should be homogeneous and white. Discard if it appears otherwise.
• Use vaccine as supplied; no dilution or reconstitution is necessary.
• After removal of the appropriate volume from the single-dose vial, discard any remaining vaccine.
• Administer IM in deltoid region, or anterolateral thigh in toddlers and older children if deltoid muscle mass is inadequate. Avoid gluteal injection, which may result in less than optimal immune response.
• Record manufacturer’s name and vaccine lot number in patient’s permanent medical record file. Include date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of serious allergic reaction.
• Store vials and syringes in refrigerator. Do not freeze. Discard if vaccine has been frozen because freezing destroys potency.

Alternative vaccination regimen using 360 EL.U strength product in patients 2 to 18 yr

• Three doses administered as primary dose, second dose 1 mo later, and third dose 6 to 12 mo later.

Interchangeability of booster dose

• Products are interchangeable for booster dose (eg, Vaqta can be used for booster dose following primary dose of Havrix). Do not alternate between the 360 EL.U. and 720 EL.U. doses. Booster dose should be same strength as primary dose.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of serious reactions to previous doses of hepatitis A vaccines, anticoagulant therapy, bleeding disorder, and thrombocytopenia.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of moderate or severe acute febrile illness.
• Monitor patient for signs of anaphylaxis or severe allergic reaction. Discontinue therapy and immediately notify health care provider if noted. Be prepared to treat appropriately.

Missed boster dose

• If booster dose is missed, administer as soon as possible. Do not restart the series. Delaying booster dose does not reduce final effectiveness of vaccine but may allow protective effect of primary dose to drop below protective levels until booster is administered.

 Patient/Family Education

• Explain name, action, and potential side effects of vaccine.
• Advise patient that hepatitis A vaccine does not protect from other causes of food and waterborne diseases and to continue taking all necessary precautions to avoid contact with, or ingestion of, contaminated food and water.
• Review immunization schedule and advise patient that for vaccine to provide long-term protection, the booster dose needs to be administered as scheduled.
• Provide patient with immunization history record.
• Advise patient to use otc analgesics (eg, acetaminophen or ibuprofen) for fever or pain or discomfort at injection site.
• Advise patient to notify health care provider if bothersome side effects last more than 24 hr.

Drug Dose ::

 Action Provides active immunization.

 Indications Active immunization of patients 2 yr and older against disease caused by hepatitis A virus.

 Contraindications Hypersensitivity to any component of the vaccine.

 Route/Dosage

Adults 19 yr and older: IM (in the deltoid region) Havrix: 1440 EL.U (1 mL) or Vaqta: 50 U (1 mL) in 2 doses at 0 and 6 to 12 mo later. Children 2 to 18 yr: IM Havrix: 360 EL.U (0.5 mL) in 3 doses at 0, 1, and 6 to 12 mo later or Havrix: 720 EL.U (0.5 mL) in 2 doses at 0 and 6 to 12 mo later or Vaqta: 25 U (0.5 mL) in 2 doses at 0 and 6 to 18 mo later.

 Interactions

Anticoagulants: Since bleeding may occur following IM administration, use with caution. Immunosuppressants: May result in inadequate response to immunization; therefore, additional administration of vaccine may be required. Immune Globulin (IG): Compared with giving hepatitis A vaccine alone, when coadministered with IG, lower antibody titers may be obtained. However, hepatitis A vaccine and IG may be given concurrently using different syringes and different injection sites.

