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

Immunization to Prevent HPV Infection

Protects against diseases/precancerous conditions caused by human papillomavirus (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 age through 26 years)

Indications for males

  • Prevention of the following diseases
    • Anal, oropharyngeal, and other head and neck cancers 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, anal, oropharyngeal, and other head and neck cancers 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, vulvar, vaginal, anal, oropharyngeal and other head and neck 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 or HPV types not covered by the vaccine
  • Not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN
  • Not all vulvar, vaginal, anal, oropharyngeal, and other head and neck 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

Protects against diseases/precancerous conditions caused by human papillomavirus (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, oropharyngeal, and other head and neck cancers 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, anal, oropharyngeal, and other head and neck cancers 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, vulvar, vaginal, anal, oropharyngeal, and other head and neck 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 or HPV types not covered by the vaccine
  • Not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers; CIN; VIN; VaIN; or AIN
  • Not all vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers are caused by HPV
  • May not result in protection in all vaccine recipients
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Interactions

Interaction Checker

and human papillomavirus vaccine, nonavalent

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              Serious - Use Alternative (40)

              • adalimumab

                adalimumab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • alefacept

                alefacept decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • anakinra

                anakinra decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • antithymocyte globulin equine

                antithymocyte globulin equine decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • antithymocyte globulin rabbit

                antithymocyte globulin rabbit decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • azathioprine

                azathioprine decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • basiliximab

                basiliximab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • belimumab

                belimumab decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • budesonide

                budesonide decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • canakinumab

                canakinumab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • certolizumab pegol

                certolizumab pegol decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • cortisone

                cortisone decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • deflazacort

                deflazacort decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • dexamethasone

                dexamethasone decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • etanercept

                etanercept decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • everolimus

                everolimus decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • fludrocortisone

                fludrocortisone decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • glatiramer

                glatiramer decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • golimumab

                golimumab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • hydrocortisone

                hydrocortisone decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • hydroxychloroquine sulfate

                hydroxychloroquine sulfate decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • infliximab

                infliximab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • leflunomide

                leflunomide decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • mercaptopurine

                mercaptopurine decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • methotrexate

                methotrexate decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • methylprednisolone

                methylprednisolone decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • muromonab CD3

                muromonab CD3 decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • mycophenolate

                mycophenolate decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • ocrelizumab

                ocrelizumab decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.

              • ofatumumab SC

                ofatumumab SC decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 2 weeks before initiating ofatumumab SC for inactivated vaccines, and whenever possible.

              • prednisolone

                prednisolone decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • prednisone

                prednisone decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • rilonacept

                rilonacept decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • secukinumab

                secukinumab decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating secukinumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with secukinumab may not elicit an immune response sufficient to prevent disease.

              • siponimod

                siponimod decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.

              • sirolimus

                sirolimus decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • tacrolimus

                tacrolimus decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • temsirolimus

                temsirolimus decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • tocilizumab

                tocilizumab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • triamcinolone acetonide injectable suspension

                triamcinolone acetonide injectable suspension decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              Monitor Closely (14)

              • cyclosporine

                cyclosporine decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. If possible, complete all age-appropriate vaccinations at least 2 weeks before initiating immunosuppressant therapy. Patients vaccinated <14 days before starting immunosuppressive therapy or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Longer waiting periods may be required for drugs that maintain their immunosuppressive effects for more than 3 months after discontinuation (eg, ocrelizumab). .

              • dengue vaccine

                dengue vaccine, human papillomavirus vaccine, nonavalent. unspecified interaction mechanism. Use Caution/Monitor. Data are not available to establish safety and immunogenicity of coadministration of dengue vaccine with recommended adolescent vaccines.

              • ibrutinib

                ibrutinib decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              • ifosfamide

                ifosfamide decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              • lomustine

                lomustine decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              • mechlorethamine

                mechlorethamine decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              • melphalan

                melphalan decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              • onasemnogene abeparvovec

                onasemnogene abeparvovec decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

              • oxaliplatin

                oxaliplatin decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              • ponesimod

                ponesimod decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. If possible, complete all age-appropriate vaccinations at least 4 weeks before initiating ponesimod.

