Methotrexat-ebeve

1. What is Methotrexat-Ebewe and what is it used for

Methotrexat-Ebewe is an anticancer medicine from the group of antimetabolites. Tissues that are particularly sensitive to the action of the preparation are rapidly growing tissues, such as cancerous, bone marrow, fetal cells, mucous membranes of the mouth and intestines, or bladder cells. The mechanism of action of the medicine is based on inhibiting the growth of cancer. If cell proliferation in cancerous tissue is stronger than in healthy tissues, methotrexate may inhibit cancer growth without harming healthy tissues.

Tissue growth of skin epithelium is significantly greater in patients with psoriasis than in healthy individuals; this symptom is the basis for using methotrexate in severe forms of psoriasis.

Indications for use:

• malignant tumors, e.g., acute lymphoblastic leukemia (ALL) including meningeal leukemia, non-Hodgkin's lymphoma (NHL), breast cancer, testicular cancer, ovarian cancer, head and neck tumors, small cell lung cancer, squamous cell carcinoma, bone sarcomas;
• psoriasis resistant to other treatments.

2. Important information before using Methotrexat-Ebewe

When not to use Methotrexat-Ebewe

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has liver function disorders;
• if the patient has severe kidney function disorders (in the case of small doses of methotrexate (<100 mg m²) or moderate kidney function disorders (in the case of medium large doses methotrexate (>100 mg/m²);
• if the patient has blood system disorders (e.g., after previous radiation or chemotherapy);
• if the patient has severe and/or active acute infections;
• if the patient abuses alcohol;

Standard text – January 22, 2004 / June, 2005

• if the patient has immune system disorders;
• if the patient has oral mucositis and active peptic ulcer disease of the stomach or duodenum;
• during breastfeeding and additionally during pregnancy, if the patient is using the medicine for non-oncological indications (in the treatment of non-cancerous diseases) (see "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Before starting treatment with Methotrexat-Ebewe, discuss with your doctor if:

• the patient has diabetes and is being treated with insulin;
• the patient has an inactive, chronic infection (e.g., tuberculosis, hepatitis B or C, shingles);
• the patient has or has had kidney or liver disease in the past;
• the patient has lung function disorders;
• the patient has significant obesity;
• fluid accumulates in the abdominal cavity or in the space between the lungs and the chest (ascites, pleural effusion);
• the patient is dehydrated or has disorders leading to dehydration (vomiting, diarrhea, oral mucositis).

During methotrexate treatment, a recurrence of radiation-induced skin inflammation (post-radiation dermatitis) or sunburn (so-called "recall reaction") may occur.

Exposure to UV radiation during Methotrexat-Ebewe therapy may exacerbate skin changes associated with psoriasis.

Methotrexate may increase skin sensitivity to sunlight. It is recommended to avoid intense sun exposure and not to use a solarium or sun lamp without consulting a doctor.

To protect the skin from intense sunlight, it is recommended to wear appropriate clothing or use a sunscreen with a high protection factor.

During methotrexate treatment, cases of acute pulmonary bleeding have been reported in patients with underlying rheumatologic disease. If the patient experiences hemoptysis, i.e., coughing up sputum with blood, they should immediately consult a doctor.

If the patient, their partner, or caregiver notices new onset or worsening of neurological symptoms, including general muscle weakness, vision disturbances, changes in thinking, memory, and orientation leading to disorientation and personality changes, they should immediately contact a doctor, as these may be symptoms of a very rare, severe brain infection called progressive multifocal leukoencephalopathy (PML).

Recommended tests and precautions

Even after using small doses of Methotrexat-Ebewe, severe side effects may occur. To detect these effects early, the doctor must perform control tests and laboratory tests.

Before starting treatment

Before starting treatment, the doctor will order blood tests to check the number of blood cells and liver function, as well as to detect hepatitis. Tests will be performed to determine the level of albumin in the blood serum (protein in the blood), liver inflammation, and kidney function. The doctor may also recommend performing other liver tests - imaging tests or tests that require taking a small tissue sample from the liver to examine it more closely. They may also recommend taking a chest X-ray or lung function test to check if the patient has tuberculosis. Further tests may also be performed during and after treatment.

Standard text – January 22, 2004 / June, 2005

During treatment:

The doctor may order the following tests:

• examination of the mouth and throat to rule out changes in the mucous membranes, such as inflammation or ulcers;
• blood tests and/or complete blood count with assessment of the number of individual types of blood cells and measurement of methotrexate levels in the blood serum;
• blood tests to monitor liver function;
• imaging tests to monitor liver condition;
• taking a small liver biopsy for detailed examination;
• blood tests to monitor kidney function;
• control of respiratory system function and, if necessary, lung function tests.

It is necessary to attend all scheduled blood tests and other tests recommended by the doctor.

If the result of any of these tests is abnormal, treatment will be resumed only when all tested parameters return to normal.

Children and adolescents

Treatment with methotrexate in children and adolescents should be initiated and monitored by a specialist with appropriate experience in diagnosing and treating diseases covered by the indications for use.

During treatment with Methotrexat-Ebewe, the doctor will carefully monitor the child's condition to detect any potential side effects as early as possible.

Elderly

During treatment with Methotrexat-Ebewe, it is necessary to carefully monitor the condition of elderly patients to detect any potential side effects as early as possible.

The doses used in elderly patients should be relatively small, among other things, due to age-related liver and kidney function disorders and low folate reserves in the body.

Special precautions for using Methotrexat-Ebewe

Methotrexate temporarily disrupts the production of sperm and egg cells. Methotrexate may cause miscarriage and severe birth defects. Female patients should avoid becoming pregnant while taking methotrexate and for at least 6 months after treatment. Male patients should avoid fathering a child while taking methotrexate and for at least 3 months after treatment. See also "Pregnancy, breastfeeding, and fertility".

Methotrexat-Ebewe and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription, herbal medicines, or natural products.

If your doctor prescribes you other medicines, inform them that you are taking Methotrexat-Ebewe.

It is especially important to inform your doctor about taking the following medicines:

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Incompatibilities

Strong oxidizers and acids. Combination with chlorpromazine hydrochloride, droperidol, idarubicin,
metoclopramide hydrochloride, heparin solution, sodium phosphate prednisolone salt,
and promethazine hydrochloride results in precipitation or clouding of the solution.