Gardasil 9 (Pf)

Drug overview for GARDASIL 9 (PF) (human papillomavirus vaccine, 9-valent/pf):

Generic name: human papillomavirus vaccine, 9-valent/PF
Drug class: Human Papillomavirus (HPV) Vaccines
Therapeutic class: Biologicals

Human papillomavirus (HPV) vaccine is an inactivated (recombinant) virus vaccine containing virus-like particles (VLPs) of the major capsid (L1) proteins of certain HPV types and is used to stimulate active immunity to the HPV serotypes represented in the vaccine.

No enhanced Uses information available for this drug.

DRUG IMAGES

GARDASIL 9 VIAL

The following indications for GARDASIL 9 (PF) (human papillomavirus vaccine, 9-valent/pf) have been approved by the FDA:

Indications:
Prevention of head and neck cancer due to human papillomavirus
Prevention of oropharyngeal cancer due to human papillomavirus
Vaccination to prevent anal cancer due to human papillomavirus
Vaccination to prevent cervical cancer due to human papillomavirus
Vaccination to prevent genital warts due to human papillomavirus
Vaccination to prevent vaginal cancer due to human papillomavirus
Vaccination to prevent vulvar cancer due to human papillomavirus

Professional Synonyms:
Active immunization against human papillomavirus anal cancer
Active immunization against human papillomavirus to prevent cervical cancer
Active immunization against human papillomavirus to prevent vulvar cancer
Active immunization to prevent cervical cancer due to human papillomavirus
Active immunization to prevent genital warts due to human papillomavirus
Active immunization to prevent human papillomavirus anal cancer
Active immunization to prevent human papillomavirus vaginal cancer
Active immunization to prevent human papillomavirus vulvar cancer
Human papillomavirus vaccination for vulvar cancer
Human papillomavirus vaccination to prevent genital warts
Vaccination for vaginal cancer due to human papillomavirus
Vaccination to prevent cervical cancer due to human papillomavirus infection
Vaccination to prevent human papillomavirus vulvar cancer
Verruca vulgaris virus vaccination to prevent vulvar cancer

The following dosing information is available for GARDASIL 9 (PF) (human papillomavirus vaccine, 9-valent/pf):

Dosing
Administration
Dosing Information
Generic

Efficacy of 9vHPV given in a 2-dose series in individuals 9-14 years of age is inferred from immunogenicity data. In a randomized, parallel-group study, immunogenicity of 9vHPV given in a 2-dose series (second dose given at 6 or 12 months after the first dose) to females and males 9-14 years of age was compared with immunogenicity of 9vHPV given in a 3-dose series (second and third doses given 2 and 6 months, respectively, after the first dose) in females 16-26 years of age. For all 9 HPV types contained in the vaccine, the immune response 1 month after the last dose in females and males 9-14 years of age who received 2 doses of the vaccine was noninferior to that in females 16-26 years of age who received 3 doses of the vaccine.

More than 98% of individuals enrolled in the study had an antibody response (seroconversion) to each of the 9 HPV types contained in the vaccine by 1 month after completion of the 2- or 3-dose vaccination series. In addition, geometric mean titers (GMTs) of antibodies to the 9 HPV vaccine types that were attained in individuals who received the 2-dose vaccination series were noninferior to GMTs attained in those who received the 3-dose vaccination series. In a 3-year follow-up study, females and males 9-14 years of age who received 2 doses of the 9vHPV vaccine maintained antibody responses (based on GMTs) over 2-2.5

years after administration of the second dose; the GMTs over 2-2.5 years were generally similar to or greater than the GMTs of females 16-26 years of age who received the 3-dose vaccination series with 9vHPV.

Efficacy of 9vHPV given in a 3-dose series in females 9-15 years of age is inferred from immunogenicity data. In one study, 600 females 9-15 years of age were randomized to receive 9vHPV or 4vHPV (no longer available in the US). Results from this study found that females 9-15 years of age who received a 3-dose regimen of 9vHPV had GMTs of antibodies to the HPV types 6, 11, 16, and 18 by 1 month after dose 3 that were noninferior to those attained in females 9-15 years of age who received 4vHPV.

