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Трексан

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Трексан

Quick Facts

Property Description
Active ingredient Methotrexate (MTX)
Form Tablets (Oral), Solution for injection (Parenteral)
Pharmacological class Antimetabolite, Immunosuppressant, DMARD
Common use Modulates immune system; inhibits cell proliferation
Origin Synthetic (Folic acid analogue)

What is Трексан and What is its Active Ingredient?

Трексан is a specific prescription-only medicine whose active ingredient is Methotrexate (MTX), a chemically synthetic compound that acts as a folic acid analogue. Methotrexate is a single-ingredient medication, originally known as Amethopterin, whose chemical structure is designed to interfere with certain cellular processes. Its function as an antifolate stems from its ability to competitively inhibit the enzyme dihydrofolate reductase (DHFR), distinguishing it from simple anti-inflammatory agents.

What Type of Medicine is Трексан Classified As?

Трексан is classified across several high-level pharmacological groups, including an Antimetabolite, a potent Immunosuppressant, an Antineoplastic Agent (a chemotherapy drug), and a Disease Modifying Anti-Rheumatic Drug (DMARD). This multi-classification confirms its wide-ranging impact on the body, particularly its ability to suppress immune responses and prevent rapid cell division. The successful use of Methotrexate has established it as a gold standard for treating certain chronic conditions.

What Forms are Available and What is its General Purpose?

This medicine is available for its target audience of both adults and children in various dosage forms, including oral tablets and a sterile solution for injection (e.g., in pre-filled pens). The overarching general purpose of Трексан is to provide long-term disease management by modulating the immune system's activity to reduce chronic inflammation and by inhibiting the growth of rapidly dividing cells. The availability of both oral and parenteral routes of administration allows healthcare providers to choose the format that ensures the most effective drug delivery for the patient's individual therapeutic needs.

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What side effects are possible with Трексан?

Possible side effects and safety information

The safety profile of Methotrexate (Трексан) is officially classified by regulatory authorities based on the affected System-Organ Class and the estimated frequency of the reaction. This profile establishes a spectrum of possible adverse reactions from common, expected effects to rare, serious toxicities.

Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized in official labeling:

  • Very Common (ge 1/10): Stomatitis (sore mouth), nausea, vomiting, abdominal pain, and elevated liver enzymes.
  • Common (ge 1/100 to < 1/10): Leukopenia (low white blood cells), headache, fatigue, diarrhea, rash, and temporary alopecia (hair loss).

Systemic Toxicities and Serious Concerns

The medicine is associated with documented toxicities across major organ systems. Serious adverse reactions highlighted in regulatory documents include pulmonary toxicity (e.g., pneumonitis, pulmonary fibrosis), severe hepatotoxicity (potentially leading to fibrosis and cirrhosis), and severe myelosuppression (bone marrow depression). These effects primarily involve the Blood and Lymphatic System, Hepatobiliary System, and Respiratory System.

Population-Specific Safety Notes

Safety restrictions are explicitly stated for certain patient groups. Methotrexate is contraindicated in pregnancy due to established risk of teratogenicity (fetal malformation). Caution or contraindication is also advised in patients with pre-existing severe renal or hepatic impairment, as clearance may be reduced, increasing the risk of systemic toxicity. The risk of specific toxicities, notably hepatic fibrosis, is recognized to be associated with cumulative dose and long-term exposure.

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Overdose and Emergency Response

Overdose: When to Seek Help

Overdosage of Methotrexate is a documented medical emergency that may result in severe, potentially fatal outcomes. Manifestations often include signs of severe systemic toxicity, primarily myelosuppression (such as leukopenia and pancytopenia) and severe gastrointestinal toxicity (including stomatitis, mucositis, and ulceration). Overdosage, particularly due to mistaken daily use of the intended weekly dose, has been associated with fatal toxicity. Specific severe outcomes listed in regulatory documents include septic shock, acute renal failure, and, in cases of intrathecal exposure, acute toxic encephalopathy.

Immediate medical evaluation is required upon any suspicion of overdosage or dosing error. The primary action mandated by regulatory authorities is the administration of the antidote leucovorin (or levoleucovorin) as soon as possible to diminish toxicity and counteract the effects. For patients with delayed drug clearance due to impaired renal function, the specialized antidote glucarpidase may be indicated. Close monitoring of serum Methotrexate and creatinine concentrations is mandated to guide antidote therapy and manage the risk of organ damage.

