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.
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.
- 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.