You are now leaving GSK’s website

You are now leaving a GSK Website. By clicking this link, you will be taken to a website that is not owned or controlled by GSK, and GSK is not responsible for the content provided on that site

Continue

Go back

Cervarix Contraindications and precautions

Contraindications 1

  • Hypersensitivity to the active substances or to any of the excipients listed in the Summary of Product Characteristics section 6.1
  • Administration of Cervarix should be postponed in subjects suffering from an acute severe febrile illness
    However, the presence of a minor infection, such as a cold, is not a contraindication for immunisation

Special warnings and precautions for use 1

  • As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine
  • Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints
  • Cervarix should under no circumstances be administered intravascularly or intradermally
  • No data are available on subcutaneous administration of Cervarix
  • As with other vaccines administered intramuscularly, Cervarix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects
  • As with any vaccine, a protective immune response may not be elicited in all vaccinees
  • Cervarix will only protect against diseases that are caused by HPV types 16 and 18 and to some extent against diseases caused by certain other oncogenic related HPV types. Therefore, appropriate precautions against sexually transmitted diseases should continue to be used 
  • Cervarix is for prophylactic use only and has no effect on active HPV infections or established clinical disease. Cervarix has not been shown to have a therapeutic effect. The vaccine is therefore not indicated for treatment of cervical cancer or cervical intra-epithelial neoplasia (CIN). It is also not intended to prevent progression of other established HPV-related lesions or existing HPV infections with vaccine or non-vaccine types
  • Vaccination is not a substitute for routine cervical screening. Since no vaccine is 100% effective, and Cervarix will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations
  • Duration of protection has not fully been established. Timing and need of booster dose(s) has not been established
  • Except for asymptomatic human immunodeficiency virus (HIV)-infected subjects for whom limited immunogenicity data are available, there are no data on the use of Cervarix in subjects with impaired immune responsiveness such as patients receiving immunosuppressive treatment. As with other vaccines, an adequate immune response may not be elicited in these individuals
  • There are no safety, immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines

Interactions 1

In all clinical trials individuals who had received immunoglobulin or blood-derived products within 3 months prior to the first vaccine dose were excluded.

Use with other vaccines 1

  • Cervarix may be administered concomitantly with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa-IPV vaccines), with no clinically relevant interference with antibody response to any of the components of either vaccine. The sequential administration of combined dTpa-IPV followed by Cervarix 1 month later tended to elicit lower anti-HPV 16 and anti-HPV 18 GMTs as compared to Cervarix alone. The clinical relevance of this observation is not known
  • Cervarix may be administered concomitantly with a combined hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (Twinrix) or with hepatitis B (rDNA) vaccine (Engerix B). Administration of Cervarix at the same time as Twinrix has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens. Anti-HBs geometric mean antibody concentrations were significantly lower on co-administration, but the clinical relevance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs ≥10mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix given alone. Similar results were observed when Cervarix was given concomitantly with Engerix B with 97.9% of subjects reaching anti-HBs ≥ 10mIU/ml compared to 100% for Engerix B given alone
  • If Cervarix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites

Use with hormonal contraceptives 1

  • In clinical efficacy studies, approximately 60% of women who received Cervarix used hormonal contraceptives. There is no evidence that the use of hormonal contraceptives has an impact on the efficacy of Cervarix.

Use with systemic immunosuppressive medications 1

  • As with other vaccines it may be expected that, in patients receiving immunosuppressive treatment, an adequate response may not be elicited

Pregnancy1

  • Specific studies of the vaccine in pregnant women were not conducted. However, during the clinical development programme, a total of 10,476 pregnancies were reported including 5,387 in women who had received Cervarix. Overall, the proportions of pregnant subjects who experienced specific outcomes (e.g. normal infant, abnormal infants including congenital anomalies, premature birth, and spontaneous abortion) were similar between treatment groups
  • Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryo-foetal development, parturition or post-natal development. These data are insufficient to recommend use of Cervarix during pregnancy. Vaccination should, therefore, be postponed until after completion of pregnancy

Breast-feeding 1

  • The effect on breast-fed infants of the administration of Cervarix to their mothers has not been evaluated in clinical studies
  • Cervarix should only be used during breast-feeding when the possible advantages outweigh the possible risk

Fertility 1

  • No fertility data are available

Reference:

  1. Cervarix IPI Version number: GDS024/ IPI019 / Date of issue: 02/Mar/15 2015 GSK group of companies

Cervarix is a registered trademark of GlaxoSmithKline group of companies.