• Indications and Usage

    CERVARIX is a vaccine indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18:

    • cervical cancer,
    • cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and
    • cervical intraepithelial neoplasia (CIN) grade 1.

    CERVARIX is approved for use in females 9 through 25 years of age.

    Limitations of Use and Effectiveness

    • CERVARIX does not provide protection against disease due to all HPV types.
    • CERVARIX has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity.
  • Dosage and Administration

    Three doses (0.5-mL each) by intramuscular injection according to the following schedule: 0, 1, and 6 months.

  • Dosage Forms and Strengths

    Single-dose prefilled syringes containing a 0.5-mL suspension for injection.

  • Contraindications

    Severe allergic reactions (e.g., anaphylaxis) to any component of CERVARIX.

  • Warnings and Precaution

    • Vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with CERVARIX. When syncope is associated with tonic- clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
    • CERVARIX is available in 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. Use of these syringes may cause allergic reactions in latex-sensitive individuals.
  • Adverse Reactions

    • Most common local adverse reactions in ≥20% of subjects were pain, redness, and swelling at the injection site.
    • Most common general adverse events in ≥20% of subjects were fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.
  • Use in Specific Populations

    • Safety has not been established in pregnant women.
    • Immunocompromised individuals may have a reduced immune response to CERVARIX.