Clinical medicine profile
Methotrexate
Therapeutic agent (verify pharmacological class)
- Route
- See product SmPC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- Hypersensitivity to the active substance or excipients.
- Additional absolute contraindications are indication- and product-specific — consult SmPC.
Precautions
- Should be used in the treatment of neoplastic diseases in pregnancy only when the potential benefit outweighs the risk to the fetus
- pregnancy should be avoided if either partner is on the drug.
- 8, 10a, 20
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Orally or IM, 15-30 mg daily x 5/7. This is repeated for 3-5 times with rest periods of at least one week interjected between courses, until any manifesting toxic symptoms subside. Consult specialist literature for further information.
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- Gestational choriocarcinoma, chorioadenoma destruens
- hydatidiform mole
- acute lymphocytic leukemia
- meningeal leukemia
- breast cancer
- epidermoid cancers of the head and neck
- advanced mycosis fungoides
- lung cancer, particularly squamous cell and small cell types
- non-Hodgkin's lymphomas
- non-metastatic osteosarcoma
- severe, recalcitrant, disabling psoriasis
- severe, active, classical or definite rheumatoid arthritis unresponsive to conventional therapy.
Adverse effects
- Ulcerative stomatitis
- leukopenia
- anorexia
- vomiting
- abdominal distress
- asthenia
- chills and fever
- dizziness
- decreased resistance to infection
- gingivitis
- pharyngitis
- diarrhoea
- hematemesis
- GI ulceration and bleeding
Drug interactions
Open multi-drug checker ↗- Professional use: confirm indication, dose, duration, monitoring and patient counselling points against current Kenya STG / EML and the product SmPC.
- Document allergy status and key interactions.
Mechanism & disposition
It reversibly inhibits dihydro-folate reductase an enzyme that reduces folic acid to tetrahydrofolic acid.
Read complete mechanism
It reversibly inhibits dihydro-folate reductase an enzyme that reduces folic acid to tetrahydrofolic acid. Inhibition of tetrahy-drofolate formation limits the accessibility of one-carbon fragments necessary for synthesis of purines and the conversion of deoxyuridylate to thymidylate in the synthesis of DNA and cell reproduction
Product-specific
Product-specific
See product SmPC
are product-specific. Consider food effects, protein binding, hepatic CYP/UGT
when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Pregnancy, lactation & diet
Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist.
Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| Biotrexate | Biochem | inj 50ml 1's | Unavailable |
| METHOTREXATE | DAIMA BIASHARA / Wholesale Import | 2.5MG 30*S (TREXGLO) | KES 432.15Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.