Gardasil 9 (human papillomavirus vaccine, 9-valent/PF)
Human Papillomavirus (HPV) Vaccines Intramuscular Syringe (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
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.
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 associated with anogenital infections. Some HPV types are classified as high-risk (oncogenic) types and can cause low-grade cervical cell abnormalities or high-grade cervical cell abnormalities that are precursors to cancer; other HPV types are classified as low-risk types and can cause genital warts, benign or low-grade cervical cell changes, and recurrent respiratory papillomatosis. HPV vaccine is used to stimulate active immunity to the HPV types represented in the vaccine.
VLPs contained in HPV vaccine are produced using recombinant DNA technology and are structurally indiscernible from native HPV virions; the VLPs are noninfectious because they do not contain DNA.
HPV vaccine is commercially available in the US as a 9-valent vaccine (9vHPV) that contains the purified VLPs of the L1 proteins of 9 HPV types (types 6, 11, 16, 18, 31, 33, 45, 52, and 58). The type-specific L1 proteins are prepared by separate fermentations in recombinant S. cerevisiae and self-assemble into VLPs. The VLPs are released from the yeast cells by cell disruption; purified by a series of chemical and physical methods; and adsorbed onto preformed aluminum-containing adjuvant (amorphous aluminum hydroxyphosphate sulfate).
In addition to the 9 HPV type-specific VLPs, each 0.5 mL dose of 9vHPV contains approximately 500 mcg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, less than 7 mcg of yeast protein, and water for injection.
Administration of a 3-dose vaccination series of 9vHPV can prevent disease caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including genital warts caused by HPV types 6 and 11; cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; and precancerous anal and genital lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Data indicate that at least 99.5% of all female and male vaccine recipients 9-26 years of age develop antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 by 1 month following the third dose of 9vHPV. The immune response to a 2-dose regimen of 9vHPV administered to females and males 9-14 years of age is noninferior to that reported with a 3-dose regimen of 9vHPV administered to females 16-26 years of age.
The minimum titer of anti-HPV antibody that provides protection against disease caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 and the duration of immunity following vaccination with 9vHPV have not been established to date. HPV vaccines appear to provide long-term protection against HPV infection and the diseases it can cause. Studies on the bivalent and quadrivalent vaccines have tracked vaccinated individuals for over 10 years, showing no decline in protection over time.
Ongoing studies continue to monitor how long the protection from HPV vaccination lasts.
USES: This vaccine is used to help 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).
This vaccine works 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. Vaccines may not fully protect everyone who receives them.
Generic name: human papillomavirus vaccine, 9-valent/PF
Drug class: Human Papillomavirus (HPV) Vaccines
Therapeutic class: Biologicals
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Gardasil 9
Indications
The following indications are listed for Gardasil 9:
- 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
Also known as: 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.
Dosing
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.
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Drug interactions
There is no enhanced messaging for this drug.
Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Non-Live Or Non-Replicating Vaccines/Efalizumab
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Efalizumab-induced immunosuppression may prevent proper immune response to the vaccine.(1)
CLINICAL EFFECTS: The use of vaccines in patients who have recently received efalizumab may be ineffective.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Patients should receive all appropriate immunizations prior to beginning efalizumab therapy. The use of vaccines in patients who have recently received efalizumab may be ineffective.(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: In a small study with intravenous efalizumab, a single dose of 0.3 mg/kg of efalizumab given before primary immunization with a neoantigen decreased the secondary immune response, and a dose of 1 mg/kg almost completely ablated it. (This dose has comparable pharmacodynamic effects to the recommended subcutaneous dose of 1 mg/kg.) In chimpanzees treated with greater than 10 times the normal clinical exposure level of efalizumab, antibody responses were decreased following immunization with tetanus toxoid compared with untreated control animals.(1)
Non-Live, Non-Replicating Vaccine/Rebisufligene Etisparvovec
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Rebisufligene etisparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of rebisufligene etisparvovec states that vaccines should be avoided 30 days prior to rebisufligene etisparvovec administration.(1)
DISCUSSION: Rebisufligene etisparvovec therapy may decrease the effectiveness of vaccines.(1)
Vaccines/Pariglasgene Brecaparvovec
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of pariglasgene brecaparvovec states that vaccines should be avoided for 1 month prior to pariglasgene brecaparvovec administration.(1)
DISCUSSION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines.(1)
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
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)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Non-Live Or Non-Rep Vaccines/Systemic Corticosteroids; Acth
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)
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.
