Hepatitis a vaccine (Intramuscular)

Hepatitis A vaccine is used to prevent infection from the hepatitis A virus (HAV). The vaccine helps your body create its own protection (antibodies) against the disease.

Hepatitis A is a serious liver disease that can be fatal. It is caused by the hepatitis A virus (HAV) and is most often spread through contaminated food or water. Hepatitis A can also spread through close contact with infected people (for example, among people living in the same household). Some infected individuals may not show symptoms, but they can still spread the virus to others.

Hepatitis A is less common in the U.S. and other areas with high sanitation and good water and sewage systems. However, it remains a major health issue in parts of the world lacking these systems. If you are traveling to certain countries or remote areas, the hepatitis A vaccine can help protect you from hepatitis A disease.

It is recommended that adults and children 12 months of age and older receive the hepatitis A vaccine when traveling to the following regions:

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

Vaccination against hepatitis A disease is also recommended for adults and children 12 months of age and older who live in areas with a high rate of hepatitis A disease or who may be at greater risk of infection from the hepatitis A virus. These individuals include:

• Military personnel.
• People living in or moving to areas with a high rate of HAV infection.
• People who may be repeatedly exposed to the hepatitis A virus due to high rates of hepatitis A disease, such as Alaskan Eskimos and Native Americans.
• People engaging in high-risk sexual activities, such as homosexual and bisexual males.
• People who use illegal injection drugs.
• People living in a community experiencing a hepatitis A outbreak.
• People working in facilities for individuals with intellectual disabilities.
• Employees of child day-care centers.
• People working with hepatitis A virus in a laboratory.
• People who handle primate animals.
• People with hemophilia.
• Food handlers.
• People with chronic liver disease.

This vaccine must be given only by or under the supervision of a doctor.

It is very important that you or your child go back to your doctor’s office at the correct time for the second dose. Make sure to inform your doctor of any unwanted effects that happen after you or your child receive this vaccine.

This vaccine may cause a serious allergic reaction known as anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Let your doctor know right away if you or your child experience a rash, itching, swelling of the tongue and throat, or trouble breathing after getting the injection.

Inform your doctor if you or your child are allergic to latex. The needle cover and the rubber plunger of the prefilled syringe have dry natural latex rubber, which can cause an allergic reaction in people with a latex allergy.

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

In deciding to use a vaccine, you need to think about the risks of the vaccine compared to the benefits it may provide. This is a decision you will make with your doctor. For this vaccine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems that would limit the use of hepatitis A vaccine in children. However, safety and effectiveness have not been established in infants younger than 12 months of age.

Geriatric

Studies done so far have not shown any specific problems that would limit the use of hepatitis A vaccine in elderly patients.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these cases, your doctor may adjust the dose, or other precautions may be needed. When you receive this vaccine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen for 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 necessary in some situations. If both medicines are prescribed together, your doctor might change the dose or how often you take one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical problems, especially:

• Allergy to neomycin—Should not be used in patients with this condition.

• Bleeding problems (e.g., hemophilia)—Use with caution. May have an increased risk of bleeding at the injection site.

• Liver disease or
• Weak immune system from a disease or medicine—May not work as well in patients with these conditions.

• Severe illness with fever—Your dose may need to be given at a later time.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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
• general feeling of discomfort or illness
• unusual tiredness or weakness

Rare

• Body aches or pain
• chills
• congestion
• cough
• difficulty with breathing or swallowing
• dryness or soreness of the throat
• ear congestion
• headache
• hives
• hoarseness
• itching, especially of the feet or hands
• loss of voice
• nasal congestion
• reddening of the skin, especially around the ears
• runny nose
• shortness of breath
• sneezing
• sore throat
• swelling of the eyes, face, or inside of the nose
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tender, swollen glands in the neck
• tightness in the chest
• unusual tiredness or weakness (sudden and severe)
• voice changes
• wheezing

Incidence not known

• Abdominal or stomach pain
• agitation
• back pain
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings in the hands, arms, feet, or legs
• clay-colored stools
• coma
• confusion
• dark urine
• diarrhea
• difficulty controlling your bladder or bowels
• difficulty with walking
• dizziness
• drowsiness
• fainting
• fast heartbeat
• feeling of discomfort
• feeling sad or depressed
• flu-like symptoms
• forgetful
• hallucinations
• inability to move the arms and legs
• increased sweating
• inflammation of the joints
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• muscle aches or cramps
• nausea
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red, irritated eyes
• seizures
• sensation of pins and needles
• shakiness and unsteady walk
• slurred speech
• sores, ulcers, or white spots in the mouth or on the lips
• stabbing pain
• stiff neck
• sudden numbness and weakness in the arms and legs
• swollen lymph glands
• unpleasant breath odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• vomiting of blood
• yellow eyes or 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. 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

• Pain, redness, swelling, or lumps at the injection site
• weight loss

Less common

• Arm pain
• bleeding between periods
• change in the amount of bleeding during periods
• change in the pattern of monthly periods
• lack or loss of strength
• tenderness or warmth at the injection site
• unusual stopping of menstrual bleeding

Rare

• Change in color vision
• change in taste
• collection of blood under the skin
• deep, dark purple bruise
• difficulty seeing at night
• difficulty with moving
• dizziness or lightheadedness
• excessive muscle tone
• feeling of constant movement of self or surroundings
• increased sensitivity of the eyes to sunlight
• loss of taste
• muscle tension or tightness
• sensation of spinning
• sleeplessness
• trouble with sleeping
• unable to sleep
• welts

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• sleepiness or unusual drowsiness

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.

In the U.S.

• Havrix
• Havrix Pediatric
• Vaqta
• Vaqta Pediatric

Available Dosage Forms:

• Solution
• Suspension

Therapeutic Class: Vaccine

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

This vaccine is usually given as 2 doses. After the first dose, the Havrix® booster dose is given anytime between 6 to 12 months later, while the Vaqta® booster dose is given anytime between 6 to 18 months later, unless your doctor tells you otherwise.