human papillomavirus vaccine, quadrivalent (Rx) - Gardasil, hpv vaccine, quadrivalent
- Class: Vaccines, Inactivated, Viral
Adult Dosing & Uses
Dosing Forms & Strengths
vaccine
- 0.5mL (single-dose vial)
Prevention of Diseases Caused by HPV Types 6, 11, 16, & 18
9-26 years: 0.5 mL IM x3 doses administered at 0, 2, & 6 months
If age 26 yr reached before vaccination series completed, remaining doses can be administered after age 26 yr (CDC guidelines)
Indicated for prevention in girls & women (9-26 years)
- Cervical, vulvar, and vaginal cancer caused by HPV types 16 & 18
- Genital warts (condyloma acuminata) caused by HPV types 6 & 11
Precancerous or dysplastic lesions in girls & women (9-26 years) caused by HPV types 6, 11, 16, & 18
- Cervical intraepithelial neoplasia grade 2/3
- Cervical adenocarcinoma in situ
- Cervical intraepithelial neoplasia (CIN) grade 1
- Vulvar intraepithelial neoplasia (VIN) grade 2/3
- Vaginal intraepithelial neoplasia (VaIN) grade 2/3
Indicated for prevention in boys & men (9-26 years)
- Genital warts (condyloma acuminata) caused by HPV types 6 & 11
- CDC ACIP guidelines recommends routine immunization for all boys aged 11-12 years (MMWR Dec 23, 2011/Vol 60[50];1705-8)
- Recommended for previously unvaccinated males aged 22–26 years who are immunocompromised, test positive for HIV infection, or who have sex with men
Anal cancer
- Indicated for prevention of anal cancer and associated precancerous lesions caused by HPV types 6, 11, 16, and 18 people aged 9-26 years
Other Information
Administration: deltoid region of upper arm or higher anterolateral area of thigh
Up-to-date vaccination schedules available at www.cdc.gov/nip/publications
Pediatric Dosing & Uses
Dosing Forms & Strengths
vaccine
- 0.5mL (single-dose vial)
Prevention of Diseases Caused by HPV Types 6, 11, 16, & 18
>9 years: as adult; 0.5 mL IM x 3 doses at 1, 2, & 6 months
Indicated for prevention in girls & women (9-26 years)
- Cervical, vulvar, and vaginal cancer cuased by HPV types 16 & 18
- Genital warts (condyloma acuminata) caused by HPV types 6 & 11
Precancerous or dysplastic lesions in girls & women (9-26 years) caused by HPV types 6, 11, 16, & 18
- Cervical intraepithelial neoplasia grade 2/3
- Cervical adenocarcinoma in situ
- Cervical intraepithelial neoplasia (CIN) grade 1
- Vulvar intraepithelial neoplasia (VIN) grade 2/3
- Vaginal intraepithelial neoplasia (VaIN) grade 2/3
Indicated for prevention in boys & men (9-26 years)
- Genital warts (condyloma acuminata) caused by HPV types 6 & 11
Anal cancer
- Indicated for prevention of anal cancer and associated precancerous lesions caused by HPV types 6, 11, 16, and 18 people aged 9-26 years
Drug Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
>10%
Inj site pain
Inj site erythema & swelling
Fever
Contraindications & Cautions
Contraindications
Hypersensitivity
<9 yo; >26 yo
Bleeding d/o, anticoagulant tx (unless benefits outweigh risks)
Cautions
Individuals who develop Sx indicative of hypersensitivity after 1st dose should not receive additional doses
Monitor for 15 min following vaccination for syncope/convulsive syncope
Not shown to be protective against non-vaccine HPV types
Pregnancy & Lactation
Pregnancy Category: B
Lactation: not known whether excreted in breast milk, use caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Duration: unknown
These products convey active immunity via stimulation of production of endogenously produced antibodies
The onset of protection from disease is relatively slow, but duration is long lasting (years)
Mechanism of Action
Recombinant vaccine prepared from L1 protein of HPV types 6, 11, 16 & 18
