Vaccine, human Papillomavirus types 16 and 18 (recombinant)


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IM Prevention of cervical cancer, cervical intraepithelial neoplasia (CIN), CIN 1 to 3 and adenocarcinoma in situ caused by HPV types 16 and 18 Females: 0.5 mL given at 0, 1, and 6 months.
Dosage Details
Intramuscular
Prevention of adenocarcinoma in situ caused by HPV types 16 and 18, Prevention of cervical cancer caused by HPV types 16 and 18, Prevention of cervical intraepithelial neoplasia (CIN), CIN 1 and pre-cancerous lesions (CIN 2 and 3) caused by HPV types 16 and 18
Adult: Females: 0.5 mL given at 0, 1, and 6 months. If flexibility in the schedule is needed, may administer 2nd and 3rd doses within 3-12 months after the 1st dose.
Child: Females: 9-14 years 2 doses each of 0.5 mL. May administer 2nd dose between 5 and 13 months after the 1st dose; ≥15 years Same as adult dose.
Contraindications
Hypersensitivity.
Special Precautions
Patient with coagulation disorders (e.g. thrombocytopenia). Immunocompromised patients. Postpone administration in patients with acute moderate or severe febrile illness. Not indicated for the treatment of cervical cancer or CIN. Children (not recommended for children <9 years). Pregnancy (postpone/interrupt vaccination until completion of pregnancy) and lactation.
Adverse Reactions
Significant: Injection site reactions (e.g. pain, redness, swelling), fever, syncope, transient visual disturbance, tonic-clonic limb movements, paraesthesia, bleeding or haematoma.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain).
General disorders and administration site conditions: Fatigue.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Pruritus, rash, urticaria.
Potentially Fatal: Severe hypersensitivity reactions (e.g. anaphylaxis), angioedema.
Patient Counseling Information
This drug may cause syncope or temporary loss of vision, if affected, do not drive or operate machinery. Avoid becoming pregnant 2 months after vaccination.
MonitoringParameters
Monitor for hypersensitivity reactions and syncope 15 minutes after administration of vaccine. Cervical screening should be done regularly after vaccination.
Drug Interactions
Increased risk of bleeding with anticoagulants. Decreased immune response with immunosuppressive therapies (e.g. radiation, cytotoxic drugs, corticosteroids).
Action
Description: Human Papillomavirus (HPV) bivalent 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 oncogenic HPV types 16 and 18 which facilitate the production of IgG neutralising antibodies to prevent cervical cancer, adenocarcinoma, and neoplasia caused by HPV.
Storage
Store between 2-8°C. Protect from light. Do not freeze.
ATC Classification
J07BM02 - papillomavirus (human types 16, 18) ; Belongs to the class of papillomavirus vaccines.
References
Anon. Papillomavirus (Types 16,18) Vaccine (Human, Recombinant). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/03/2018.

Cervarix Vaccine (GlaxoSmithKline Biologicals). U.S. FDA. https://www.fda.gov/. Accessed 19/03/2018.

Disclaimer: This information is independently developed by MIMS based on Vaccine, human Papillomavirus types 16 and 18 (recombinant) 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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