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Hepatitis A and hepatitis B vaccine (Intramuscular route)

Pronunciation:

hep-a-TYE-tis A VAX-een, in-AK-ti-vay-ted, hep-a-TYE-tis B VAX-een re-KOM-bin-ant

Brand Names:

  • Twinrix
  • Twinrix Adult
  • Twinrix Junior

Dosage Forms:

  • Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Hepatitis A and hepatitis B combination vaccine is used to prevent infection caused by 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.
  • Persons engaging in high-risk sexual activity, such as homosexual and bisexual 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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

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 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 from a disease or medicine—The vaccine may not work as well in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot into your muscles.

This vaccine is usually given as 3 doses. After the first dose, two more doses are given 1 month and 6 months after the first dose, unless your doctor tells you otherwise.

It is important that you receive all doses at the right time. If you miss your scheduled shot, call your doctor to make another appointment as soon as possible.

Precautions While Using This Medicine:

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 unwanted 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.

Tell your doctor if you are allergic to latex. The needle cover and the rubber plunger of the prefilled syringe contains dry natural latex rubber, which may cause an allergic reaction in people with a latex allergy.

This vaccine may not protect you against hepatitis A or hepatitis B infection if you are already infected with the virus at the time you receive the shot.

Side Effects of This Medicine:

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
chills
coma
confusion
convulsions or seizures
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
severe headache
shortness of breath
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
tightness in the chest
unusual bleeding or bruising
unusual tiredness or weakness
upper right abdominal or stomach pain
wheezing
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
Abdominal or stomach pain
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
sweating
trouble with sleeping
unable to sleep
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.


Last Updated: 4/4/2014

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