Gardasil is a Human Papillomavirus Quadrivalent Vaccine Suspension for Intramuscular Injection. The drug is used in girls and women 9 through 26 years old for the prevention of the diseases caused by HPV.
Gardasil is a non-infectious recombinant quadrivalent vaccine made from the purified particles resembling the virus-like particles of the major capsid protein of HPV Types 6, 11, 16 and 18. The capsid proteins are made by separate fermentations in recombinant Saccharomyces cerevisiae and assemble themselves into virus-like particles. Gardasil is a sterile suspension for intramuscular administration and each 0.5mL dose of the drug contains around 20mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein.
Each 0.5 dose of the Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine contains around 225mcg of aluminum, 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, less than 7mcg yeast protein per dose, and water for injection. Preservatives and antibiotics are not contained in the product.
Gardasil is used in girls and women 9 through 26 years old for the prevention of the diseases caused by HPV types included in the vaccine. The diseases includes cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18;Genital warts (condyloma acuminata) caused by HPV types 6 and 11; Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS) caused by HPV types 6, 11, 16, and 18; Cervical intraepithelial neoplasia (CIN) grade 1 caused by HPV types 6, 11, 16, and 18; Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3 caused by HPV types 6, 11, 16, and 18; Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3 caused by HPV types 6, 11, 16, and 18.
All patients should be informed by their healthcare provider that vaccination is not a substitute for routine cervical cancer screening. Cervical cancer screening should still be experienced per standard care by women who receive Gardasil.
Gardasil has not been demonstrated to provide protection against diseases caused by HPV types that are not contained in the vaccine or against disease from vaccine and non-vaccine HPV types to which the woman has been exposed through sexual activity before. The drug is not for the use of treatment of active genital warts, cervical cancers, vulvar cancers, and vaginal cancers. Gardasil only protects against vulvar and vaginal cancers caused by HPV 16 and 18. Not all vulvar and vaginal cancers are caused by HPV.
Gardasil should be shaken well before administration and should be administered intramuscularly. It should be administered a as 0.5mL dose at a schedule of 0 months, 2 months, and 6 months. Gardasil should not be mixed or diluted with other vaccines. The drug should be inspected visually before administration for particulate matter and discoloration. Gardasil is not to be administered intravenously, intradermally, or subcutaneously.
Syncope has been reported following vaccination with Gardasil. Syncope is sometimes associated with tonic-clonic movements and other seizure-like activity. Observation for 15 minutes after administration is recommended because patient may develop syncope, sometimes resulting in injury.
The following adverse events and side effects are associated with Gardasil:
local injection site reactions