human papillomavirus vaccine, nonavalent (Rx)

Brand and Other Names:Gardasil 9
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

suspension for IM injection

  • 0.5mL/single-dose vial or syringe
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Prevention of HPV in Boys & Men

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 26 years: 0.5 mL IM as a 3-dose series at 0, 2, and 6 months

Indications in boys and men

  • 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 Girls & Women

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 26 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
more...

Prevention of HPV in Boys & Men

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 26 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 boys and men

  • 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 Girls & Women

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 26 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
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Interactions

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and human papillomavirus vaccine, nonavalent

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            Adverse Effects

            >10%

            Females 16-26 yr

            • Injection site pain (89.9%)
            • Injection site swelling (40%)
            • Injection site erythema (34%)
            • Headache (14.6%)

            Girls 9-15 yr

            • Injection site pain (89.3%)
            • Injection site swelling (47.8%)
            • Injection site erythema (34.1%)
            • Headache (11.4%)

            Boys 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 16-26 yr

            • Pyrexia (5%)

            Girls 9-15 yr

            • Pyrexia (5%)

            Boys 9-26 yr

            • Headache (9.4%)
            • Pyrexia (8.9%)
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            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

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            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.

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            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

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            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

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            Images

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            Formulary

            FormularyPatient Discounts

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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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