Havrix

Drug overview for HAVRIX (hepatitis a virus vaccine/pf):

Generic name: HEPATITIS A VIRUS VACCINE/PF (hep-uh-TIE-tuss A)
Drug class: Hepatitis A Virus Vaccine
Therapeutic class: Biologicals

Hepatitis A vaccine is an inactivated vaccine containing cell culture-adapted, inactivated hepatitis A virus (HAV).

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for HAVRIX (hepatitis a virus vaccine/pf) have been approved by the FDA:

Indications:
Hepatitis A vaccination

Professional Synonyms:
Vaccination to prevent hepatitis A infection

The following dosing information is available for HAVRIX (hepatitis a virus vaccine/pf):

Dosing
Administration
HAVRIX
Generic

The recommended dose and dosing schedule for hepatitis A vaccine vary according to the individual's age and specific vaccine administered (Havrix(R) or Vaqta(R) monovalent vaccines or Twinrix(R) fixed-combination vaccine). Dosage recommendations for the specific preparation used should be followed.

According to the US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), the monovalent vaccine chosen for the initial dose should be used for subsequent doses in the same individual whenever possible. If this is not possible or if the manufacturer of previously administered doses is unknown, then the vaccine that is available should be administered. This dose is considered valid; it does not need to be repeated.

No differences in immunogenicity have been observed when one dose of hepatitis A vaccine produced by one manufacturer is followed by a dose from a different manufacturer, administered according to the recommended schedule.

When vaccination against both HAV and hepatitis B virus (HBV) infection is indicated in adults 18 years of age or older, the commercially available fixed-combination vaccine containing hepatitis A vaccine and hepatitis B vaccine (HepA-HepB; Twinrix(R)) can be used.

Consult the CDC/ACIP guidance and immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and management of patients with high-risk conditions.

Hepatitis A vaccine inactivated (hepatitis A vaccine) is commercially available in the US as monovalent (single-antigen) vaccines (Havrix(R), Vaqta(R)) and in a fixed-combination with hepatitis B vaccine (HepA-HepB; Twinrix(R)). Hepatitis A vaccines are administered by IM injection; do not administer IV, intradermally, or subcutaneously. To ensure delivery of vaccine into the muscle, IM injections should be made at a 90degrees angle to the skin using a needle size that is appropriate for the individual's age and body mass, thickness of adipose tissue and muscle at the injection site, and injection technique.

Since syncope may occur following vaccination, vaccinees should be observed for approximately 15 minutes after the vaccine dose is administered. If syncope occurs, the patient should be observed until symptoms resolve. Syncope after vaccination occurs most frequently in adolescents and young adults.

Do not mix with any other vaccine or product in the same syringe or vial. Hepatitis A vaccine may be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different injection sites). Hepatitis A vaccine may also be given simultaneously with IM immune globulin, using different injection sites, when indicated.

Injection sites should be separated by >=1 inch if possible. Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees. All vaccines should be inspected upon delivery and monitored during storage to ensure that the appropriate temperature is maintained.

Single antigen hepatitis A vaccine (Havrix(R), Vaqta(R)) or fixed-combination vaccine containing hepatitis A vaccine and hepatitis B vaccine (HepA-HepB; Twinrix(R)) that has been mishandled or has not been stored at the recommended temperature should not be administered. If there are concerns about mishandling, the manufacturer or state or local health departments should be contacted for guidance on whether the vaccine is usable.

Dosing information for HAVRIX
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
HAVRIX 1,440 UNIT/ML SYRINGE	Maintenance	Adults inject 1 milliliter by intramuscular route once

No generic dosing information available.

The following drug interaction information is available for HAVRIX (hepatitis a virus vaccine/pf):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Teplizumab SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames. The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy. Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)	TZIELD

Drug Interaction

Drug Names

Non-Live or Non-Replicating Vaccines/Teplizumab

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames.

The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy.

Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3)

DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)

TZIELD

There are 8 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Fingolimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Fingolimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for 2 months following fingolimod therapy may result in decreased effectiveness of the vaccine.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating fingolimod therapy. The immune response to non-live vaccines should be monitored in patients receiving fingolimod or who have received fingolimod in the previous two months. Vaccinations given during and for 2 months after stopping fingolimod therapy may need to be repeated.(1,2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective during and for 2 months following fingolimod therapy(1) however they are considered safe to administer.(2)	FINGOLIMOD, GILENYA, TASCENSO ODT
Non-Live or Non-Replicating Vaccines/Siponimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Siponimod is an immunosuppressant and may alter the immune system's response to vaccines.(2) CLINICAL EFFECTS: Administration of a vaccine during and for up to 1 month after discontinuation of siponimod therapy may result in decreased effectiveness of the vaccine. Siponimod treatment should be paused 1 week prior and for 4 weeks after vaccination.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating siponimod therapy. The immune response to non-live vaccines should be monitored in patients receiving siponimod or who have received siponimod in the previous week. Vaccinations given during and for up to 1 month after discontinuation of siponimod therapy may need to be repeated.(2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective if administered during and for up to 1 month after siponimod treatment(2) however they are considered safe to administer.(1)	MAYZENT
Non-Live or Non-Replicating Vaccines/Satralizumab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Satralizumab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during satralizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiation of satralizumab.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines two weeks prior to initiating satralizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving satralizumab. Vaccinations given during satralizumab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during satralizumab treatment.(1)	ENSPRYNG
Non-Live or Non-Replicating Vaccines/Ublituximab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ublituximab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within 2 weeks before or during ublituximab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ublituximab therapy.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ublituximab therapy. The immune response to non-live vaccines should be monitored in patients receiving ublituximab. Vaccinations given during ublituximab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before or during ublituximab treatment.(1)	BRIUMVI
Systemic Corticosteroids; Corticotropin/Non-Live or Non-Replicating Vaccines SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Vaccines administered during or within 2 weeks prior to therapy with corticosteroids or corticotropin may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1) PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 2 weeks after a non-live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines.(1) The immune response to non-live vaccines should be monitored in patients receiving corticosteroids. Vaccinations given during corticosteroid therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(1) DISCUSSION: Vaccinations given during and within 2 weeks prior to corticosteroid therapy may be less effective. However they are considered safe to administer.(1) Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1)	ACTHAR, ACTHAR SELFJECT, ADRENOCORTICOTROPHIC HORMONE, ALDOSTERONE, ALKINDI SPRINKLE, ANUCORT-HC, ANUSOL-HC, BECLOMETHASONE DIPROPIONATE, BETALOAN SUIK, BETAMETHASONE ACETATE MICRO, BETAMETHASONE ACETATE-SOD PHOS, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SOD PHOS-ACETATE, BETAMETHASONE SOD PHOS-WATER, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE, BUDESONIDE, BUDESONIDE DR, BUDESONIDE EC, BUDESONIDE ER, BUDESONIDE MICRONIZED, BUPIVACAINE-DEXAMETH-EPINEPHRN, CELESTONE, CLOBETASOL PROPIONATE MICRO, CORTEF, CORTENEMA, CORTICOTROPHIN, CORTIFOAM, CORTISONE ACETATE, CORTROPHIN, DEFLAZACORT, DEPO-MEDROL, DESONIDE MICRONIZED, DESOXIMETASONE, DESOXYCORTICOSTERONE ACETATE, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE ACETATE, DEXAMETHASONE ACETATE MICRO, DEXAMETHASONE INTENSOL, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE MICRONIZED, DEXAMETHASONE SOD PHOS-WATER, DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE-0.9% NACL, DMT SUIK, DOUBLEDEX, EMFLAZA, EOHILIA, FLUDROCORTISONE ACETATE, FLUNISOLIDE, FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE MICRO, FLUOCINONIDE MICRONIZED, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE MICRO, HEMADY, HEMMOREX-HC, HEXATRIONE, HYDROCORTISONE, HYDROCORTISONE ACETATE, HYDROCORTISONE SOD SUCCINATE, JAYTHARI, KENALOG-10, KENALOG-40, KENALOG-80, KHINDIVI, KYMBEE, LIDOCIDEX-I, MAS CARE-PAK, MEDROL, MEDROLOAN II SUIK, MEDROLOAN SUIK, METHYLPREDNISOLONE, METHYLPREDNISOLONE AC MICRO, METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCC, MILLIPRED, MILLIPRED DP, MOMETASONE FUROATE, ORAPRED ODT, P-PACK PREDNISONE, PREDNISOLONE, PREDNISOLONE ACETATE MICRONIZE, PREDNISOLONE MICRONIZED, PREDNISOLONE SODIUM PHOS ODT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISONE, PREDNISONE INTENSOL, PREDNISONE MICRONIZED, PROCTOCORT, PYQUVI, SOLU-CORTEF, SOLU-MEDROL, TAPERDEX, TARPEYO, TRIAMCINOLONE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATE MICRO, TRILOAN II SUIK, TRILOAN SUIK, UCERIS, VERIPRED 20, ZCORT
Non-Live or Non-Replicating Vaccines/Etrasimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Etrasimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 5 weeks after discontinuation of etrasimod therapy may result in decreased effectiveness of the vaccine. Etrasimod treatment should be paused 5 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating etrasimod therapy. The immune response to non-live vaccines should be monitored in patients receiving etrasimod or who have received etrasimod in the previous 5 weeks. Vaccinations given during and for up to 5 weeks after discontinuation of etrasimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 5 weeks after etrasimod treatment.(1) However they are considered safe to administer.	VELSIPITY
Non-Live or Non-Replicating Vaccines/Ozanimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ozanimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 3 months after discontinuation of ozanimod therapy may result in decreased effectiveness of the vaccine. Ozanimod treatment should be paused 3 months prior and for 1 month after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ozanimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ozanimod or who have received ozanimod in the previous 3 months. Vaccinations given during and for up to 3 months after discontinuation of ozanimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 3 months after ozanimod treatment.(1) However they are considered safe to administer.	ZEPOSIA
Non-Live or Non-Replicating Vaccines/Ponesimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ponesimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 2 weeks after discontinuation of ponesimod therapy may result in decreased effectiveness of the vaccine. Ponesimod treatment should be paused 1-2 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ponesimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ponesimod or who have received ponesimod in the previous 2 weeks. Vaccinations given during and for up to 2 weeks after discontinuation of ponesimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 2 weeks after ponesimod treatment.(1) However they are considered safe to administer.	PONVORY

