Hepatitis A Vaccine, Inactivated

Trade Names:Havrix- Injection 720 enzyme-linked immunosorbent assay (ELISA) units (ELU) per 0.5 mL of viral antigen- Injection 1,440 ELU per mL of viral antigen

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

Pharmacology

Provides active immunization against hepatitis A.

Indications and Usage

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

Contraindications

Previous severe allergic reaction (eg, anaphylaxis) to any hepatitis A–containing vaccine; hypersensitivity to any component of the vaccine, including neomycin.

Dosage and Administration

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

IM Havrix 720 ELU (0.5 mL) followed by a booster dose of 720 ELU 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.

Products are interchangeable for booster dose (ie, 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

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

Compared with giving hepatitis A vaccine alone, when coadministered with immune globulin, lower antibody titers may be obtained; however, hepatitis A vaccine and immune globulin may be given concurrently using different syringes and different injection sites.

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

Use separate injection sites and syringes when injecting concomitant vaccines.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Syncope (postmarketing).

CNS

Fatigue, malaise (1% to 10%).

Irritability (24% to 36%); drowsiness (29%); loss of appetite (26%); headache (less than 9%).

Dizziness, encephalopathy, Guillian-Barré syndrome, multiple sclerosis, myelitis, neuropathy, paresthesia, seizures, somnolence.

Headache (16%); asthenia/fatigue (4%).

Irritability (11%); crying (2%).

Headache (2%).

Cerebellar ataxia; encephalitis; Guillian-Barré syndrome.

Dermatologic

Angioedema, erythema multiforme, hyperhidrosis (postmarketing).

Rash (5%); measles-like rash, varicella-like rash, viral erythema (1%).

EENT

Pharyngitis (3%); nasal congestion (1%).

Otitis media (8%); rhinorrhea (6%); otitis (2%); conjunctivitis, nasal congestion (1%).

Pharyngitis (2%).

GI

Anorexia, nausea (1% to 10%)

Diarrhea (3%); nausea (2%).

Diarrhea (6%); vomiting (4%); anorexia (1%).

Abdominal pain (2%); diarrhea, vomiting (1%).

Genitourinary

Menstrual disorder (1%).

Hematologic-Lymphatic

Thrombocytopenia (postmarketing).

Ecchymosis (2%).

Ecchymosis (1%).

Thrombocytopenia.

Hepatic

Hepatitis, jaundice (postmarketing).

Hypersensitivity

Anaphylactic and anaphylactoid reactions (postmarketing).

Local

Soreness (56%); tenderness (8%); induration, redness, swelling (1% to 10%).

Pain (28%); redness (22%); soreness (21%); swelling (8% to 10%); tenderness (8%).

Tenderness (53%); pain (51%); warmth (17%); swelling (14%); erythema (13%); ecchymosis (2%); pain/soreness (1%).

Pain/soreness/tenderness (4%); erythema, swelling (2%); ecchymosis, warmth (1%).

Pain (19%); tenderness (17%); warmth (9%); erythema (8%); swelling (7%); ecchymosis (1%).

Musculoskeletal

Myalgia (2%); arm pain, back pain, stiffness (1%).

Respiratory

Dyspnea (postmarketing).

Upper respiratory tract infection (3%).

Upper respiratory tract infection (10%); cough (5%); respiratory congestion (2%); laryngotracheobronchitis (1%).

Cough, upper respiratory infection (1%).

Miscellaneous

Fever (1% to 10%).

Fever (9%).

Congenital anomaly.

Fever (3%); abdominal pain (1%).

Fever (11%).

Fever (3%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

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

Elderly

No differences in overall safety between subjects 65 yr of age and older compared with younger subjects have been identified.

Hepatic Function

Patients with liver disease had a lower antibody response than healthy subjects.

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.

Copyright © 2009 Wolters Kluwer Health.