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Therapeutic Uses of Трексан

Трексан is relevant across three major therapeutic domains, supporting patients with conditions characterized by severe, sustained symptoms. This medication is commonly used to manage severe, active Rheumatoid Arthritis and Polyarticular Juvenile Idiopathic Arthritis (PJIA), as well as severe, disabling psoriasis, and specific neoplastic diseases like certain leukemias and lymphomas.

In rheumatologic use, Трексан is relevant for easing symptom clusters related to inflammatory or irritative states, such as chronic joint pain, swelling, and debilitating morning stiffness. This supportive management may assist with maintaining functional stability and contributes to easing the overall symptom load. For dermatological conditions, it helps manage symptoms that may become intense or disruptive, like extensive scaling and thick plaque formation.

“The therapeutic support provided by this medicine assists patients with coping more steadily with symptom fluctuations in chronic inflammatory disease.”

In cases of severe, chronic inflammatory or malignant conditions, Трексан is applied when additional symptomatic support is needed. It plays a role in managing systemic disease and may be part of symptomatic management protocols to support the patient during difficult episodes.


Quick Fact: Support for Symptom Management

Symptom Domain Key Use Context Primary Benefit
Joint & Tissue Distress Chronic, active autoimmune inflammation (RA, PJIA) Supports a sense of stability; eases overall symptom load.
Skin Plaque Formation Severe, refractory psoriasis Assists with coping more steadily with visible manifestations.
Cell Proliferation Effects Systemic malignancy protocols Plays a role in managing systemic disease.

Regulatory References

  1. Official NIH/DailyMed Prescribing Information
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Eligibility and Restrictions for Use

Official Eligibility and Contraindication Profile (Methotrexate)

Regulatory agencies strictly define who can and cannot use Trexan, primarily due to risks related to reproductive health and vital organ function. The medicine is contraindicated (must not be used) in several key populations.

Contraindicated Populations
Pregnancy (for non-cancer conditions, due to embryo-fetal toxicity)
Breastfeeding women (not recommended due to risk to the infant)
Patients with Severe Renal Impairment or Significant Hepatic Impairment (including alcoholic liver disease)
Patients with Pre-existing Blood Dyscrasias (e.g., severe leukopenia, thrombocytopenia) or Overt Immunodeficiency Syndromes

Age-Related and Conditional Use: The medicine's use is established in adults and for specific conditions in pediatric patients (typically ge 2 years old). Individuals of reproductive potential (both male and female) must use effective contraception during and for a specified period after treatment. Patients with conditions like pleural effusions or ascites require special caution and close monitoring, as these can severely restrict the body's ability to clear the drug, increasing toxicity risk.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Methotrexate's interaction profile is defined by two primary risks: interference with its elimination and additive toxicity with co-administered substances. All interaction patterns are strictly documented in regulatory information.

Documented Interaction Restrictions

Classification Interacting Entity Official Interaction Description
Contraindicated Acitretin Prohibited due to the risk of severe, additive hepatotoxicity.
Restricted Live Virus Vaccines Use is restricted due to the potential for decreased vaccine effectiveness and risk of disseminated infection.
Additive Toxicity Alcohol (Ethanol) Consumption may increase the risk of liver damage due to documented additive hepatotoxicity.

Exposure-Modifying Interactions

Co-administration with several medicinal products may increase and prolong serum Methotrexate (MTX) levels due to competitive inhibition of its renal clearance. This category includes Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), Penicillins, Probenecid, and Proton Pump Inhibitors (PPIs). Oral Antibiotics like Sulfonamides may also increase the risk of MTX toxicity. Furthermore, Folic Acid or Folinic Acid may reduce the effectiveness of Methotrexate in treating neoplastic diseases.

Population and Procedure Cautions

Regulatory documentation notes that the severity of drug interactions is greatest in patients with renal impairment due to delayed drug elimination. Concomitant Radiation Therapy may increase the risk of soft tissue necrosis. Additionally, official documents report that Caffeine may reduce the effectiveness of Methotrexate in arthritis treatment.

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Mechanism of Action

Трексан is a folate antagonist that operates primarily by competitively inhibiting the enzyme dihydrofolate reductase (DHFR) . This action prevents the reduction of dihydrofolate to tetrahydrofolate, a necessary precursor for the de novo synthesis of purine nucleotides and thymidylate. The resulting intracellular depletion of these precursors leads to the inhibition of DNA synthesis and cell division, especially in rapidly proliferating immune and inflammatory cells.

