Vaccine against human papillomavirus, recurrent (type 6, 11, 16, 18) - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Vaccines, serums, phages and toxoids

Included in the formulation

Gardasil®

suspension w / m

Merck Sharp and Doum B.V. Netherlands

Cervarix®

suspension w / m

GlaxoSmithKline Trading, ZAO Russia

Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

VED

АТХ:

J.07.B Vaccines for the prevention of viral infections

J.07 Vaccines

Pharmacodynamics:

The quadrivalent recombinant vaccine against human papillomavirus.

The effectiveness of the vaccine is mediated by the formation of protective immunity with the development of a humoral and cellular immune response against human papillomavirus. Risk of infection human papillomavirus during life, without vaccination, in sexually active people more than 50%, and it is constantly growing. Carrying out a course of vaccination with the drug leads to the prevention of diseases caused by human papillomavirus.

Infection with oncogenic types human papillomavirus is an indispensable condition for the development of cervical cancer (squamous and adenocarcinoma) and precancerous dysplastic conditions.In addition, in men and women human papillomavirus is the cause of cancers of the external genitalia and anal canal, significantly increases the risk of cancer of the head and neck organs, especially the oropharyngeal cancer, leads to the development of anogenital condylomas and causes recurrent respiratory papillomatosis in children and adults.

Clinical efficacy. Based on the studies conducted, 24,358 women and girls aged 9 to 45 years and 4055 men and boys aged 9 to 26 years had a high profile of vaccine efficacy and safety.

In women 16 to 26 years of age, the vaccine effectively prevented cancer and precancerous dysplastic conditions of the cervix, vulva, vagina, as well as anogenital warts in 98-100% of cases. An analysis of cross protective efficacy shows that administration of the vaccine reduces the risk of developing cervical dysplasia (CIN 1/2/3) and adenocarcinoma in situ (AIS) caused by the most common oncogenic types human papillomavirus, not included in the vaccine.

In women aged 24 to 45, the vaccine was effective in preventing persistent CIN infection (of any degree) or anogenital lesions caused by human papillomaviruses 6th, 11th, 16th and 18th types, in 88.7% of cases.

In young men and men, the vaccine prevented external genital lesions (anogenital condylomas and perineal, perianal intraepithelial neoplasia, intraepithelial neoplasia of the penis of the 1st / 2nd / 3rd degree) caused by human papillomavirus 6th, 11th, 16th, 18th types, in 90.6% of cases, as well as anal intraepithelial neoplasia (AIN) of the 1st / 2nd / 3rd degree in 77.5% of cases .

Immunogenicity

The full course of vaccination leads to the formation of specific antibodies to four types human papillomavirus - 6th, 11th, 16th and 18th - more than 98% of the vaccinated. The presence of immunological memory was shown during vaccination of seropositive (at the time of vaccination) women. In addition, women who received an additional dose of vaccine five years after the completed vaccination course had a rapid and pronounced anamnestic immune response, in which the average geometric antibody titres exceeded the titers obtained one month after the initial vaccination.

Pharmacokinetics:

Data on the pharmacokinetics of the vaccine are not available.

Indications:

Prevention of the following diseases in girls and women aged 9 to 45:

cancer of the cervix, vulva, vagina and anal canal caused by human papillomavirus of the 16th and 18th types;

anogenital condylomas (condiloma acuminata) caused by human papillomavirus 6th and 11th types;

cervical intraepithelial neoplasia of the 1 st / 2 nd / 3 rd degree (CIN), cervical adenocarcinoma in situ (AIS) caused by human papillomavirus 6th, 11th, 16th and 18th types;

intraepithelial neoplasia of the vulva (VIN) and vagina (VaIN) of the 1st / 2nd / 3rd degree caused by human papillomavirus 6th, 11th, 16th and 18th types;

intraepithelial neoplasia of the 1st / 2nd / 3rd degree anal channel, caused by HPV of the 6th, 11th, 16th and 18th types.

