Monograph Details
|
|
Immune System
> Immunization
|
|
GARDASIL |
| Manufacturer |
|
Merck & Co., Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
HPV. |
| Generic Name |
|
Quadrivalent human papillomavirus (HPV) types 6, 11, 16, and 18 vaccine; recombinant; aluminum adsorbed, susp for IM inj; preservative-free. |
| Indications |
|
In females 9–26 yrs old, to prevent cervical cancer, genital warts, cervical adenocarcinoma in situ (AIS), cervical intraepithelial neoplasia (CIN) grades 2 and 3, vulvar intraepithelial neoplasia (VIN) grades 2 and 3, vaginal intraepithelial neoplasia (VaIN) grades 2 and 3, and cervical intraepithelial neoplasia (CIN) grade 1 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. <9 yrs: not recommended. Females 9–26 yrs of age: Give 1st dose at elected date, 2nd dose 2 months after the 1st dose, and 3rd dose 6 months after the 1st dose. |
| Precautions |
|
Not a substitute for routine cervical screening. May not protect all vaccine recipients. Immunosuppressed. Bleeding disorders. Pregnancy (Cat.B): not recommended. Nursing mothers. |
| Interactions |
|
Immunosuppressants: may get suboptimal response. |
| Adverse Reactions |
|
Inj site reactions, fever. |
| Extra Text |
|
Note: Register pregnant patients exposed to Gardasil by calling (800) 986-8999. |
| How Supplied |
Single-dose vials—1, 10
Prefilled syringes (w. needle)—1, 6 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
