Human papillomavirus 9-valent recombinant vaccine


Generic Medicine Info
Indications and Dosage
Intramuscular
Prevention of human papillomavirus infection
Adult: ≤45 years In women, for prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (grades 1 and 2/3 cervical intraepithelial neoplasia; cervical adenocarcinoma in situ; grades 2 and 3 vulvar intraepithelial neoplasia; grades 2 and 3 vaginal intraepithelial neoplasia; grades 1, 2 and 3 anal intraepithelial neoplasia); in men, for prevention of anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (grades 1, 2 and 3 anal intraepithelial neoplasia): As 3-dose schedule: 0.5 mL for 3 doses given at 0, 2 and 6 months via IM inj in the deltoid area of the upper arm or higher anterolateral area of the thigh. The 2nd dose may be given at least 1 month following the 1st dose and the 3rd dose at least 3 months after the 2nd dose. All 3 doses should be administered within 1 year. Recommendations may vary between countries; use must be in accordance with the local official guidelines.
Child: In girls and boys: 9-14 years As 2-dose schedule: 0.5 mL for 2 doses given at 0 and 6-12 months (administer a 3rd dose if the 2nd dose is given earlier than 5 months after the 1st dose); As 3-dose schedule: Same as adult dose. ≥15 years As 3-dose schedule: Same as adult dose. Doses are given via IM inj in the deltoid area of the upper arm or higher anterolateral area of the thigh. Recommendations may vary between countries; use must be in accordance with the local official guidelines.
What are the brands available for Human papillomavirus 9-valent recombinant vaccine in Hong Kong?
Contraindications
Hypersensitivity to human papillomavirus 9-valent recombinant vaccine or human papillomavirus (type 6, 11, 16, 18) recombinant vaccine.
Special Precautions
Patient with thrombocytopenia or any coagulation disorder. Patient receiving anticoagulant therapy. Immunocompromised patients (e.g. HIV infection, receiving immunosuppressive therapy). Defer administration in patients with moderate to severe acute illness (with or without fever); vaccination may be given in patients with mild acute illness. Not indicated for the treatment of active HPV infection or established HPV-related diseases (including cervical, vulvar, vaginal and anal cancer, cervical, vulvar and vaginal dysplastic lesions or genital warts). Not intended to prevent the progression of other established HPV-related lesions. Not a substitute for routine cervical screening. Children. Administration during pregnancy is not recommended; vaccination should be delayed until completion of pregnancy. Lactation.
Adverse Reactions
Significant: Anaphylactoid or hypersensitivity reactions; syncope (occasionally associated with falling, tonic-clonic movements and other seizure-like activity).
Gastrointestinal disorders: Nausea, diarrhoea, upper abdominal pain.
General disorders and administration site conditions: Pain, swelling, erythema, pruritus, and bruising at the inj site; pyrexia, fatigue.
Musculoskeletal and connective tissue disorders: Myalgia.
Nervous system disorders: Headache, dizziness.
Monitoring Parameters
Observe patients for syncope and hypersensitivity reactions for 15 minutes after administration. Assess for signs and symptoms of inj site reactions. Women must continue to undergo gynaecological examination, HPV test and cervical cancer screening according to current guidelines after vaccination.
Drug Interactions
May diminish therapeutic effect with immunosuppressive agents (e.g. antimetabolites, alkylating agents, cytotoxic agents, corticosteroids).
Action
Description:
Mechanism of Action: Human papillomavirus 9-valent recombinant vaccine is an adjuvanted non-infectious vaccine. It contains highly purified virus-like particles (VLPs) of the major capsid L1 protein from the same 4 human papillomavirus (HPV) types 6, 11, 16 and 18 in quadrivalent HPV vaccine and 5 additional HPV types 31, 33, 45, 52 and 58, which produce neutralising antibodies to prevent anogenital precancerous lesions, cancers, and genital warts caused by HPV. The exact mechanism of protection is unknown; however, its efficacy is believed to be mediated by humoural immune response induced by the vaccine.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BM03 - papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58) ; Belongs to the class of papillomavirus vaccines.
References
Brayfield A, Cadart C (eds). Human Papillomavirus Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/07/2024.

Gardasil 9 Suspension for Injection (Merck Sharp & Dohme [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/07/2024.

Gardasil 9 Suspension for Injection (Merck Sharp & Dohme [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/07/2024.

Gardasil 9 Vaccine, Recombinant Injection, Suspension (Merck Sharp & Dohme LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/07/2024.

Human Papillomavirus Vaccine (9-Valent). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 02/07/2024.

Joint Formulary Committee. Human Papillomavirus Vaccines. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 25/07/2024.

Merck Sharp & Dohme (NZ) Limited. Gardasil 9 Suspension for Intramuscular Injection data sheet 10 Jan 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 02/07/2024.

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