Havrix

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

Havrix is given as a shot into the muscle in the thigh or upper arm. 

Common side effects of Havrix include pain, redness, and swelling at the injection site. 

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.

Children and Adolescents: Primary immunization for children and adolescents 12 months through 18 years of age, consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later. 

Adults: Primary immunization for adults consists of a single 1-mL dose and a 1-mL booster dose administered anytime between 6 and 12 months later. 

Serious side effects have been reported with Havrix including the following:

• Allergic reactions. Tell your healthcare provider about any signs or symptoms of  allergic reactions, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• Latex. The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
• Fainting. Fainting can occur in association with administration of Havrix.
• Limitations of vaccine effectiveness. Vaccination with Havrix may not protect all individuals.
• Altered immunocompetence. If Havrix is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

Do not get Havrix if 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.

Serious side effects have been reported with Havrix. See the “Havrix Precautions” section.

Common side effects reported with Havrix include:

• pain, redness, and swelling at the injection site
• irritability
• drowsiness
• loss of appetite
• fever

This is not a complete list of Havrix side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to VAERS at 1-800-822-7967.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you use:

• immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids

This is not a complete list of Havrix drug interactions. Ask your doctor or pharmacist for more information. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Havrix falls into category C. No studies have been conducted in animals, and no well-controlled studies have been done in pregnant women. Havrix should only be given to a pregnant woman if clearly needed. 

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