Human Papillomavirus Quadrivalent vaccine is indicated in girls and women aged 9 to 26 years for prevention of diseases caused by HPV types included in the vaccine:

• Cervical, vulvar, vaginal, and anal cancers caused by HPV types 16 and 18
• Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And for prevention of the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

• Cervical intraepithelial neoplasia (CIN) grades 2/3 and cervical adenocarcinoma in situ (AIS)
• Cervical intraepithelial neoplasia (CIN) grade 1
• Vulvar intraepithelial neoplasia (VIN) grades 2 and 3
• Vaginal intraepithelial neoplasia (VaIN) grades 2 and 3
• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Human Papillomavirus Quadrivalent vaccine is also indicated in boys and men aged 9 to 45 years for prevention of:

• Anal, oropharyngeal, and other head and neck cancers associated with HPV types 16, 18, 31, 33, 45, 52, and 58
• Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And for prevention of the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:

• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

HPV infects only humans. Studies in animals using similar papillomaviruses indicate that L1 VLP vaccines work by stimulating humoral immune responses. The effectiveness of the Human Papillomavirus Quadrivalent vaccine against anogenital diseases associated with the included HPV types is believed to be due to these antibody-mediated immune responses, although the exact mechanism of protection is not fully understood.

9 through 14 years:

• 2-dose: 0, 6 to 12 months. If the second dose is administered earlier than 5 months after the first dose, a dminister a third dose at least 4 months after the second dose.
• 3-dose: 0, 2, 6 months.

15 through 45 years:

• 3-dose: 0, 2, 6 months

For intramuscular use only. Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. Human Papillomavirus Quadrivalent should not be diluted or mixed with other vaccines. After thorough agitation, Human Papillomavirus Quadrivalent is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the product if particulates are present or if it appears discolored. Human Papillomavirus Quadrivalent should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. Syncope has been reported following vaccination with Human Papillomavirus Quadrivalent and may result in falling with injury; observation for 15 minutes after administration is recommended.

Immunosuppressive treatments such as irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and high-dose corticosteroids may decrease the immune response to vaccines.

Hypersensitivity, including severe allergic reactions to yeast (a component of the vaccine), or a history of such reactions following a previous dose of Human Papillomavirus Quadrivalent vaccine.

The most common (≥10%) local and systemic adverse reactions reported:

• In girls and women 16–26 years: injection-site pain (89.9%), injection-site swelling (40.0%), injection-site redness (34.0%), and headache (14.6%).
• In girls 9–15 years: injection-site pain (89.3%), injection-site swelling (47.8%), injection-site redness (34.1%), and headache (11.4%).
• In women 27–45 years: injection-site pain (82.8%), injection-site swelling (23.3%), injection-site redness (16.9%), and headache (13.6%).
• In boys and men 16–26 years: injection-site pain (63.4%), injection-site swelling (20.2%), and injection-site redness (20.7%).
• In boys 9–15 years: injection-site pain (71.5%), injection-site swelling (26.9%), and injection-site redness (24.9%).

Pregnancy Category B. Animal reproduction studies in female rats at doses comparable to the recommended human dose have shown no evidence of impaired fertility or fetal harm due to Human Papillomavirus Quadrivalent. However, there are no adequate and well-controlled studies in pregnant women. As animal studies may not always predict human response, this vaccine should be used during pregnancy only if clearly necessary. It is not known whether Human Papillomavirus Quadrivalent is excreted in human milk. Since many drugs are excreted in breast milk, caution is advised when administering this vaccine to nursing mothers.

Vaccinated individuals may experience syncope (fainting), which can lead to falls and injury; therefore, observation for at least 15 minutes after vaccination is recommended. Syncope may sometimes be accompanied by tonic-clonic movements or seizure-like activity. These events are usually temporary and respond to appropriate positioning, such as lying flat or in the Trendelenburg position to restore cerebral blood flow.

Pediatric Use: Safety and effectiveness have not been established in children below 9 years of age.

Geriatric Use: Safety and effectiveness have not been evaluated in individuals aged 65 years and older.

There have been reports of administration of doses higher than recommended for Human Papillomavirus Quadrivalent. Generally, the adverse effects observed with overdose are similar to those seen with standard recommended doses.

Vaccines, Anti-sera & Immunoglobulin

Store the HPV Quadrivalent vaccine refrigerated at 2°C to 8°C. Do not freeze and protect from light. The vaccine should be administered as soon as possible after removal from refrigeration.