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 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:
Premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic human papilloma virus (HPV) types. Genital warts (Condyloma acuminata) causally related to specific HPV types.

Administration

The vaccine should be administered by intramuscular injection.

The preferred site is the deltoid area of the upper arm. Human papilloma virus (HPV) vaccine type 6, 11, 16, 18 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
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 HPV exposure and the potential benefit from vaccination.

Vaccination may not result in protection in all vaccine recipients. Appropriate precautions against transmitted diseases should continue to be used.

Human papillomavirus 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 cancer, high-grade cervical, vulvar and vaginal 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 human papilloma virus 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 is contraindicated in 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.

Schaefer (2015) suggests that HPV vaccine should not be routinely administered during pregnancy but an accidental vaccination should carry no consequences. Booster injections should be carried out after completion of the pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Human papilloma virus vaccine type 6, 11, 16, 18 may be used during breastfeeding.

The manufacturer suggests that there have been no reports of adverse reactions in nursing infants whose mothers were receiving the vaccination.

Schaefer (2015) also agrees that the use of this vaccine during breastfeeding is safe.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acute disseminated encephalomyelitis
Anaphylactic reaction
Anaphylactoid reaction
Arthralgia
Arthritis
Arthropathy
Asthenia
Bronchospasm
Bruising at injection site
Cellulitis (injection site)
Chills
Dizziness
Erythema at injection site
Extremity pain
Fatigue
Guillain-Barre syndrome
Haematoma
Headache
Hypersensitivity reactions
Idiopathic thrombocytopenic purpura (ITP)
Local pain (injection site)
Lymphadenopathy
Malaise
Myalgia
Nausea
Paraesthesia
Pruritus
Pyrexia
Swelling (injection site)
Syncope
Syncope accompanied by tonic-clonic movements
Urticaria
Vomiting

Presentation

Suspension for injection containing Human Papilloma virus L1 protein in a 0.5ml pre-filled syringe.

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 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:
Premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic human papilloma virus (HPV) types. Genital warts (Condyloma acuminata) causally related to 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

Children

Administration

The vaccine should be administered by intramuscular injection.

The preferred site is the deltoid area of the upper arm. Human papilloma virus (HPV) vaccine type 6, 11, 16, 18 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
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 HPV exposure and the potential benefit from vaccination.

Vaccination may not result in protection in all vaccine recipients. Appropriate precautions against transmitted diseases should continue to be used.

Human papillomavirus 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 cancer, high-grade cervical, vulvar and vaginal 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 human papilloma virus 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 is contraindicated in 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.

Schaefer (2015) suggests that HPV vaccine should not be routinely administered during pregnancy but an accidental vaccination should carry no consequences. Booster injections should be carried out after completion of the pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Human papilloma virus vaccine type 6, 11, 16, 18 may be used during breastfeeding.

The manufacturer suggests that there have been no reports of adverse reactions in nursing infants whose mothers were receiving the vaccination.

Schaefer (2015) also agrees that the use of this vaccine during breastfeeding is safe.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acute disseminated encephalomyelitis
Anaphylactic reaction
Anaphylactoid reaction
Arthralgia
Arthritis
Arthropathy
Asthenia
Bronchospasm
Bruising at injection site
Cellulitis (injection site)
Chills
Dizziness
Erythema at injection site
Extremity pain
Fatigue
Guillain-Barre syndrome
Haematoma
Headache
Hypersensitivity reactions
Idiopathic thrombocytopenic purpura (ITP)
Local pain (injection site)
Lymphadenopathy
Malaise
Myalgia
Nausea
Paraesthesia
Pruritus
Pyrexia
Swelling (injection site)
Syncope
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: October 2016

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 January 2020

Summary of Product Characteristics: Gardasil. Sanofi Pasteur MSD Limited. Revised March 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

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Human papillomavirus vaccines. Last revised: 02 June 2016
Last accessed: 21 October 2016