Information on GARDASIL®

GARDASIL® is a non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18. The quadrivalent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum containing adjuvant and the final purification buffer. The VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.

GARDASIL®  is for use among females 9 to 26 years of age to prevent cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18 in. GARDASIL®  is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

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. 

GARDASIL®  is not recommended for use in pregnant women.       

Vaccination with GARDASIL®  may not result in protection in all vaccine recipients.  GARDASIL®  is not intended to be used for treatment of active genital warts; cervical cancer; CIN, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN).  GARDASIL®  has not been shown to protect against disease due to other HPV types.

In clinical studies for GARDASIL® , vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL®  and also greater than those observed among recipients of placebo, respectively, were pain, swelling, erythema, fever, nausea, pruritis and dizziness.  In addition, common post-marketing reports include vomiting and syncope.

Dosage and administration for GARDASIL®
       
GARDASIL®  is a ready-to-use, three-dose, intramuscular vaccine.  GARDASIL®  should be administered in three separate intramuscular injections in the upper arm or upper anterior thigh over a six-month period.  The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

GARDASIL® is administered in a three-dose series administered by intramuscular injection. The second and third doses should be administered 2 and 6 months after the first dose. The minimum interval between the first and second doses is 4 weeks. 

• Product Circular (US): Click here to download
• Patient Information (US): Click here to download
• Summary of Product Characteristics (Europe): Click here to download
• Patient Information (Europe): Click here to download
• Product Circular (Nicaragua): Click here to download