Version May 2024
Human papillomavirus infection prevention: IM: Females ≤45 years of age: 0.5 mL at 0, 1, and 6 months. Administer the second dose 1 to 2.5 months after the first dose; administer the third dose 5 to 12 months after the first dose.
National Advisory Committee on Immunization recommendations: Recommended for females <27 years of age; may be given to those ≥27 years of age who are at ongoing risk (NACI 2017).
Females who are vaccine-naive, immunocompromised, or immunocompetent HIV-infected: IM: 3-dose series of 0.5 mL at 0, 1, and 6 months. There should be a 4-week minimum interval between the first and second dose; a 12-week minimum interval between the second and third dose; a 24-week minimum interval between the first and third dose (NACI 2017).
Females who are immunocompetent and received first dose at age 9 to <15 years of age: IM: May administer a 2-dose series of 0.5 mL at 0 and 6 months, or 3-dose series of 0.5 mL at 0, 1, and 6 months (NACI 2017).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Human papillomavirus bivalent vaccine (2vHPV) (United States: Not available): Pediatric drug information")
Note: Bivalent HPV vaccine has been discontinued from the US market; other HPV vaccines should be used for immunization. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Kroger 2023]).
Primary immunization:
CDC (ACIP) recommendations: In a 2-dose series, the minimum interval between the first and second dose is 5 months. In a 3-dose schedule, minimum interval between first and second doses is 4 weeks; the minimum interval between the second and third dose is 12 weeks; the minimum interval between first and third doses is 5 months (CDC/ACIP [Meites 2016])
Non-immunocompromised patients and certain specified medical conditions: Asplenia, asthma, chronic granulomatous disease, chronic liver disease, chronic lung disease, chronic renal disease, central nervous system anatomic barrier defects (eg, cochlear implant), complement deficiency, diabetes, heart disease, or sickle cell disease:
Children ≥9 years and Adolescents <15 years: Females: 2-dose series: IM: 0.5 mL at 0, and 6 to 12 months. Administer first dose at age 11 to 12 years; for patients with any history of sexual abuse or assault, vaccination should be started at 9 years of age
Adolescents ≥15 years: Females: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months
Immunocompromised patients including those with immunocompromising conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasms, transplantation, autoimmune disease, or immunosuppressive therapy): Children ≥9 years and Adolescents: Females: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months
Manufacturer's labeling: Females: Children ≥9 years and Adolescents: IM: 0.5 mL per dose for a total of 3 doses. Administer the second and third doses at 1 and 6 months after initial dose.
Catch-up immunization: CDC (ACIP) recommendations (Meites 2016): Note: Do not restart the series. If doses have been given, begin the below schedule at the applicable dose number. Children ≥9 years and Adolescents: IM: 0.5 mL per dose for a total of 2 to 3 doses (See CDC/ACIP recommendations above for 2-dose vs 3-dose schedule criteria):
First dose given on the elected date
Second dose given at least 4 weeks after the first dose (for 3-dose schedule) or 5 months after the first dose (for a 2-dose schedule)
Third dose (for a 3-dose schedule) given at least 12 weeks after the second dose and at least 5 months after the first dose
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Fatigue (55%)
Local: Pain at injection site (92%), erythema at injection site (48%), swelling at injection site (44%)
Neuromuscular & skeletal: Myalgia (49%), arthralgia (21%)
1% to 10%:
Dermatologic: Urticaria (7%), injection site pruritus (1%)
Genitourinary: Vaginal infection (1%)
Infection: Influenza (3%), infection (chlamydia: 2%)
Respiratory: Nasopharyngitis (4%), pharyngolaryngeal pain (3%), pharyngitis (2%)
<1%, postmarketing, and/or case reports: Anaphylactoid reaction, anaphylaxis, angioedema, erythema multiforme, hypersensitivity reaction, induration at injection site, lymphadenopathy, paresthesia (local), syncope (may be associated with tonic-clonic movements), vasodepressor syncope
Hypersensitivity to the vaccine or to any component of the formulation.
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NACI 2017).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinitis) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]; NACI 2017).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NACI 2017).
• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]; NACI 2017).
• Human papillomavirus infection: Will not provide therapeutic benefit for active human papillomavirus (HPV) disease or abnormal Pap test; will not protect against diseases not caused by HPV vaccine types 16 and 18. For individuals already infected with ≥1 vaccine HPV type(s), the vaccine will provide protection against the other HPV type(s) contained in the vaccine.
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).
• Vaccines: In order to maximize vaccination rates, simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) is recommended of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist. The NACI prefers each dose in a HPV vaccine series be the same vaccine when possible; however, if the previous vaccine is not known then any of the HPV vaccines licensed for use in Canada may be used (NACI 2017).
