Vaqta Pediatric

Hepatitis is a serious disease caused by a virus. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.

The hepatitis A pediatric vaccine is used to help prevent this disease in children.

This vaccine works by exposing your child to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis A pediatric vaccine is recommended for all children who are 12 months of age or older. This vaccine is also recommended in children who travel to certain areas of the world where hepatitis A is a common disease.

Other risk factors for hepatitis in children include: receiving treatment for hemophilia or other bleeding disorders, or being in an area where there has been an outbreak of hepatitis A.

Like any vaccine, the hepatitis A pediatric vaccine may not provide protection from disease in every person.

Hepatitis A pediatric vaccine will not protect against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect against hepatitis A if your child is already infected with the virus, even without showing symptoms.

Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to any vaccine containing hepatitis A, or if the child is allergic to neomycin.

Before receiving this vaccine, tell the doctor if your child has:

• an allergy to latex rubber; or

• a weak immune system (caused by disease or by using certain medicine.

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Hepatitis A vaccine is not approved for use by anyone younger than 12 months old.

An overdose of this vaccine is unlikely to occur.

In the U.S.

• Havrix
• Havrix Pediatric
• Vaqta
• Vaqta Pediatric

Available Dosage Forms:

• Suspension
• Solution
• Injectable

Therapeutic Class: Vaccine

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 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.

Geriatric

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

Pregnancy

Breast Feeding

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

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

This section provides information on the proper use of a number of products that contain hepatitis a vaccine. It may not be specific to Vaqta Pediatric. Please read with care.

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.

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:

• Fever more than 99.5 degrees F
• general feeling of discomfort or illness
• unusual tiredness or weakness

• 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

• 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:

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

• 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

• 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

• 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.