Human papillomavirus (type 16 and 18) recombinant ...

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Intramuscular
Prevention of human papillomavirus infection

Adult: ≤45 years For the prevention of pre-malignant anogenital lesions (cervical, vulvar, vaginal, and anal), cervical cancers, and anal cancers caused by HPV type 16 and 18 in women: As 3-dose schedule: 0.5 mL for 3 doses given at 0, 1, and 6 months via IM inj in the deltoid area of the upper arm. If flexibility in schedule is needed, may administer the 2nd dose between 1 and 2.5 months after the 1st dose; may give the 3rd dose between 5 and 12 months after the 1st dose. Recommendations may vary between countries and use must be in accordance with local official guidelines.
Child: In girls: 9-14 years As 2-dose schedule: 0.5 mL for 2 doses. Administer the 2nd dose between 5 and 13 months after the 1st 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. Recommendations may vary between countries and use must be in accordance with local official guidelines.

What are the brands available for Human papillomavirus (type 16 and 18) recombinant vaccine in Indonesia?

Cervarix

Contraindications

Hypersensitivity.

Special Precautions

Patient with thrombocytopenia or any coagulation disorder. Patients receiving anticoagulant treatment. 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 (e.g. cold). Not indicated for the treatment of active HPV infection or established clinical disease (including cervical cancer or cervical intraepithelial neoplasia). Not intended to prevent the progression of other established HPV-related lesions or existing HPV infections with vaccine/non-vaccine types. Not a substitute for routine cervical screening. Administration during pregnancy is not recommended; vaccination should be delayed until completion of pregnancy. Lactation.

Adverse Reactions

Significant: Anaphylactoid or hypersensitivity reactions; syncope (may be accompanied by transient visual disturbance, paraesthesia, tonic-clonic limb movements); shoulder injury (e.g. shoulder bursitis, tendinitis) following administration.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain.
General disorders and administration site conditions: Inj site reactions (e.g. pain, swelling, redness, induration), fatigue, fever.
Infections and infestations: Upper respiratory tract infection.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
Nervous system disorders: Headache, dizziness.
Skin and subcutaneous tissue disorders: Pruritus, urticaria, rash.

Pregnancy Category (US FDA)

Parenteral: B

Monitoring Parameters

Monitor for hypersensitivity reactions and syncope for at least 15 minutes after administration. Perform gynaecological/cervical screening and papillomavirus test as per current local guidelines following vaccination.

Drug Interactions

May diminish therapeutic effect with immunosuppressive agents (e.g. chemotherapeutic drugs, high dose corticosteroids).

Action

Description:
Mechanism of Action: Human papillomavirus (type 16 and 18) recombinant vaccine is a non-infectious adjuvanted vaccine produced by recombinant technology. It contains highly purified virus-like particles (VLPs) of the major capsid L1 protein of human papillomavirus (HPV) types 16 and 18 which facilitate the production of neutralising antibodies to prevent anogenital precancerous lesions and cancers caused by HPV.

Storage

Store between 2-8°C. Do not freeze. Protect from light.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07BM02 - papillomavirus (human types 16, 18) ; 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 01/07/2024.

Cervarix (GlaxoSmithKline Philippines, Inc). MIMS Philippines. http://www.mims.com/philippines. Accessed 12/08/2024.

Cervarix Suspension for Injection in Pre-filled Syringe (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/08/2024.

Cervarix Suspension for Injection in Pre-filled Syringe (GlaxoSmithKline UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/07/2024.

Human Papillomavirus Vaccine (Bivalent). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 01/07/2024.

Joint Formulary Committee. Human Papillomavirus Vaccines. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/08/2024.

Disclaimer: This information is independently developed by MIMS based on Human papillomavirus (type 16 and 18) recombinant vaccine 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 © 2025 MIMS. All rights reserved. Powered by MIMS.com