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About GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18])

About GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18])About GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18])

Updated on 12/06/2019

VACCINES

GARDASIL is a vaccine indicated for the prevention of:1

  • premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types
  • genital warts (condyloma acuminata) causally related to specific HPV types

The use of GARDASIL should be in accordance with official recommendations.

GARDASIL helps to prevent HPV types 6 associated with genital warts, 11 known to lead to low grade cervical intraepithelial neoplasia, and 16 and 18 which can lead to cervical cancer, anal cancer as well as other diseases.1 Full details are provided within the Summary of Product Characteristics.

The national HPV immunisation programme was initiated in 2008.2 GARDASIL has protected over 2 million girls in the UK and is currently the vaccine used in the programme for girls aged 12-18 in schools.3

National Immunisation Programme and Eligibility

Posology/dosing1

Please refer to the Summary of Product Characteristics for full prescribing information.

The use of GARDASIL should be in accordance with official recommendations.

Example dosing schedule

Posology/dosing

*If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.

The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.

Contraindications1

Please refer to the Summary of Product Characteristics for full prescribing information.

Hypersensitivity to the active substances or to any of the excipients.

  • Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL should not receive further doses of GARDASIL
  • Administration of GARDASIL should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation
Interaction with other medicinal products1

Please refer to the Summary of Product Characteristics for full prescribing information.

In all clinical trials, individuals who had received immunoglobulin or blood-derived products during the 6 months prior to the first vaccine dose were excluded.

Use with other vaccines:

  • Administration of GARDASIL at the same time (but, for injected vaccines, at a different injection site) as hepatitis B (recombinant) vaccine did not interfere with the immune response to the HPV types.
    • The seroprotection rates (proportion of individuals reaching seroprotective level anti-HBs ≥10 mIU/ml) were unaffected (96.5% for concomitant vaccination and 97.5% for hepatitis B vaccine only)
    • Anti-HBs geometric mean antibody titres were lower on co-administration, but the clinical significance of this observation is not known
  • GARDASIL may be administered concomitantly with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) with no significant interference with antibody response to any of the components of either vaccine. However, a trend of lower anti-HPV GMTs was observed in the concomitant group.
    • The clinical significance of this observation is not known. This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of GARDASIL
    • The concomitant administration of GARDASIL with vaccines other than the ones above has not been studied

Use with hormonal contraceptives:

  • In clinical studies, 57.5% of women aged 16 to 26 years and 31.2% of women aged 24 to 45 years who received GARDASIL used hormonal contraceptives during the vaccination period. Use of hormonal contraceptives did not appear to affect the immune response to GARDASIL
Adverse events1

Please refer to the Summary of Product Characteristics for full prescribing information.

Many people have no problems after their vaccination, but some people may experience side effects. The side effects of the vaccine generally don’t last for very long and are similar to those seen with other vaccines.

Adverse events

A full list of side effects can be found in the Summary of Product Characteristics and Patient information Leaflet.

Useful links

HPVWise
HPVWise is a website developed and provided by MSD.

References

  1. GARDASIL Summary of Product Characteristics.
  2. Department of Health, Public Health England; Your HPV vaccination guide from September 2017, July 2017. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/628711/HPV_leaflet.pdf.
  3. HPV vaccine: vaccination guide leaflet. https://www.gov.uk/government/publications/hpv-vaccine-vaccination-guide-leaflet?epoch=1522154715777.
  4. HPVWise. http://www.hpvwise.co.uk/what-is-hpv.xhtml.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-HPV-00053 | Date of Preparation: June 2019