              • procarbazine

                procarbazine decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              • rituximab

                rituximab, human papillomavirus vaccine, nonavalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • rituximab-hyaluronidase

                rituximab-hyaluronidase, human papillomavirus vaccine, nonavalent. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.

              • ustekinumab

                ustekinumab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Use Caution/Monitor. Inactivated vaccinations administered during ustekinumab treatment may not elicit an immune response sufficient to prevent disease.

              Minor (2)

              • chloroquine

                chloroquine decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Minor/Significance Unknown. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

              • ozanimod

                ozanimod decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Minor/Significance Unknown. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Vaccinations may be less effective if coadministered with ozanimod.

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              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%)
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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; when syncope is associated with tonic-clonic movements, activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position

              Not shown to be protective against nonvaccine HPV types

              Decision to defer administration in patients with febrile illness depends on etiology of the disease and severity of symptoms; do not delay administration in acute illness with or without fever; defer administration in moderate to severe acute illness

              Bleeding hematoma may occur from IM administration; use caution in patients with history of bleeding disorders, including thrombocytopenia; IM injection may be scheduled shortly after antihemophilia or similar therapy is administered

              Does not protect against disease not caused by HPV types not included in the vaccine; not for the treatment of active disease; cervical or anal cancer screening is still required following vaccine administration

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              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.

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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

              BRAND FORM. UNIT PRICE PILL IMAGE
              Gardasil 9 (PF) intramuscular
              -
              0.5 mL solution
              Gardasil 9 (PF) intramuscular
              -
              0.5 mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              human papillomavirus vaccine,9-valent (PF) intramuscular

              HUMAN PAPILLOMAVIRUS VACCINE - INJECTION

              COMMON BRAND NAME(S): Gardasil, Gardasil 9

              USES: This medication is a vaccine used to prevent cancer of the anus, abnormal tissue growth of the anus, genital warts, or certain head and neck cancers. In girls and women, it is also used to prevent cancer of the cervix/vagina/vulva and abnormal tissue growth in these areas that can lead to cancer. These conditions are commonly caused by certain types of human papillomavirus (HPV). Vaccines work by increasing the body's natural defense (immunity) against the virus.This vaccine does not protect against all types of HPV, only the types in the vaccine. It is used to prevent the diseases and will not treat active anal/cervical/head/neck/vaginal/vulvar cancer, genital warts, or other diseases caused by the types of HPV in the vaccine.

              HOW TO USE: Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.This vaccine is given by injection into the muscle of the thigh or upper arm by a health care professional.This vaccine is usually given as 3 separate doses. The second dose should be given 2 months after the first dose, and the third dose should be given 6 months after the first dose. For children younger than 15 years, this vaccine may also be given as 2 separate doses with the second dose given 6 to 12 months after the first dose. The vaccination schedule should be followed closely for the vaccine to be most effective.

              SIDE EFFECTS: Redness, itching, swelling, bruising, and pain at the injection site may occur. Fever and headache may also occur. If any of these effects persist or worsen, tell your health care professional promptly.Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Seizure-like movements may also rarely happen after injection with this vaccine. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.Remember that your health care professional has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

              PRECAUTIONS: Before receiving this vaccine, tell the health care professional if you are allergic to it; or to yeast; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your health care professional for more details.Before receiving this vaccination, tell your health care professional your medical history, especially of: immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment), current fever/illness.This vaccine is not recommended for use during pregnancy. Consult your health care professional for more details.It is unknown if this vaccine passes into breast milk. Consult your health care professional before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this vaccine include: drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone).This vaccine can be given at the same time as other vaccines, using separate injection sites and separate syringes.

              OVERDOSE: Not applicable.

              NOTES: As with any vaccine, this vaccine may not fully protect everyone who receives it.Getting this vaccine does not replace cervical cancer screening. Continue to have regular obstetrician/gynecologist checkups.

              MISSED DOSE: If you miss a dose in the vaccination schedule, contact your health care professional right away.

              STORAGE: Store in the refrigerator. Do not freeze. Protect from light. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised July 2020. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

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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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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.