Bydureon and Human Papillomavirus Vaccine

• Generic Name: exenatide
• Dosage Forms: injection, suspension, extended release
• Other Brand Names: Bydureon, Bydureon BCise, Bydureon Pen, Bydureon Tray, Byetta Prefilled Pen

Bydureon is an extended release injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently. Bydureon is a long-acting form of exenatide.

Bydureon is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. This medicine is not for treating type 1 diabetes.

This medication guide provides information about the Bydureon brand of exenatide. Byetta is another brand of exenatide that is not covered in this medication guide.

• Generic Name: human papillomavirus vaccine
• Dosage Forms: n.a.
• Other Brand Names: Gardasil 9, Cervarix

Prevention of cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 in females 9 through 45 years of age. Also prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including cervical intraepithelial neoplasia (CIN) grades 1 and 2/3, cervical adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN) grades 2 and 3, vaginal intraepithelial neoplasia (VaIN) grades 2 and 3, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3, in females 9 through 45 years of age.

Prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 and prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including AIN grades 1, 2, and 3, in males 9 through 45 years of age.

Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11 in females and males 9 through 45 years of age.

Anogenital HPV is the most common sexually transmitted infection in US; approximately 79 million individuals already infected and 14 million more become infected each year (about 50% of cases are occurring in adolescents and young adults 15 through 24 years of age). Most HPV infections are asymptomatic and resolve spontaneously within 1–2 years, but some low-risk (nononcogenic) HPV types cause anogenital warts (condyloma acuminata) and some high-risk (oncogenic) HPV types are associated with persistent anogenital infections, dysplastic lesions, and development of cervical and other anogenital cancers (e.g., penile, vulvar, vaginal, anal). High-risk HPV types 16 and 18 cause about 70% of all cases of cervical and anogenital cancer in females and about 70% of all cases of anal cancer in males.

The 9-valent HPV vaccine (9vHPV) provides protection against disease caused by high-risk (oncogenic) HPV types 16, 18, 31, 33, 45, 52, and 58; also provides protection against disease caused by low-risk (nononcogenic) HPV types 6 and 11.

The CDC Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend that all females and males 9 through 26 years of age receive routine and catch-up vaccination with 9vHPV.

ACIP states that routine and catch-up vaccination with 9vHPV recommended for females and males 9 through 26 years of age with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity (e.g., B-lymphocyte antibody deficiencies, T-lymphocyte complete or partial defects, HIV infection, malignant neoplasms, transplantation, autoimmune disease, immunosuppressive therapy).

ACIP states make decisions regarding use of 9vHPV in females and males 27 through 45 years of age based on shared decision-making and discussion between patient and clinician regarding benefits and risks of the vaccine.

First dose of HPV vaccine usually given at 11 through 12 years of age, but may be given to those as young as 9 years of age. ACIP and other experts recommend routine HPV vaccination in individuals as young as 9 years of age when sexual abuse or sexual assault is suspected.

Ideally, complete HPV vaccination before potential exposure to HPV occurs through sexual activity; however, 9vHPV may still be given to age-appropriate individuals who are sexually active and may have already been exposed to HPV. Although sexually active individuals who have not been infected with any HPV types contained in the vaccine receive the full benefit of vaccination, vaccination may still be beneficial for those who have already been infected with ≥1 of the vaccine HPV types.

9vHPV can be used to continue or complete HPV vaccination series in individuals who previously received 1 or more doses of HPV vaccine no longer available in US (4vHPV, 2vHPV). ACIP states that individuals who initiated HPV vaccination prior to 15 years of age and received 2 or 3 doses of any HPV vaccine administered at recommended dosage schedule are considered adequately vaccinated. Individuals who initiated HPV vaccination at ≥15 years of age and received 3 doses of any HPV vaccine administered at recommended dosage schedule also considered adequately vaccinated. ACIP has made no recommendations to date regarding additional vaccination with 9vHPV in individuals considered adequately vaccinated with 4vHPV or 2vHPV.

Prevaccination HPV testing or screening (e.g., Papanicolaou [Pap] testing or screening for high-risk HPV DNA, type-specific HPV DNA tests, HPV antibody test) not needed and not recommended. HPV vaccine can be used regardless of history of anogenital warts, abnormal Pap or HPV tests, or anogenital precancer.

Does not prevent infection or disease caused by HPV types not represented in the vaccine.

Does not provide protection against disease from vaccine and nonvaccine HPV types to which an individual has previously been exposed through sexual activity.

Not used for treatment of active genital warts and not used for treatment of precancerous or dysplastic lesions (e.g., AIN, CIN, VIN, VaIN) or cervical, vulvar, vaginal, or anal cancer.