Gardasil - instructions for use, reviews, analogs and form of release (suspension of a vaccine or injections in ampoules for injection) of a drug for the treatment of human papillomavirus and prevention of cervical cancer in women and girls, as well as in men. Composition

In this article, you can read the instructions for using the drug Gardasil. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of physicians specialists on the use of Gardasil in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of the Gardasil vaccine in the presence of existing structural analogs.Use to treat human papillomavirus and prevent cervical cancer in women and girls, including during pregnancy and lactation, as well as in men for the treatment of anogenital warts. Composition of the preparation.

Gardasil - a quadrivalent recombinant human papillomavirus (HPV) vaccine.

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

Infection with oncogenic types of HPV is a prerequisite for the development of cervical cancer (squamous and adenocarcinoma) and precancerous dysplastic conditions. In addition, in men and women, HPV causes cancer of the vulva and anal canal, significantly increases the risk of developing cancer of the head and neck, especially the oropharyngeal cancer, leads to the development of anogenital warts 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 confirmed the high profile of the efficacy and safety of the Gardasil vaccine.

Women between 16 and 26 years vaccinated Gardasil effectively prevents cancer and premalignant dysplastic cervix uteri, vulva, vagina, and anogenital warts in 98-100% of cases. Analysis of cross-protective efficacy shows that administering Gardasil vaccine thereby reducing the risk of cervical dysplasia (CIN 1/2/3) and adenocarcinoma in situ (AIS), caused by the most common oncogenic HPV types not included in the vaccine.

In women 24 to 45 years, the Gardasil vaccine was effective in preventing persistent infection CIN (any grade) or anogenital lesions caused by HPV 6, 11, 16 and 18 types in 88.7% of cases.

In boys and men Gardasil vaccine prevents external genital lesions (anogenital warts and perineal, perianal intraepithelial neoplasia, penile intraepithelial neoplasia 1/2/3 degree) caused by HPV types 6,11,16,18 in 90.6% of cases, as well as anal intraepithelial neoplasia (AIN) 1/2/3 in 77.5% of cases.

Immunogenicity.The full course of vaccination leads to the formation of specific antibodies to the four types of HPV - 6, 11, 16 and 18 - 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 Gardasil 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.

In girls and boys from 9 to 15 years, clinical studies were conducted on safety and immunogenicity studies, and on the basis of immune bridging, the effectiveness of grafting in adolescents was demonstrated.

Composition

L1 protein of human papilloma virus (including type 6, type 11, type 16, type 18) + auxiliary substances.

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 HPV 16 and 18 types;
• anogenital condylomas (condiloma acuminata) caused by HPV types 6 and 11;
• cervical intraepithelial neoplasia 1/2/3 degree (CIN), cervical adenocarcinoma in situ (AIS) caused by HPV 6, 11, 16 and 18 types;
• intraepithelial neoplasia of the vulva (VIN) and vagina (VaIN) 1/2/3 degree caused by HPV 6, 11, 16 and 18 types;
• intraepithelial neoplasia of the anal canal 1/2/3 degree, caused by HPV 6, 11, 16 and 18 types.

Gardasil vaccine can provide protection in girls and women aged 9 to 26 years from diseases caused by HPV types that are not part of the vaccine.

The vaccine Gardasil 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 HPV 16 and 18 types;
• anogenital condylomas (condiloma acuminate) caused by HPV types 6 and 11;
• precancerous, dysplastic conditions and intraepithelial neoplasia of the anal canal 1/2/3 degree caused by HPV 6, 11,16, 18 types.

Forms of release

Suspension for intramuscular injection (injections in ampoules for injection).

Instructions for use and how to use them

The vaccine Gardasil is injected intramuscularly into the deltoid muscle or 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.

If the first dose of Gardasil vaccine was used for vaccination, the full course of vaccination should be carried out using the Gardasil vaccine.

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.

Regulations for the introduction of the vaccine

Vials with a single dose of vaccine: dial 0.5 ml of a suspension from a vial of a single dose of a vaccine with a sterile needle into a disposable sterile syringe. Enter the entire dose. Remove the vial with the remainder of the vaccine.

