Dosing & Uses
Dosage Forms & Strengths
suspension for IM injection
- 0.5mL/single-dose vial or syringe
Prevention of HPV in Males
Demonstrated to protect against diseases/precancerous conditions caused by human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Ages 15 through 45 years: 0.5 mL IM as a 3-dose series at 0, 2, and 6 months
Indications in males
- Prevention of the following diseases
- Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11
- Following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
Prevention of HPV in Females
Demonstrated to protect against diseases/precancerous conditions caused by human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Ages 15 through 45 years: 0.5 mL IM as a 3-dose series at 0, 2, and 6 months
Indicated for prevention of the following diseases
- Cervical, vulvar, vaginal, and anal cancer caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11
Precancerous or dysplastic lesions
- Indicated for prevention of the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
- Cervical intraepithelial neoplasia (CIN) grade 2/3 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
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
Dosing Considerations
For more vaccine information see: http://www.cdc.gov/vaccines/schedules/hcp/index.html
Limitations of use and effectiveness
- Inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening
- Recipients should not discontinue anal cancer screening
- Has not been demonstrated to provide protection against disease from vaccine HPV types to which a person has previously been exposed through sexual activity
- Not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN
- Not all vulvar, vaginal, and anal cancers are caused by HPV
- May not result in protection in all vaccine recipients
Dosage Forms & Strengths
suspension for IM injection
- 0.5mL/single-dose vial or syringe
Prevention of HPV in Males
Demonstrated to protect against diseases/precancerous conditions caused by human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Ages 15 through 45 years: 0.5 mL IM as a 3-dose series at 0, 2, and 6 months
Ages 9 through 14 years
- 0.5 mL IM as a 2-dose series at 0 and 6-12 months, OR
- 0.5 mL IM as a 3-dose series at 0, 2, and 6 months
- NOTE: For the 2-dose series, if the second dose is administered earlier than 5 months after the first dose, administer a third dose at least 4 months after the second dose
Indications in males
- Prevention of the following diseases
- Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11
- Following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
Prevention of HPV in Females
Demonstrated to protect against diseases/precancerous conditions caused by human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Ages 15 through 45 years: 0.5 mL IM as a 3-dose series at 0, 2, and 6 months
Ages 9 through 14 years
- 0.5 mL IM as a 2-dose series at 0 and 6-12 months, OR
- 0.5 mL IM as a 3-dose series at 0, 2, and 6 months
- NOTE: For the 2-dose series, if the second dose is administered earlier than 5 months after the first dose, administer a third dose at least 4 months after the second dose
Indicated for prevention of the following diseases
- Cervical, vulvar, vaginal, and anal cancer caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11
Precancerous or dysplastic lesions
- Indicated for prevention of the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
- Cervical intraepithelial neoplasia (CIN) grade 2/3 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
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
Dosing Considerations
For more vaccine information see: http://www.cdc.gov/vaccines/schedules/hcp/index.html
Limitations of use and effectiveness
- Inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening
- Recipients should not discontinue anal cancer screening
- Has not been demonstrated to provide protection against disease from vaccine HPV types to which a person has previously been exposed through sexual activity
- Not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN
- Not all vulvar, vaginal, and anal cancers are caused by HPV
- May not result in protection in all vaccine recipients
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Females aged 16-26 yr
- Injection site pain (89.9%)
- Injection site swelling (40%)
- Injection site erythema (34%)
- Headache (14.6%)
Females aged 9-15 yr
- Injection site pain (89.3%)
- Injection site swelling (47.8%)
- Injection site erythema (34.1%)
- Headache (11.4%)
Males aged 9-26 yr
- Injection site pain (71.5%)
- Injection site swelling (26.9%)
- Injection site erythema (24.9%)
- Oral temperature ≥100.0°F (10.4%)
1-10%
Females aged 16-26 yr
- Pyrexia (5%)
Females aged 9-15 yr
- Pyrexia (5%)
Maled aged 9-26 yr
- Headache (9.4%)
- Pyrexia (8.9%)
Warnings
Contraindications
Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous Gardasil dose
Cautions
Individuals who develop symptoms indicative of hypersensitivity after first dose should not receive additional doses
Monitor for 15 min following vaccination for syncope/convulsive syncope and allergic reactions
Not shown to be protective against nonvaccine HPV types
Pregnancy & Lactation
Pregnancy Category: B
Lactation: Unknown if distributed in human breast milk; caution advised
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
Mechanism of Action
Induces humoral immune response
Recombinant vaccine that targets 9 HPV subtypes: 6, 11, 16, 18, 31, 33, 45, 52, and 58
Pharmacokinetics
The peak anti-HPV GMTs occurred at Month 7 in clinical trials; proportions of individuals who remained seropositive to each vaccine HPV type at Month 24 were similar to the corresponding seropositive proportions at Month 7
Administration
IM Preparation
Shake well before use
Thoroughly agitate immediately before administration is necessary to maintain suspension of the vaccine
Do not diluted or mix with other vaccine
After thorough agitation, appears as a white, cloudy liquid
Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit
Do not use the product if particulates are present or if it appears discolored
IM Administration
Administer IM in the deltoid region of the upper arm or in the higher anterolateral area of the thigh
Observe patients for 15 minutes after administration
Storage
Store refrigerated at 2-8°C (36-46°F)
Do not freeze
Protect from light
Administer as soon as possible after being removed from refrigeration
Can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8-25°C) does not exceed 72 hr
Cumulative multiple excursions between 0-2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hr
Images
Patient Handout
Formulary
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