Vaccine, human Papillomavirus types 16 and 18 (recombinant)

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

Hypersensitivity.

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.

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.

Parenteral: B

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.

Monitor for hypersensitivity reactions and syncope 15 minutes after administration of vaccine. Cervical screening should be done regularly after vaccination.

Increased risk of bleeding with anticoagulants. Decreased immune response with immunosuppressive therapies (e.g. radiation, cytotoxic drugs, corticosteroids).

Description:
Mechanism of Action: 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.

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

Vaccin, kháng huyết thanh & thuốc miễn dịch

J07BM02 - papillomavirus (human types 16, 18) ; Belongs to the class of papillomavirus vaccines.

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.