Consumer Information

Cervarix

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Generic Name: Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Date of Approval: October 16, 2009
Company: GlaxoSmithKline

Treatment for: Human Papillomavirus Prophylaxis

FDA Approves Cervarix

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The U.S. Food and Drug Administration (FDA) has approved Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

Highlights of Cervarix Prescribing Information

These highlights do not include all the information needed to use Cervarix safely and effectively. See full prescribing information for Cervarix.

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 10 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

0.5-mL suspension for injection as a single-dose vial or pre-filled syringe.

Contraindications

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

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.
Do not use the prefilled syringes in latex sensitive individuals.

Cervarix Side Effects

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.

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Drug Interactions

Do not mix Cervarix with any other vaccine in the same syringe or vial.

Use in Specific Populations

Safety has not been established in pregnant women. Register women who receive Cervarix while pregnant in the pregnancy registry by calling 1-888-452-9622.
Immunocompromised individuals may have a reduced immune response to Cervarix.

Patient Counseling Information

Provide the Vaccine Information Statements prior to immunization. This is required by the National Childhood Vaccine Injury Act of 1986 and are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Inform the patient, parent, or guardian:

Vaccination does not substitute for routine cervical cancer screening. Women who receive Cervarix should continue to undergo cervical cancer screening per standard of care.
Cervarix does not protect against disease from HPV types to which a woman has previously been exposed through sexual activity.
Since syncope has been reported following vaccination in young females, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended.
Information regarding potential benefits and risks associated with vaccination.
Report any adverse events to their healthcare provider.
Safety has not been established in pregnant women. Cervarix is not recommended for use in pregnant women or women planning to become pregnant during the vaccination course. Register women who receive Cervarix while pregnant in the pregnancy registry by calling 1-888-452-9622.