Hepatitis A Vaccine Inactivated and Hepatitis B Vaccine Recombinant (Intramuscular Route)

The vaccine works by causing your body to produce its own protection (antibodies) against the disease. Hepatitis A and Hepatitis B are highly contagious, serious diseases of the liver .

The hepatitis A virus (HAV) 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.

Hepatitis B (HBV) is spread by contact with body fluids, such as blood, saliva, semen, or vaginal fluids; by needle sticks or sharing needles; or from mother to child.

Hepatitis A and Hepatitis B combination vaccine is recommended for all persons 18 years of age or older who are at risk from infection from their jobs or some behaviors, or from traveling to the following parts of the world:

• Africa.


• the Caribbean.


• Central and South America.


• Eastern and southern Europe.


• the Middle East .


• South and southeast Asia (except Japan).


• the Soviet Union (former).

Hepatitis A and Hepatitis B combination vaccine is also recommended for:

• Military personnel .


• Persons living in or moving to areas that have a high rate of HAV infection and who are at a high risk of HBV infection.


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


• Persons who use illegal injectable drugs.


• Persons at risk through their work, such as laboratory workers who handle live hepatitis A and hepatitis B virus, police and those who give first aid or medical help, and workers who come in contact with stool or sewage.


• People who work in child daycare centers and correctional facilities, residents of drug and alcohol treatment centers, and patients and staff in hemodialysis units.


• Patients who frequently receive blood and blood products, including those people who have problems with clotting, such as hemophiliacs.


• Persons with chronic liver disease.


• Healthcare workers who give first aid or emergency medical care .


• People who are at increased risk for HBV infection and who are in close contact with patients that have hepatitis A or B.

This medicine is available only with your doctor`s prescription .

This product is available in the following dosage forms:

• Suspension

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

Appropriate studies have not been performed on the relationship of age to the effects of hepatitis A and hepatitis B combination vaccine in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of hepatitis A and hepatitis B combination vaccine in the elderly .

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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:

• Allergy to neomycin or


• Allergy to yeasta€”Should not use in patients with these conditions .

• Bleeding problems or


• Low blood platelet counta€”Because hepatitis A and hepatitis B combination vaccine must be injected into a muscle, it may cause bleeding .

• Hepatitis A or


• Hepatitis Ba€”The vaccine will not work in patients who already have the disease .

• Illness, moderate or severe, with or without fevera€”The vaccine should not be given until after the illness has cleared up .

• Immune system problemsa€”The vaccine may not work properly in patients with this condition .

Proper Use

A nurse or other trained health professional will give you this vaccine . Hepatitis A and hepatitis B combination vaccine is given as a shot into your muscle .

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 and hepatitis B:
    
    
    
    • Adultsa€”One milliliter (mL) injected into the arm muscle during the first office visit, then again at one month and six months after the first dose, for a total of three doses. Alternatively, an accelerated dosing schedule may be used, which starts at the first office visit, with additional doses at 7 days and 21 to 30 days after the first dose . This is followed by a fourth (booster) dose 12 months after the first dose .
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Precautions

It is very important that you return to your doctor`s office at the right time for all of the doses. Be sure to notify your doctor of any side effects that occur after you receive this vaccine .

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention . Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection .

It is very important to tell your doctor if you are allergic to rubber. The prefilled syringe contains dry natural latex rubber, which may cause an allergic reaction if you have a latex allergy .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

Symptoms of allergic reaction

• 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)

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 the place of injection

Less common

• Cough


• Fever


• Hardening or thickening of skin at the place of injection


• Sneezing


• Sore throat

Rare

• Abdominal or stomach pain


• Back pain


• Bruising at the place of injection


• Difficulty in moving


• Dizziness


• Fainting or lightheadedness when getting up from a lying or sitting position suddenly


• Fast heartbeat


• Feeling of constant movement of self or surroundings


• Feeling of warmth


• Headache, may be severe


• Irritability and agitation


• Itching, redness, or swelling at the place of injection


• Large, flat, blue or purplish patches in the skin at the place of injection


• Loss of appetite


• Muscle pain


• Nausea


• Pain, swelling, or redness in joints


• Rash


• Runny nose


• Sensation of spinning


• Sleepiness


• Sleeplessness


• Small, red or purple spots on skin


• Sweating


• Tingling, burning, or prickly sensations


• Trouble sleeping


• Unusual drowsiness


• Unusually fast heartbeat


• Unusually warm skin


• Vomiting


• Weakness


• Weight loss

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.