Product image of Havrix (Hepatitis A Virus (Inactivated), Aluminium Hydroxide) supplied by GNH India

Havrix

Active Ingredient:
Hepatitis A Virus (Inactivated), Aluminium Hydroxide
Origin:
EU

Havrix (Hepatitis A Virus (Inactivated), Aluminium Hydroxide)

Havrix is an injectable vaccine that contains inactivated hepatitis A virus and aluminium hydroxide as adjuvant. It is supplied as a sterile solution for intramuscular administration. The product is prescribed in the European Union for prophylaxis against hepatitis A infection. Havrix is a prescription‑only medication that stimulates the immune system to produce protective antibodies against the hepatitis A virus. It is administered in two doses to achieve lasting immunity.

Manufacturer / TM Owner

Glaxosmithkline Biologicals S.A.

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Indications & Clinical Uses

Havrix is indicated for the prevention of hepatitis A infection in individuals who are at risk of exposure.

  • Adults and children aged 12 months and older who require hepatitis A prophylaxis.
  • Travelers to regions where hepatitis A is endemic or where outbreaks have occurred.
  • Persons with occupational exposure to hepatitis A virus, such as laboratory workers.
  • Individuals with chronic liver disease who need additional protection against hepatitis A.
  • Close contacts of patients with confirmed hepatitis A infection.

Side Effects

The safety profile of Havrix includes both common, mild reactions and rare, serious adverse events.

Common

  • Mild pain, redness, or swelling at the injection site that usually resolves within a few days.
  • Low‑grade fever lasting 24‑48 hours after vaccination.
  • Headache that is transient and improves without medication.
  • Fatigue or general malaise that may last one to two days.

Serious

  • Severe allergic reaction (anaphylaxis) presenting with difficulty breathing, hives, or swelling of the face and throat.
  • Guillain‑Barré syndrome, a rare neurological disorder that can develop weeks after vaccination.
  • Persistent high fever that continues beyond 48 hours and is not responsive to antipyretics.
  • Seizures (rare) occurring shortly after immunization.

Precautions & Warnings

Before administering Havrix, healthcare providers should consider several precautionary measures to ensure safe use.

  • Avoid vaccinating individuals with a known severe allergy to any vaccine component, including aluminium hydroxide.
  • Postpone vaccination in persons with an acute moderate or severe illness until they recover.
  • Use caution in patients who have previously experienced hypersensitivity reactions to other vaccines.
  • Assess the need for vaccination in individuals with chronic liver disease, as they may benefit from protection.
  • Consider deferring the vaccine in pregnant or breastfeeding women until a risk‑benefit evaluation is completed.
  • Observe the injection site for at least 15 minutes after administration to detect immediate allergic reactions.

Avoid Interactions

Havrix generally has a low potential for drug interactions, but certain situations warrant attention.

Avoid

  • Do not co‑administer with other live vaccines in the same injection site, as it may affect immune response.
  • Avoid simultaneous administration with immunoglobulin products intended for passive immunization against hepatitis A, which can interfere with vaccine efficacy.

Use with caution

  • Concomitant use of immunosuppressive therapy (e.g., corticosteroids, chemotherapy) may reduce antibody response; monitor serology if needed.
  • Patients receiving blood products or plasma derivatives should be evaluated for timing relative to vaccination.
  • Individuals on antipyretic or analgesic medication may experience masked fever; assess clinical status accordingly.

Frequently Asked Questions

Havrix is approved for individuals aged 12 months and older, including children, adolescents, and adults.

The standard schedule consists of two doses given six months apart to achieve long‑term immunity.

Vaccination during pregnancy should be considered only after a risk‑benefit assessment by a healthcare professional.

Individuals with chronic liver disease are often recommended to receive Havrix because they are at higher risk for severe hepatitis A infection.

Typical reactions include mild pain, redness, or swelling at the injection site, low‑grade fever, headache, and temporary fatigue.

Seek immediate medical attention; severe reactions such as anaphylaxis require emergency treatment.

Havrix may be given at the same visit as other non‑live vaccines, but it should not be injected in the same site as a live vaccine.

Immunosuppressive drugs can reduce the antibody response to Havrix; serologic testing may be advised to confirm immunity.

There are no specific restrictions on alcohol consumption, but excessive intake may interfere with the immune response.

Protection can persist for at least 20 years, and many individuals remain immune for life.

A booster is not routinely required unless the individual is at continued high risk or serology shows waning immunity.

Havrix is not approved for infants under 12 months; alternative vaccination strategies should be discussed with a pediatrician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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