Methoject is an antirheumatic drug for the treatment of chronic inflammatory rheumatic diseases.
Warehouse
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.
Contraindication
Hypersensitivity to methotrexate or any of the components, impaired liver function (alcoholic liver disease or other chronic liver diseases); alcohol abuse.
Method of application
The recommended initial dose is 7.5 mg of methotrexate, which should be administered subcutaneously, intramuscularly or intravenously 1 time per 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 each week. The maximum weekly dose of 25 mg should not be exceeded. Also, doses exceeding 20 mg/week may be accompanied by a significant increase in toxicity, especially bone marrow suppression. Usually, a response to treatment can be expected after about 4-8 weeks. After achieving the desired therapeutic effect, the dose should be gradually reduced to the lowest effective maintenance dose.
Application features
The patient should be clearly informed that the drug should be administered once a week, not daily. Also, doses exceeding 20 mg/week may be associated with a significant increase in toxicity, especially bone marrow suppression.
If symptoms of toxic effects on the digestive tract appear (usually stomatitis develops first), methotrexate treatment should be suspended, since if therapy is continued, hemorrhagic enteritis and intestinal perforation may develop, which pose a threat to the patient's life.
Methotrexate has been reported to have adverse effects on reproductive function, causing oligospermia, menstrual irregularities, and amenorrhea during therapy and for a short period after its discontinuation. In addition, methotrexate has been shown to cause embryotoxicity, miscarriage, and intrauterine malformations. Accordingly, physicians should advise patients of reproductive age of all possible risks associated with the drug.
Pregnant women
Studies have shown that methotrexate is teratogenic (the drug has caused abortion, fetal death and/or congenital malformations, especially when used in the first trimester of pregnancy), so it should not be used by pregnant women. Pregnancy should be excluded before starting treatment with Methotrexate®.
Children
Children and adolescents are given only subcutaneous or intramuscular injections.
Methotrexate is not recommended for use in children under 3 years of age due to a lack of sufficient information on efficacy and safety.
Methoject® 50 mg/ml is not recommended for the treatment of Crohn's disease in children due to the lack of sufficient experience with its use in this category of patients.
Drivers
During treatment with Methoject®, you should refrain from driving or operating other mechanisms, as side effects from the nervous system (fatigue and dizziness) may occur.
Overdose
Overdose has been reported after oral, intravenous or intramuscular administration. Overdose has also been reported when methotrexate was administered orally daily instead of once a week (as a single dose or in several divided doses). The symptoms reported in these cases were mostly haematological and gastrointestinal. Symptoms include leukopenia, thrombocytopenia, anaemia, pancytopenia, neutropenia, bone marrow depression, mucosal inflammation, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration and haemorrhage. In some cases, symptoms of intoxication were absent. Fatalities due to sepsis, septic shock, renal failure and aplastic anaemia have been reported.
Side effects
On the part of the immune system: hypogammaglobulinemia, severe allergic reactions, anaphylactic shock, hypogammaglobulinemia, fever (needs clarification regarding bacterial or fungal septicemia), immunosuppression.
Metabolic disorders: initial stage of diabetes.
Mental disorders: depression, confusion, mood swings.
Nervous system: headache, fatigue, drowsiness, hemiparesis, dizziness, convulsions, depression, paralysis, speech disorders, including dysarthria and aphasia, confusion, transient perceptual disturbances, pain.
Storage conditions
Store pre-filled syringes at a temperature not exceeding 25 °C, out of the reach of children, in the original packaging to protect from light.
