Approved October 16, 2009

HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE BIVALENT (TYPES 16, 18)
(FDA Category 1S)

CERVARIX(R) (GlaxoSmithKline, Pharmaceuticals) is an adjuvanted vaccine of oncogenic human papillomavirus types 16 and 18.

DOSING INFORMATION: The recommended dose is 0.5 milliliters intramuscularly for 3 doses at 0, 1, and 6 months.

PHARMACOKINETICS: Geometric mean titers of both HPV-16 and HPV-18 peaked at month 7 and reached a plateau that was sustained from month 18 up to month 76. The duration of immunity following a complete schedule of immunization has not been established.

CAUTIONS: Allergic reactions, some severe (eg, anaphylaxis) may occur. The tip cap and rubber plunger of needleless prefilled syringes contain dry natural latex rubber and may cause a reaction in latex sensitive patients. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported; monitoring is recommended. The most commonly reported adverse events included injection site reactions (pain, swelling, redness), fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.

FDA APPROVED INDICATIONS: Human papillomavirus recombinant vaccine bivalent (types 16, 18) is indicated for the prevention of cervical cancer and cervical intraepithelial neoplasia (CIN) grade 1, 2 or worse and adenocarcinoma in situ, caused by oncogenic human papillomavirus (HPV) types 16 and 18, in females 10 through 25 years of age.