Vaccine, human Papillomavirus (type 6, 11, 16, 18)


Generic Medicine Info
Indications and Dosage
Intramuscular
Human papillomavirus infection, prevention
Adult: 3 doses of 0.5 mL each given at 0, 2, and 6 months in the deltoid region. All doses should be given within a 1-year period.
Child: 9-13 years 2 doses of 0.5 mL each at 0, and 6 months. Administer 3rd dose at 9 months, if 2nd dose is given at <6 months after the 1st dose. ≥14 years Same as adult dose.
Contraindications
Hypersensitivity.
Special Precautions
Patient with history of bleeding/coagulation disorders (including thrombocytopenia), altered immunocompetence. Not indicated for the treatment of active HPV infection, cervical cancer, high-grade cervical, vulvar, and vaginal dysplastic lesions or genital warts. Postpone vaccination in case of acute severe febrile illness.
Adverse Reactions
Significant: Anaphylactoid/hypersensitivity reactions, inj site reactions (e.g. pain, redness, bruising, swelling); fever, syncope, headache.
Gastrointestinal disorders: Nausea, vomiting.
General disorders and administration site conditions: Fatigue.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
Skin and subcutaneous tissue disorders: Pruritus, rash. Rarely, urticaria.
Patient Counseling Information
This drug may cause syncope, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor for hypersensitivity reactions 15 minutes after administration. Perform gynaecological exam, papillomavirus test, and cervical cancer screening regularly post-vaccination.
Drug Interactions
Increased risk of bleeding with anticoagulants. Decreased immune response with immunosuppressive therapies (e.g. chemo/radiation therapy, high dose corticosteroids).
Action
Description: Human Papillomavirus (HPV) quadrivalent vaccine is a non-infectious adjuvanted vaccine produced by recombinant technology. It contains inactive virus-like particles (VLP) of the major capsid L1 protein of HPV types 6, 11, 16 and 18 thereby facilitating the production of neutralizing antibodies and development of humoral immune response to prevent premalignant anogenital lesions and cancers, and genital warts caused by HPV.
Storage
Store between 2-8°C. Do not freeze. Protect from light. Stable for 72 hours below 25°C.
Any unused portions or waste material should be disposed of in accordance with local requirements.
ATC Classification
J07BM01 - papillomavirus (human types 6, 11, 16, 18) ; Belongs to the class of papillomavirus vaccines.
References
Anon. Papillomavirus (Types 6, 11, 16, 18) Vaccine (Human, Recombinant). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 28/06/2018.

Buckingham R (ed). Human Papillomavirus Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 28/06/2018.

Gardasil Suspension for Intramuscular Injection (Merck Sharp & Dohme Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 28/06/2018.

Joint Formulary Committee. Human Papillomavirus Vaccines. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 28/06/2018.

Disclaimer: This information is independently developed by MIMS based on Vaccine, human Papillomavirus (type 6, 11, 16, 18) from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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