human papillomavirus vaccine, quadrivalent (Gardasil, hpv vaccine, quadrivalent)

Dosing and uses of Gardasil (human papillomavirus vaccine, quadrivalent)

• Adult
• Pediatric

 

Adult dosage forms and strengths

vaccine

• 0.5mL (single-dose vial)

 

Prevention of Diseases Caused by HPV Types 6, 11, 16, & 18

0.5 mL IM x3 doses administered at 0, 1-2, & 6 months

For more vaccine information see https://www.cdc.gov/vaccines/schedules/hcp/index.htmL

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
• CDC recommends 3-dose series for routine vaccination for girls at age 11-12 yr
• Catch-up vaccination: 3-dose series for those aged 13 through 26 yr
• If age 26 yr reached before vaccination series completed, remaining doses can be administered after age 26 yr (CDC guidelines)

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)
• Catch-up vaccination: 3-dose series for those aged 13 through 21 yr
• Also, 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

 

Administration

Administer in deltoid region of upper arm or higher anterolateral area of thigh

 

Pediatric dosage forms and strengths

vaccine

• 0.5mL (single-dose vial)

 

Prevention of Diseases Caused by HPV Types 6, 11, 16, & 18

0.5 mL IM x 3 doses at 1, 1-2, and 6 months

For more vaccine information see https://www.cdc.gov/vaccines/schedules/hcp/index.htmL

CDC recommendations

• CDC recommends routine vaccination for females at age 11 or 12 yr with either HPV2 or HPV4; may begin vaccination series as early as age 9 yr

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
• Catch-up vaccination: 3-dose series for those aged 13 through 26 yr
• If age 26 yr reached before vaccination series completed, remaining doses can be administered after age 26 yr (CDC guidelines)

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 (9-21 years)

• Genital warts (condyloma acuminata) caused by HPV types 6 & 11
• Catch-up vaccination: 3-dose series for those aged 13 through 21 yr

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

 

Gardasil (human papillomavirus vaccine, quadrivalent) adverse (side) 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

 

Warnings

Contraindications

Hypersensitivity

Age <9 yr or >26 yr

Bleeding disorder, anticoagulant therapty (unless benefits outweigh risks)

 

Cautions

Individuals who develop symptoms 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 and lactation

Pregnancy category: B; Not recommended for use in pregnant women

Women who become pregnant after initiating the vaccination series, no intervention is needed; delay the remaining doses until completion of pregnancy

Lactation: not known whether excreted in breast milk, use caution

 

Pregnancy categories

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 of Gardasil (human papillomavirus vaccine, quadrivalent)

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