Vaccine can provide protection for girls and women between the ages of 9 and 26 from diseases caused by human papillomaviruses types that are not part of the vaccine.

The vaccine is indicated for use in boys and men aged 9 to 26 years for the prevention of the following diseases:

cancers of the anal canal caused by human papillomaviruses 16th and 18th types;

anogenital condyloma (condiloma acuminate) caused by human papillomaviruses 6th and 11th types;

precancer, dysplastic conditions and intraepithelial neoplasia of the 1st / 2nd / 3rd degree anal canal caused by human papillomavirus 6th, 11th, 16th, 18th types.

ICD-10

I.A50-A64.A63.0 Anogenital (venereal) warts

I.B95-B97.B97.7 Papillomaviruses as a cause of diseases classified elsewhere

II.C15-C26.C21 Malignant neoplasm of anus [anus] and anal canal

II.C51-C58.C51 Malignant neoplasm of vulva

II.C51-C58.C53 Malignant neoplasm of cervix

XXI.Z20-Z29.Z25 The need for immunization against one of the other viral diseases

Contraindications:

Pincreased sensitivity to active components and excipients of the vaccine; When there are symptoms of hypersensitivity to the drug, the introduction of a subsequent dose of the vaccine is contraindicated.

Carefully:

Have children under the age of 9 years the safety and efficacy of the vaccine was not assessed.

There is no data on the safety and efficacy of vaccines in adults over 45 years of age.

Relative contraindications: disorders of blood clotting due to hemophilia, thrombocytopenia, or on the background of taking anticoagulants. If a vaccine is needed in this category of patients, the potential benefits of vaccination and the associated risk should be assessed. When vaccinating in such cases, it is necessary to take measures to reduce the risk of post-injection hematoma.

Pregnancy and lactation:

Adequate and strictly controlled studies of the safety of the drug during pregnancy have not been conducted.

Data showing that administration of the vaccine has an adverse effect on fertility, pregnancy or fetal is not available.

Data on the use of the vaccine in pregnancy and the potential impact of the vaccine on the reproductive function of women and on the fetus in pregnant women are not enough to recommend the use of the vaccine in pregnancy.

Vaccinated women should be warned about the need to protect themselves from pregnancy during the course of vaccination, and at the onset of pregnancy, vaccination should be postponed until it is completed.

Clinical studies that examined the efficacy, immunogenicity and safety of the vaccine in nursing mothers and infants showed that the vaccine can be administered to women during lactation (breastfeeding).

Dosing and Administration:

Vaccine injected intramuscularly into the deltoid muscle or the upper-upper surface of the middle third of the thigh.

The vaccine is not intended for intravenous administration.

For all age groups a single dose of the vaccine is 0.5 ml.

The recommended vaccination course consists of 3 doses and is carried out according to the scheme (0-2-6 months): the first dose on the appointed day; the second dose - 2 months after the first; the third dose - 6 months after the first.

An accelerated vaccination scheme is possible, in which the second dose is administered 1 month after the first vaccination, and the third one - 3 months after the second vaccination.

If the interval between vaccinations is broken, the vaccination course is considered complete if 3 vaccinations are carried out within 1 year.

The need for revaccination is not established.

Before use, the vial / syringe with the vaccine is shaken until a homogeneous turbid suspension is obtained. The loss of homogeneity, the appearance of the included particles and the discoloration of the suspension indicate the unfitness of the vaccine.

A syringe filled with a vaccine is intended only for single use and only for one person.

The vials are opened and the vaccination procedure is carried out with strict adherence to aseptic and antiseptic rules. Place of injection before and after injection is treated with 70% alcohol.

You should enter the entire recommended dose - 0.5 ml.

Side effects:

Adverse reactions that were observed in connection with the introduction of the vaccine in 1% of cases and more often than those administered placebo.

Determination of the frequency of adverse reactions: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1000, <1/100); rarely (≥ 1/10 000, <1/1 000); very rarely (<1/10 000).