 Adverse Reactions

CNS: Headache; hypertonic episodes; insomnia; photophobia; vertigo; convulsions; encephalopathy; dizziness; neuropathy; myelitis; paresthesia; multiple sclerosis; Guillain-Barré syndrome; somnolence. DERMATOLOGIC: Pruritus; rash; urticaria; erythema multiforme; hyperhydrosis; generalized erythema; dermatitis; angioedema. EENT: Pharyngitis; nasal congestion; eye irritation and itching. GI: Anorexia; nausea; abdominal pain; diarrhea; dysgeusia; vomiting. GU: Menstrual disorder. HEPATIC: Jaundice; hepatitis. RESPIRATORY: Cough; upper respiratory tract infection; bronchial constriction; asthma; wheezing; dyspnea. OTHER: Injection site soreness, pain, pruritus, and rash; tenderness; warmth; induration; redness; swelling; hematoma; ecchymosis; localized edema; arthralgia; myalgia; arm and back pain; stiffness; elevated creatine phosphokinase; fever; malaise; lymphadenopathy; congenital abnormality; syncope; anaphylaxis/anaphylactoid reactions; edema.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established in children younger than 2 yr. Anaphylaxis: There have been rare reports of anaphylaxis and anaphylactoid reactions. Hepatitis: Hepatitis A vaccine will not prevent hepatitis caused by other agents, such as hepatitis B, C, or E virus or other pathogens that infect the liver. Preexisting Infection: Hepatitis A vaccine may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination; in addition, it may not prevent infection in individuals who do not achieve protective antibody titers.

 Administration/Storage

• For IM injection only. Not for IV, SC, or ID administration.
• Vaccination regimen consists of one primary dose and one booster dose. Booster dose is administered 6 to 18 mo after primary dose in patients 2 to 18 yr and 6 to 12 mo after primary dose in patients 19 yr.
• Shake vial or syringe well before use to maintain suspension of the vaccine.
• Examine vial or syringe after shaking. Suspension should be homogeneous and white. Discard if it appears otherwise.
• Use vaccine as supplied; no dilution or reconstitution is necessary.
• After removal of the appropriate volume from the single-dose vial, discard any remaining vaccine.
• Administer IM in deltoid region, or anterolateral thigh in toddlers and older children if deltoid muscle mass is inadequate. Avoid gluteal injection, which may result in less than optimal immune response.
• Record manufacturer’s name and vaccine lot number in patient’s permanent medical record file. Include date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of serious allergic reaction.
• Store vials and syringes in refrigerator. Do not freeze. Discard if vaccine has been frozen because freezing destroys potency.

Alternative vaccination regimen using 360 EL.U strength product in patients 2 to 18 yr

• Three doses administered as primary dose, second dose 1 mo later, and third dose 6 to 12 mo later.

Interchangeability of booster dose

• Products are interchangeable for booster dose (eg, Vaqta can be used for booster dose following primary dose of Havrix). Do not alternate between the 360 EL.U. and 720 EL.U. doses. Booster dose should be same strength as primary dose.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of serious reactions to previous doses of hepatitis A vaccines, anticoagulant therapy, bleeding disorder, and thrombocytopenia.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of moderate or severe acute febrile illness.
• Monitor patient for signs of anaphylaxis or severe allergic reaction. Discontinue therapy and immediately notify health care provider if noted. Be prepared to treat appropriately.

Missed boster dose

• If booster dose is missed, administer as soon as possible. Do not restart the series. Delaying booster dose does not reduce final effectiveness of vaccine but may allow protective effect of primary dose to drop below protective levels until booster is administered.

 Patient/Family Education

• Explain name, action, and potential side effects of vaccine.
• Advise patient that hepatitis A vaccine does not protect from other causes of food and waterborne diseases and to continue taking all necessary precautions to avoid contact with, or ingestion of, contaminated food and water.
• Review immunization schedule and advise patient that for vaccine to provide long-term protection, the booster dose needs to be administered as scheduled.
• Provide patient with immunization history record.
• Advise patient to use otc analgesics (eg, acetaminophen or ibuprofen) for fever or pain or discomfort at injection site.
• Advise patient to notify health care provider if bothersome side effects last more than 24 hr.

Contraindication ::

 Action Provides active immunization.

 Indications Active immunization of patients 2 yr and older against disease caused by hepatitis A virus.

 Contraindications Hypersensitivity to any component of the vaccine.