All patients who received 3 doses of either the 9vHPV or 4vHPV vaccine seroconverted for HPV types 6, 11, 16, and 18. In another immunogenicity study, females 9-15 years of age who received a 3-dose regimen of 9vHPV became seropositive for antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 by 1 month after dose 3 and GMTs of these antibodies attained in this age group were noninferior to those attained in females 16-26 years of age (i.e., immunogenicity bridging). Results from this study reported GMTs of these antibodies 1 month after the third vaccine dose of 714-6980 mMU/mL in females 9-15 years of age, and GMTs of 272-3523 mMU/mL in females 16-26 years of age.

In a 10-year follow-up, females 9-15 years of age who received a 3-dose regimen of the 9vHPV vaccine were actively followed from 16 years of age onward for clinical endpoints related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 persistent infection and disease. The median follow-up from the last dose of the 9vHPV vaccine was 10 years. Overall, seropositivity rates remained at >=81% across the 9 HPV types at 10 years post-dose 3 of the vaccine.

In females 9-15 years of age, there were no cases of HPV related CIN 2/3, AIS, VIN, VaIN, external genital warts, cervical cancer, vulvar cancer, or vaginal cancer for the HPV types covered by the 9vHPV vaccine. One case of CIN 1 was observed that tested positive for HPV types 16, 39, and 59 by PCR.

Efficacy of 9vHPV given in a 3-dose series in males 9-15 years of age is inferred based on evidence that more than 99% of males 9-15 years of age became seropositive for antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 by 1 month after the third vaccine dose and GMTs of these antibodies attained in this age group are noninferior to those attained in females 16-26 years of age (i.e., immunogenicity bridging). Immunogenicity studies in males 9-15 years of age indicate that GMTs of these antibodies 1 month after the third vaccine dose range from 907-8629 mMU/mL in this age group. In a 10-year follow-up, males 9-15 years of age who received a 3-dose regimen of the 9vHPV vaccine were actively followed from 16 years of age onward for clinical endpoints related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 persistent infection and disease.

The median follow-up from the last dose of the 9vHPV vaccine was 10 years. Overall, seropositivity rates remained at >=81% across the 9 HPV types at 10 years post-dose 3 of the vaccine. In males 9-15 years of age, there were no cases of HPV related penile intraepithelial neoplasia (PIN), external genital warts, penile cancer, perineal cancer, or perianal cancer for the HPV types covered by the 9vHPV vaccine.

Safety and efficacy of 9vHPV for the prevention of disease caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 have been evaluated in a double-blind, randomized, active comparator-controlled study in 14,204 women 16-26 years of age at the time of enrollment. Study participants were randomized to receive a 3-dose series of either 9vHPV or 4vHPV (no longer available in the US). The second and third vaccine doses were given 2 and 6 months, respectively, after the first dose, and the median duration of follow-up was 3.3

years. The efficacy analysis was based on clinical endpoints including high-grade CIN , AIS, high-grade VIN, high-grade VaIN, invasive cervical carcinoma, vulvar cancer, or vaginal cancer related to HPV types 31, 33, 45, 52, and 58. For HPV types 6, 11, 16, and 18, efficacy of 9vHPV was inferred from immunogenicity data comparisons with 4vHPV.

The per-protocol efficacy (PPE) population consisted of those who completed the 3-dose vaccine series within 1 year of enrollment, did not have major study protocol deviations, and were naive (seronegative and cervicovaginal specimens PCR negative) to the relevant vaccine HPV types when tested prior to the first vaccine dose and at 1 month after the third dose.