Moderate List
Fever

The following adverse reaction information is available for HAVRIX (hepatitis a virus vaccine/pf):

Overview
Severe
Less Severe

Adverse reaction overview.

Havrix(R): In studies of adults and children >=2 years of age, the most frequently reported solicited adverse effects were injection-site soreness and headache. In studies of children 11-25 months of age, the most frequently reported solicited local reactions were pain and redness, and the frequently reported solicited general adverse reactions were irritability, drowsiness, and loss of appetite. Vaqta(R): In studies of children 12-23 months of age, the most frequently reported local and systemic adverse effects when the vaccine was administered alone or concomitantly were pain, tenderness, and erythema at the injection site, and fever.

In studies of children and adolescents 2-18 years of age, the most frequently reported adverse effect when the vaccine was administered alone or concomitantly was pain at the injection site. In studies of adults >=19 years of age, the most frequently reported local and systemic adverse effects when the vaccine was administered alone or concomitantly were pain, tenderness, soreness, or warmth at the injection site, and headache. Twinrix(R): The most frequently reported local and systemic adverse effects following any dose of the vaccine were soreness and redness at the injection site; headache, and fatigue.

There are 13 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Angioedema Encephalopathy Erythema multiforme Guillain-barre syndrome Hepatitis Jaundice Myelitis Seizure disorder Serum sickness Syncope Thrombocytopenic disorder Vasculitis

There are 35 less severe adverse reactions.

