Human Papillomavirus Vaccine, Nonavalent

Human papillomavirus vaccine, nonavalent is an immunization used to protect against diseases/precancerous conditions caused by human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

The human papillomavirus vaccine, nonavalent is available under the following different brand names: Gardasil 9.

Dosages of Human Papillomavirus Vaccine, Nonavalent:

Dosage Forms and Strengths

Suspension for intramuscular (IM) Injection

• 0.5mL/single-dose vial or syringe

Dosage Considerations – Should be Given as Follows:

Immunization to Prevent HPV Infection

• Demonstrated to protect against diseases/precancerous conditions caused by human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58
• 0.5 mL IM as a 2- or 3-dose series depending on age at initial vaccination

HPV vaccination is routinely recommended at age 11-12 years (can start at age 9 years)

Routine and catch-up vaccination

• 0.5 mL IM as a 2- or 3-dose series depending on age at initial vaccination
• Age 9 through 14 years at initial vaccination: 2-dose series at 0, 6-12 months (minimum interval: 5 months; repeat dose if administered too soon)
• Age 15 years and older at initial vaccination: 3-dose series at 0, 1-2, 6 months (minimum intervals: 4 weeks between doses 1 and 2; 12 weeks between doses 2 and 3; 5 months between doses 1 and 3; repeat dose if administered too soon)
• Special situations
  • Immunocompromising conditions, including HIV infection: 3-dose series as above
  • History of sexual abuse or assault: Start at age 9 years

Adults though age 26 years

• Recommended as a routine vaccination for all adults through age 26 years
• Age of initial vaccination
  • 15 years and older: 3-dose series at 0, 1-2, 6 months (minimum intervals: 4 weeks between doses 1 and 2; 12 weeks between doses 2 and 3; 5 months between doses 1 and 3; repeat dose if administered too soon)
  • 9-14 years and received 1 dose or 2 doses less than 5 months apart: 1 dose
  • 9-14 years and received 2 doses at least 5 months apart: HPV vaccination complete, no additional dose needed

Adults aged 27-45 years

• Need for vaccination based on shared decision making between patient and clinician
• 2- or 3-dose series depending on age at initial vaccination (see dosing for adults through age 26 years)

Indications for males

• Prevention of the following diseases
  • Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11
• 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

Indications for females

• Cervical, vulvar, vaginal, and anal cancer caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58
• Genital warts (condyloma acuminata) caused by HPV types 6 and 11
• Indicated for the prevention of the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
  • Cervical intraepithelial neoplasia (CIN) grade 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

Indications for males

• Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Genital warts (condyloma acuminata) caused by HPV types 6 and 11
• 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

Dosing Considerations

For more vaccine information see: http://www.cdc.gov/vaccines/schedules/hcp/index.html

Limitations of use and effectiveness

• Inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening
• Recipients should not discontinue anal cancer screening
• Has not been demonstrated to protect against disease from vaccine HPV types to which a person has previously been exposed through sexual activity
• Not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN
• Not all vulvar, vaginal, and anal cancers are caused by HPV
• May not result in protection in all vaccine recipients

Common side effects of human papillomavirus vaccine, nonavalent include:

• Females aged 16-26 years
• Injection site pain
• Injection site swelling
• Injection site redness
• Headache
• Fever

Females aged 9-15 years

• Injection site pain
• Injection site swelling
• Injection site redness
• Headache
• Fever

Males aged 9-26 years

• Injection site pain
• Injection site swelling
• Injection site redness
• Oral temperature 100.0°F or greater
• Headache
• Fever

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• The human papillomavirus vaccine, nonavalent has no listed severe interactions with other drugs.
• The human papillomavirus vaccine, nonavalent has serious interactions with at least 40 different drugs.
• Moderate interactions of human papillomavirus vaccine, nonavalent include:
  • daclizumab
  • dengue vaccine
  • ibrutinib
  • ifosfamide
  • lomustine
  • mechlorethamine
  • melphalan
  • onasemnogene abeparvovec
  • oxaliplatin
  • procarbazine
  • rituximab
  • ustekinumab
• Mild interactions of human papillomavirus vaccine, nonavalent include:
  • chloroquine

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains a human papillomavirus vaccine, nonavalent. Do not take Gardasil 9 if you are allergic to human papillomavirus vaccine, nonavalent, or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous Gardasil dose

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Human Papillomavirus Vaccine, Nonavalent?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Human Papillomavirus Vaccine, Nonavalent?”

Cautions

• Individuals who develop symptoms indicative of hypersensitivity after the first dose should not receive additional doses
• Monitor for 15 minutes following vaccination for syncope/convulsive syncope and allergic reactions
• Not shown to be protective against nonvaccine HPV types

Pregnancy and Lactation

• Human papillomavirus vaccine, nonavalent is not recommended until after pregnancy through age 26 years. No intervention is needed if vaccinated while pregnant. Pregnancy testing is not needed before vaccination. There is a pregnancy exposure registry: 1-800-986-8999 that monitors outcomes of women who receive human papillomavirus vaccine, nonavalent during pregnancy.
• Data are not sufficient to assess the effects of the Human papillomavirus vaccine, nonavalent on breastfed infants, or milk production/excretion. Consult your doctor before breastfeeding.