Havrix

Mechanism of Action

Attenuated strain of hepatitis A virus (HAV) which stimulates active immunity

Onset: 4 wk

Duration: unknown

These products convey active immunity via stimulation of production of endogenously produced antibodies

The onset of protection from disease is relatively slow, but duration is long lasting (years)

Havrix is a vaccine used for prevention of disease caused by hepatitis A virus (HAV).

Havrix is approved for use in persons 12 months of age and older.

Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.

Tell your healthcare provider you or your child:

• had a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of Havrix, including neomycin
• are allergic to latex
• are immunocompromised
• are pregnant or plan to become pregnant
• are breastfeeding

Tell you doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if Havrix crosses into human milk. Because some vaccines can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this vaccine, caution should be exercised when Havrix is administered to a nursing woman

• Hepatitis (Viral Hepatitis, A, B, C, D, E, G)
• Vaccination and Immunization Safety Information

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.

• If you have an allergy to any part of Havrix (hepatitis A vaccine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are allergic to neomycin, talk with the doctor.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Havrix is a hepatitis A vaccine. 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.

Havrix vaccine is used to help prevent this disease in adults.

Havrix works by exposing you 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.

Like any vaccine, Havrix may not provide protection from disease in every person.

Contact your doctor if you miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure to receive all recommended doses of Havrix or you may not be fully protected against disease.

Hepatitis A vaccine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. The vaccine is only recommended for use during pregnancy when clearly indicated. The Advisory Committee on Immunization Practices recommends that vaccination of pregnant women who are at risk of exposure be considered.