Prevention of Disease Caused by Human Papillomavirus (HPV)
Prevention of genital warts (condyloma acuminata), cervical cancer, and precancerous or dysplastic lesions (e.g., cervical adenocarcinoma in situ [AIS], cervical intraepithelial neoplasia [CIN] grades 1, 2, and 3, vulvar intraepithelial neoplasia [VIN] grades 2 and 3, vaginal intraepithelial neoplasia [VaIN] grades 2 and 3) caused by HPV types 6, 11, 16, and 18 in females 9–26 years of age.
Genital HPV is the most common sexually transmitted infection in the US. Most genital HPV infections are asymptomatic and transient, but some high-risk HPV types may cause abnormal cells on the cervical lining that evolve into cancer.
USPHS Advisory Committee on Immunization Practices (ACIP), AAP, American Academy of Family Physicians (AAFP), and American College of Obstetricians and Gynecologists (ACOG) recommend that all females 9–26 years of age receive a 3-dose series of quadrivalent HPV vaccine, unless contraindicated. (See Contraindications under Cautions.)
Ideally, HPV vaccine should be administered before potential exposure to HPV occurs through sexual activity; however, age-appropriate females who are already sexually active should be vaccinated.
May be used in females 9–26 years of age with or without prior exposure to HPV, equivocal or abnormal Papanicolaou (Pap) tests, positive HPV DNA tests (Hybrid Capture 2® [HC2] high-risk test), or genital warts.
There is no evidence that vaccination has any beneficial effects on preexisting Pap test abnormalities or on preexisting HPV infection or genital warts (including those caused by HPV types represented in the vaccine). However, vaccination provides protection against infection with vaccine HPV types not already acquired.
Does not prevent infection or disease caused by HPV types not represented in the vaccine.
Does not prevent non-HPV related cervical disease.
Not used for treatment of active genital warts, cervical cancer, or precancerous genital lesions (i.e., CIN, VIN, or VaIN).
Safety and efficacy not established in females <9 years of age or >26 years of age. Efficacy studies have been initiated in females >26 years of age.
Safety and efficacy not established in males of any age. Efficacy studies have been initiated in adolescent boys and adult men.
Dosage and Administration
Administration
IM Administration
Administer by IM injection.
Do notadminister sub-Q, intravascularly, or intradermally.
Shake vaccine well immediately prior to administration to provide a uniform, white, cloudy suspension. Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.
Administer in the deltoid region of the upper arm or in the anterolateral aspect of the upper thigh. To ensure delivery of vaccine into the muscle, IM injections should be made at a 90° angle to the skin using a needle size that is appropriate for the individual.
Administer undiluted; do not mix with any other vaccine or solution.
Observe vaccinee for approximately 15 minutes following administration of the vaccine since syncope has occurred.
May be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites). (See Interactions.)
When multiple vaccines are administered during a single health-care visit, each vaccine should preferably be given at a different anatomic site. Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.
Dosage
Pediatric Patients
Prevention of Disease Caused by Human Papillomavirus (HPV)
Female Children and Adolescents 9–18 Years of Age
IM
Primary immunization consists of a series of 3 doses. Each dose consists of the entire contents (0.5 mL) of the commercially available single-dose vial or prefilled syringe.
Give initial dose at ≥9 years of age and give second and third doses 2 and 6 months, respectively, after initial dose.
ACIP, AAP, AAFP, and ACOG recommend that the first dose be given routinely to all girls at 11–12 years of age, but first dose may be given to girls as young as 9 years of age at the discretion of the clinician.
Catch-up vaccination recommended for all female children and adolescents 13–18 years of age who have not previously received the complete 3-dose series. Give second dose 4 weeks after first dose and give third dose 12 weeks after second dose (not earlier than 6 months after first dose).
Duration of immunity following the recommended 3-dose vaccine series not fully determined. (See Duration of Immunity under Cautions.) Additional (booster) doses not recommended.
Adults
Prevention of Disease Caused by Human Papillomavirus (HPV)
Adult Women 19–26 Years of Age
IM
Primary immunization consists of a series of 3 doses. Each dose consists of the entire contents (0.5 mL) of the commercially available single-dose vial or prefilled syringe.
In previously unvaccinated adult women, give initial dose at 19–26 years of age and give the second and third doses 2 and 6 months, respectively, after initial dose.
Catch-up vaccination recommended for all adult women ≤26 years of age who are unvaccinated or incompletely vaccinated. Give second and third doses 2 and 6 months, respectively, after initial dose.
Duration of immunity following the recommended 3-dose vaccine series not fully determined. (See Duration of Immunity under Cautions.) Additional (booster) doses not recommended.
Special Populations
Hepatic Impairment
No specific dosage recommendations.
Renal Impairment
No specific dosage recommendations.
Geriatric Patients
Safety and efficacy not established in adults >26 years of age, including geriatric adults.
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