Havrix

It is caused by the hepatitis A virus (HAV), and is spread most often through infected food or water . Hepatitis A may also be spread by close person-to-person contact with infected persons (such as between persons living in the same household). Although some infected persons do 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 that have 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 do not 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 hepatitis A 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 hepatitis A 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 2 years 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 who may be at increased risk of infection from hepatitis A virus. These persons include:

• Military personnel


• Persons living in or moving to areas that have a high rate of HAV infection


• Persons who may be exposed to the hepatitis A virus repeatedly due to a high rate of hepatitis A disease, such as Alaskan Eskimos and Native Americans


• Persons engaging in high-risk sexual activity, such as homosexual and bisexual males


• Persons who use illegal injectable drugs


• Persons living in a community experiencing an outbreak of hepatitis A


• 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 a doctor .

This product is available in the following dosage forms:

• Suspension


• Solution


• Injectable

Before Using

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Havrix brand hepatitis A vaccine is not recommended for infants and children younger than 2 years of age. For children 2 years of age and older, this vaccine is not expected to cause different side effects or problems than it does in adults.

Vaqta brand hepatitis A vaccine is not recommended for infants and children younger than 12 months of age. For infants 12 months of age and older, this vaccine is not expected to cause different side effects or problems than it dose in adults.

Geriatric

This vaccine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. Elderly people may be more sensitive than younger adults to the effects of hepatitis A vaccine .

Pregnancy

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine . Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems such as hemophilia or abnormal bleedinga€”Hepatitis A vaccine injection should be given with caution to avoid increased risks.

• Illness with fever or


• Severe infectiona€”May need to delay receiving vaccine until patient is feeling better

• Patients with unsatisfactory immune responsea€”May cause the vaccine to not work as well

Proper Use

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  
  
  • For prevention of hepatitis A disease:
    
    
    
    • Adultsa€”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 agea€”One or two pediatric doses injected into a muscle. A booster (repeat) dose may be needed six to twelve months after the first dose .
    
    
    • Children up to 2 years of agea€”Use is not recommended .
    
    
    • Vaqta brand: Children 12 months to 18 years of agea€”One or two pediatric doses injected into a muscle. A booster (repeat) dose may be needed six to eighteen months after the first dose .
    
    
    • Infants up to 12 months of agea€”Use is not recommended .
    
    
    
    
  
  
  
  

Side Effects

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

Check with your doctor immediately if any of the following 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


• Unusual tiredness 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 numbness and weakness in the arms and legs


• Unsteadiness, trembling, or other problems with muscle control or coordination


• Unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Soreness at place of injection

Less common

• Arm or back pain


• Bleeding between periods


• Body aches or pain


• Change in amount of bleeding during periods


• Change in pattern of monthly periods


• Congestion


• Cough


• Dryness of throat


• Fever of 37.7 A°C (100 A°F) or higher


• General feeling of discomfort or illness


• Headache


• Hoarseness


• Lack of appetite


• Lack or loss of strength


• Nausea


• Pain, soreness


• Runny nose


• Sneezing


• Sore throat


• Stiffness


• Stuffy nose


• Tender, swollen glands in neck


• Tenderness or warmth at injection site


• Trouble in swallowing


• Unusual stopping of 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.