Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine

Pronunciation: Hep-uh-TIGHT-iss
Class: Vaccine, viral

Trade Names

Twinrix
- Injection at least 720 EL.U. inactivated hepatitis A, 20 mcg recombinant HBsAg protein/mL

Pharmacology

Provides active immunization.

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Indications and Usage

Active immunization of patients 18 yr of age or older against disease caused by hepatitis A and infection by all known subtypes of hepatitis B virus.

Contraindications

Hypersensitivity to yeast or any other component of the vaccine or hypersensitivity after previous administration of this product or monovalent hepatitis A or hepatitis B vaccines.

Dosage and Administration

Adults

IM 3 doses given on a 0-, 1-, and 6-mo schedule.

General Advice

  • For IM injection only. Not for IV or ID 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.

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.

Immunosuppressants

May result in inadequate response to immunization.

Adverse Reactions

CNS

Headache; fatigue.

GI

Diarrhea; nausea; vomiting.

Respiratory

Upper respiratory tract infections.

Miscellaneous

Local soreness, redness, induration, and swelling; fever.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in patients younger than 18 yr of age.

Anaphylaxis

There have been rare reports of anaphylaxis and anaphylactoid reactions.

Patient Information

  • Advise patient that vaccine does not provide protection from other causes of food and waterborne diseases other than hepatitis A and to continue to take all necessary precautions to avoid contact with, or ingestion of, contaminated food and water.
  • Review immunization schedule and advise patient that for vaccine to be effective, the complete series of 3 injections must be completed.
  • Provide patient with immunization history record.
  • Advise patient to use OTC analgesics (eg, acetaminophen, 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 h.

Copyright © 2009 Wolters Kluwer Health.

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