Indications

CERVARIX (human papillomavirus bivalent vaccine) ® is indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18 [see Clinical Studies]:

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

CERVARIX (human papillomavirus bivalent vaccine) is approved for use in females 10 through 25 years of age.

Limitations of Use and Effectiveness

CERVARIX (human papillomavirus bivalent vaccine) does not provide protection against disease due to all HPV types [see Clinical Studies].

CERVARIX (human papillomavirus bivalent vaccine) 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 [see Clinical Studies].

Females should continue to adhere to recommended cervical cancer screening procedures [see Patient Counseling Information].

Vaccination with CERVARIX (human papillomavirus bivalent vaccine) may not result in protection in all vaccine recipients.

Preparation for Administration

Shake vial or syringe well before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. CERVARIX (human papillomavirus bivalent vaccine) also should be inspected visually for cracks in the vial or syringe prior to administration. If any of these conditions exist, the vaccine should not be administered. With thorough agitation, CERVARIX (human papillomavirus bivalent vaccine) is a homogeneous, turbid, white suspension. Discard if it appears otherwise.

Dose and Schedule

Immunization with CERVARIX (human papillomavirus bivalent vaccine) consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm.

Do not administer this product intravenously, intradermally, or subcutaneously.

Dosage Forms And Strengths

CERVARIX (human papillomavirus bivalent vaccine) is a suspension for intramuscular injection available in 0.5-mL single-dose vials and prefilled TIP-LOK® syringes.

CERVARIX (human papillomavirus bivalent vaccine) is available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes.

Single-Dose Vials

NDC 58160-830-11 (package of 10)

Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged without needles)

NDC 58160-830-32 (package of 1)
NDC 58160-830-46 (package of 5)

Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen. Upon storage, a fine, white deposit with a clear, colorless supernatant may be observed. This does not constitute a sign of deterioration.

Manufactured by GlaxoSmithKline Biologicals. Rixensart, Belgium. Distributed by GlaxoSmithKline Research Triangle Park, NC 27709.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.