From the musculoskeletal system: often - pain in the limbs.

From the respiratory system: very rarely - bronchospasm.

General disorders: often pyrexia.

Local Reactions (more often in the group administered with the vaccine compared to any preparations containing an aluminum hydroxylphosphate sulfate amorphous aluminum adjuvant, or compared to the placebo group administered), very often redness, pain, and swelling; often - itching, bruising. Most local reactions were of mild severity.

Overdose:

There are reports of cases of administration of the vaccine in doses exceeding the recommended ones. In general, the nature and severity of adverse events in an overdose were comparable to those observed with the administration of the recommended single doses of this vaccine.

Interaction:

The results of clinical studies show that the vaccine can be administered simultaneously (at another site) with a recombinant hepatitis B vaccine, a meningococcal vaccine, a diphtheria toxoid conjugate and an inactivated diphtheria, tetanus, pertussis (acellular component) vaccine, and polio.

The use of analgesics, anti-inflammatory drugs, antibiotics and vitamin preparations did not affect the efficacy, immunogenicity and safety of the vaccine.

Hormonal contraceptives, corticosteroids for inhaled local and parenteral administration did not affect the immunogenicity, efficacy and safety of the vaccine.

Data on simultaneous use of systemic immunosuppressants and vaccines are absent.

Special instructions:

When deciding on vaccination, it is necessary to compare the possible risk from previous infection human papillomavirus and the potential benefits of vaccination.

It is not intended for treatment of cervical, vulvar or vaginal cancer, CIN, VIN or VaIN or active condylomatosis and is used exclusively for prophylactic purposes. The vaccine is designed to prevent infection by those types human papillomavirus, which the patient does not have. The vaccine has no effect on the course of active infections caused by human papillomaviruses. As with any other vaccine, it is not possible to obtain a protective immune response in all vaccinees when using the vaccine.The drug does not protect against sexually transmitted diseases, another etiology. In this regard, vaccinated patients should be encouraged to continue using other preventive protective equipment.

Efficacy and safety with subcutaneous and intradermal administration have not been studied, therefore these methods of administration are not recommended.

As with any vaccine, in the treatment and prophylactic office it is always necessary to have appropriate medications for immediate relief of the anaphylactic reaction and the means of emergency and anti-shock therapy.

Immediately after the introduction of the vaccine, the patient should be monitored for 30 minutes to promptly detect post-vaccination reactions and complications and provide emergency medical care. In any vaccination, syncope may occur, especially in adolescents and young women.

The decision to administer the drug or postpone the vaccination due to a current or recent illness accompanied by fever is largely dependent on the etiology of the disease and severity.

In persons with impaired reactivity of the immune system due to the use of immunosuppressants (systemic corticosteroids, antimetabolites, alkylating drugs, cytotoxic drugs), genetic defect, human immunodeficiency virus infection and other causes, the protective effect can be reduced.

The vaccine should be administered with caution to patients with thrombocytopenia and any disorders of blood coagulation, since after intramuscular injection, such individuals may develop bleeding.

Medical personnel are required to provide all necessary vaccine and vaccine information to patients, parents and caregivers, including information on benefits and the associated risk.

Vaccinated should be warned about the need to report to your doctor or nurse about any adverse reactions and that the vaccination does not replace or supersede routine screening examinations. To achieve effective results, the vaccination course should be completed completely if there is no contraindication for this.

There is no data on the safety and efficacy of vaccines in adults over 45 years of age.

Use in Pediatrics

Have children under the age of 9 years safety and efficacy of the vaccine was not evaluated.

Impact on the ability to drive vehicles and manage mechanisms

Studies of the effect of the vaccine on the ability to drive vehicles and work with mechanisms have not been conducted.

Instructions

The human papillomavirus vaccine is a recurrent (pancreatic) type (types 6, 11, 16, 18) (The human papillomavirus vaccine is a recurrent (pancreatic) type (types 6, 11, 16, 18))