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GARDASIL 9
Vaccines
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Drug Name:

GARDASIL 9 Rx

Generic Name and Formulations:
9-valent human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58 vaccine; recombinant; aluminum adsorbed, susp for IM inj; preservative-free.

Company:
Merck & Co., Inc.

Therapeutic Use:

Indications for GARDASIL 9:

In females 9–26 years old, to prevent cervical, vulvar, vaginal and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; genital warts caused by HPV types 6 and 11; cervical intraepithelial neoplasia (CIN) grades 2 and 3 and cervical adenocarcinoma in situ (AIS), cervical intraepithelial neoplasia (CIN) grade 1, vulvar intraepithelial neoplasia (VIN) grades 2 and 3, vaginal intraepithelial neoplasia (VaIN) grades 2 and 3, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. In males 9–26 years old, to prevent anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; 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, 18, 31, 33, 45, 52, and 58.

Limitations Of use:

Not a substitute for routine cervical or anal cancer screening. Not for protection against disease from vaccine HPV types through exposure to sexual activity or diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58. Not for treating external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN. May not protect all vaccine recipients. Not studied in patients >26 years old.

Adults and Children:

Give by IM inj in deltoid or upper thigh. Each dose is 0.5mL. <9yrs: not established. 9–14yrs: 2-dose regimen: give 1st dose at elected date, 2nd dose 6–12 months after the 1st dose (if the 2nd dose is given earlier than 5 months after the 1st dose, administer a 3rd dose at least 4 months after the 2nd dose). Or, 9–26yrs: 3-dose regimen: 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:

Immunosuppressed. Have treatment available to manage anaphylactic reactions. Pregnancy (Cat.B). Nursing mothers.

Interactions:

Immunosuppressants: may get suboptimal response.

Pharmacological Class:

HPV.

Adverse Reactions:

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

Note:

Register pregnant patients exposed to Gardasil 9 by calling (800) 986-8999.

Generic Availability:

NO

How Supplied:

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

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