Human papillomavirus type 6, 11, 16, 18, 31, 33, 45, 52, 58 vaccine
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing 9-valent Human Papilloma Virus (HPV).
Drugs List
Therapeutic Indications
Uses
Genital warts: Active immunisation
Human papilloma virus related cancer: Active immunisation
Human papilloma virus (HPV) vaccine type 6, 11, 16, 18, 31, 33, 45, 52, 58 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:
Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types. Genital warts (Condyloma acuminata) caused by specific HPV types.
Dosage
The use of the vaccine should follow official recommendations.
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed:
https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Adults
Three doses of 0.5ml at 0, 2 and 6 months. The second dose must be given at least one month after the initial dose and the third dose must be administered at least 3 months after the second dose. All doses are to be given within a 1 year period.
Children
Children aged 15 years and over at the time of first injection
Three doses of 0.5ml at 0, 2 and 6 months. The second dose must be given at least one month after the initial dose and the third dose must be administered at least 3 months after the second dose. All doses are to be given within a 1 year period.
Children aged 9 to 14 years at the time of first injection
Two doses of 0.5ml. The second dose is to be administered between 5 and 13 months after the initial dose. If the second dose is administered before the 5th month after the initial dose, a third dose should always be administered.
Alternatively, three doses of 0.5ml at 0, 2 and 6 months may be given. The second dose must be given at least one month after the initial dose and the third dose must be administered at least 3 months after the second dose. All doses are to be given within a 1 year period.
Additional Dosage Information
Patients previously vaccinated with a 3-dose regimen of the quadrivalent HPV vaccine types 6, 11, 16, and 18 may receive 3 doses of this 9-valent HPV vaccine (type 6, 11, 16, 18, 31, 33, 45, 52 and 58).
Administration
The vaccine should be administered by intramuscular injection.
The preferred site is the deltoid area of the upper arm. Human papilloma virus vaccine type 6, 11, 16, 18, 31, 33, 45, 52, 58 can also be administered into the higher anterolateral area of the thigh.
Contraindications
Children under 9 years
Severe febrile conditions
Pregnancy
Precautions and Warnings
Immunosuppression
Coagulopathy
Immunodeficiency syndromes
Thrombocytopenia
Postpone immunisation if there is active or suspected infection
Advise ability to drive/operate machinery may be affected by side effects
Impaired response possible in immunocompromised patients
Vaccine may not be effective in 100% of patients
Different brands may not be interchangeable
Do not mix with other vaccines in the same syringe
Do not use if any signs of precipitate or particulate matter apparent
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
Risk of syncope. Monitor patients for 15 min after vaccination
Follow national immunisation guidelines
Advise women to participate in breast/cervical cancer screening programmes
Treatment does not protect against risk of sexually transmitted disease
The decision to vaccinate an individual should take into account the risk of previous human papilloma virus (HPV) exposure and the potential benefit from vaccination.
HPV vaccine is for prophylactic use only. It has not been shown to have a therapeutic effect. The vaccine is therefore not indicated for the treatment of cervical, vulvar, vaginal and anal cancer, high-grade cervical, vulvar, vaginal and anal dysplastic lesions or genital warts. It is also not intended to prevent progression of other established HPV-related lesions. Human papillomavirus vaccine does not prevent lesions due to a vaccine HPV type in patients already infected with that HPV type at the time of vaccination.
The use of human papillomavirus in adults should take into consideration the variability of HPV type prevalence in different geographical areas. Since no vaccination is 100% effective and human papilloma virus vaccine will not provide protection against non-vaccine HPV types, or against existing HPV infections, routine cervical screening in women remains critically important and should follow local recommendations. Vaccination is not a substitute for routine cervical screening in women.
There are no data on the use of HPV vaccine in subjects with impaired immune responsiveness. Individuals with impaired immune responsiveness, whether due to the use of potent immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may not respond to the vaccine.
The duration of protection is currently unknown. Timing and need of booster dose(s) has not been established.
Pregnancy and Lactation
Pregnancy
Human papilloma virus vaccine type 6, 11, 16, 18, 31, 33, 45, 52, 58 is contraindicated during pregnancy.
Limited data on pregnant women indicated no malformative nor foetal toxicity when using this HPV vaccine during pregnancy. However this data is insufficient and thus vaccination should be postponed until the completion of the pregnancy.
Lactation
Human papilloma virus vaccine type 6, 11, 16, 18, 31, 33, 45, 52, 58 is considered safe for use during breastfeeding.
The manufacturer suggests that there have been no reports of adverse reactions in nursing infants whose mothers were receiving the vaccination.
Side Effects
Acute disseminated encephalomyelitis
Anaphylactic reaction
Anaphylactoid reaction
Arthralgia
Asthenia
Bronchospasm
Bruising at injection site
Cellulitis (injection site)
Chills
Dizziness
Erythema at injection site
Fatigue
Guillain-Barre syndrome
Headache
Hypersensitivity reactions
Idiopathic thrombocytopenic purpura (ITP)
Itching (injection site)
Local pain (injection site)
Lymphadenopathy
Malaise
Myalgia
Nausea
Pruritus
Pyrexia
Swelling (injection site)
Syncope accompanied by tonic-clonic movements
Urticaria
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111.
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: January 2019
Reference Sources
Summary of Product Characteristics: Gardasil 9. Merck Sharp & Dohme Limited. Revised April 2019.
Immunisation against infectious diseases: 'The Green Book', Department of Health.
Available at: https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book
Last accessed: 14 January 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 January 2020
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