 Route/Dosage

Adults 19 yr and older: IM (in the deltoid region) Havrix: 1440 EL.U (1 mL) or Vaqta: 50 U (1 mL) in 2 doses at 0 and 6 to 12 mo later. Children 2 to 18 yr: IM Havrix: 360 EL.U (0.5 mL) in 3 doses at 0, 1, and 6 to 12 mo later or Havrix: 720 EL.U (0.5 mL) in 2 doses at 0 and 6 to 12 mo later or Vaqta: 25 U (0.5 mL) in 2 doses at 0 and 6 to 18 mo later.

 Interactions

Anticoagulants: Since bleeding may occur following IM administration, use with caution. Immunosuppressants: May result in inadequate response to immunization; therefore, additional administration of vaccine may be required. Immune Globulin (IG): Compared with giving hepatitis A vaccine alone, when coadministered with IG, lower antibody titers may be obtained. However, hepatitis A vaccine and IG may be given concurrently using different syringes and different injection sites.

 Adverse Reactions

CNS: Headache; hypertonic episodes; insomnia; photophobia; vertigo; convulsions; encephalopathy; dizziness; neuropathy; myelitis; paresthesia; multiple sclerosis; Guillain-Barré syndrome; somnolence. DERMATOLOGIC: Pruritus; rash; urticaria; erythema multiforme; hyperhydrosis; generalized erythema; dermatitis; angioedema. EENT: Pharyngitis; nasal congestion; eye irritation and itching. GI: Anorexia; nausea; abdominal pain; diarrhea; dysgeusia; vomiting. GU: Menstrual disorder. HEPATIC: Jaundice; hepatitis. RESPIRATORY: Cough; upper respiratory tract infection; bronchial constriction; asthma; wheezing; dyspnea. OTHER: Injection site soreness, pain, pruritus, and rash; tenderness; warmth; induration; redness; swelling; hematoma; ecchymosis; localized edema; arthralgia; myalgia; arm and back pain; stiffness; elevated creatine phosphokinase; fever; malaise; lymphadenopathy; congenital abnormality; syncope; anaphylaxis/anaphylactoid reactions; edema.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established in children younger than 2 yr. Anaphylaxis: There have been rare reports of anaphylaxis and anaphylactoid reactions. Hepatitis: Hepatitis A vaccine will not prevent hepatitis caused by other agents, such as hepatitis B, C, or E virus or other pathogens that infect the liver. Preexisting Infection: Hepatitis A vaccine may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination; in addition, it may not prevent infection in individuals who do not achieve protective antibody titers.

 Administration/Storage

• For IM injection only. Not for IV, SC, or ID administration.
• Vaccination regimen consists of one primary dose and one booster dose. Booster dose is administered 6 to 18 mo after primary dose in patients 2 to 18 yr and 6 to 12 mo after primary dose in patients 19 yr.
• Shake vial or syringe well before use to maintain suspension of the vaccine.
• Examine vial or syringe after shaking. Suspension should be homogeneous and white. Discard if it appears otherwise.
• Use vaccine as supplied; no dilution or reconstitution is necessary.
• After removal of the appropriate volume from the single-dose vial, discard any remaining vaccine.
• Administer IM in deltoid region, or anterolateral thigh in toddlers and older children if deltoid muscle mass is inadequate. Avoid gluteal injection, which may result in less than optimal immune response.
• Record manufacturer’s name and vaccine lot number in patient’s permanent medical record file. Include date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of serious allergic reaction.
• Store vials and syringes in refrigerator. Do not freeze. Discard if vaccine has been frozen because freezing destroys potency.

Alternative vaccination regimen using 360 EL.U strength product in patients 2 to 18 yr

• Three doses administered as primary dose, second dose 1 mo later, and third dose 6 to 12 mo later.

Interchangeability of booster dose

• Products are interchangeable for booster dose (eg, Vaqta can be used for booster dose following primary dose of Havrix). Do not alternate between the 360 EL.U. and 720 EL.U. doses. Booster dose should be same strength as primary dose.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of serious reactions to previous doses of hepatitis A vaccines, anticoagulant therapy, bleeding disorder, and thrombocytopenia.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of moderate or severe acute febrile illness.
• Monitor patient for signs of anaphylaxis or severe allergic reaction. Discontinue therapy and immediately notify health care provider if noted. Be prepared to treat appropriately.

