Human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant
- Atc Codes:J07BM01
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Drug Interactions
- Dosage
- Special Considerations
Brand Names
Europe
Austria: Gardasil, Silgard; Belgium: Gardasil; Bulgaria: Gardasil, Silgard; Czech Republic: Gardasil, Silgard; Denmark: Gardasil, Silgard; Estonia: Gardasil, Silgard; Finland: Gardasil; France: Gardasil; Germany: Gardasil, Silgard; Greece: Gardasil, Silgard; Hungary: Silgard; Ireland: Gardasil, Silgard; Italy: Gardasil; Latvia: Gardasil, Silgard; Lithuania: Gardasil, Silgard; Luxembourg: Gardasil, Silgard; Malta: Gardasil, Silgard; Netherlands: Gardasil, Silgard; Poland: Gardasil, Silgard; Portugal: Gardasil, Silgard; Romania: Gardasil, Silgard; Slovakia: Gardasil, Silgard; Slovenia: Gardasil, Silgard; Spain: Gardasil; Sweden: Gardasil, Silgard; UK: Gardasil.
North America
Canada: Gardasil; USA: Gardasil.
Latin America
Argentina: Gardasil; Brazil: Vac. quad recom contra papil vírus human.
Drug combinations
Chemistry
Human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant: Non-infectious recombinant quadrivalent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV types 6, 11, 16, and 18. The L1 proteins are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs.
Pharmacologic Category
Serums, Toxoids, and Vaccines; Vaccines. (ATC-Code: J07BM01).
Mechanism of action
HPV only infects humans, but animal studies with analogous papillomaviruses suggest that the efficacy of LI VLP vaccines is mediated by the development of a humoral immune response. Human beings develop a humoral immune response to the vaccine, although the exact mechanism of protection is unknown.
HPV 16 and HPV 18 are estimated to be responsible for approximately 70% of cervical cancers; 80% of adenocarcinoma in situ (AIS); 45-70% of high-grade cervical intraepithelial neoplasia (CIN 2/3); 25% of low-grade cervical intraepithelial neoplasia (CIN 1); approximately 70% of HPV-related high-grade vulvar (VIN 2/3) and vaginal (VaIN 2/3) intraepithelial neoplasia. HPV 6 and 11 are responsible for approximately 90% of genital warts and 10% of low-grade cervical intraepithelial neoplasia (CIN 1). CIN 3 and AIS have been accepted as immediate precursors of invasive cervical cancer.
Therapeutic use
Vaccine for use from the age of 9 years for the prevention of premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic HPV types and of external genital warts (condyloma acuminata) causally related to specific HPV types.
Pregnancy and lactiation implications
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Since specific studies of the vaccine in pregnant women were not conducted, vaccination should, therefore, be postponed until completion of pregnancy. Can be given to breastfeeding women.
Unlabeled use
The U.S. Food and Drug Administration (Dec. 2010) approved this vaccine for the prevention of anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in people aged 9 through 26 years.
Contraindications
Hypersensitivity to the active substances or to any of the excipients. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of vaccine should not receive further doses. Administration 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 immunization.
Warnings and precautions
The decision to vaccinate an individual woman should take into account her risk for previous HPV exposure and her potential benefit from vaccination. As with all injectable vaccines, anaphylactic reactions following the administration of the vaccine may occur. Syncope (fainting) may follow any vaccination, especially in adolescents and young adults (vaccinees should be carefully observed for approximately 15 minutes after administration). As with any vaccine, vaccination with HPV may not result in protection in all vaccine recipients. Only protects against diseases caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (precautions against sexually-transmitted diseases should continue to be used). For prophylactic use only; has no effect on active HPV infections or established clinical disease (has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity). Its use in adult women should take into consideration the variability of HPV type prevalence in different geographical areas. Vaccination is not a substitute for routine cervical screening or anal cancer screening, if it has been recommended by a healthcare provider. Individuals with impaired immune responsiveness may not respond to the vaccine. This vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals. The duration of protection is currently unknown (sustained protective efficacy has been observed for 4.5 years after completion of the 3-dose series; longer term follow-up studies are ongoing). There are no safety, immunogenicity or efficacy data to support interchangeability of this HPV quadrivalent vaccine with other HPV vaccines.