Professional Information

Hepatitis A Vaccine, Inactivated

Pronouncation: (Hep-ah-TY-tiss)
Class: Vaccine, viral

Trade Names:
Havrix
- Injection 720 ELISA units (EL.U.) per 0.5 mL of viral antigen
- Injection 1,440 EL.U./mL of viral antigen

Trade Names:
Vaqta
- Injection 25 units per 0.5 mL of hepatitis A virus protein
- Injectable 50 units per 1 mL of HAV protein

Avaxim (Canada)
Avaxim Pediatric (Canada)
Epaxal Berna (Canada)

Pharmacology

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Provides active immunization.

Indications and Usage

Active immunization of patients 12 mo of age and older against disease caused by hepatitis A virus.

Contraindications

Previous hypersensitivity to any hepatitis A–containing vaccine; hypersensitivity to any component of the vaccine, including neomycin.

Dosage and Administration

Adults (19 yr of age and older)

IM (in the deltoid region) Havrix 1,440 EL.U. (1 mL) followed by a booster dose 6 to 12 mo later or Vaqta 50 units (1 mL) followed by a booster dose 6 to 18 mo later.

Children (12 mo through 18 yr of age)

IM Havrix 720 EL.U. (0.5 mL) followed by a booster dose of 720 EL.U. 6 to 12 mo later or Vaqta 25 units (0.5 mL) followed by a booster dose of 25 units (0.5 mL) 6 to 18 mo later.

General Advice

For IM injection only. Not for IV, subcutaneous, or intradermal administration.
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.
Do not mix with any other vaccine in the same syringe or vial.

Interchangeability of booster dose

Products are interchangeable for booster dose (eg, Vaqta can be used for booster dose following primary dose of Havrix ). Booster dose should be same strength as primary dose.

Storage/Stability

Store vials and syringes in refrigerator (36° to 46°F). Do not freeze. Discard if vaccine has been frozen because freezing destroys potency.

Drug Interactions

Anticoagulants

Because bleeding may occur following IM administration, use with caution.

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.

Immunosuppressants

May result in inadequate response to immunization; therefore, additional administration of vaccine may be required.

Other vaccines

Use separate injection sites and syringes when injecting concomitant vaccines.

Adverse Reactions

Cardiovascular

Havrix

Syncope (postmarketing).

CNS

Havrix

Headache (14%); fatigue, malaise (1% to 10%); hypertonic episode, insomnia, photophobia, vertigo (greater than 1%); convulsions, dizziness, encephalopathy, Guillain-Barré syndrome, multiple sclerosis, myelitis, neuropathy, paresthesia, somnolence (postmarketing).

Vaqta

Adults: headache (16%); asthenia/fatigue (4%). Children (12ߙthrough 23 mo of age): irritability (11%); crying (2%). Children (2 through 18 yr of age): headache (2%). Postmarketing: cerebellar ataxia; encephalitis; Guillain-Barré syndrome.

Dermatologic

Havrix

Angioedema, erythema multiforme, hyperhidrosis (postmarketing).

Vaqta

Children (12 through 23 mo of age): rash (4%); measles-like rash, varicella-like rash, viral erythema (1%).

EENT

Vaqta

Adults: pharyngitis (3%); nasal congestion (1%). Children (12 through 23 mo of age): otitis media (8%); rhinorrhea (6%); otitis (2%); conjunctivitis, nasal congestion (1%). Children (2 through 18 yr of age): pharyngitis (2%).

GI

Havrix

Anorexia, nausea (1% to 10%).

Vaqta

Adults: diarrhea (3%); nausea (2%). Children (12 through 23 mo of age): diarrhea (6%); vomiting (4%); anorexia (1%). Children (2 through 18 yr of age): abdominal pain (2%); diarrhea, vomiting (1%).

Genitourinary

Vaqta

Adults: menstrual disorder (1%).

Hematologic-Lymphatic

Vaqta

Adults: ecchymosis (2%). Children (12 through 23 mo of age): ecchymosis (1%). Postmarketing: thrombocytopenia.

Hepatic

Havrix

Postmarketing: hepatitis; jaundice.

Local

Havrix

Pain (22%); induration, redness, swelling (1% to 10%).

Vaqta

Adults: tenderness (53%); pain (51%); warmth (17%); swelling (14%); erythema (13%); ecchymosis (2%); pain/soreness (1%). Children (12 through 23 mo of age): pain/soreness/tenderness (4%); erythema, swelling (2%); warmth (1%). Children (2 through 18 yr of age): pain (19%); tenderness (17%); warmth (9%); erythema (8%); swelling (7%); ecchymosis (1%).

Musculoskeletal

Vaqta

Adults: myalgia (2%); arm pain, back pain, stiffness (1%).

Respiratory

Havrix

Dyspnea (postmarketing).

Vaqta

Adults: upper respiratory tract infection (3%). Children (12 through 23 mo of age): upper respiratory tract infection (10%); cough (5%); respiratory congestion (2%); laryngotracheobronchitis (1%). Children (2ߙthrough 18 yr of age): cough, upper respiratory infection (1%).

Miscellaneous

Havrix

Fever (1% to 10%); anaphylaxis/anaphylactoid reactions, congenital abnormalities (postmarketing).

Vaqta

Adults: fever (3%); abdominal pain (1%). Children (12 through 23 mo of age): fever (11%). Children (2 through 18 yr of age): fever (3%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 12 mo of age.

Anaphylaxis

There have been rare reports of anaphylaxis and anaphylactoid reactions.

Bleeding disorders

Because bleeding may occur with IM injections, do not administer to individuals with bleeding disorders, such as hemophilia or thrombocytopenia, or patients on anticoagulant therapy.

Febrile illness

May need to delay administration.

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.

Immunosuppression

The expected immune response may not be obtained in immunosuppressed patients.

Latex allergy

Products may contain dry natural latex rubber.

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.

Patient Information

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, ibuprofen) for fever, pain, or discomfort at injection site.
Advise patient to notify health care provider if bothersome adverse reactions last more than 24 h.