Havrix Pediatric (Intramuscular)

Hepatitis A vaccine is used to prevent infection from the hepatitis A virus (HAV). The vaccine helps your body create its own defense (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 commonly spread through contaminated food or water. Hepatitis A can also spread through close contact with infected individuals (for example, among people living in the same household). Some infected people may not show symptoms, but they can still transmit the virus to others.

Hepatitis A is less common in the U.S. and other areas with better sanitation and reliable water and sewage systems. However, it remains a significant 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 these 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 high rates of hepatitis A disease or who may be at increased risk of infection from the hepatitis A virus. This includes:

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

This vaccine should only be administered by or under the supervision of a doctor.

It is very important that you or your child return to your doctor’s office at the correct time for the second dose. Make sure to inform your doctor of any side 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. Contact your doctor right away if you or your child experience a rash, itching, swelling of the tongue and throat, or trouble breathing after the injection.

Let your doctor know 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 trigger an allergic reaction in individuals 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 and your doctor need to think about the risks of the vaccine compared to the benefits it provides. Here are some important points to consider:

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

Geriatric

Studies to date have not identified any specific problems in older adults that would limit the effectiveness of the hepatitis A vaccine.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a chance of interaction. In these situations, your doctor may adjust the dose or take other precautions. When you receive this vaccine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The interactions listed below are based on their potential significance and may not be all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Allergy to neomycin—This vaccine should not be used if you have this allergy.

• Bleeding problems (e.g., hemophilia)—Use with caution. There may be a higher risk of bleeding at the injection site.

• Liver disease or
• Weak immune system due to a disease or medicine—The vaccine may not work as well in these patients.

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

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, 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. 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, 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.