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Cervarix

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Cervarix

Cervarix

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Syncope

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 (human papillomavirus bivalent vaccine) . 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.

Latex

The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals. The vial stopper does not contain latex.

Preventing and Managing Allergic Vaccine Reactions

Prior to administration, the healthcare provider should review the immunization history for possible vaccine hypersensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Appropriate medical treatment and supervision should be readily available in case of anaphylactic reactions following administration of CERVARIX (human papillomavirus bivalent vaccine) .

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 (human papillomavirus bivalent vaccine) should continue to undergo cervical cancer screening per standard of care.
  • CERVARIX (human papillomavirus bivalent vaccine) 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 (human papillomavirus bivalent vaccine) is not recommended for use in pregnant women or women planning to become pregnant during the vaccination course. Register women who receive CERVARIX (human papillomavirus bivalent vaccine) while pregnant in the pregnancy registry by calling 1-888-452-9622

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

CERVARIX (human papillomavirus bivalent vaccine) has not been evaluated for its carcinogenic or mutagenic potential. Vaccination of female rats with CERVARIX (human papillomavirus bivalent vaccine) , at doses shown to be significantly immunogenic in the rat, had no effect on fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category B

Reproduction studies have been performed in rats at a dose approximately 47 times the human dose (on a mg/kg basis) and revealed no evidence of impaired fertility or harm to the fetus due to CERVARIX (human papillomavirus bivalent vaccine) . There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Non-Clinical Studies: An evaluation of the effect of CERVARIX (human papillomavirus bivalent vaccine) on embryo-fetal, pre-and post-natal development was conducted using rats. One group of rats was administered CERVARIX (human papillomavirus bivalent vaccine) 30 days prior to gestation and during the period of organogenesis (gestation days 6, 8, 11, and 15). A second group of rats was administered saline at 30 days prior to gestation followed by CERVARIX (human papillomavirus bivalent vaccine) on days 6, 8, 11, and 15 of gestation. Two additional groups of rats received either saline or adjuvant following the same dosing regimen. CERVARIX (human papillomavirus bivalent vaccine) was administered at 0.1 mL/rat/occasion (approximately 47-fold excess relative to the projected human dose on a mg/kg basis) by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, or embryo-fetal, pre- and post-natal development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis.

Clinical Studies: Overall Outcomes: In clinical studies, pregnancy testing was performed prior to each vaccine administration and vaccination was discontinued if a subject had a positive pregnancy test. In all clinical trials, subjects were instructed to take precautions to avoid pregnancy until 2 months after the last vaccination. During pre-licensure clinical development, a total of 7,276 pregnancies were reported among 3,696 females receiving CERVARIX (human papillomavirus bivalent vaccine) and 3,580 females receiving a control (Hepatitis A Vaccine 360 EL.U., Hepatitis A Vaccine 720 EL.U., or 500 mcg Al(OH)3). The overall proportions of pregnancy outcomes were similar between treatment groups. The majority of women gave birth to normal infants (62.2% and 62.6% of recipients of CERVARIX (human papillomavirus bivalent vaccine) and control, respectively). Other outcomes included spontaneous abortion (11.0% and 10.8% of recipients of CERVARIX (human papillomavirus bivalent vaccine) and control, respectively), elective termination (5.8% and 6.1% of recipients of CERVARIX (human papillomavirus bivalent vaccine) and control, respectively), abnormal infant other than congenital anomaly (2.8% and 3.2% of recipients of CERVARIX (human papillomavirus bivalent vaccine) and control, respectively), and premature birth (2.0% and 1.7% of recipients of CERVARIX (human papillomavirus bivalent vaccine) and control, respectively). Other outcomes (congenital anomaly, stillbirth, ectopic pregnancy, and therapeutic abortion) were reported less frequently in 0.1% to 0.8% of pregnancies in both groups.

Outcomes Around Time of Vaccination: Sub-analyses were conducted to describe pregnancy outcomes in 761 women [N = 396 for CERVARIX (human papillomavirus bivalent vaccine) and N = 365 pooled control, HAV 360 EL.U., HAV 720 EL.U., and 500 mcg Al(OH)3] who had their last menstrual period within 30 days prior to, or 45 days after a vaccine dose and for whom pregnancy outcome was known. The majority of women gave birth to normal infants (65.2% and 69.3% of recipients of CERVARIX (human papillomavirus bivalent vaccine) and control, respectively). Spontaneous abortion was reported in a total of 11.7% of subjects (13.6% of recipients of CERVARIX (human papillomavirus bivalent vaccine) and 9.6% of control recipients) and elective termination was reported in a total of 9.7% of subjects (9.9% of recipients of CERVARIX (human papillomavirus bivalent vaccine) and 9.6% of control recipients). Abnormal infant other than congenital anomaly was reported in a total of 4.9% of subjects (5.1% of recipients of CERVARIX (human papillomavirus bivalent vaccine) and 4.7% of control recipients) and premature birth was reported in a total of 2.5% of subjects (2.5% of both groups). Other outcomes (congenital anomaly, stillbirth, ectopic pregnancy, and therapeutic abortion) were reported in 0.3% to 1.8% of pregnancies among recipients of CERVARIX (human papillomavirus bivalent vaccine) and in 0.3% to 1.4% of pregnancies among control recipients.

It is not known whether the observed numerical imbalance in spontaneous abortions in pregnancies which occurred around the time of vaccination is due to a vaccine-related effect.

Pregnancy Registry: Healthcare providers are encouraged to register pregnant women who inadvertently receive CERVARIX (human papillomavirus bivalent vaccine) in the GlaxoSmithKline vaccination pregnancy registry by calling 1-888-452-9622.

Nursing Mothers

In non-clinical studies in rats, serological data suggest a transfer of anti-HPV-16 and anti-HPV-18 antibodies via milk during lactation in rats. Excretion of vaccine-induced antibodies in human milk has not been studied for CERVARIX (human papillomavirus bivalent vaccine) . Because many drugs are excreted in human milk, caution should be exercised when CERVARIX (human papillomavirus bivalent vaccine) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients younger than 10 years of age have not been established. The safety and effectiveness of CERVARIX (human papillomavirus bivalent vaccine) have been evaluated in 1,193 subjects 10 through 14 years of age and 6,316 subjects 15 through 17 years of age. [See ADVERSE REACTIONS and Clinical Studies.]

Geriatric Use

Clinical studies of CERVARIX (human papillomavirus bivalent vaccine) did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. CERVARIX (human papillomavirus bivalent vaccine) is not approved for use in subjects 65 years of age and older.

Immunocompromised Individuals

The immune response to CERVARIX may be diminished in immunocompromised individuals [see DRUG INTERACTIONS].

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

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