Mechanistically, the compound modulates multiple inflammatory pathways. This includes the suppression of lymphocyte proliferation and the modification of cytokine release profiles. Additionally, the inhibition of aminoimidazole-carboxamide-ribonucleotide transformylase (AICAR transformylase) by Трексан may increase the extracellular concentration of adenosine. This increase leads to anti-inflammatory effects mediated by adenosine binding to its A2 and A3 cell surface receptors. The overall physiological consequence is a reduction in inflammatory cell recruitment and activation.

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Dosage and Administration Information

How to Use Трексан (Methotrexate)

Established instructions for using Methotrexate are defined by clinical guidelines detailing administration route, frequency, and dosing specific to the indication. The medicine is available as oral tablets or an injectable solution for injection for subcutaneous (SC), intramuscular (IM), or intravenous (IV) administration. The intrathecal (IT) route is reserved for specific neoplastic protocols.


Standard Dosing and Schedule

For non-oncology conditions, such as Rheumatoid Arthritis (RA) and Psoriasis, the medicine is administered once weekly to prevent fatal dosing errors. The typical adult starting dose for RA is 7.5 mg once weekly, with the dose generally not exceeding 20 mg weekly. The oral tablets must be swallowed whole and may be taken with or without food. An alternative regimen allows for the total weekly dose to be divided into three sequential doses given 12 hours apart on the designated day.


Administration Requirements

High-dose intravenous use and the intrathecal route require the use of a preservative-free formulation and are often administered with mandatory supportive therapy, such as Leucovorin rescue (folinic acid). Dosing is typically calculated by Body Surface Area (BSA) for pediatric patients with Juvenile Idiopathic Arthritis. For older adults and patients with renal impairment, dose reduction or discontinuation is mandated based on assessed kidney function, reflecting the drug's physiological clearance requirements.

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Recent Clinical Evidence

Research evidence / Overview of Studies for Трексан (Methotrexate)

Evidence for Use in Severe, Active Rheumatoid Arthritis (RA)

The research for severe, active Rheumatoid Arthritis (RA) includes numerous short-term, controlled clinical trials as well as long-term studies that monitor patient cohorts over many years. Studies monitored multiple outcomes related to physical discomfort, systemic imbalance, and daily functioning or activity level. Studies tracked and reported measurements of joint swelling and tenderness using standardized disease activity scores across patient groups. Long-term observational studies were evaluated in patient cohorts, tracking the continuation of the medication and changes observed in structural joint health assessed using X-ray measurements.

Evidence for Use in Severe, Disabling Psoriasis

The research for severe, disabling psoriasis was evaluated in adults whose conditions were not adequately addressed by other treatments. The evidence primarily comes from controlled trials that compared the medication against a placebo or other conventional treatments. Research examined outcomes linked to inflammatory states on the skin, focusing specifically on measured changes in the severity and extent of plaque formation. Studies reported measurements of change in plaque severity and the proportion of participants who reached specific thresholds of change in index scores over the short-term study period.

Evidence for Use in Polyarticular Juvenile Idiopathic Arthritis (PJIA)

The use of this medicine in children and young people with Polyarticular Juvenile Idiopathic Arthritis (PJIA) was studied for conditions marked by functional limitations. Research examined patient cohorts through short-term controlled trials. Studies report how symptoms were measured in the observed pediatric populations, specifically using response criteria designed for pediatric trials to track change in disease activity. Data for long-term outcomes, such as sustained disease control, remain insufficient and often depend on observational records.

What Remains Uncertain About the Evidence Base

The evidence highlights what is known, but also where scientific certainty remains low. The factors that predict whether an individual patient was observed in trials to achieve the study endpoints are complex, and studies have provided limited insight into which subgroups show the clearest change. Furthermore, there is limited information for long-term outcomes related to daily functioning for all populations, and data for older adults with significant co-existing conditions remain insufficient to draw broad conclusions.

Key Studies & References

  1. Individualized high dose methotrexate for the treatment of malignancies in children and adolescents with a significant risk for... (Protocol detailing high-dose use and toxicity in ALL)
  2. High dose METHOTREXATE - [High grade NHL CNS prophylaxis] - NSSG Chemotherapy Protocol (Example of multi-drug high-dose regimen protocols in oncology)
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Frequently Asked Questions (FAQ)

Common questions about Трексан (FAQ)

Q: Why do I need to take folic acid while I am taking Трексан?

A: Folic acid is often prescribed for patients taking Methotrexate to help reduce the occurrence of common side effects, such as mouth sores (stomatitis) and gastrointestinal upset. Official guidance indicates this supplementation is used to mitigate potential toxicity without compromising the medicine's ability to treat inflammatory conditions.