Special populations:
• Altered immunocompetence: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; may have a reduced response to vaccination (NACI 2017). In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]; NACI 2017).
• Males: Not approved for use in males.
Other warnings/precautions:
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (NACI 2017).
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension [preservative free]:
Cervarix: HPV 16 L1 protein 20 mcg and HPV 18 L1 protein 20 mcg per 0.5 mL (0.5 mL) [contains aluminum, rubber in prefilled syringe; manufactured using Trichoplusia ni (insect cells)]
IM: Shake well prior to use; vaccine should be a white, cloudy liquid. Do not use if discolored or if containing particulate matter, or if syringe is cracked. Inject IM into the deltoid region of the upper arm. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013). Do not administer IV, SUBQ, or intradermally. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2023]). When given with other age-appropriate vaccines, human papillomavirus vaccine should be given after other vaccines because it may cause more pain with injection (NACI 2017).
For patients at risk of hemorrhage, the vaccine should be administered IM if, in the opinion of the health care provider familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]). A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for 5 to 10 minutes (NACI 2017). The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Kroger 2023]; NACI 2017).
IM: Shake suspension well prior to use; do not use suspension if it is discolored or contains particulate matter; should be a homogenous, turbid, white suspension. Do not dilute or mix with other vaccines. Administer IM into the deltoid region of the upper arm. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013). Not for IV, intradermal, or SUBQ administration. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (ACIP [Kroger 2023]). To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (ACIP [Kroger 2023]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person’s name, title and address be entered into the patient’s permanent medical record.
For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) should be used for the vaccination and firm pressure on the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Kroger 2023]).
Human papillomavirus infection prevention: Prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18 in females 9 to 45 years of age: cervical cancer (squamous cell cancer and adenocarcinoma), cervical intraepithelial neoplasia grades 1 to 3, and cervical adenocarcinoma in situ.
The Canadian National Advisory Committee on Immunization recommends routine HPV vaccination for females 9 to <27 years of age. It should not be administered in females <9 years of age but may be administered to females ≥27 years of age who are at ongoing risk of exposure (NACI 2017).
Cervarix may be confused with Cerebyx, CeleBREX
Human papillomavirus vaccine bivalent (Cervarix) may be confused with human papillomavirus vaccine 9-valent (Gardasil 9)
HPV (human papilloma virus vaccine) may be confused with IPV (inactivated poliovirus vaccine)
HPV (human papilloma virus vaccine) may be confused with HBV (previously used for hepatitis B vaccine)
HPV (human papilloma virus vaccine) may be confused with Hib (Haemophilus b conjugate vaccine)
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
The manufacturer recommends pregnancy be avoided for 2 months following vaccination.
Outcome data following inadvertent exposure to this vaccine during pregnancy are available (Bi 2020; Kalliala 2021; Panagiotou 2015).
Administration of the human papillomavirus vaccine during pregnancy is not recommended. Although exposure to human papillomavirus vaccine has not been causally associated with adverse pregnancy outcomes, until additional information is available the vaccine series (or completion of the series) should be delayed until pregnancy is completed (NACI 2017).
Data collection to monitor pregnancy and infant outcomes following exposure to this vaccine is ongoing. Health care providers are encouraged to enroll patients exposed to the bivalent human papillomavirus vaccine during pregnancy to the manufacturer (1-800-387-7374).
It is not known if the components of this vaccine are present in breast milk.
Breastfeeding patients may receive the human papillomavirus vaccine if otherwise indicated. Nonlive vaccines have not been shown to affect the safety of the breastfed infant or mother. Breastfeeding infants should be vaccinated according to the recommended schedules (NACI 2017; NACI 2018).
Gynecologic screening exam, papillomavirus test as per current guidelines; screening for HPV is not required prior to vaccination and screening for cervical cancer should continue as recommended following vaccination. Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]; NACI 2017). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Contains inactive human papillomavirus (HPV) proteins HPV 16 L1, and HPV 18 L1 which produce neutralizing antibodies to prevent cervical cancer, cervical adenocarcinoma, and cervical neoplasia cause by HPV.
Efficacy: HPV2 has shown to be 95% to 99% effective against HPV types 16 and 18-related cervical disease in females 15 to 25 years of age. In addition, vaccination against HPV types 16 and 18 may prevent ~70% of anogenital cancers and 60% of high-risk precancerous cervical lesions (NACI 2017).
Onset: Seroconversion was observed at month 7
Duration: Unknown. Clinical studies followed HPV2 vaccinated participants for 10 years and found no evidence of waning protection (NACI 2017).
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