Syringes with a single dose of vaccine: enter the entire contents of the syringe completely.

Disposable sterile, pre-filled syringes with a single dose complete with a protective device: for the introduction of the vaccine, a nested needle should be used. If you need to use another needle, make sure that the needle is securely attached to the syringe and that its length does not exceed 2.5 cm, which is a prerequisite for the proper functioning of the protective device.

Remove the cap from the end of the syringe. Press both of the anti-rotation protrusions, fix the syringe, and attach the Luer needle by turning it clockwise. Remove the protective cap from the needle.

When carrying out the injection, as indicated above, you should press the piston, firmly holding the syringe under the finger protrusions and insert the entire dose. The needle guard will not work unless the entire dose is administered. Remove the needle. Release the plunger and allow the syringe to move up until the entire needle is completely closed. To document the vaccination, separate the removable labels by slowly pulling them. After the procedure, throw the syringe into a container for sharp objects.

To document the vaccination, detachable labels should be separated by slowly pulling them.

Side effect

• pain in the limbs;
• bronchospasm;
• pyrexia;
• redness, pain and swelling (at the injection site);
• itching and bruising (at the injection site);
• cellulite;
• lymphadenopathy, idiopathic thrombocytopenic purpura;
• dizziness;
• acute primary idiopathic polyradiculoneuritis;
• headache;
• Guillain-Barre syndrome;
• acute disseminated encephalomyelitis;
• Syncope, sometimes accompanied by tonic-clonic seizures;
• nausea, vomiting;
• arthralgia;
• myalgia;
• asthenia;
• fatigue;
• chills;
• discomfort;
• hypersensitivity reactions, including anaphylactic / anaphylactoid reactions;
• hives.

Contraindications

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

Application in pregnancy and lactation

Adequate and strictly controlled studies of the safety of Gardasil in pregnancy have not been conducted.

Data suggesting that the administration of the Gardasil vaccine has an adverse effect on fertility, pregnancy or fetus is not available.

Data on the use of Gardasil vaccine in pregnancy and the potential impact of Gardasil vaccine on the reproductive function of women and on the fetus in pregnant women is 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 Gardasil vaccine in nursing mothers and infants showed that Gardasil vaccine can be administered to women during lactation (breastfeeding).

Use in children

In children under 9 years of age, the safety and efficacy of Gardasil vaccine has not been evaluated.

Application in elderly patients

There is no data to assess the safety and efficacy of Gardasil vaccine in adults over 45 years of age.

special instructions

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

Gardasil is not intended for the 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 with those types of HPV that the patient does not have. The vaccine has no effect on the course of active infections caused by HPV. As with any other vaccine, with the use of the Gardasil vaccine, it is not possible for all vaccinees to obtain a protective immune response. 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.

The efficacy and safety of Gardasil 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 people with impaired reactivity of the immune system due to the use of immunosuppressants (systemic corticosteroids, antimetabolites, alkylating drugs, cytotoxic drugs), genetic defect, HIV infection and other causes, the protective effect can be reduced.

The vaccine Gardasil should be administered with caution to patients with thrombocytopenia and any disorders of blood clotting, since after a / m 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 to assess the safety and efficacy of Gardasil vaccine in adults over 45 years of age.

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.

Drug Interactions

Clinical studies show that Gardasil vaccine may be administered simultaneously (other portion) with a recombinant hepatitis B vaccine, meningococcal vaccine conjugated to diphtheria toxoid and inactivated vaccine against diphtheria, tetanus, Pertussis (acellular component), poliomyelitis.

The use of analgesics, anti-inflammatory drugs, antibiotics and vitamin supplements had no effect on the efficiency, safety and immunogenicity of the vaccine.

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

Data on simultaneous use of systemic immunosuppressants and Gardasil vaccine are absent.

Analogs of the drug Gardasil

Structural analogs for the active substance:

• Cervarix.

Analogues on the curative effect (agents for the treatment of human papillomavirus):

• Allokin-alpha;
• Viferon;
• Galavit;
• Genferon;
• Isoprinosine;
• Lycopid;
• Metovit;
• Panavir;
• Ferrovir;
• Cervarix;
• Epigen sex.

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