Information on GARDASIL
GARDASIL is a vaccine indicated in girls and women 9 through 45 years for the prevention of cervical, vulvar and vaginal cancers; precancerous or dysplastic lesions; genital warts; and infections caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18.
GARDASIL is indicated to prevent the following diseases:
- Cervical, vulvar and vaginal cancers caused by HPV types 16 and 18
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11
And infections 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
GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL should not receive further doses of GARDASIL.
As for any vaccine, vaccination with GARDASIL may not result in protection in all vaccine recipients. This vaccine is not intended to be used for treatment of active external genital lesions; cervical, vulvar or vaginal cancers; CIN, VIN or VaIN. This vaccine will not protect against diseases that are not caused by HPV.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after vaccination with GARDASIL. Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of GARDASIL.
In clinical studies for GARDASIL, the most common adverse reaction was headache. The vaccine-related adverse experiences that were observed among recipients of GARDASIL at a frequency of at least 1.0% and greater than placebo were pain at the injection site, swelling, erythema, pruritus, hematoma, fever, nausea, dizziness, and pain in extremity.
Pregnancy should be avoided during the vaccination regimen for GARDASIL.
The safety and efficacy of GARDASIL have not been evaluated in children younger than 9 years.
The safety and efficacy of GARDASIL have not been evaluated in adults above the age of 45 years.
The safety, immunogenicity, and efficacy of GARDASIL have not been fully evaluated in HIV-infected individuals.
The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.
Dosage and administration for GARDASIL
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine that should be administered in the upper arm or upper anterior thigh over a six-month period. GARDASIL should be administered intramuscularly in three separate 0.5-mL doses according to the following schedule: first dose at elected date, second dose 2 months after the first dose and the third dose 6 months after the first dose.
GARDASIL must not be injected intravascularly. Neither subcutaneous nor intradermal administration has been studied. These methods of administration are not recommended. The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used.
Individuals are encouraged to adhere to the 0, 2, and 6 months vaccination schedule. However, in clinical studies, efficacy has been demonstrated in individuals who have received all 3 doses within a 1-year period. If an alternate vaccination schedule is necessary, the second dose should be administered at least 1 month after the first dose, and the third dose should be administered at least 3 months after the second dose.
Before administering GARDASIL, please consult the full Prescribing Information.