Pronunciation:

hep-a-TYE-tis A VAX-een, in-AK-ti-vay-ted

Brand Names:

• Havrix
• Havrix Pediatric
• Vaqta
• Vaqta Pediatric

Dosage Forms:

• Solution
• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Hepatitis A vaccine is used to prevent infection caused by the hepatitis A virus (HAV). 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.

It is recommended that adults and children 12 months of age and older to 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.

Immunization against hepatitis A disease is also recommended for adults and children 12 months of age and older who live in areas that have a high rate 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 injection 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.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hepatitis A vaccine in children. However, safety and efficacy have not been established in infants younger than 12 months of age.

Older adults—

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

Breast-feeding—

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

• Elivaldogene Autotemcel
• 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—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.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that you or your child return to your doctor’s office at the right time for the second dose. Be sure to notify your doctor of any unwanted effects that occur after you or your child 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 or your child have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.

Tell your doctor if you or your child are allergic to latex. The needle cover and the rubber plunger of the prefilled syringe contain 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 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

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. 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

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.