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Gardasil

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Gardasil

Indications
Dosage
How Supplied

INDICATIONS

Girls And Women

GARDASIL® is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

  • Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

  • Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)
  • Cervical intraepithelial neoplasia (CIN) grade 1
  • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
  • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Boys And Men

GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV types included in the vaccine:

  • Anal cancer caused by HPV types 16 and 18
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

  • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Limitations Of GARDASIL Use And Effectiveness

The health care provider should inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care. [See PATIENT INFORMATION]

Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider. [See PATIENT INFORMATION]

GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. [See Clinical Studies]

GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN.

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. [See Clinical Studies]

Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal, and anal cancers caused by HPV 16 and 18.

GARDASIL does not protect against genital diseases not caused by HPV.

Vaccination with GARDASIL may not result in protection in all vaccine recipients.

GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. [See Clinical Studies]

DOSAGE AND ADMINISTRATION

Dosage

GARDASIL should be administered intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months. [See Clinical Studies]

Method Of Administration

For intramuscular use only.

Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. GARDASIL should not be diluted or mixed with other vaccines. After thorough agitation, GARDASIL is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the product if particulates are present or if it appears discolored.

GARDASIL should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

Syncope has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended. [See WARNINGS AND PRECAUTIONS]

Single-Dose Vial Use

Withdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterile needle and syringe and use promptly.

Prefilled Syringe Use

This package does not contain a needle. Shake well before use. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.

HOW SUPPLIED

Dosage Forms And Strengths

GARDASIL is a suspension for intramuscular administration available in 0.5-mL single dose vials and prefilled syringes. See DESCRIPTION for the complete listing of ingredients.

Storage And Handling

All presentations for GARDASIL contain a suspension of 120 mcg L1 protein from HPV types 6, 11, 16, and 18 in a 0.5-mL dose. GARDASIL is supplied in vials and syringes.

Carton of one 0.5-mL single-dose vial. NDC 0006-4045-00.

Carton of ten 0.5-mL single-dose vials. NDC 0006-4045-41.

Carton of six 0.5-mL single-dose prefilled Luer-Lok® syringes with tip caps. NDC 0006-4109-09.

Carton of ten 0.5-mL single-dose prefilled Luer-Lok® syringes with tip caps. NDC 0006-4109-02.

Store refrigerated at 2 to 8°C (36 to 46°F). Do not freeze. Protect from light.

GARDASIL should be administered as soon as possible after being removed from refrigeration.

GARDASIL can be out of refrigeration (at temperatures at or below 25°C/77°F), for a total time of not more than 72 hours.

Manufactured and Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA. Revised: March 2014.

Last reviewed on RxList: 9/8/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Gardasil - User Reviews

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