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Gardasil

"A new study looking at the prevalence of human papillomavirus (HPV) infections in girls and women before and after the introduction of the HPV vaccine shows a significant reduction in vaccine-type HPV in U.S. teens. The study, published in [th"...

Gardasil

Gardasil

INDICATIONS

Girls and Women

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ®1 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, and vaginal 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

Boys and Men

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) is indicated in boys and men 9 through 26 years of age for the prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11.

Limitations of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 Counseling Information.]

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) has not been demonstrated to provide protection against disease from vaccine and nonvaccine HPV types to which a person has previously been exposed through sexual activity. [See Clinical Studies]

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) is not intended to be used for treatment of active external genital lesions; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN.

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. [See Clinical Studies.]

Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) protects only against those vulvar and vaginal cancers caused by HPV 16 and 18.

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) does not protect against genital diseases not caused by HPV.

Vaccination with GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) may not result in protection in all vaccine recipients.

DOSAGE AND ADMINISTRATION

Dosage

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) should not be diluted or mixed with other vaccines. After thorough agitation, GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 With and Without Needle Guard (Safety) Device
Prefilled Syringe With Needle Guard (Safety) Device

Instructions for using the prefilled single-dose syringes preassembled with needle guard (safety) Device

Prefilled Syringe With Needle Guard (Safety) Device - Illustration

NOTE: Please use the enclosed needle for administration. If a different needle is chosen, it should fit securely on the syringe and be no longer than 1 inch to ensure proper functioning of the needle guard device. Two detachable labels are provided which can be removed after the needle is guarded.

At any of the following steps, avoid contact with the Trigger Fingers to keep from activating the safety device prematurely.

Remove Syringe Tip Cap and Needle Cap. Attach Luer Needle by pressing both Anti-Rotation Tabs to secure syringe and by twisting the Luer Needle in a clockwise direction until secured to the syringe. Remove Needle Sheath. Administer injection per standard protocol as stated above under DOSAGE AND ADMINISTRATION. Depress the Plunger while grasping the Finger Flange until the entire dose has been given. The Needle Guard Device will NOT activate to cover and protect the needle unless the ENTIRE dose has been given. While the Plunger is still depressed, remove needle from the vaccine recipient. Slowly release the Plunger and allow syringe to move up until the entire needle is guarded. For documentation of vaccination, remove detachable labels by pulling slowly on them. Dispose in approved sharps container.

Prefilled Syringe Without Needle Guard (Safety) Device

This package does not contain a needle guard (safety device) or 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 Lock syringes, preassembled with UltraSafe Passive®2 delivery system. One-inch, 25-gauge needles are provided separately in the package. NDC 0006-4109-06.

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

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

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) should be administered as soon as possible after being removed from refrigeration.

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) can be out of refrigeration (at temperatures at or below 25°C/77°F), for a total time of not more than 72 hours.

REFERENCE

2 UltraSafe Passive® delivery system is a Trademark of Safety Syringes, Inc.

Manufactured and Distributed by: MERCK & CO., INC., Whitehouse Station, NJ 08889, USA.

Last reviewed on RxList: 1/26/2010
This monograph has been modified to include the generic and brand name in many instances.

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