HPV (GARDASIL) VACCINE

VACCINE USAGE: 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 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:

  • GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.
  • Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider.
  • 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.
  • 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.
  • 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.

VACCINE DOSAGE: 0.5-mL suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months.

VACCINE INGEDIENTS: yeast protein, vitamins, amino acids, mineral salts, carbohydrates, amorphous aluminum hydroxyphosphate sulfate, L-histidine, polysorbate 80, sodium borate.

ADVERSE VACCINE REACTIONS: headache, fever, nausea, arthritis, death, autoimmune thyroiditis, celiac disease, inflammatory bowel disease, multiple sclerosis, nephritis, pigmentation disorder, diabetes, chills, fatigue, malaise, autoimmune disease, seizures, cellulitis, deep venous thrombosis.