Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (42)
- 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.
- elivaldogene autotemcel
elivaldogene autotemcel, human papillomavirus vaccine, nonavalent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- 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.
- teplizumab
teplizumab decreases effects of human papillomavirus vaccine, nonavalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.
- 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 (18)
- 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.
- satralizumab
satralizumab decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .
- tralokinumab
tralokinumab will decrease the level or effect of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.
- ublituximab
ublituximab decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.
- 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.
- voclosporin
voclosporin decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment.
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.
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; 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
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
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Gardasil 9 (PF) intramuscular - | 0.5 mL vial |  | |
| Gardasil 9 (PF) intramuscular - | 0.5 mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 last or get worse, 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 this medication has been prescribed because your health care professional 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 January 2022. Copyright(c) 2023 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.
Formulary
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