Description
Hepatitis A and hepatitis B combination vaccine is used to prevent infection caused by all known subtypes of the hepatitis A and hepatitis B virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.
Hepatitis A is a serious disease of 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 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 is caused by hepatitis B virus (HBV), and 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.
- Central and South America.
- Eastern and Southern Europe.
- South and Southeast Asia (except Japan).
- The Caribbean.
- The Middle East.
- The former Soviet Union
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.
- Males who have sex with males.
- Persons who use illegal injection 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.
- People who are at increased risk for HBV infection and who are in close contact with patients that have hepatitis A or B.
- Persons with hemophilia.
- Persons with chronic liver disease.
This vaccine is to be given only by or under the supervision of a doctor.
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 on the relationship of age to the effects of hepatitis A and hepatitis B combination vaccine have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.
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. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Atidarsagene Autotemcel
- Elivaldogene Autotemcel
- Ocrelizumab
- Teplizumab-mzwv
- Ublituximab-xiiy
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 yeast—Should not be used in patients with these conditions.
- Moderate or severe illness with fever—Your dose may need to be given at a later time.
- Weak immune system—This condition may decrease the useful effects of the vaccine.
Proper Use
A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot into one of your muscles, usually in the deltoid area (shoulder or upper arm).
This vaccine is usually given as 3 or 4 doses. The first 2 doses are given at least 1 month (for patients receiving 3 doses) or 7 days apart (for patients receiving 4 doses). The third dose is given at least 6 months (for patients receiving 3 doses) or 21 to 30 days (for patients receiving 4 doses) after the first dose. The booster dose is given at least 12 months (for patients receiving 4 doses) after the first dose. To get the best possible protection against infection with the HAV or HBV, you should complete your vaccine dosing schedule.
Precautions
It is important that your doctor check your progress to make sure this vaccine is working properly. Blood tests may be needed to check for unwanted effects.
Fainting may occur after you receive this vaccine. Your doctor may want you to be observed after you get the injection to prevent and manage fainting.
This vaccine may not protect everyone who receives it. This vaccine will not treat symptoms of hepatitis A or hepatitis B infection if you already have the disease. It is very important to take precautions to reduce the risk of hepatitis A or hepatitis B infection.
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 or nurse immediately if any of the following side effects occur:
More common
- Fever more than 99.5 degrees F
- unusual tiredness or weakness
Rare
- Difficulty with breathing or swallowing
- hives
- itching, especially of the hands or feet
- reddening of the skin, especially around the ears
- swelling of the eyes, face, or inside of the nose
- unusual tiredness or weakness (sudden and severe)
Incidence not known
- Agitation
- back pain
- being forgetful
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- bloody nose
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest tightness
- chills
- coma
- confusion
- cough
- dark urine
- diarrhea
- difficulty controlling your bladder or bowels
- difficulty with walking
- dizziness
- drowsiness
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of discomfort
- feeling sad or depressed
- general feeling of illness
- general tiredness and weakness
- hallucinations
- headache
- heavier menstrual periods
- inability to move the arms and legs
- increased sweating
- inflammation of the joints
- irritability
- itching
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- muscle aches or cramps
- nausea or vomiting
- numbness or tingling in your arms, face, hands, or legs
- partial or slight paralysis
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rash
- red, irritated eyes
- redness, soreness, or itching skin
- seizures
- severe headache
- slurred speech or problems with swallowing
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- sores, welting, or blisters
- stiff neck or back
- sudden numbness and weakness in the arms and legs
- swollen lymph glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- yellow eyes and skin
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
- Body aches or pain
- ear congestion
- hard lump, redness, soreness, or swelling at the injection site
- loss of voice
- nasal congestion
- runny nose
- sneezing
Rare
- Bruising at the injection site
- dry mouth
- fainting or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of constant movement of self or surroundings
- feeling of warmth
- headache, severe and throbbing
- hyperventilation
- large, flat, blue or purplish patches in the skin at the injection site
- loss of appetite
- muscle pain or stiffness
- pain, swelling, or redness in the joints
- redness of the face, neck, arms, and occasionally, upper chest
- restlessness
- sensation of spinning
- shaking
- sleepiness or unusual drowsiness
- sleeplessness
- small, red or purple spots on the skin
- stomach pain
- sweating
- trouble with sleeping
- unusually fast heartbeat
- unusually warm skin
- weakness
- weight loss
Incidence not known
- Acid or sour stomach
- belching
- continuing ringing or buzzing or other unexplained noise in the ears
- disturbed color perception
- double vision
- earache
- hair loss or thinning of the hair
- halos around lights
- hearing loss
- heartburn
- indigestion
- night blindness
- overbright appearance of lights
- painful blisters on the trunk of the body
- stomach discomfort or upset
- tunnel vision
- weakness of the muscles in your face
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.
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