Results from the efficacy analysis found that 9vHPV was effective in preventing HPV disease caused by HPV types 31, 33, 45, 52, and 58 in individuals who were seronegative and PCR negative to these HPV types at baseline. In the PPE population, the vaccine was 96.7% effective in preventing CIN 2/3, AIS, VIN 2/3, VaIN 2/3, cervical cancer, vulvar cancer, or vaginal cancer related to HPV types 31, 33, 45, 52, and 58 and 98.6%

effective in preventing CIN 1 related to HPV types 31, 33, 45, 52, and 58. For HPV types 6, 11, 16, and 18, the 9vHPV vaccine was noninferior to the 4vHPV vaccine based on the GMTs attained 1 month after the third dose. A follow-up study reported efficacy of 9vHPV for up to 6 years following first administration of the vaccine; the median follow-up was 4.0

years after the first dose and 3.5 years after the third dose. In the PPE population, 9vHPV had a 97.4%

efficacy, compared to 4vHPV, against high-grade cervical, vulvar, and vaginal disease related to HPV 31, 33, 45, 52, and 58.

Efficacy of 9vHPV for the prevention of disease caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in males 16-26 years of age is inferred based on evidence from an open-label study that included males (including heterosexual males and men having sex with men (MSM)) and females 16-26 years of age who received 9vHPV in a 3-dose series (second and third dose given 2 and 6 months, respectively, after first dose). Results from this study demonstrated that the immune response observed in heterosexual males 16-26 years of age after the third vaccine dose was noninferior to that observed in females 16-26 years of age (i.e., immunogenicity bridging). More than 99% of males (including heterosexual males and MSM) and females 16-26 years of age became seropositive for antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Results from this study reported GMTs of these antibodies 1 month after the third vaccine dose of 236-3346 mMU/mL in heterosexual males 16-26 years of age, GMTs of 158-2294 mMU/mL in MSM 16-26 years of age, and GMTs of 186-2788 mMU/mL in females 16-26 years of age.

Efficacy of 9vHPV for the prevention of disease caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 is based on immunobridging comparison data from an open-label study that included females 27-45 years of age and females 16-26 years of age who received 9vHPV in a 3-dose series (second and third dose given 2 and 6 months, respectively, after first dose). Results from this study found that females 27-45 years of age who received a 3-dose regimen of 9vHPV had GMTs of antibodies (attained 1 month after dose 3) to the HPV types 16, 18, 31, 33, 45, 52, and 58 that were noninferior to those attained in females 16-26 years of age. More than 99% of all vaccine recipients became seropositive for antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Efficacy of 4vHPV for the prevention of HPV disease in males 27-45 years of age is inferred from efficacy data from the clinical trial in females 27-45 years of age and is supported by immunogenicity data from a clinical trial that included 150 males 27-45 years of age who received a 3-dose regimen of 4vHPV (second and third doses given 2 and 6 months, respectively, after the first dose). In addition, results of a cross-study analysis of per-protocol immunogenicity populations that compared HPV 6, 11, 16, and 18 GMTs at month 7 in males 27-45 years of age (study A) to GMTs in males 16-26 years of age in whom efficacy of 4vHPV had been established (study B) indicated that GMT ratios (study A/study B) for antibodies to HPV 6, 11, 16, and 18 were 0.82, 0.79,

0.91, and 0.74, respectively.

The manufacturer recommends a 2- or 3-dose series if HPV vaccination is initiated at 9-14 years of age and a 3-dose series if HPV vaccination is initiated at 15-45 years of age. 9vHPV is administered IM in 0.5 mL doses.

If interruptions occur resulting in an interval between doses longer than recommended, there is no need to restart the vaccination series.

An accelerated schedule for the HPV vaccination series (i.e., using intervals between doses shorter than recommended) should not be used.

Consult the US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) vaccination schedules for specific dosage information, including detailed recommendations for certain scenarios (e.g., catch-up vaccination) and high-risk conditions.

