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USP DI Vol. II - HEPATITISA VACCINE INACTIVATED (Systemic)

HEPATITISA VACCINE INACTIVATED (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Havrix
  • Vaqta

In Canada?

  • Havrix
  • Vaqta

Category

  • Immunizing agent, active

Description

Hepatitis (hep-ah-TY-tiss) A is a serious diseaseof the liver that can cause death. It is caused by the hepatitis A virus (HAV),and is spread most often through infected food or water. Hepatitis A may alsobe spread by close person-to-person contact with infected persons (such asbetween persons living in the same household). Although some infected personsdo not appear to be sick, they are still able to spread the virus to others.

Hepatitis A is less common in the U.S. and other areas of the world thathave a higher level of sanitation and good water and sewage (waste) systems.However, it is a significant health problem in parts of the world that donot have such systems. If you are traveling to certain countries or remote(out-of-the-way) areas, hepatitis A vaccine will help protect you from hepatitisA disease.

It is recommended that persons 12 months of age or 2 years of age and older(depending on which brand of the vaccine is given) be vaccinated with hepatitisA vaccine when traveling to the following parts of the world:

  • Africa
  • Asia (except Japan).
  • Parts of the Caribbean
  • Central and South America.
  • Eastern Europe
  • The Mediterranean basin
  • The Middle East
  • Mexico

Hepatitis A vaccine is also recommended for all persons 12 months or 2years of age and older (depending on which brand of the vaccine is given)who live in areas that have frequent outbreaks of hepatitis A disease or whomay be at increased risk of infection from hepatitis A virus. These personsinclude:

  • Military personnel
  • Persons living in or moving to areas that have a high rate of HAVinfection
  • Persons who may be exposed to the hepatitis A virus repeatedly dueto a high rate of hepatitis A disease, such as Alaskan Eskimos and NativeAmericans
  • Persons engaging in high-risk sexual activity, such as homosexualand bisexual males
  • Persons who use illegal injectable drugs
  • Persons living in a community experiencing an outbreak of hepatitisA
  • Persons working in facilities for the mentally retarded
  • Employees of child day-care centers
  • Persons who work with hepatitis A virus in the laboratory
  • Persons who handle primate animals
  • Persons with hemophilia
  • Food handlers
  • Persons with chronic liver disease

Hepatitis A vaccine is to be used only by or under the supervision of adoctor. It is available in the following dosage form:

    Parenteral
  • Injection (U.S. and Canada)


Before Receiving This Vaccine

In deciding to use a medicine, the risks of taking the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For hepatitis A vaccine, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to hepatitis A vaccine. Also tell your health care professionalif you are allergic to any other substances, such as preservatives.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals. However, since the vaccine does not contain contagiousparticles, it is not expected to cause problems during pregnancy. Before receivingthis vaccine, make sure your doctor knows if you are pregnant or if you maybecome pregnant.

Breast-feeding?This vaccine has not been reported to cause problemsin nursing babies. Be sure you have discussed the risks and benefits of thevaccine with your doctor.

Children?Havrix brand hepatitisA vaccine is not recommended for infants and children younger than 2 yearsof age. For children 2 years of age and older, this vaccine is not expectedto cause different side effects or problems than it does in adults.

Vaqta brand hepatitis A vaccine is not recommendedfor infants and children younger than 12 months of age. For infants 12 monthsof age and older, this vaccine is not expected to cause different side effectsor problems than it does in adults.

Older adults?This vaccine has been tested and has not been shownto cause different side effects or problems in older people than it does inyounger adults. Elderly people may be more sensitive than younger adults tothe effects of hepatitis A vaccine.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of hepatitis A vaccine. Make sure you tell yourdoctor if you have any other medical problems, especially:

  • Bleeding problems such as hemophilia or abnormal bleeding?HepatitisA vaccine injection should be given with caution to avoid increased risks.
  • Illness with fever or
  • Severe infection?May need to delay receiving vaccine untilpatient is feeling better
  • Patients with unsatisfactory immune response?May cause thevaccine to not work as well

Proper Use of This Vaccine

Dosing?The dose of hepatitis A vaccine will be differentfor different patients. Follow your doctor's orders.The following information includes only the average doses of hepatitis A vaccine.

  • For injection dosage form:
    • For prevention of hepatitis A disease:
      • Adults?One adult dose injected into a muscle. A booster (repeat)dose may be needed six to eighteen months after the first dose.
        Havrix brand:
      • Children 2 to 18 years of age?One or two pediatric doses injectedinto a muscle. A booster (repeat) dose may be needed six to twelve monthsafter the first dose.
      • Children up to 2 years of age?Use is not recommended.
        Vaqta brand:
      • Children 12 months to 18 years of age?One or two pediatricdoses injected into a muscle. A booster (repeat) dose may be needed six toeighteen months after the first dose.
      • Infants up to 12 months of age?Use is not recommended.

Side Effects of This Vaccine

Along with its needed effects, a vaccine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention. Itis very important that you tell your doctor about any side effects that occurafter a dose of hepatitis A vaccine, even though the side effect mayhave gone away without treatment. Some types of side effects may mean thatyou should not receive any more doses of hepatitis A vaccine.

Get emergency help immediately if any of thefollowing side effects occur:

    Rare

      Difficulty in breathing or swallowing; hives; itching, especially of feet or hands; reddening of skin, especially around ears; swelling of eyes, face, or inside of nose; unusualtiredness or weakness (sudden and severe)

    Incidence not known

      Black, tarry stools; bleeding gums; blood in urine or stools; confusion; inability to move arms and legs; irritability; pinpoint red spots on skin; seizures; shakiness and unsteady walk; stiff neck; sudden numbnessand weakness in the arms and legs; unsteadiness,trembling, or other problems with muscle control or coordination; unusual bleeding or bruising

Other side effects may occurthat usually do not need medical attention. However, check with your doctorif any of the following side effects continue or are bothersome:

    More common

      Soreness at place of injection

    Less common

      Arm or back pain; bleeding between periods; body aches or pain; changein amount of bleeding during periods; change in patternof monthly periods; congestion; cough; dryness of throat; fever of 37.7 ?C (100 ?F) or higher; generalfeeling of discomfort or illness; headache; hoarseness; lack of appetite; lack or loss of strength; nausea; pain, soreness, tenderness or warmth at injection site; runny nose; sneezing; sore throat; stiffness; stuffy nose; tender, swollen glands in neck; trouble in swallowing; unusual stoppingof menstrual bleeding; voice changes

    Rare

      Aches or pain in joints or muscles; diarrhea or stomach cramps or pain; itching; swelling of glands in armpits or neck; vomiting; welts

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.


Revised: 09/14/2005