Gardasil 9

HPV 9-valent (types 6, 11, 16, 18, 31, 33, 45, 52, 58) recombinant vaccine

Active immunisation of individuals ≥9 yr against premalignant lesions & cancers affecting the cervix, vulva, vagina & anus caused by vaccine HPV types; genital warts (Condyloma acuminata) caused by specific HPV types. Active immunisation of individuals 9-45 yr against cancers affecting the oropharynx & other head & neck sites caused by HPV types 16, 18, 31, 33, 45, 52, & 58.

IM Primary vaccination Patient 9-14 yr Administer according to a 2- or 3-dose schedule. 2-dose schedule: 1st dose at elected date; 2nd dose at 5-13 mth after 1st dose. If 2nd dose is administered earlier than 5 mth after 1st dose, a 3rd dose should always be administered. 3-dose schedule (0, 2, 6 mth): 1st dose at elected date; 2nd dose at least 1 mth after 1st dose; 3rd dose at least 3 mth after 2nd dose. All 3 doses should be given w/in 1 yr. Patient ≥15 yr 3-dose schedule (0, 2, 6 mth): 1st dose at elected date; 2nd dose at least 1 mth after 1st dose; 3rd dose at least 3 mth after 2nd dose. All 3 doses should be given w/in 1 yr. Complete the 3-dose vaccination course.

Hypersensitivity.

Do not inj intravascularly, subcutaneously, or intradermally. Do not mix in the same syringe w/ any other vaccines & soln. Observe vaccinees for approx 15 min after vaccination. Postpone vaccination in patients w/ acute severe febrile illness. May not result in protection in all vaccine recipients. Not for treatment of cervical, vulvar, vag, anal, oropharyngeal & other head & neck cancers, high-grade cervical, vulvar, vag & anal dysplastic lesions or genital warts. Not intended to prevent progression of other established HPV-related lesions. Not for prevention of lesions due to a vaccine HPV type in individuals infected w/ that HPV type at the time of vaccination. Not a substitute for routine cervical screening. Patients w/ impaired immune responsiveness, due to use of potent immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may not respond to the vaccine. Caution to patients w/ thrombocytopenia or any coagulation disorder. No safety, immunogenicity or efficacy data to support interchangeability of Gardasil 9 w/ bivalent or quadrivalent HPV vaccines. Postpone vaccination until completion of pregnancy. Safety & efficacy in childn <9 yr have not been established.

Headache; inj site pain, swelling, & erythema. Dizziness; nausea; pyrexia, fatigue, inj site pruritus & bruising.

Vaccines, Antisera & Immunologicals

J07BM03 - papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58) ; Belongs to the class of papillomavirus vaccines.

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