Vaqta (Hepatitis A Vaccine Inactivated) - Indications and Dosage

INDICATIONS AND USAGE

VAQTA is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus in persons 2 years of age and older. Primary immunization should be given at least 2 weeks prior to expected exposure to HAV.

Individuals who are or will be at increased risk of infection by HAV include:

TRAVELERS

Persons traveling to areas of higher endemicity for hepatitis A. These areas include, but are not limited to, Africa, Asia (except Japan), the Mediterranean basin, Eastern Europe, the Middle East, Central and South America, Mexico, and parts of the Caribbean. Current CDC (Centers for Disease Control and Prevention) advisories should be consulted with regard to specific locales.

MILITARY PERSONNEL

PEOPLE LIVING, IN, OR RELOCATING TO, AREAS OF HIGH ENDEMICITY

CERTAIN ETHNIC AND GEOGRAPHIC POPULATIONS THAT EXPERIENCE CYCLIC HEPATITIS A EPIDEMICS SUCH AS:

Native peoples of Alaska and the Americas.

OTHERS

Persons engaging in high-risk sexual activity (such as homosexually active males); users of illicit injectable drugs; residents of a community experiencing an outbreak of hepatitis A.

Hemophiliacs and other recipients of therapeutic blood products (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).

Persons who test positive for hepatitis C virus and have diagnosed liver disease.

Although the epidemiology of hepatitis A does not permit the identification of other specific populations at high risk of disease, outbreaks of hepatitis A or exposure to hepatitis A virus have been described in a variety of populations in which VAQTA may be useful:

• Certain institutional workers (e.g., caretakers for the developmentally challenged)
• Employees of child day-care centers
• Laboratory workers who handle live hepatitis A virus
• Handlers of primate animals that may be harboring HAV

PEOPLE EXPOSED TO HEPATITIS A

For those requiring both immediate and long-term protection, VAQTA may be administered concomitantly with IG.

REVACCINATION

See DOSAGE AND ADMINISTRATION, DOSAGE.

Use With Other Vaccines

VAQTA may be given concomitantly at separate injection sites with typhoid and yellow fever vaccines. The GMTs for hepatitis A when VAQTA, typhoid and yellow fever vaccines were administered concomitantly were reduced when compared to VAQTA alone. Following receipt of the booster dose of VAQTA, the GMTs for hepatitis A in these two groups were observed to be comparable. (See CLINICAL PHARMACOLOGY, Use With Other Vaccines and DOSAGE AND ADMINISTRATION, Use With Other Vaccines.)

The Advisory Committee on Immunization Practices has stated that limited data from studies conducted among adults indicate that simultaneous administration of hepatitis A vaccine with diphtheria, poliovirus (oral and inactivated), tetanus, oral typhoid, cholera, Japanese encephalitis, rabies, or yellow fever vaccine does not decrease the immune response to either vaccine or increase the frequency of reported adverse events. Studies indicate that hepatitis B vaccine can be administered with VAQTA without affecting immunogenicity or increasing the frequency of adverse events.

Use With Immune Globulin

For individuals requiring either post-exposure prophylaxis or combined immediate and longer-term protection (e.g., travelers departing on short notice to endemic areas), VAQTA may be administered concomitantly with IG using separate sites and syringes (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

VAQTA IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 2 YEARS OF AGE SINCE DATA ON USE IN THIS AGE GROUP ARE NOT CURRENTLY AVAILABLE.

DOSAGE AND ADMINISTRATION

Do not inject intravenously, intradermally, or subcutaneously.

VAQTA is for intramuscular injection. The deltoid muscle is the preferred site for intramuscular injection.

DOSAGE

The vaccination regimen consists of one primary dose and one booster dose for healthy children, adolescents, and adults, as follows:

Pediatric/Adolescent

Individuals 2 through 18 years of age should receive a single 0.5 mL (~25U) dose of vaccine at elected date and a booster dose of 0.5 mL (~25U) 6 to 18 months later.

A 1.0 mL (~50U) dose also was evaluated in individuals 18 years of age and was found to be immunogenic and generally well tolerated. (See CLINICAL PHARMACOLOGY, Immunology.)

Adult

Adults 19 years of age and older should receive a single 1.0 mL (~50U) dose of vaccine at elected date and a booster dose of 1.0 mL (~50U) 6 to 18 months later.

For all age groups, a booster dose is recommended anytime between 6 and 18 months after the administration of the primary dose in order to elicit a high antibody titer.

Interchangeability of the Booster Dose

A booster dose of VAQTA may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines (e.g., HAVRIX). (See CLINICAL PHARMACOLOGY, Interchangeability of Booster Dose.)

