Papillomavirus (Types 6, 11, 16, 18) Vaccine (Human, Recombinant)

For all patients taking papillomavirus (types 6, 11, 16, 18) vaccine (human, recombinant):

• It is used to prevent anal cancer, genital warts, and anal growths that may lead to cancer.
• It may be given to you for other reasons. Talk with the doctor.

Women:

• It is used to prevent these health problems caused by HPV: Cervical cancer; vaginal or vulvar cancer; and cervical, vaginal, or vulvar growths that may lead to cancer.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Prevention of human papillomavirus infection:

US labeling:

Females 9 to 26 years of age:

For the prevention of the following diseases: Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18; genital warts (condyloma acuminatum) caused by HPV types 6 and 11;

For the prevention of the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18: Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ; CIN grade 1; vulvar intraepithelial neoplasia grade 2 and 3; vaginal intraepithelial neoplasia grade 2 and 3; and anal intraepithelial neoplasia grades 1, 2, and 3.

Males 9 through 26 years of age:

For the prevention of the following diseases: Anal cancer caused by HPV types 16 and 18; genital warts (condyloma acuminata) caused by HPV types 6 and 11;

For the prevention of anal intraepithelial neoplasia grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18.

Limitations of use: Does not provide protection against vaccine HPV types to which a person has already been previously exposed, or HPV types not contained in the vaccine; does not prevent CIN grade 2/3 or worse in women >26 years. Not intended for the treatment of active external genital lesions or cervical, vulvar, vaginal, and anal cancers.

Canadian labeling:

Females ≥9 years and ≤26 years: Prevention of anal cancer caused by HPV types 16 and 18; anal intraepithelial neoplasia caused by HPV types 6, 11, 16, and 18

Females ≥9 years and ≤45 years: Prevention of cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; cervical adenocarcinoma in situ, vulvar, vaginal, or cervical intraepithelial neoplasia caused by HPV types 6, 11, 16, and 18

Males ≥9 years and ≤26 years: Prevention of anal cancer caused by HPV types 16 and 18; anal intraepithelial neoplasia caused by HPV types 6, 11, 16, and 18; genital warts caused by HPV types 6 and 11

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for females and males 11 to 12 years; for patients with any history of sexual abuse or assault, vaccination should be started at 9 years of age. Catch-up vaccination is recommended for females and transgender persons 13 to 26 years and males 13 to 21 years. Vaccination for males 22 through 26 years is recommended if immunocompromised (including HIV) and for men who have sex with men and may be considered for any other male in this age group (CDC/ACIP [Meites 2016]).

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 (ACIP [Kroger 2017]).

• 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 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. Defer 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) (ACIP [Kroger 2017]; CDC/ACIP [Markowitz 2014]).

• 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 2017]).

• Human papillomavirus (HPV) infection: There is no evidence that individuals already infected with HPV will be protected; those already infected with 1 or more HPV types were protected from disease in the remaining HPV types. Not for the treatment of active disease; will not protect against diseases not caused by HPV vaccine types 6, 11, 16, and 18.

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2017]).

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (ACIP [Kroger 2017]).

Special populations:

• Altered immunocompetence: May be administered to those who are immunosuppressed (CDC/ACIP [Markowitz 2014]). Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high dose corticosteroids]); may have a reduced response to vaccination (ACIP [Kroger 2017]; CDC/ACIP [Markowitz 2014]). In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2017]; IDSA [Rubin 2014]).

• Pregnancy: Not recommended for use during pregnancy.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

• Yeast: Product may contain yeast.

Other warnings/precautions:

• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the ACIP Recommended Immunization Schedules (ACIP [Kim 2017]; CDC/ACIP [Robinson 2017]). Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions are available from the IDSA (Rubin 2014).

• 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. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2017]).

• Maximum efficacy: The entire 3-dose regimen should be completed for maximum efficacy.