Vaccine, human Papillomavirus 9-valent


Concise Prescribing Info
Indications/Uses
Human papillomavirus infection, prevention.
Dosage/Direction for Use
Adult : IM 3 doses of 0.5 mL each given at 0, 2, and 6 months in the deltoid region of the upper arm or in higher anterolateral area of thigh. All doses should be given within a 1-year period.
Dosage Details
Intramuscular
Human papillomavirus infection, prevention
Adult: 3 doses of 0.5 mL each given at 0, 2, and 6 months in the deltoid region of the upper arm or in higher anterolateral area of thigh. All doses should be given within a 1-year period.
Child: 9-14 years 2 doses of 0.5 mL each given at 0, and 6-12 months in the deltoid region of the upper arm or in higher anterolateral area of thigh. Administer 3rd dose, if 2nd dose is given at <5 months after the 1st dose. ≥15 years Same as adult dose.
Contraindications
Hypersensitivity.
Special Precautions
Patient with coagulation disorders (including thrombocytopenia), impaired immune responsiveness. Postpone vaccination in patients with severe acute febrile illness. Children. Pregnancy and lactation. Not indicated for the treatment of active HPV infection, cervical cancer, high-grade cervical, vulvar, and vaginal dysplastic lesions or genital warts. Not a substitute for routine cervical or anal cancer screening.
Adverse Reactions
Significant: Inj site reactions (e.g. pain, redness, bruising, swelling); fever, syncope, headache.
Gastrointestinal disorders: Nausea.
General disorders and administration site conditions: Fatigue.
Musculoskeletal and connective tissue disorders: Myalgia.
Nervous system disorders: Dizziness.
Skin and subcutaneous tissue disorders: Pruritus.
Potentially Fatal: Hypersensitivity reactions (e.g. anaphylaxis).
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor for hypersensitivity reactions 15 minutes after admin. Perform gynaecological exam, papillomavirus test, and cervical or anal cancer screening post-vaccination.
Drug Interactions
Increased risk of bleeding with anticoagulants. Decreased immune response with immunosuppressive therapies (e.g. high dose corticosteroids).
Action
Description: Human Papillomavirus (HPV) 9-valent vaccine is a non-infectious adjuvanted vaccine produced by recombinant technology. It contains inactive virus-like particles (VLP) of the major capsid L1 protein from the same 4 HPV types (6, 11, 16 and 18) found in quadrivalent vaccine and 5 additional types (31, 33, 45, 52, 58) 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
J07BM - Papillomavirus vaccines ; Used for active immunizations.
References
Anon. Human Papillomavirus Vaccine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/07/2018.

Anon. Papillomavirus (9-Valent) Vaccine (Human, Recombinant). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/07/2018.

Buckingham R (ed). Human Papillomavirus Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/07/2018.

Gardasil 9 (A-S Medication Solutions). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/07/2018.

Disclaimer: This information is independently developed by MIMS based on Vaccine, human Papillomavirus 9-valent 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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