Missed boster dose

• If booster dose is missed, administer as soon as possible. Do not restart the series. Delaying booster dose does not reduce final effectiveness of vaccine but may allow protective effect of primary dose to drop below protective levels until booster is administered.

 Patient/Family Education

• Explain name, action, and potential side effects of vaccine.
• Advise patient that hepatitis A vaccine does not protect from other causes of food and waterborne diseases and to continue taking all necessary precautions to avoid contact with, or ingestion of, contaminated food and water.
• Review immunization schedule and advise patient that for vaccine to provide long-term protection, the booster dose needs to be administered as scheduled.
• Provide patient with immunization history record.
• Advise patient to use otc analgesics (eg, acetaminophen or ibuprofen) for fever or pain or discomfort at injection site.
• Advise patient to notify health care provider if bothersome side effects last more than 24 hr.

Drug Precautions ::

 Action Provides active immunization.

 Indications Active immunization of patients 2 yr and older against disease caused by hepatitis A virus.

 Contraindications Hypersensitivity to any component of the vaccine.

 Route/Dosage

Adults 19 yr and older: IM (in the deltoid region) Havrix: 1440 EL.U (1 mL) or Vaqta: 50 U (1 mL) in 2 doses at 0 and 6 to 12 mo later. Children 2 to 18 yr: IM Havrix: 360 EL.U (0.5 mL) in 3 doses at 0, 1, and 6 to 12 mo later or Havrix: 720 EL.U (0.5 mL) in 2 doses at 0 and 6 to 12 mo later or Vaqta: 25 U (0.5 mL) in 2 doses at 0 and 6 to 18 mo later.

 Interactions

Anticoagulants: Since bleeding may occur following IM administration, use with caution. Immunosuppressants: May result in inadequate response to immunization; therefore, additional administration of vaccine may be required. Immune Globulin (IG): Compared with giving hepatitis A vaccine alone, when coadministered with IG, lower antibody titers may be obtained. However, hepatitis A vaccine and IG may be given concurrently using different syringes and different injection sites.

 Adverse Reactions

CNS: Headache; hypertonic episodes; insomnia; photophobia; vertigo; convulsions; encephalopathy; dizziness; neuropathy; myelitis; paresthesia; multiple sclerosis; Guillain-Barré syndrome; somnolence. DERMATOLOGIC: Pruritus; rash; urticaria; erythema multiforme; hyperhydrosis; generalized erythema; dermatitis; angioedema. EENT: Pharyngitis; nasal congestion; eye irritation and itching. GI: Anorexia; nausea; abdominal pain; diarrhea; dysgeusia; vomiting. GU: Menstrual disorder. HEPATIC: Jaundice; hepatitis. RESPIRATORY: Cough; upper respiratory tract infection; bronchial constriction; asthma; wheezing; dyspnea. OTHER: Injection site soreness, pain, pruritus, and rash; tenderness; warmth; induration; redness; swelling; hematoma; ecchymosis; localized edema; arthralgia; myalgia; arm and back pain; stiffness; elevated creatine phosphokinase; fever; malaise; lymphadenopathy; congenital abnormality; syncope; anaphylaxis/anaphylactoid reactions; edema.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established in children younger than 2 yr. Anaphylaxis: There have been rare reports of anaphylaxis and anaphylactoid reactions. Hepatitis: Hepatitis A vaccine will not prevent hepatitis caused by other agents, such as hepatitis B, C, or E virus or other pathogens that infect the liver. Preexisting Infection: Hepatitis A vaccine may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination; in addition, it may not prevent infection in individuals who do not achieve protective antibody titers.

