Folitrax (Methotrexate)
Also sold as: Folitrax, Biotrexate, Methofar, Imutrex, Neotrexate
Pregnancy
Cat X
Lactation
Avoid
Schedule
H
Forms
Tablet 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 25mg +1
Indications
- Rheumatoid arthritis (RA) — first-line DMARD
- Psoriasis (moderate-severe) — systemic
- Psoriatic arthritis
- Juvenile idiopathic arthritis (JIA)
- Cancers: ALL, AML, NHL, osteosarcoma (oncology — high doses)
- Ectopic pregnancy (medical management)
- Crohn's disease / Ulcerative colitis (adjunct)
Adult Dosing
Rheumatoid arthritis
7.5-15 mg PO once weekly; increase to 20-25 mg/week if needed
ONCE WEEKLY ONLY — not daily (daily is an overdose error, potentially fatal). Always co-prescribe folic acid 5 mg once weekly (on different day).
Psoriasis
10-25 mg PO/SC/IM once weekly
Start 2.5-5 mg test dose; increase by 2.5 mg/week
Ectopic pregnancy (medical)
50 mg/m² IM single dose (with β-hCG monitoring)
Hospital protocol — for stable ectopic without cardiac activity
Pediatric Dosing
SPECIALIST USE ONLY in all paediatric indications.
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| CrCl > 50 mL/min | No adjustment |
| CrCl 10-50 mL/min | Reduce dose by 50%; monitor closely |
| CrCl < 10 mL/min | AVOID — severe accumulation and toxicity |
Hepatic Adjustment
AVOID in significant hepatic disease (hepatotoxicity, cirrhosis risk). Avoid alcohol completely.
Pregnancy & Lactation
Pregnancy: Category X
CONTRAINDICATED — potent abortifacient and teratogen. Causes embryotoxicity, fetal death, skull/limb abnormalities. Stop methotrexate ≥3 months before conception (male and female). Mandatory folic acid supplementation.
Lactation: Avoid
CONTRAINDICATED in breastfeeding — accumulates in breast milk, neonatal toxicity.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| NSAIDs (ibuprofen, diclofenac, naproxen) | Reduce MTX renal clearance — MTX toxicity at even low doses. Avoid or use with extreme caution. | Major |
| Co-trimoxazole / Trimethoprim | Additive folate antagonism — severe pancytopenia | Major |
| Proton pump inhibitors (especially omeprazole) | Reduce MTX renal clearance — hold PPIs before high-dose MTX | Major |
| Penicillins (amoxicillin) | Reduce MTX clearance — toxicity | Major |
| Leflunomide | Additive hepatotoxicity and myelosuppression | Major |
| Live vaccines | CONTRAINDICATED — immunosuppression | Major |
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Side Effects
Common
- Nausea / vomiting (especially day of/after dose)
- Fatigue
- Stomatitis / mouth ulcers
- Alopecia
- Elevated LFTs
Serious / Discontinue If
- Bone marrow suppression (pancytopenia — can be fatal)
- Hepatotoxicity / cirrhosis (cumulative dose-related)
- Pulmonary toxicity — methotrexate pneumonitis (dry cough, dyspnoea — stop immediately)
- Severe mucositis
- Renal toxicity (high-dose)
- Teratogenicity / embryotoxicity
Contraindications
- Pregnancy / breastfeeding
- Significant hepatic impairment or active liver disease
- Alcoholism
- Immunodeficiency states
- Active severe infection
- CrCl < 10 mL/min
- Blood dyscrasias
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Folitrax 7.5mg | IPCA | 10 tab ₹42 |
| Biotrexate 10mg | Biochem | 10 tab ₹52 |
| Imutrex 10mg | Alkem | 10 tab ₹48 |
| Neotrexate 2.5mg | Lupin | 10 tab ₹28 |
Monitoring Required
- CBC with differential (monthly for first 6 months, then every 3 months)
- LFTs (monthly × 6 months, then 3-monthly)
- Serum creatinine / eGFR (3-6 monthly)
- Chest X-ray if new respiratory symptoms (pneumonitis)
- Liver biopsy if cumulative dose > 1.5g (some guidelines)
Patient Counseling Points
- ⚠️ ONCE WEEKLY ONLY — not daily. Prescribe clearly as "weekly on [day]". Daily dosing causes fatal bone marrow suppression.
- Take folic acid 5 mg on a DIFFERENT day each week (e.g., MTX on Monday, folate on Thursday)
- STRICTLY avoid alcohol — liver damage risk
- DO NOT get pregnant while on MTX and for 3 months after stopping (both partners)
- Report immediately: mouth ulcers, fever, breathlessness, unusual bruising
- Avoid live vaccines (flu, typhoid oral, yellow fever)
- Inform all doctors/dentists about methotrexate use
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Clinically reviewed by: Dr. Suresh Pillai, MS (Orthopaedics), Pain Specialist
Last reviewed: 2026-04-01
References
- BNF — Methotrexate
- ACR RA Guidelines 2021
- EULAR RA Guidelines 2022
- BSR Methotrexate Guidelines