Concise Prescribing Info
Contents
Human papillomavirus (HPV) vaccine types 16 & 18 (recombinant, AS04 adjuvanted)
Indications/Uses
Prevention of incident & persistent infection, premalignant ano-genital lesions (cervical, vulvar, vag & anal) (including ASCUS, CIN, VIN, VaIN, AIS) & cervical, vulvar, vag & anal cancers (squamous-cell carcinoma & adenocarcinoma) caused by oncogenic HPV for individuals ≥9 yr.
Dosage/Direction for Use
IM in the deltoid region ≥15 yr 3-doses of 0.5 mL given at 0, 1 & 6 mth, 2nd dose can be administered between 1 & 2.5 mth & 3rd dose between 5 & 12 mth after 1st dose, if flexibility in vaccination schedule is necessary; 9-14 yr 2-doses of 0.5 mL, given between 5 & 13 mth after the 1st dose. If 2nd vaccine dose is administered before the 5th mth after the 1st dose, a 3rd dose should always be administered.
Contraindications
Special Precautions
Do not administer intravascularly or intradermally. Anaphylactic event & syncope may occur. Postpone vaccination in patients w/ acute severe febrile illness. Thrombocytopenia or any coagulation disorder. Not intended for the prevention of progression of HPV-related lesions present at the time of vaccination or protection against all oncogenic HPV types. Not a substitute for regular cervical screening or against exposure to HPV & STD. Patients receiving immunosuppressive treatment. Postpone vaccination in women who are pregnant or trying to become pregnant until completion of pregnancy. Lactation.
Adverse Reactions
Headache; myalgia; inj site reactions including pain, redness, swelling, fatigue. GI disorders including nausea, vomiting, diarrhoea, abdominal pain; itching/pruritus, rash, urticaria; arthralgia; fever (≥38°C).
Drug Interactions
May not elicit an adequate response in patients receiving immunosuppressive treatment.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BM02 - papillomavirus (human types 16, 18) ; Belongs to the class of papillomavirus vaccines.
Presentation/Packing
Form
Cervarix susp for inj
Packing/Price
0.5 mL x 1's (P1,658/vial)
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