 Administration/Storage

• For IM injection only. Not for IV, SC, or ID administration.
• Vaccination regimen consists of one primary dose and one booster dose. Booster dose is administered 6 to 18 mo after primary dose in patients 2 to 18 yr and 6 to 12 mo after primary dose in patients 19 yr.
• Shake vial or syringe well before use to maintain suspension of the vaccine.
• Examine vial or syringe after shaking. Suspension should be homogeneous and white. Discard if it appears otherwise.
• Use vaccine as supplied; no dilution or reconstitution is necessary.
• After removal of the appropriate volume from the single-dose vial, discard any remaining vaccine.
• Administer IM in deltoid region, or anterolateral thigh in toddlers and older children if deltoid muscle mass is inadequate. Avoid gluteal injection, which may result in less than optimal immune response.
• Record manufacturer’s name and vaccine lot number in patient’s permanent medical record file. Include date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of serious allergic reaction.
• Store vials and syringes in refrigerator. Do not freeze. Discard if vaccine has been frozen because freezing destroys potency.

Alternative vaccination regimen using 360 EL.U strength product in patients 2 to 18 yr

• Three doses administered as primary dose, second dose 1 mo later, and third dose 6 to 12 mo later.

Interchangeability of booster dose

• Products are interchangeable for booster dose (eg, Vaqta can be used for booster dose following primary dose of Havrix). Do not alternate between the 360 EL.U. and 720 EL.U. doses. Booster dose should be same strength as primary dose.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of serious reactions to previous doses of hepatitis A vaccines, anticoagulant therapy, bleeding disorder, and thrombocytopenia.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of moderate or severe acute febrile illness.
• Monitor patient for signs of anaphylaxis or severe allergic reaction. Discontinue therapy and immediately notify health care provider if noted. Be prepared to treat appropriately.

Missed boster dose

• If booster dose is missed, administer as soon as possible. Do not restart the series. Delaying booster dose does not reduce final effectiveness of vaccine but may allow protective effect of primary dose to drop below protective levels until booster is administered.

 Patient/Family Education

• Explain name, action, and potential side effects of vaccine.
• Advise patient that hepatitis A vaccine does not protect from other causes of food and waterborne diseases and to continue taking all necessary precautions to avoid contact with, or ingestion of, contaminated food and water.
• Review immunization schedule and advise patient that for vaccine to provide long-term protection, the booster dose needs to be administered as scheduled.
• Provide patient with immunization history record.
• Advise patient to use otc analgesics (eg, acetaminophen or ibuprofen) for fever or pain or discomfort at injection site.
• Advise patient to notify health care provider if bothersome side effects last more than 24 hr.

Drug Side Effects ::

 Action Provides active immunization.

 Indications Active immunization of patients 2 yr and older against disease caused by hepatitis A virus.

 Contraindications Hypersensitivity to any component of the vaccine.

 Route/Dosage

Adults 19 yr and older: IM (in the deltoid region) Havrix: 1440 EL.U (1 mL) or Vaqta: 50 U (1 mL) in 2 doses at 0 and 6 to 12 mo later. Children 2 to 18 yr: IM Havrix: 360 EL.U (0.5 mL) in 3 doses at 0, 1, and 6 to 12 mo later or Havrix: 720 EL.U (0.5 mL) in 2 doses at 0 and 6 to 12 mo later or Vaqta: 25 U (0.5 mL) in 2 doses at 0 and 6 to 18 mo later.

 Interactions

Anticoagulants: Since bleeding may occur following IM administration, use with caution. Immunosuppressants: May result in inadequate response to immunization; therefore, additional administration of vaccine may be required. Immune Globulin (IG): Compared with giving hepatitis A vaccine alone, when coadministered with IG, lower antibody titers may be obtained. However, hepatitis A vaccine and IG may be given concurrently using different syringes and different injection sites.