The only commercially available human papillomavirus (HPV) vaccine in the US is human papillomavirus 9-valent vaccine recombinant (9vHPV; Gardasil(R) 9). The previous HPV quadrivalent vaccine (4vHPV; Gardasil(R)) and HPV bivalent vaccine (2vHPV; Cervarix(R)) are no longer commercially available in the US. Human papillomavirus 9-valent vaccine recombinant (9vHPV) is administered only by IM injection.

IM injections of 9vHPV should be made in the deltoid region of the upper arm or anterolateral aspect of the upper thigh. 9vHPV may be given simultaneously with other age-appropriate vaccines. When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given using separate syringes and different injection sites. Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for GARDASIL 9 (PF) (human papillomavirus vaccine, 9-valent/pf):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Teplizumab SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames. The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy. Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)	TZIELD

Drug Interaction

Drug Names

Non-Live or Non-Replicating Vaccines/Teplizumab

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames.

The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy.

Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3)

DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)

TZIELD

There are 8 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Fingolimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Fingolimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for 2 months following fingolimod therapy may result in decreased effectiveness of the vaccine.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating fingolimod therapy. The immune response to non-live vaccines should be monitored in patients receiving fingolimod or who have received fingolimod in the previous two months. Vaccinations given during and for 2 months after stopping fingolimod therapy may need to be repeated.(1,2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective during and for 2 months following fingolimod therapy(1) however they are considered safe to administer.(2)	FINGOLIMOD, GILENYA, TASCENSO ODT
Non-Live or Non-Replicating Vaccines/Siponimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Siponimod is an immunosuppressant and may alter the immune system's response to vaccines.(2) CLINICAL EFFECTS: Administration of a vaccine during and for up to 1 month after discontinuation of siponimod therapy may result in decreased effectiveness of the vaccine. Siponimod treatment should be paused 1 week prior and for 4 weeks after vaccination.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating siponimod therapy. The immune response to non-live vaccines should be monitored in patients receiving siponimod or who have received siponimod in the previous week. Vaccinations given during and for up to 1 month after discontinuation of siponimod therapy may need to be repeated.(2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective if administered during and for up to 1 month after siponimod treatment(2) however they are considered safe to administer.(1)	MAYZENT
Non-Live or Non-Replicating Vaccines/Satralizumab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Satralizumab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during satralizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiation of satralizumab.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines two weeks prior to initiating satralizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving satralizumab. Vaccinations given during satralizumab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during satralizumab treatment.(1)	ENSPRYNG
Non-Live or Non-Replicating Vaccines/Ublituximab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ublituximab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within 2 weeks before or during ublituximab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ublituximab therapy.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ublituximab therapy. The immune response to non-live vaccines should be monitored in patients receiving ublituximab. Vaccinations given during ublituximab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before or during ublituximab treatment.(1)	BRIUMVI
