GARDASIL 9

GARDASIL®9 Product Monograph

IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION

Safety information

GARDASIL®9 is a vaccine indicated for individuals 9 through 45 years of age for the prevention of infection caused by the human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58 and the following diseases associated with the HPV types included in the vaccine: oropharyngeal and other head and neck cancers caused by the HPV types 16, 18, 31, 33, 45, 52, and 58. GARDASIL®9 has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization.


For further information for GARDASIL®9 please refer to Health Canada’s Notice of Compliance with conditions – drug products website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html.


Indications and clinical use:

GARDASIL®9 is also indicated for individuals 9 through 45 years of age for the prevention of infection caused by the human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 and the following diseases associated with the HPV types included in the vaccine: cervical, vulvar, vaginal and 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; and the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58: cervical adenocarcinoma in situ (AIS); cervical intraepithelial neoplasia (CIN) grade 1, 2 and 3; vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3; vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3; anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.


Contraindications:

  • Patients who are hypersensitive to either GARDASIL®* or GARDASIL®9 or to any ingredient in the 
 formulation or component of the container
  • Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL®9
 or GARDASIL®* should not receive further doses of GARDASIL®9


Relevant warnings and precautions:

  • May not result in protection in all vaccine recipients
  • Not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, anal,
 oropharyngeal, and other head and neck cancers; CIN, VIN, VaIN or AIN
  • Will not protect against diseases that are not caused by HPV
  • Not been shown to protect against diseases due to all HPV types
  • Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions
 following administration of the vaccine
  • Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope,
 sometimes associated with falling, has occurred after vaccination. Therefore, vaccinees should be carefully
 observed for approximately 15 minutes after administration of GARDASIL®9
  • Routine monitoring and Pap test in women should continue to be performed as indicated
  • Do not discontinue screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck 
 cancer if it has been recommended by a healthcare provider
  • Consider delaying vaccination in presence of current or recent febrile illness
  • Immunocompromised, including HIV, patients may have a reduced antibody response
  • Safety and efficacy have not been evaluated in geriatric (≥ 65 years of age) and pediatric ( < 9 years of age)
 patients
  • Caution in individuals with thrombocytopenia or any coagulation disorder
  • Use appropriate precautions against sexually transmitted diseases
  • The administration of GARDASIL®9 during pregnancy should be avoided. Advise women who become or 
 plan to become pregnant during the vaccination series to interrupt or postpone the vaccination regimen until
 completion of pregnancy. Pregnant women exposed to GARDASIL®9 should be encouraged to report their
 exposure to any suspected adverse reactions to Merck Canada Inc., at 1-800-567-2594.
  • Not known whether vaccine antigens are excreted in human milk


For more information:

Please consult the GARDASIL®9 Product Monograph for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-567-2594.

* GARDASIL® is no longer available/marketed in Canada.
Reference: 1. GARDASIL®9 Product Monograph. Merck Canada Inc. January 2, 2025.