Methodject solution for injection 10mg / ml, 1ml No. 1 complete with a needle

trophoblastic tumors;

acute leukemias (especially lymphoblastic and myeloblastic variants);

neuroleukemia;

non-Hodgkin's lymphomas (including lymphosarcoma);

breast cancer, squamous cell carcinoma of the head and neck, lung cancer, skin cancer, cervical cancer, vulvar cancer, esophageal cancer, bladder cancer, testicular cancer, ovarian cancer, penile cancer, retinoblastoma, medulloblastoma;

osteosarcoma and soft tissue sarcoma;

fungal mycosis (advanced stages);

Severe forms of psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile chronic arthritis, dermatomyositis, systemic lupus erythematosus, ankylosing spondylitis (with the ineffectiveness of standard therapy).

The dosage regimen is set individually, depending on the indications and stage of the disease, the patient's age, the state of the hematopoietic system, the anticancer therapy scheme, and the dosage form used.

It is necessary to strictly follow the instructions in the instructions for methotrexate preparations for the use of the appropriate dosage forms and methods of administration of methotrexate, depending on the indications.

The Methodject solution is used only for subcutaneous injections, the needle integrated into the syringe is already adapted for this.

The contents of the syringe are intended for single administration only; it is prohibited to mix it with other drugs.

The patient should be clearly informed of the single weekly dosing regimen.

The recommended dosage for s / c administration of the Method in adults: rheumatoid arthritis: the initial dose is 7.5 mg.

Provided that it is well tolerated and to achieve a therapeutic effect, a single dose can be gradually increased by 2.5 mg per week.

A single dose should not exceed 25 mg due to the high toxicity of the drug.

The clinical effect of the drug usually occurs after 4Ц8 injections.

In the future, for the appointment of a maintenance dose, the initial dose is gradually reduced to the lowest effective dose.

Treatment is carried out for a long time (up to 10 years and longer);

psoriasis and psoriatic arthritis: a test dose of 5-10 mg should be given 7 days before starting treatment.

In the absence of intolerance reactions, the patient is prescribed an initial dose of 7.5 mg.

In the future, the dose is gradually increased, usually up to 25 mg.

The clinical effect occurs after 2-6 injections.

To prescribe a maintenance dose, the dose used is reduced to the lowest effective dose.

The maximum dose is 30 mg per week (used only in exceptional, clinically justified cases).

When the doctor decides to introduce the Methodject by the patient, he must independently be trained in the technique of performing subcutaneous injections.

In this case, the patient should carry out the first self-injection in the presence of a doctor.
Method of administration of the drug Introduction Methodject requires compliance with standard requirements for hygiene and asepsis.

Wash your hands thoroughly before the procedure.

You should make sure that the dosage of the syringe corresponds to the prescribed dose and check the expiration date of the solution.

After opening the package and the blister containing the filled syringe with the preparation, visually check the solution for the absence of foreign particles in it.

If foreign particles are found, the solution cannot be used.

In 1 ml

active substance:

disodium methotrexate 10.96 mg,

which corresponds to the content of methotrexate 10 mg

Excipients: sodium chloride, sodium hydroxide, water d / i.

Hypersensitivity to methotrexate; severe renal failure; severe liver failure; alcohol abuse; a history of disorders of the hematopoietic system (in particular, bone marrow hypoplasia, leukopenia, thrombocytopenia, or clinically significant anemia); immunodeficiency; severe acute and chronic infectious diseases such as tuberculosis and HIV infection; concomitant vaccination with live vaccines; oral ulcers, gastrointestinal ulcers in the active phase; simultaneous use of methotrexate in a dose? 15 mg / week with acetylsalicylic acid; pregnancy; period of breastfeeding.

Carefully:if patients have impaired liver and kidney function, diabetes mellitus, obesity, previous therapy with hepatotoxic drugs, dehydration, ascites, inhibition of bone marrow hematopoiesis, pleural or peritoneal effusion, parasitic and infectious diseases of a viral, fungal or bacterial nature - the risk of developing a severe generalized disease ( currently or recently transferred, including recent contact with the patient) - herpes simplex, herpes zoster (viremic phase), chickenpox, measles, amebiasis, strongyloidosis (established or suspected), gout (including history) or urate nephrourolithiasis (including history), infections and inflammation of the oral mucosa, vomiting, diarrhea, gastric ulcer and duodenal ulcer, ulcerative colitis, obstructive gastrointestinal diseases,previous chemotherapy or radiation therapy, asthenia, aciduria (urine pH less than 7), in children and elderly patients.