Systemic Corticosteroids; Corticotropin/Non-Live or Non-Replicating Vaccines SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Vaccines administered during or within 2 weeks prior to therapy with corticosteroids or corticotropin may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1) PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 2 weeks after a non-live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines.(1) The immune response to non-live vaccines should be monitored in patients receiving corticosteroids. Vaccinations given during corticosteroid therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(1) DISCUSSION: Vaccinations given during and within 2 weeks prior to corticosteroid therapy may be less effective. However they are considered safe to administer.(1) Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1)	ACTHAR, ACTHAR SELFJECT, ADRENOCORTICOTROPHIC HORMONE, ALDOSTERONE, ALKINDI SPRINKLE, ANUCORT-HC, ANUSOL-HC, BECLOMETHASONE DIPROPIONATE, BETALOAN SUIK, BETAMETHASONE ACETATE MICRO, BETAMETHASONE ACETATE-SOD PHOS, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SOD PHOS-ACETATE, BETAMETHASONE SOD PHOS-WATER, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE, BUDESONIDE, BUDESONIDE DR, BUDESONIDE EC, BUDESONIDE ER, BUDESONIDE MICRONIZED, BUPIVACAINE-DEXAMETH-EPINEPHRN, CELESTONE, CLOBETASOL PROPIONATE MICRO, CORTEF, CORTENEMA, CORTICOTROPHIN, CORTIFOAM, CORTISONE ACETATE, CORTROPHIN, DEFLAZACORT, DEPO-MEDROL, DESONIDE MICRONIZED, DESOXIMETASONE, DESOXYCORTICOSTERONE ACETATE, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE ACETATE, DEXAMETHASONE ACETATE MICRO, DEXAMETHASONE INTENSOL, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE MICRONIZED, DEXAMETHASONE SOD PHOS-WATER, DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE-0.9% NACL, DMT SUIK, DOUBLEDEX, EMFLAZA, EOHILIA, FLUDROCORTISONE ACETATE, FLUNISOLIDE, FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE MICRO, FLUOCINONIDE MICRONIZED, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE MICRO, HEMADY, HEMMOREX-HC, HEXATRIONE, HYDROCORTISONE, HYDROCORTISONE ACETATE, HYDROCORTISONE SOD SUCCINATE, JAYTHARI, KENALOG-10, KENALOG-40, KENALOG-80, KHINDIVI, KYMBEE, LIDOCIDEX-I, MAS CARE-PAK, MEDROL, MEDROLOAN II SUIK, MEDROLOAN SUIK, METHYLPREDNISOLONE, METHYLPREDNISOLONE AC MICRO, METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCC, MILLIPRED, MILLIPRED DP, MOMETASONE FUROATE, ORAPRED ODT, P-PACK PREDNISONE, PREDNISOLONE, PREDNISOLONE ACETATE MICRONIZE, PREDNISOLONE MICRONIZED, PREDNISOLONE SODIUM PHOS ODT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISONE, PREDNISONE INTENSOL, PREDNISONE MICRONIZED, PROCTOCORT, PYQUVI, SOLU-CORTEF, SOLU-MEDROL, TAPERDEX, TARPEYO, TRIAMCINOLONE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATE MICRO, TRILOAN II SUIK, TRILOAN SUIK, UCERIS, VERIPRED 20, ZCORT
Non-Live or Non-Replicating Vaccines/Etrasimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Etrasimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 5 weeks after discontinuation of etrasimod therapy may result in decreased effectiveness of the vaccine. Etrasimod treatment should be paused 5 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating etrasimod therapy. The immune response to non-live vaccines should be monitored in patients receiving etrasimod or who have received etrasimod in the previous 5 weeks. Vaccinations given during and for up to 5 weeks after discontinuation of etrasimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 5 weeks after etrasimod treatment.(1) However they are considered safe to administer.	VELSIPITY
Non-Live or Non-Replicating Vaccines/Ozanimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ozanimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 3 months after discontinuation of ozanimod therapy may result in decreased effectiveness of the vaccine. Ozanimod treatment should be paused 3 months prior and for 1 month after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ozanimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ozanimod or who have received ozanimod in the previous 3 months. Vaccinations given during and for up to 3 months after discontinuation of ozanimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 3 months after ozanimod treatment.(1) However they are considered safe to administer.	ZEPOSIA
Non-Live or Non-Replicating Vaccines/Ponesimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ponesimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 2 weeks after discontinuation of ponesimod therapy may result in decreased effectiveness of the vaccine. Ponesimod treatment should be paused 1-2 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ponesimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ponesimod or who have received ponesimod in the previous 2 weeks. Vaccinations given during and for up to 2 weeks after discontinuation of ponesimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 2 weeks after ponesimod treatment.(1) However they are considered safe to administer.	PONVORY

Moderate List
No disease contraindications

The following adverse reaction information is available for GARDASIL 9 (PF) (human papillomavirus vaccine, 9-valent/pf):

Overview
Severe
Less Severe

Adverse reaction overview.

