Metodject solution for injections 50 mg/ml. 0.3 ml. 15 mg. syringe

Description

Metodject composition
active substance: methotrexate;
1 ml of solution contains methotrexate 50 mg (as methotrexate disodium 54.84 mg);
Excipients: sodium hydroxide, sodium chloride, water for injections.

Dosage form
Solution for injection.

Pharmacological properties
This Metodject drug belongs to the group of pharmaceutical antineoplastic agents used to treat cancer.
Refers to antianginal, vasodilator, coronary dilator drugs. It is included in the group of analogue drugs (generics) of folic acid, which plays an important role in the functioning of various human systems and organs.
It has the property of inhibiting the processes in which dihydrofolic acid is converted to tetrahydrofolic acid.
It is capable of disrupting the synthesis of thymidylic acid during the metabolism. Also inhibits the production of purine. As a result, DNA synthesis is suppressed in the body. The process of cell reproduction, the synthesis of RNA, as well as proteins is disrupted.
The greatest effect of inhibition of the synthesis of proteins, RNA and DNA cells occurs in tumor tissues, including cancerous ones. Bone marrow tissues, epithelial cells, and cells of a gestating fetus are sensitive to the action of the drug.
Metodject also has immunosuppressive properties.

Indications
This drug, Metodject , is used to treat cancer. In particular, when treating:

• acute lymphocytic leukemia;
• non-Hodgkin’s lymphoma;
• breast cancer;
• choriocarcinoma;
• severe cases of psoriasis or rheumatoid arthritis.

Contraindications
You should not use the specified drug if the patient has had a previous hypersensitivity (allergy) with respect to one of the components that are part of the drug – both basic and auxiliary.
Also, use is contraindicated in:

• significant violations of the liver and / or kidneys;
• alcoholism;
• violations of the hematopoietic system (leukopenia, anemia, etc.);
• severe, acute or chronic infections (tuberculosis, HIV);
• ulcers of the oral cavity, gastrointestinal tract;
• vaccination with live vaccines during the treatment period.

Avoid eating foods / drinks containing tannin or caffeine.
Incompatible with oxidants and acids.

Children
The drug can be used in children with acute lymphocytic leukemia, neuroleukemia and non-Hodgkin’s lymphoma, only as part of combination therapy. The use of the drug for the treatment of children under 3 years of age is not recommended, as there are no data on the effectiveness and safety of therapy in this group of patients.

Application during pregnancy and lactation
Treatment of pregnant women with this drug is contraindicated.
During treatment with this drug, breastfeeding should be suspended.

Method of administration and dosage
Metodject should be prescribed by physicians who have experience and who know all the features of this drug and its mechanism of action.
The method project should be introduced once a week.
The patient should be clearly informed that the drug should be administered once a week. It is desirable to set a fixed day of the week as the day of injection.
The contents of one pre-filled syringe are for single use only.
Metodject solution for injection can be administered intramuscularly, intravenously or subcutaneously (for children and adolescents use only subcutaneous or intramuscular injections).
The duration of treatment is determined by the doctor.
When changing oral to parenteral administration, it may be necessary to reduce the dose of methotrexate due to different bioavailability at different routes of administration.
The possibility of adding folic acid to the current treatment regimen may be considered.

• Adult patients with rheumatoid arthritis
  The recommended starting dose is 7.5 mg of methotrexate, which should be administered subcutaneously, intramuscularly or intravenously once a week. Depending on the specific course of the disease and tolerability of the drug, the initial dose can be gradually increased by 2.5 mg weekly. The maximum weekly dose of 25 mg should not be exceeded. Also, doses in excess of 20 mg / week may be accompanied by a significant increase in toxicity, especially bone marrow suppression. Usually a response to treatment can be expected in about 4-8 weeks. After achieving the desired therapeutic effect, the dose should be gradually reduced to the lowest effective maintenance dose.
  Children under 16 years of age, patients with polyarthritis form of juvenile (idiopathic) arthritis.
  The recommended dose is 10-15 mg / m2 of body surface area / week. In case of insufficient action, the weekly dose can be increased to 20 mg / m2 of body surface area / week. Due to the lack of reliable information on intravenous methotrexate in this group of patients, methotrexate should be administered subcutaneously or intramuscularly.
  This group of patients should be treated under the supervision of a rheumatologist who has experience working with children and adolescents.
• Patients with psoriasis vulgaris and psoriatic arthritis
  It is recommended to administer a parenteral trial dose of 5-10 mg 1 week before treatment to detect idiosyncratic side effects. The recommended starting dose is 7.5 mg of methotrexate, which should be administered subcutaneously, intramuscularly or intravenously once a week. The dose should be increased gradually, but should not exceed the maximum weekly dose of methotrexate 25 mg. Doses in excess of 20 mg / week may be accompanied by a significant increase in toxicity, especially bone marrow suppression. The usual response to treatment can be expected in about 2-6 weeks. Once the desired therapeutic effect has been achieved, the dose should be gradually reduced to the lowest possible effective maintenance dose.
• Patients with Crohn’s disease:                                                                                                                                          Induction therapy
  The recommended dose is 25 mg of the drug, which should be administered subcutaneously, intramuscularly or intravenously once a week. A response to treatment can be expected in about 8-12 weeks.                                                                                                                                                                                  Supportive therapy
  The recommended dose is 15 mg of the drug, which should be administered subcutaneously, intramuscularly or intravenously once a week.

The maximum weekly dose
The dose may be increased as needed, but in general it should not exceed the maximum recommended weekly dose of 25 mg. In some cases, an increased dose may be clinically justified, but should not exceed the maximum weekly dose of 30 mg methotrexate, as toxicity increases.

Overdose
An overdose of this drug can cause a reaction of the body in the form of disorders of the hematopoietic system.
Calcium folinate is recommended as an antidote, which has the property of neutralizing the toxic effects of methotrexate.

Side effects
Side effects can occur in the form:

• effusion in the pericardial cavity, pericardial tamponade;
• inhibition of bone marrow function (leukopenia, thrombocytopenia, anemia, pancytopenia);
• drowsiness, headache, fatigue;
• encephalopathy, subacute myelopathy;
• visual impairment, pain, myasthenia gravis, epileptic seizures, paralysis, ataxia, dementia, coma;
• eye irritation, cataracts, photophobia, conjunctivitis;
• pneumonitis, cough, shortness of breath, bronchial asthma, fever;
• epistaxis, alveolitis, pleural effusion;
• upset stomach, stomatitis, nausea, anorexia, dyspepsia;
• diarrhea, mouth ulcers;
• ulcers of the gastrointestinal tract, impaired renal function, impaired urination;
• exanthema, erythema, itching;
• alopecia, vasculitis, allergic urticaria;
• arthralgia, myalgia, osteoporosis;
• increasing susceptibility to infections;
• impairment of wound healing.

Storage conditions and periods
This Metodject medicinal product is able to maintain its medicinal properties for 2 years from the date of manufacture.
Storage temperature should not exceed 25 ° C.