Prevention of human papillomavirus infection.(UTD)

Contains inactive human papillomavirus (HPV) proteins (types 6 L1,11 L1, 16 L1, 18 L1, 31 L1, 33 L1, 45 L1, 52 L1, and 58 L1) which produce neutralizing antibodies to prevent cervical, vulvar, vaginal, and anal cancers, cervical adenocarcinoma, cervical, vaginal, vulvar, and anal neoplasia, and genital warts caused by HPV. Efficacy of HPV 9-valent vaccine against anogenital diseases related to the vaccine HPV types in humans is thought to be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of protection is unknown.(UTD)

Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of this vaccine or human papillomavirus vaccine (recombinant) for types 6, 11, 16, 18.(UTD)

Adverse events were not observed in animal reproduction studies.(UTD)

It is not known if this vaccine is excreted into breast milk.(UTD)

>10%:
Central nervous system: Headache (9% to 20%)
Local: Pain at injection site (63% to 90%), swelling at injection site (13% to 49%; swelling increased with successive doses and/or concomitant vaccines), erythema at injection site (7% to 42%; erythema increases with successive doses)
1% to 10%:
Cardiovascular: Syncope
Central nervous system: Dizziness (?3%), fatigue (?2%)
Gastrointestinal: Diarrhea (?1%), upper abdominal pain (?2%), nausea (1% to 4%)
Immunologic: Autoimmune disease (2%)
Local: Itching at injection site (4% to 8%), hematoma at injection site (1% to ?5%), bruising at injection site (2%), induration at injection site (1% to ?2%), bleeding at injection site (1%), injection site nodule (1%), injection site reaction (?1%)
Neuromuscular & skeletal: Myalgia (?1%)
Respiratory: Oropharyngeal pain (1% to 3%)
Miscellaneous: Fever (4% to ?10%)
<1%, postmarketing, and/or case reports: Anaphylactoid reaction, hypersomnia, postural orthostatic tachycardia, pulmonary embolism, status asthmaticus, tonsillitis, upper respiratory tract infection, warm sensation at injection site
(UTD)

Immunization: IM:
Adults ?26 years: 3-dose series: 0.5 mL at 0, 2, and 6 months.(UTD)

Immunization:
Children ?9 years and Adolescents <15 years:
2-dose series: IM: 0.5 mL at 0, and 6 to 12 months. If the second dose is inadvertently administered earlier than 5 months after the first dose, then patient should be converted to a 3-dose series.
3-dose series: IM: 0.5 mL at 0, 2, and 6 months
Adolescents ?15 years: 3-dose series: IM: 0.5 mL at 0, 2, and 6 months(UTD)

There are no dosage adjustments provided in the manufacturer’s labeling.(UTD)

There are no dosage adjustments provided in the manufacturer’s labeling.(UTD)