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GARDASIL
Vaccines
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Drug Name:

GARDASIL Rx

Generic Name and Formulations:
Quadrivalent human papillomavirus (HPV) types 6, 11, 16, and 18 vaccine; recombinant; aluminum adsorbed, susp for IM inj; preservative-free.

Company:
Merck & Co., Inc.

Therapeutic Use:

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.

Contraindications:

Yeast allergies.

Warnings/Precautions:

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.

Interactions:

Immunosuppressants: may get suboptimal response.

Pharmacological Class:

HPV.

Adverse Reactions:

Headache, fever, nausea, dizziness, inj-site reactions; post-administration syncope (may be associated with tonic-clonic movements and other seizure-like activity).

Note:

Register pregnant patients exposed to Gardasil by calling (800) 986-8999.

How Supplied:

Single-dose vials—1, 10; Prefilled syringes (w. needles or tip caps)—6

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