More Frequent	Less Frequent
Drowsy Headache disorder Injection site sequelae Irritability	Anorexia Fatigue Fever Induration of skin Malaise Nausea

Rare/Very Rare
Acute abdominal pain Arthralgia Chills Diarrhea Dizziness Dysgeusia Dyspnea Hyperhidrosis Hypertonia Hypoesthesia Insomnia Localized edema Lymphadenopathy Muscle rigidity Myalgia Paresthesia Peripheral sensory neuropathy Photophobia Pruritus of skin Rhinitis Skin rash Upper respiratory infection Urticaria Vertigo Vomiting

The following precautions are available for HAVRIX (hepatitis a virus vaccine/pf):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of monovalent hepatitis A vaccine (Havrix(R), Vaqta(R)) have not been established in infants younger than 12 months of age. Safety and efficacy of the fixed-combination vaccine containing hepatitis A vaccine and hepatitis B vaccine (HepA-HepB; Twinrix(R)) have not been established in children younger than 18 years of age.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Monovalent hepatitis A vaccine (Havrix(R), Vaqta(R)): There are no adequate and well-controlled studies of monovalent hepatitis A vaccine in pregnant women. Available data do not suggest an increased risk of major birth defects or miscarriage in pregnant women who received the vaccine. No animal studies have been conducted with the vaccine.

Fixed-combination vaccine containing HAV vaccine and HBV vaccine (HepA-HepB; Twinrix(R)): There are no adequate and well-controlled studies of the vaccine in pregnant women. Available data do not suggest an increased risk of major birth defects or miscarriage in pregnant women who received the vaccine within 28 days prior to conception or during pregnancy. In a developmental toxicity study in female rats administered the vaccine prior to mating and during gestation (0.2 mL at each occasion), no adverse effects on fetal or pre-weaning development were observed.

ACIP states that data on the administration of the hepatitis A vaccine during pregnancy remain limited. However, a published safety review of 139 reports submitted to the Vaccine Adverse Event Reporting System (VAERS) between 1996 and 2013 involving pregnant women who received either the hepatitis A vaccine or the combination HepA-HepB (Twinrix(R)) vaccine did not reveal any concerning patterns of adverse events in either the pregnant individuals or their infants. Additionally, a multisite study conducted through the CDC's Vaccine Safety Datalink-- a population-based research and surveillance system-- found no association between maternal hepatitis A vaccination and an increased risk of adverse outcomes among pregnancies resulting in live births.

ACIP recommends that pregnant women identified as being at risk for HAV infection (e.g., international travelers, individuals who use injection or non-injection drugs (i.e., illegal drug users), those with occupational exposure risks, individuals expecting close contact with an international adoptee, individuals experiencing homelessness) or who are at increased risk for severe outcomes from HAV infection (e.g., individuals with chronic liver disease or human immunodeficiency virus infection) should receive the hepatitis A vaccine during pregnancy if they have not been previously vaccinated. CDC states that pregnant women receive hepatitis A vaccination for the same indications as nonpregnant women. Unvaccinated or partially vaccinated pregnant adolescents should receive catch-up vaccination.

Pregnant women at risk for HAV infection during pregnancy should receive counseling regarding prevention methods (e.g., hand hygiene) to prevent infection.

Monovalent hepatitis A vaccine (Havrix(R), Vaqta(R)) and fixed-combination vaccine containing hepatitis A vaccine and hepatitis B vaccine (HepA-HepB; Twinrix(R)): It is not known whether the vaccine is distributed into human milk. Data are not available to assess the effects of the vaccine on the breast-fed child or on milk production. The manufacturers state that the benefits of breast-feeding and the importance of hepatitis A vaccine to the woman should be considered along with the potential adverse effects on the breast-fed child from the vaccine or from the underlying maternal condition.

Clinical studies of Havrix(R) did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently from younger patients; however, other clinical experience has revealed no evidence of age-related differences. Postmarketing safety studies evaluating Vaqta(R) have included 4769 individuals 65 years of age or older, including 1073 who were 75 years of age or older. Although no overall differences in immunogenicity or safety were observed between geriatric and younger patients, and other clinical experience revealed no evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the vaccine cannot be ruled out. Clinical studies of the fixed-combination vaccine containing hepatitis A vaccine and hepatitis B vaccine (HepA-HepB; Twinrix(R)) did not include sufficient numbers of individuals 65 years of age or older to determine whether geriatric individuals respond differently than younger adults.