Q: Are the side effects of low-dose Трексан as serious as those from chemotherapy?

A: According to official patient information, low-dose Methotrexate prescribed for conditions like arthritis or psoriasis is generally not classified as conventional chemotherapy. However, the medicine is associated with a documented risk of serious toxicities to vital organs, including the liver, lungs, and bone marrow, even at lower doses. This necessitates consistent medical monitoring, such as blood testing, to ensure safety during treatment.

Q: How long after stopping Трексан is it safe to try to conceive a child (for women)?

A: Due to the established risk of birth defects, regulatory information states that women of childbearing potential must use effective contraception while taking Methotrexate. Official regulatory guidance advises waiting for at least one full ovulatory cycle after stopping the medicine before attempting to conceive. Some medical organizations recommend a slightly longer period of three to six months to ensure the drug has fully cleared the body.

Q: Is it safe to get the flu shot or COVID-19 vaccine while on Трексан?

A: Regulatory and patient safety guidelines generally consider inactivated (non-live) vaccines, such as the seasonal flu shot and most COVID-19 vaccines, safe for individuals taking Methotrexate. However, official information typically advises restricting the use of live virus vaccines due to the drug's effect on the immune system.

Q: What are the signs of Treксан toxicity that I should watch out for?

A: Official patient safety information advises contacting a doctor immediately if a patient develops a fever, persistent sore throat, unexplained bruising or bleeding, or signs of liver issues such as the yellowing of the skin or eyes (jaundice). Difficulty breathing or a new, persistent cough may also indicate serious complications, and official information advises they be reported right away.

Q: Can taking Treксан cause a headache or dizziness?

A: Regulatory documents list both headache and fatigue as common adverse reactions experienced by patients. Dizziness and a feeling of drowsiness are also reported side effects.

Q: Are there any specific vitamins or supplements I should avoid while on Treксан?

A: Official regulatory warnings emphasize the potential for interactions that could affect how the medicine works or increase the risk of toxicity. Official regulatory warnings advise that all new supplements, vitamins, or over-the-counter products be discussed with a doctor before starting them. This is a general caution to manage the risk of unforeseen interaction patterns.

Q: Is it true that Treксан can cause a rash or skin blisters?

A: Official information confirms that a rash is a common adverse reaction. Although rare, severe skin reactions, including those that cause blistering (such as Stevens-Johnson syndrome), have been reported in regulatory documents. The official documents state that these severe reactions warrant immediate medical attention.

Q: What is the risk of developing lung complications (pulmonary toxicity) with Трексан?

A: Pulmonary (lung) toxicity, such as pneumonitis or pulmonary fibrosis, is classified as a serious adverse reaction in regulatory safety documents. Studies and clinical data indicate that this complication occurs in rare cases for patients receiving low-dose treatment for inflammatory conditions. This potential risk is one reason why close medical monitoring is required during therapy.

Q: How can I reduce the chance of stomach upset when taking Treксан?

A: According to official patient guidance, simple strategies may help to mitigate common gastrointestinal side effects like nausea and stomach pain. These include ensuring the use of a prescribed Folic Acid supplement, taking the dose in the evening, or using an anti-sickness medication if prescribed by the doctor.

Q: Is it true that taking Трексан requires special handling of bodily waste or fluids?

A: For patients taking the typical low dose of Methotrexate at home, special measures for handling bodily waste or fluids are generally not required by regulatory standards. Waste items, such as used materials or cleaning cloths, should be bagged and disposed of in household rubbish. However, official safety guidelines recommend that pregnant or breastfeeding individuals wear disposable gloves if they must handle contaminated waste.

Q: What happens if I forget to take my weekly dose of Трексан?

A: Official safety information advises immediately contacting your doctor or pharmacist for specific guidance if a dose is missed. Official patient information cautions against taking a double dose to compensate for the missed one.

Q: What kind of blood tests are needed to monitor safety while taking Трексан?

A: Regulatory documents require that patients undergo specific blood tests to monitor for potential toxic effects on major organs. These tests include a Complete Blood Count (CBC), Liver Function Tests (LFTs), and Renal Function Tests to check kidney function. These laboratory tests are essential for safely continuing treatment.

Q: How often will I need to get blood work done while on Трексан?

A: The frequency of required blood work is determined by the prescribing doctor and is often adjusted over the course of treatment. Official guidelines generally recommend monitoring blood counts at least monthly initially. Liver and kidney function tests are typically repeated every one to three months once a stable maintenance dose is achieved.