Use With Other Vaccines

VAQTA may be given concomitantly with typhoid and yellow fever vaccines. The GMTs for hepatitis A when VAQTA, typhoid and yellow fever vaccines were administered concomitantly were reduced when compared to VAQTA alone. Following receipt of the booster dose of VAQTA, the GMTs for hepatitis A in these two groups were observed to be comparable. Data on concomitatnt use with other vaccines are limited. Separate injection sites and syringes should be used for concomitant administration of injectable vaccines. (See CLINICAL PHARMACOLOGY, Use With Other Vaccines and INDICATIONS AND USAGE, Use With Other Vaccines.)

Use With Immune Globulin

VAQTA may be administered concomitantly with IG using separate sites and syringes. The vaccination regimen for VAQTA should be followed as stated above. Consult the manufacturer's product circular for the appropriate dosage of IG. A booster dose of VAQTA should be administered at the appropriate time as outlined above.

ADMINISTRATION

Known or Presumed Exposure to HAV/Travel to Endemic Areas

For individuals requiring either post-exposure prophylaxis or combined immediate and longer term protection (e.g., travelers departing on short notice to endemic areas), VAQTA may be administered concomitantly with IG using separate sites and syringes (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION, Use With Immune Globulin).

Injection must be accomplished with a needle long enough to ensure intramuscular deposition of the vaccine. The Advisory Committee on Immunization Practices (ACIP) has recommended that "For all intramuscular injections, the needle should be long enough to reach the muscle mass and prevent vaccine from seeping into subcutaneous tissue, but not so long as to endanger underlying neurovascular structure or bone." For toddlers and older children they further state that "[mldr ]the deltoid may be used if the muscle mass is adequate. The needle size can range from 22 to 25 gauge and from 5/8 to 1 ¼ inches, based on the size of the muscle[mldr ]the anterolateral thigh may be used, but the needle should be longer--generally ranging from 7/8 to 1 ¼ inches". For adults they state that "[mldr ]the deltoid is recommended for routine intramuscular vaccination among adults[mldr ] The suggested needle size is 1 to 1 ½ inches and from 20 to 25 gauge."

For individuals with bleeding disorders who are at risk of hemorrhage following intramuscular injection, the ACIP recommends that when any intramuscular vaccine is indicated for such patients, "[mldr ]it should be administered intramuscularly if, in the opinion of a physician familiar with the patient's bleeding risk, the vaccine can be administered with reasonable safety by this route. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle ( The vaccine should be used as supplied; no reconstitution is necessary.

Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine. Discard if the suspension does not appear homogenous.

Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit. After thorough agitation, VAQTA is a slightly opaque, white suspension.

It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infectious agents from one person to another.

HOW SUPPLIED

PEDIATRIC/ADOLESCENT FORMULATION

VIALS

No. 4831--VAQTA for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose vial, NDC 0006-4831-00.

No. 4831--VAQTA for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose vial, in a box of 5 single-dose vials, NDC 0006-4831-38.

No. 4831--VAQTA for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose vial, in a box of 10 single-dose vials, NDC 0006-4831-41.

SYRINGES

No. 4845--VAQTA for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose prefilled syringe, with a 5/8 needle, NDC 0006-4845-00.

No. 4845--VAQTA for pediatric/adolescent use is supplied as 25U/0.5 mL of hepatitis A virus protein in a 0.5 mL single-dose prefilled syringe, with a 5/8 inch needle, in a box of 5 single-dose prefilled syringes, with 5/8 inch needles, NDC 0006-4845-38.

ADULT FORMULATION

Vials

No. 4841--VAQTA for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose vial, NDC 0006-4841-00.

No. 4841--VAQTA for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose vial, in a box of 5 single-dose vials, NDC 0006-4841-38.

No. 4841--VAQTA for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose vial, in a box of 10 single-dose vials, NDC 0006-4841-41.

Syringes

No. 4844--VAQTA for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose prefilled syringe, with a one inch needle, NDC 0006-4844-00.

No. 4844--VAQTA for adult use is supplied as 50U/1 mL of hepatitis A virus protein in a 1 mL single-dose prefilled syringe, with a one inch needle, in a box of 5 single-dose, prefilled syringes, with one inch needles, NDC 0006-4844-38.

Storage

Store vaccine at 2-8°C (36-46°F).

DO NOT FREEZE since freezing destroys potency.

Manuf. and Dist. by:

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Syringes of VAQTA are also filled by:

Evans Vaccines Ltd.

Gaskill Road, Speke, Liverpool L24 9GR, England

9413405 Issued January 2004

COPYRIGHT © MERCK & CO., Inc., 2001

All rights reserved