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)
Non-Live Or Non-Replicating Vaccines/Ocrelizumab
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Ocrelizumab 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 ocrelizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ocrelizumab therapy.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ocrelizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving ocrelizumab. Vaccinations given during ocrelizumab 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 ocrelizumab treatment.(1)
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.
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.
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)
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)
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)
Non-Live Or Nonreplicating Vaccine/Vusolimogene Oderparepvec
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The interaction potential of non-live or non-replicating vaccines with vusolimogene oderparepvec is unknown.
CLINICAL EFFECTS: Concurrent administration of non-live or non-replicating vaccines with vusolimogene oderparepvec may alter the effectiveness or toxicities of either agent.
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of vusolimogene oderparepvec states that non-live and non-replicating vaccines should ideally be delayed until the current course of vusolimogene oderparepvec therapy is completed. If vaccination is required during treatment, separate administration of the vaccine and vusolimogene oderparepvec by at least 14 days.(2) Patients should be advised that their cancer gene therapy may be delayed due to administration of vaccines.(3)
DISCUSSION: The concomitant use of non-live or non-replicating vaccines and vusolimogene oderparepvec has not been evaluated. The manufacturer's recommendation is intended to minimize potential interactions and confounding factors in the safety assessments of vaccines and vusolimogene oderparepvec therapy.(2)
Vaccines/Hepatitis B Vaccine (Fendrix)
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix and other vaccines.(1)
CLINICAL EFFECTS: It is unknown if concurrent administration of the hepatitis B vaccine Fendrix and other vaccines will affect the efficacy of either vaccine.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The Swedish manufacturer of Fendrix states that since there is no data available for the concurrent administration of Fendrix with other vaccines, the administration of Fendrix and other vaccines should be separated by 2 to 3 weeks.(1)
DISCUSSION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix with other vaccines.(1)
Contraindications
*Hypersensitivity to any vaccine component (including severe allergic reactions to yeast) or hypersensitivity following a previous dose of human papillomavirus (HPV) vaccine.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
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%).
Rare or 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
More Frequent
- Headache disorder
- Injection site erythema
- Injection site inflammation
- Injection site sequelae
- Pain
Less Frequent
- Bruising
- Dizziness
- Fatigue
- Fever
- Hematoma
- Induration of skin
- Nausea
- Pain in oropharynx
- Pruritus of skin
- Skin swelling
- Upper abdominal pain
Rare or Very Rare
- Arthralgia
- Arthritis
- Autoimmune hemolytic anemia
- Chills
- Cough
- Diarrhea
- General weakness
- Insomnia
- Lymphadenopathy
- Malaise
- Myalgia
- Nasal congestion
- Toothache
- Urticaria
- Vomiting
Precautions
No enhanced messaging available.
Safety and efficacy of 9vHPV have not been established in females or males younger than 9 years of age.
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.
The manufacturer makes no specific dosage recommendations for geriatric patients.
Safety and efficacy of 9vHPV have not been established in females or males 65 years of age or older.
ICD codes
| Code | Type | Description |
|---|---|---|
| Prevention of head and neck cancer due to human papillomavirus | ||
| Z23 | ICD10CM | Encounter for immunization |
| Prevention of oropharyngeal cancer due to human papillomavirus | ||
| Z23 | ICD10CM | Encounter for immunization |
| Vaccination to prevent anal cancer due to human papillomavirus | ||
| Z23 | ICD10CM | Encounter for immunization |
| Vaccination to prevent cervical cancer due to human papillomavirus | ||
| Z23 | ICD10CM | Encounter for immunization |
| Vaccination to prevent genital warts due to human papillomavirus | ||
| Z23 | ICD10CM | Encounter for immunization |
| Vaccination to prevent vaginal cancer due to human papillomavirus | ||
| Z23 | ICD10CM | Encounter for immunization |
| Vaccination to prevent vulvar cancer due to human papillomavirus | ||
| Z23 | ICD10CM | Encounter for immunization |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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