Dosing & Uses
Dosage Forms & Strengths
suspension for IM injection
- 0.5mL/single-dose vial or syringe
Immunization to Prevent HPV Infection
Demonstrated to protect against diseases/precancerous conditions caused by human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58
0.5 mL IM as a 2- or 3-dose series depending on age at initial vaccination
Adults though age 26 years
- Recommended as routine vaccination for all adults through age 26 years
-
Age of initial vaccination
- ≥15 years: 3-dose series at 0, 1-2, 6 months (minimum intervals: 4 weeks between doses 1 and 2; 12 weeks between doses 2 and 3; 5 months between doses 1 and 3; repeat dose if administered too soon)
- 9-14 years and received 1 dose or 2 doses <5 months apart: 1 dose
- 9-14 years and received 2 doses at least 5 months apart: HPV vaccination complete, no additional dose needed
Adults aged 27-45 years
- Need for vaccination based on shared decision making between patient and clinician
- 2- or 3-dose series depending on age at initial vaccination (see dosing for adults through age 26 years)
Indications for 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
Indications for females
- 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
-
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
Immunization to Prevent HPV Infection
Demonstrated to protect against diseases/precancerous conditions caused by human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58
HPV vaccination routinely recommended at age 11-12 years (can start at age 9 years)
Routine and catch-up vaccination
- 0.5 mL IM as a 2- or 3-dose series depending on age at initial vaccination
- Age 9 through 14 years at initial vaccination: 2-dose series at 0, 6-12 months (minimum interval: 5 months; repeat dose if administered too soon)
- Age ≥15 years at initial vaccination: 3-dose series at 0, 1-2, 6 months (minimum intervals: 4 weeks between doses 1 and 2; 12 weeks between doses 2 and 3; 5 months between doses 1 and 3; repeat dose if administered too soon)
-
Special situations
- Immunocompromising conditions, including HIV infection: 3-dose series as above
- History of sexual abuse or assault: Start at age 9 years
Indications for males
- 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
Indication for females
- 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
-
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
Pregnancy exposure registry: 1-800-986-8999
A five-year pregnancy registry enrolled 2942 women who were inadvertently exposed to HPV vaccine within 1 month before the last menstrual period (LMP) or at any time during pregnancy, 2566 of whom were prospectively followed
After excluding elective terminations (n=107), ectopic pregnancies (n=5), and those lost to follow-up (n=814), there were 1,640 pregnancies with known outcomes
Rates of miscarriage and major birth defects were 6.8% of pregnancies (111/1640) and 2.4% of live born infants (37/1527), respectively
These rates of assessed outcomes in the prospective population were consistent with estimated background rates
ACIP recommendations
- Pregnancy through age 26 years: HPV vaccination not recommended until after pregnancy
- No intervention needed if vaccinated while pregnant; pregnancy testing not needed before vaccination
Lactation
Data are not sufficient to assess effects on breastfed infants or on milk production/excretion
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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