 Adverse Reactions

CNS: Headache; hypertonic episodes; insomnia; photophobia; vertigo; convulsions; encephalopathy; dizziness; neuropathy; myelitis; paresthesia; multiple sclerosis; Guillain-Barré syndrome; somnolence. DERMATOLOGIC: Pruritus; rash; urticaria; erythema multiforme; hyperhydrosis; generalized erythema; dermatitis; angioedema. EENT: Pharyngitis; nasal congestion; eye irritation and itching. GI: Anorexia; nausea; abdominal pain; diarrhea; dysgeusia; vomiting. GU: Menstrual disorder. HEPATIC: Jaundice; hepatitis. RESPIRATORY: Cough; upper respiratory tract infection; bronchial constriction; asthma; wheezing; dyspnea. OTHER: Injection site soreness, pain, pruritus, and rash; tenderness; warmth; induration; redness; swelling; hematoma; ecchymosis; localized edema; arthralgia; myalgia; arm and back pain; stiffness; elevated creatine phosphokinase; fever; malaise; lymphadenopathy; congenital abnormality; syncope; anaphylaxis/anaphylactoid reactions; edema.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established in children younger than 2 yr. Anaphylaxis: There have been rare reports of anaphylaxis and anaphylactoid reactions. Hepatitis: Hepatitis A vaccine will not prevent hepatitis caused by other agents, such as hepatitis B, C, or E virus or other pathogens that infect the liver. Preexisting Infection: Hepatitis A vaccine may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination; in addition, it may not prevent infection in individuals who do not achieve protective antibody titers.

 Administration/Storage

• For IM injection only. Not for IV, SC, or ID administration.
• Vaccination regimen consists of one primary dose and one booster dose. Booster dose is administered 6 to 18 mo after primary dose in patients 2 to 18 yr and 6 to 12 mo after primary dose in patients 19 yr.
• Shake vial or syringe well before use to maintain suspension of the vaccine.
• Examine vial or syringe after shaking. Suspension should be homogeneous and white. Discard if it appears otherwise.
• Use vaccine as supplied; no dilution or reconstitution is necessary.
• After removal of the appropriate volume from the single-dose vial, discard any remaining vaccine.
• Administer IM in deltoid region, or anterolateral thigh in toddlers and older children if deltoid muscle mass is inadequate. Avoid gluteal injection, which may result in less than optimal immune response.
• Record manufacturer’s name and vaccine lot number in patient’s permanent medical record file. Include date of administration, name, and title of person administering vaccine.
• Have epinephrine 1:1000 available in case of serious allergic reaction.
• Store vials and syringes in refrigerator. Do not freeze. Discard if vaccine has been frozen because freezing destroys potency.

Alternative vaccination regimen using 360 EL.U strength product in patients 2 to 18 yr

• Three doses administered as primary dose, second dose 1 mo later, and third dose 6 to 12 mo later.

Interchangeability of booster dose

• Products are interchangeable for booster dose (eg, Vaqta can be used for booster dose following primary dose of Havrix). Do not alternate between the 360 EL.U. and 720 EL.U. doses. Booster dose should be same strength as primary dose.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of serious reactions to previous doses of hepatitis A vaccines, anticoagulant therapy, bleeding disorder, and thrombocytopenia.
• Check patient’s immunization history to verify that administration regimen is being followed.
• Consider delaying immunization during course of moderate or severe acute febrile illness.
• Monitor patient for signs of anaphylaxis or severe allergic reaction. Discontinue therapy and immediately notify health care provider if noted. Be prepared to treat appropriately.

Missed boster dose

• If booster dose is missed, administer as soon as possible. Do not restart the series. Delaying booster dose does not reduce final effectiveness of vaccine but may allow protective effect of primary dose to drop below protective levels until booster is administered.

 Patient/Family Education

• Explain name, action, and potential side effects of vaccine.
• Advise patient that hepatitis A vaccine does not protect from other causes of food and waterborne diseases and to continue taking all necessary precautions to avoid contact with, or ingestion of, contaminated food and water.
• Review immunization schedule and advise patient that for vaccine to provide long-term protection, the booster dose needs to be administered as scheduled.
• Provide patient with immunization history record.
• Advise patient to use otc analgesics (eg, acetaminophen or ibuprofen) for fever or pain or discomfort at injection site.
• Advise patient to notify health care provider if bothersome side effects last more than 24 hr.

Drug Mode of Action ::  

 Action Provides active immunization.