In females 9-15 years of age, the most common adverse reactions to 9vHPV are injection-site pain (89.3%), injection-site swelling (47.8%), injection-site erythema (34.1%) and headache (11.4%). In females 16-26 years of age, the most common adverse reactions to 9vHPV are injection-site pain (89.9%), injection-site swelling (40.0%), injection-site erythema (34.0%) and headache (14.6%). In females 27-45 years of age, the most common adverse reactions to 9vHPV are injection-site pain (82.8%), injection-site swelling (23.3%), injection-site erythema (16.9%), and headache (13.6%).

In males 16-26 years of age, the most common adverse reactions to 9vHPV are injection-site pain (63.4%), injection-site swelling (20.2%), and injection-site erythema (20.7%). In males 9-15 years of age, the most common adverse reactions to 9vHPV are injection-site pain (71.5%), injection-site swelling (26.9%), and injection-site erythema (24.9%).

There are 16 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Appendicitis Asthma Bronchospastic pulmonary disease Cellulitis Deep venous thrombosis Gastroenteritis Guillain-barre syndrome Idiopathic thrombocytopenic purpura Inflammatory disease of female pelvic organs Myelitis Pancreatitis Pulmonary thromboembolism Seizure disorder Syncope Thromboembolic disorder

There are 31 less severe adverse reactions.

More Frequent	Less Frequent
Headache disorder Injection site erythema Injection site inflammation Injection site sequelae Pain	Bruising Dizziness Fatigue Fever Hematoma Induration of skin Nausea Pain in oropharynx Pruritus of skin Skin swelling Upper abdominal pain

Rare/Very Rare
Arthralgia Arthritis Autoimmune hemolytic anemia Chills Cough Diarrhea General weakness Insomnia Lymphadenopathy Malaise Myalgia Nasal congestion Toothache Urticaria Vomiting

The following precautions are available for GARDASIL 9 (PF) (human papillomavirus vaccine, 9-valent/pf):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of 9vHPV have not been established in females or males younger than 9 years of age.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

There are no adequate and well-controlled studies using 9vHPV in pregnant women. The manufacturer states that human data to date have not demonstrated any vaccine-associated risk of major birth defects and miscarriages when 9vHPV is administered during pregnancy. ACIP, AAP, American College of Obstetricians and Gynecologists (ACOG), and other organizations state that HPV vaccine is not recommended for use in pregnant women.

Although pregnancy testing is not needed before initiation of the HPV vaccination series, health-care providers should question sexually active individuals about the possibility of pregnancy. HPV vaccination should be deferred until pregnancy is completed. If a woman is found to be pregnant after the HPV vaccine series is initiated, ACIP, AAP, ACOG, and other organizations state that no intervention is needed, but any remaining doses of the series should be deferred until after completion of the pregnancy.

Data are insufficient to assess the effects of 9vHPV on the breast-fed infant or on milk production/excretion. The manufacturer of 9vHPV states that the benefits of breast-feeding and the importance of the vaccine to the woman should be considered along with the potential adverse effects on the breast-fed child from the vaccine or from the underlying maternal condition (i.e., susceptibility to HPV infection). ACIP states that inactivated vaccines do not pose any unusual risks for the mother or her breast-fed infant. ACIP and other organizations state that HPV vaccine may be administered to women who are breast-feeding.

Safety and efficacy of 9vHPV have not been established in females or males 65 years of age or older.

The following icd codes are available for GARDASIL 9 (PF) (human papillomavirus vaccine, 9-valent/pf)'s list of indications:

Prevention of head and neck cancer due to HPV
Z23	Encounter for immunization
Prevention of oropharyngeal cancer due to HPV
Z23	Encounter for immunization
Vaccination to prevent anal cancer due to HPV
Z23	Encounter for immunization
Vaccination to prevent cervical cancer due to HPV
Z23	Encounter for immunization
Vaccination to prevent genital warts due to HPV
Z23	Encounter for immunization
Vaccination to prevent vaginal cancer due to HPV
Z23	Encounter for immunization
Vaccination to prevent vulvar cancer due to HPV
Z23	Encounter for immunization