Methodject is an antimetabolite, anticancer drug.

Release form:

Solution for injection, yellow, transparent.

1 ml - syringes of colorless glass (1) complete with a needle d / i - blisters (1) - packs of cardboard.

Composition: In 1 ml

active substance:

disodium methotrexate 10.96 mg,

which corresponds to the content of methotrexate 10 mg

Excipients: sodium chloride, sodium hydroxide, water d / i.

Clinical and pharmacological group: Antineoplastic drug

Pharmaco-therapeutic group: Antineoplastic agent, antimetabolite

Pharmachologic effect:

Antineoplastic, cytostatic agent of the group of antimetabolites - analogs of folic acid.

Inhibits dihydrofolate reductase, which is involved in the reduction of dihydrofolic acid to tetrahydrofolic acid (carrier of carbon fragments necessary for the synthesis of purine nucleotides and their derivatives).

Inhibits synthesis, DNA repair and cellular mitosis (in the S-phase). Tissues with high cell proliferation are especially sensitive to the action of methotrexate: tumor tissue, bone marrow, epithelial cells of the mucous membranes, embryonic cells.

The mechanism of action in rheumatoid arthritis is associated with the immunomodulatory and anti-inflammatory action of the drug and is due to the induction of apoptosis of rapidly proliferating cells (activated T-lymphocytes, fibroblasts, synoviocytes), inhibition of the synthesis of anti-inflammatory cytokines (interleukin (IL) -1, tumor necrosis factor alpha cytokines IL-4, IL-10 and suppression of the activity of metalloproteinases.

In patients with rheumatoid arthritis, the use of methotrexate reduces the symptoms of inflammation (pain, swelling, stiffness), but there is limited research with long-term use (regarding the ability to maintain remission in rheumatoid arthritis).

In psoriasis, the growth rate of keratinocytes in psoriatic plaques increases compared to normal proliferation of skin cells. This difference in cell proliferation is the basis for the use of methotrexate for the treatment of psoriasis.

Pharmacokinetics:

With intramuscular administration, Cmax of methotrexate in blood plasma is achieved after 30-60 minutes. The systemic absorption of methotrexate after administration under the skin of the abdomen and thigh is the same. After intravenous administration, it is rapidly distributed within a volume equivalent to the total volume of body fluids. The initial Vd is 0.18 l / kg (18% of body weight), the equilibrium volume of distribution is 0.4-0.8 l / kg (40-80% of body weight). 50-60% of methotrexate circulating in the vascular bed is associated with proteins (mainly albumin). Competitive displacement is possible with simultaneous use with sulfonamides, salicylates, tetracyclines, chloramphenicol, phenytoin. Methotrexate does not penetrate the BBB when used in therapeutic doses. A high concentration of methotrexate in the central nervous system can be achieved with intrathecal administration.Methotrexate undergoes hepatic and intracellular metabolism with the formation of a pharmacologically active polyglutamine form, which also inhibits dihydrofolate reductase and thymidine synthesis. Small amounts of polyglutamate methotrexate can remain in tissues for a long period of time. The retention and prolongation of the action of the active metabolites of methotrexate differ depending on the type of cells, tissues and tumors. Average T1 / 2 values ??when using methotrexate at a dose of less than 30 mg / m2 are 6-7 hours. In patients receiving high doses of methotrexate, T1 / 2 is 8-17 hours. In chronic renal failure, both phases of methotrexate elimination can be significantly prolonged ...It is excreted mainly by the kidneys unchanged by glomerular filtration and tubular secretion (with intravenous administration, 80-90% is excreted within 24 hours), up to 10% is excreted with bile (with subsequent reabsorption in the intestine). Methotrexate accumulates in the liver, kidneys and organs over several weeks or months. With repeated administrations, it accumulates in tissues in the form of polyglutamates.

Indications: