Generic Name and Formulations:
Quadrivalent human papillomavirus (HPV) types 6, 11, 16, and 18 vaccine; recombinant; aluminum adsorbed, susp for IM inj; preservative-free.
Merck & Co., Inc.
Indications for GARDASIL:
In females 9–26 years old, to prevent cervical, vulvar, vaginal and anal cancer caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; cervical adenocarcinoma in situ (AIS) and cervical intraepithelial neoplasia (CIN) grades 2 and 3, vulvar intraepithelial neoplasia (VIN) grades 2 and 3, vaginal intraepithelial neoplasia (VaIN) grades 2 and 3, cervical intraepithelial neoplasia (CIN) grade 1, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18. In males 9–26 years old, to prevent anal cancer caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18.
Adults and Children:
Give by IM inj in deltoid or upper thigh. Each dose is 0.5mL. <9yrs: not recommended. 9–26yrs: Give 1st dose at elected date, 2nd dose 2 months after the 1st dose, and 3rd dose 6 months after the 1st dose. Monitor patients for 15 minutes after administration.
Not a substitute for routine cervical or anal cancer screening. Not for treating active external genital lesions; cervical, vulvar, vaginal and anal cancers; CIN; VIN; VaIN; or AIN. May not protect all vaccine recipients. Immunosuppressed. Bleeding disorders. Pregnancy (Cat.B): not recommended. Nursing mothers.
Immunosuppressants: may get suboptimal response.
Headache, fever, nausea, dizziness, inj-site reactions; post-administration syncope (may be associated with tonic-clonic movements and other seizure-like activity).
Register pregnant patients exposed to Gardasil by calling (800) 986-8999.
Single-dose vials—1, 10; Prefilled syringes (w. needles or tip caps)—6