Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine

A to Z Drug Facts

  Action Induces antibodies against hepatitis A and B viruses.

  Indications Active immunization of patients 18 yr 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.

  Route/Dosage

Adults: IM 3 doses given on a 0-, 1-, and 6-month schedule.

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

  Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established in patients less than 18 yr. Anaphylaxis: There have been rare reports of anaphylaxis and anaphylactoid reactions.

  Administration/Storage

• For IM injection only. Not for IV or ID administration.
• Primary immunizing regimen consists of 3 doses, given on a 0-, 1- and 6-month schedule.
• 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 vaccine remaining in the vial.
• Administer IM in deltoid region. Avoid gluteal injection, which may result in less than optimal immune response.
• Always record manufacturer's name and vaccine lot number in patient's permanent medical record file along with date of administration and 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.

  Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of the following: allergy to yeast; serious reactions to previous doses of hepatitis A or B vaccines; anticoagulant therapy; bleeding disorder; 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.
• If a dose is missed, administer as soon as possible and resume schedule to complete series. Do not restart the series. Delaying immunization does not reduce effectiveness of vaccine but does delay time to achieve maximum protection.

  Patient/Family Education

• Explain name, action, and potential side effects of vaccine.
• 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 hr.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts