Gardasil^® (Suspension) Instructions for Use

Marketing Authorization Holder

Merck Sharp & Dohme, B.V. (Netherlands)

Manufactured By

Merck Sharp & Dohme, LLC (USA)

Packaging and Quality Control Release

MERCK SHARP & DOHME, B.V. (Netherlands)

ATC Code

J07BM01 (Papillomavirus (human types 6 11 16 18))

Active Substance

Human papillomavirus quadrivalent vaccine, recombinant (FDA U.S. Food and Drug Administration)

Dosage Form

Gardasil®

Suspension for intramuscular injection 120 mcg/0.5 ml (1 dose): fl. 1 or 10 pcs., syringes 1 or 10 pcs. with or without a safety administration device

Dosage Form, Packaging, and Composition

Suspension for intramuscular injection white, slightly opalescent.

Excipients: aluminum in the form of amorphous aluminum hydroxyphosphate sulfate – 225 mcg, sodium chloride – 9.56 mg, L-histidine – 0.78 mg, polysorbate 80 – 50 mcg, sodium borate – 35 mcg, water for injection – 0.5 mg.

Does not contain preservatives or antibiotics.

0.5 ml (1 dose) – glass vials with a capacity of 3 ml (1) – cardboard packs^×.
0.5 ml (1 dose) – glass vials with a capacity of 3 ml (10) – cardboard packs^×.
0.5 ml (1 dose) – single-use glass syringes with a capacity of 1.5 ml (1) – contour cell packs with a lid (1) – cardboard packs^×.
0.5 ml (1 dose) – single-use glass syringes with a capacity of 1.5 ml (10) – contour cell packs with a lid (1) – cardboard packs^×.
0.5 ml (1 dose) – single-use glass syringes with a capacity of 1.5 ml (1) with a safety administration device, complete with 1 or 2 sterile needles – contour cell packs with a lid (1) – cardboard packs^×.
0.5 ml (1 dose) – single-use glass syringes with a capacity of 1.5 ml (10) with a safety administration device, complete with 1 or 2 sterile needles – contour cell packs with a lid (1) – cardboard packs^×.

^× A package opening control may be present.

Clinical-Pharmacological Group

Vaccine for the prevention of diseases caused by human papillomavirus

Pharmacotherapeutic Group

Vaccines; viral vaccines; human papillomavirus vaccines

Pharmacological Action

The efficacy of the human papillomavirus (HPV) vaccine is mediated by the formation of protective immunity with the development of humoral and cellular immune responses against HPV.

The lifetime risk of HPV infection in sexually active people, without vaccination, is more than 50%, and it is constantly increasing. Completing the vaccination course leads to the prevention of diseases caused by HPV.

Infection with oncogenic types of HPV is a mandatory condition for the development of cervical cancer (squamous cell carcinoma and adenocarcinoma) and precancerous dysplastic conditions.

Furthermore, in men and women, HPV is the cause of cancer of the external genitalia and anal canal, significantly increases the risk of developing head and neck cancer, especially oropharyngeal cancer, leads to the development of anogenital condylomas, and causes recurrent respiratory papillomatosis in children and adults.

Indications

Prevention of the following diseases in girls and women aged 9 to 45 years: cervical, vulvar, vaginal, and anal canal cancer caused by HPV types 16 and 18; anogenital condylomas (condyloma acuminata) caused by HPV types 6 and 11; cervical intraepithelial neoplasia grades 1/2/3 (CIN), adenocarcinoma in situ of the cervix (AIS) caused by HPV types 6, 11, 16, and 18; vulvar intraepithelial neoplasia (VIN) and vaginal intraepithelial neoplasia (VaIN) grades 1/2/3 caused by HPV types 6, 11, 16, and 18; anal intraepithelial neoplasia grades 1/2/3 caused by HPV types 6, 11, 16, and 18.

The vaccine may provide protection in girls and women aged 9 to 26 years against diseases caused by HPV types not included in the vaccine.

The vaccine is indicated for use in boys and men aged 9 to 26 years for the prevention of the following diseases: anal canal cancer caused by HPV types 16 and 18; anogenital condylomas (condyloma acuminata) caused by HPV types 6 and 11; precancerous, dysplastic conditions and anal intraepithelial neoplasia grades 1/2/3 caused by HPV types 6, 11, 16, and 18.

ICD codes

Dosage Regimen

Administer intramuscularly into the deltoid muscle or the upper-outer 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 administered according to the schedule (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 schedule is allowed, in which the second dose is administered 1 month after the first vaccination, and the third – 3 months after the second vaccination.

If the interval between vaccinations is violated, the vaccination course is considered completed if 3 vaccinations are administered within 1 year.

The need for revaccination has not been established.

Adverse Reactions

Musculoskeletal system: frequently – pain in the extremities.

Respiratory system: very rarely – bronchospasm.

General disorders: frequently – pyrexia.

The following adverse reactions have been reported in vaccinated individuals; it is not possible to reliably assess their frequency and causal relationship with the vaccination.

Infectious and parasitic diseases: cellulitis.

Blood and lymphatic system disorders: lymphadenopathy, idiopathic thrombocytopenic purpura.

Nervous system disorders: dizziness, acute primary idiopathic polyradiculoneuritis, headache, Guillain-Barré syndrome, acute disseminated encephalomyelitis, syncope, sometimes accompanied by tonic-clonic seizures.

Gastrointestinal disorders: nausea, vomiting.

Musculoskeletal system disorders: arthralgia, myalgia.

General disorders: asthenia, fatigue, chills, discomfort.

Allergic reactions: hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.

Contraindications

If symptoms of hypersensitivity to the administration of this vaccine occur, the administration of subsequent doses of the vaccine is contraindicated.

Relative contraindications: coagulation disorders due to hemophilia, thrombocytopenia, or while taking anticoagulants. If it is necessary to use the vaccine in this category of patients, the potential benefits of vaccination and the associated risk should be assessed. When vaccinating in such cases, measures should be taken to reduce the risk of post-injection hematoma formation.

Use in Pregnancy and Lactation

Vaccinated women should be warned about the need to use contraception during the vaccination course, and if pregnancy occurs, vaccination should be postponed until its completion.

The possibility of use during lactation depends on the specific vaccine preparation used.

Pediatric Use

Can be used in children aged 9 years and older.

Geriatric Use

Not intended for use in elderly individuals.

Special Precautions

When deciding on vaccination, it is necessary to compare the possible risk from prior HPV infection and the potential benefit from vaccination.

The vaccine 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 intended to prevent infection with those HPV types that the patient does not have. The vaccine does not affect the course of active infections caused by HPV.

As with the administration of any other vaccine, a protective immune response may not be achieved in all vaccinated individuals. The vaccine does not protect against sexually transmitted diseases of other etiologies. In this regard, vaccinated patients should be advised to continue using other prophylactic protective measures.

As with the administration of any vaccine, the treatment and prophylaxis room must always have appropriate medications for the immediate relief of an anaphylactic reaction and means for emergency and anti-shock therapy.

Immediately after vaccine administration, the patient should be observed for 30 minutes to timely identify post-vaccination reactions and complications and provide emergency medical care. Syncope may occur during any vaccination, especially in adolescents and young women.

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

In individuals with impaired immune reactivity due to the use of immunosuppressants (systemic corticosteroids, antimetabolites, alkylating agents, cytotoxic drugs), genetic defect, HIV infection, and other reasons, the protective effect may be reduced.

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

Medical personnel are obliged to provide all necessary information about vaccination and the vaccine to patients, parents, and guardians, including information about the benefits and associated risks.

Vaccinated individuals should be warned about the need to inform the doctor or nurse about any adverse reactions, as well as that vaccination does not replace or cancel routine screening examinations. To achieve effective results, the vaccination course must be completed in full, unless there are contraindications.

Drug Interactions

Results of clinical studies show that the vaccine can be administered simultaneously (at a different site) with the recombinant hepatitis B vaccine, meningococcal conjugate vaccine with diphtheria toxoid, and with the inactivated vaccine against diphtheria, tetanus, pertussis (acellular component), and poliomyelitis.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.