Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 27 June 2018

Indication(s)

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. (1.1)
CERVARIX is approved for use in females 9 through 25 years of age.

Limitations of Use and Effectiveness (1.2)
• CERVARIX does not provide protection against disease due to all HPV types. (14.3)
• 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. (14.2)

Full Prescribing information

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Advisory information

contraindications

Severe allergic reactions (e.g., anaphylaxis) to any component of CERVARIX. (4)

Special warnings and precautions

• Because 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. (5.1)
• The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.2)

Adverse reactions

• Most common local adverse reactions in ≥20% of subjects were pain, redness, and swelling at the injection site. (6.1)
• Most common general adverse events in ≥20% of subjects were fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia. (6.1)

Usage information

Dosing and administration

Three doses (0.5-mL each) by intramuscular injection according to the following schedule: 0, 1, and 6 months. (2.2)

Use in special populations
• Safety has not been established in pregnant women. (8.1)
• Immunocompromised individuals may have a reduced immune response to CERVARIX. (8.6)

Interactions

Do not mix CERVARIX with any other vaccine in the same syringe or vial. (7.1)

More information

Category Value
Orphan designation No
Marketing authorisation holder GlaxoSmithKline Biologicals