Q: Should I avoid people who are sick or have a cold while taking this medicine?

A: Since Methotrexate is an immunosuppressant, regulatory guidance suggests taking precautions to reduce the risk of infection. Official information recommends that patients try to avoid close contact with people who have active infections, such as a cold or the flu. Official information also advises contacting a doctor immediately if a patient develops any signs of infection.

Q: Does taking Трексан affect a man's ability to father a child?

A: Official patient safety information states that Methotrexate can potentially affect male fertility by causing a reversible reduction in sperm count. Due to this potential effect, official information advises that male patients use effective contraception during treatment and for a minimum of three months after stopping the therapy before attempting to father a child.

Q: What should I do if I get mouth sores or ulcers after starting Трексан?

A: Mouth sores or ulcers (stomatitis) are listed as a very common side effect in regulatory documents. Official guidance advises contacting a doctor or care team immediately for guidance if these develop. Developing stomatitis may be a sign of toxicity, and a healthcare professional may instruct you to temporarily stop or adjust your medication dose.

Q: Can Treксан make my skin more sensitive to the sun?

A: Official product information indicates that Methotrexate can cause photosensitivity, which makes the skin more sensitive to damage from sunlight. Official product information advises that intense sun exposure and tanning beds be avoided, and that adequate sun protection be used when outdoors.

Q: Is there a risk of mixing up Treксан tablets with other small yellow pills like folic acid?

A: Due to the critical once-weekly schedule, official guidance emphasizes the importance of verifying the dose and medication before taking it. Methotrexate tablets may be a similar color to some other commonly prescribed pills (such as folic acid). Official guidance states that patients must carefully check the label and dosage to prevent a potentially serious medication error.

Q: How quickly does the body eliminate Трексан after I take the dose?

A: According to pharmacological studies, the half-life of Methotrexate in the blood is relatively short, typically between 8 and 15 hours. However, the drug is known to be retained in some organs, such as the liver, for a much longer period. This longer retention time is relevant to long-term safety monitoring.

Q: Should I stop taking Treксан if I start feeling better?

A: Official patient information states that therapy with Methotrexate must only be discontinued or adjusted with the express guidance of the prescriber. Treatment with this medicine must always be managed by a doctor.

Q: Do I need to worry about being around a pregnant woman while taking Трексан?

A: When taking the typical low dose of Methotrexate, it is generally considered safe to be around other people, including pregnant women. The drug’s primary reproductive risk associated with the drug is specifically to the fetus if the patient taking the medicine is pregnant.

Q: If I am taking Treксан for psoriasis, will exposure to the sun make my skin worse?

A: Official patient education materials specifically state that for those with psoriasis, exposure to sunlight or UV rays while taking Methotrexate may cause the skin condition to worsen. This is in addition to the general risk of photosensitivity that the medication carries.

Q: Does Treксан interact with herbal remedies or products?

A: Specific herbal remedies are typically not itemized in official regulatory interaction tables. However, regulatory warnings advise that all herbal remedies and natural products be discussed with a doctor or pharmacist before use, due to the risk of potential interactions that could change the drug's effect or toxicity.

Q: Does taking Treксан affect my ability to drive or operate machinery?

A: Official safety information explicitly states that Methotrexate may cause side effects such as dizziness, drowsiness, or fatigue. If a patient experiences these symptoms, their ability to safely drive or operate heavy machinery may be impaired. Official safety information recommends caution be exercised until the individual knows how the medicine affects them.

Q: What happens if I accidentally take my dose of Трексан two days in a row?

A: Due to the severe risks associated with daily dosing, official patient guides state that if you accidentally take your dose on consecutive days or believe you have taken too much, official patient guides advise that emergency services, a hospital emergency room, or a poison control center be contacted immediately for urgent advice. This is treated as a potential overdose event.

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How should Трексан be stored and disposed of?

The storage and disposal instructions for Трексан (Methotrexate) are strictly governed by regulatory labeling, as it is classified as a hazardous drug.

Storage Conditions

Methotrexate must be stored at a Controlled Room Temperature of 20 C to 25 C (68 F to 77 F). The product must be kept in its original, tightly closed container and protected from light. It is explicitly required to not freeze the injection solution.

Handling and Child Safety

The medicine must be stored out of the sight and reach of children.

Disposal Instructions

As a cytotoxic and hazardous medicinal product, unused or expired Methotrexate must not be disposed of in household trash or poured down the sink or toilet.

Disposal of all waste material and unused product must follow specific local, regional, and national regulations for cytotoxic/hazardous waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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