Hepatitis A vaccine inactivated

Hepatitis A vaccine inactivated is a vaccine used for immunizing a person from hepatitis A infection. 

• Hepatitis A vaccine inactivated is available under the following different brand names: Havrix, Vaqta

Common side effects of Hepatitis A vaccine inactivated include:

• injection site reactions (pain, redness, swelling, or a hard lump),
• low fever,
• dizziness,
• tiredness,
• headache,
• nausea,
• vomiting,
• stomach pain,
• diarrhea,
• loss of appetite,
• joint pain, or
• sore throat.

Serious side effects of Hepatitis A vaccine inactivated include:

• fainting,
• lightheadedness,
• vision changes,
• numbness or tingling, or
• seizure-like after receiving a vaccine injection such as Havrix.

Rare side effects of Hepatitis A vaccine inactivated include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection

• 50 units/mL (Vaqta adult dose)
• 1440 ELISA units/mL (Havrix adult dose)
• 25 units/0.5 mL (Vaqta pediatric dose)
• 720 ELISA units/0.5mL (Havrix pediatric dose)
• Hepatitis A Immunization
• Adult dosage
• 2-dose vaccination series
  • Above 19 years: 1 mL IM (primary dose)
  • Administer primary dose at least 2 weeks before expected exposure to HAV
  • Havrix: Administer booster dose 6-12 months after the primary dose
  • Vaqta, ACIP guidelines: Administer booster dose 6-18 months after primary dose
• Preexposure protection against HAV for travelers (ACIP guidelines)
  • 1 mL IM given at least 2 weeks before expected exposure to HAV
  • For persons not previously vaccinated with hepatitis A vaccine, administer the dose as soon as travel is considered, and complete a 2-dose series according to the routine schedule
  • Also consider giving immune globulin to patients who are immunocompromised or have chronic liver disease, or those 40 years  or older who are otherwise healthy
• Postexposure prophylaxis (PEP) for HAV
  • 1 mL IM
  • A second dose is not required for PEP; however, for long-term immunity, ACIP recommends completing the 2-dose series
  • Age above 40 years: Consider the need to also give immunoglobulin
  • Immunocompromised or chronic liver disease: Vaccine and immune globulin should be administered simultaneously at different anatomic sites

Pediatric dosage

• Aged below 12 months: Not indicated; if administered, not counted toward the routine 2-dose series
• Aged above 12 months through 18 years (2-dose series)
  • Primary dose: 0.5 mL IM
  • Havrix: Administer booster dose 6-12 mo after the primary dose
  • Vaqta, ACIP guidelines: Administer booster dose 6-18 mo after primary dose
  • Children who have received 1 dose before the age of 24 months, should receive a second dose 6-18 months after the first dose
• Catch up schedule
  • For any person above 2 years who have not already received the hepatitis A vaccine series, give 2 doses separated by 6-18 months if immunity against hepatitis A virus infection is desired
  • The minimum interval between the 2-dose series is 6 months
• Preexposure protection against HAV for travelers (ACIP guidelines)
  • Aged below  6 months: Do not administer hepatitis A vaccine, but do administer immune globulin
  • 6-11 months: 0.5 mL IM; this dose does not count toward routine 2-dose vaccination series
  • 12 months through 18 years: 0.5 mL IM; if not previously vaccinated with hepatitis A vaccine, complete a 2-dose series according to a routine schedule
  • Immunocompromised or chronic liver disease: 0.5 mL IM; also consider giving immune globulin
• Postexposure prophylaxis (PEP) for HAV
  • 12 months through 18 years: 0.5 mL IM; if not previously vaccinated with hepatitis A vaccine, complete a 2-dose series according to a routine schedule
  • Immunocompromised or chronic liver disease: Vaccine and immune globulin should be administered simultaneously at different anatomic sites
• International travel
  • Persons traveling to or working in countries with high or intermediate endemic hepatitis A
  • Infants age 6-11 months: 1 dose before departure; revaccinate with 2 doses, separated by at least 6 months, between 12 and 23 months of age
  • Unvaccinated for more than 12 months: Administer dose 1 as soon as travel is considered; give dose 2 after 6 months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Hepatitis A vaccine inactivated has severe interactions with the following drug:
  • belimumab
• Hepatitis A vaccine inactivated has serious interactions with at least 36 other drugs.
• Hepatitis A vaccine inactivated has moderate interactions with the following drugs:
  • certolizumab pegol
  • cyclosporine
  • dengue vaccine
  • ibrutinib
  • ifosfamide
  • lomustine
  • mechlorethamine
  • melphalan
  • mercaptopurine
  • methotrexate
  • onasemnogene abeparvovec
  • oxaliplatin
  • ponesimod
  • procarbazine
  • rituximab
  • rituximab-hyaluronidase
  • tralokinumab
  • ustekinumab
  • voclosporin
• Hepatitis A vaccine inactivated has minor interactions with the following drugs:
  • chloroquine
  • ozanimod

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Hepatitis A vaccine inactivated?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Hepatitis A vaccine inactivated?”

Cautions

• First dose at least 2 weeks before exposure to HAV
• Current exposure to HAV: may co-administer IG
• The tip caps of prefilled syringes contain natural rubber latex which may cause allergic reactions
• Syncope (fainting) can occur in association with the administration of injectable vaccines; syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements; procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
• Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine
• Immunocompromised persons may have diminished immune response to drugs, including individuals receiving immunosuppressant therapy
• Hepatitis A virus has a relatively long incubation period (15 to 50 days); therapy may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination; additionally, vaccination may not protect all individuals

Pregnancy & Lactation

• Use with caution if benefits outweigh risks during pregnancy

Lactation

• Not established