Oral
Rheumatoid arthritis
Adult: In patient with severe case, unresponsive or intolerant to other therapy: Initially, 7.5-15 mg once weekly, may increase to 20-25 mg once weekly, according to patient response. Alternatively, 2.5 mg 12 hourly for 3 doses once weekly.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | Contraindicated. |
30-59 | Use 50% of the dose. |
Oral
Psoriasis
Adult: In patient with severe, uncontrolled case, unresponsive to other therapy: Test dose: 2.5-5 mg 1 week prior to therapy. Then, 7.5-15 mg once weekly, may increase to 20-25 mg weekly as necessary. Alternatively, 10-25 mg once weekly with test dose of 5-10 mg 1 week prior to therapy. Doses may be adjusted according to patient response and haematological toxicity.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | Contraindicated. |
30-59 | Use 50% of the dose. |
Oral
Juvenile idiopathic arthritis
Child: In patient with inadequate response to NSAIDs: ≥3 years Initially, 10-15 mg/m2 once weekly, adjusted gradually to achieve optimal response. In therapy-refractory cases, dose may be increased to 20 mg/m2 once weekly.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Oral
Acute lymphoblastic leukaemia
Adult: In combination with prednisolone for induction of remission: Initially, 3.3 mg/m2 daily for 4-6 weeks. Maintenance dose: 20-30 mg/m2 twice weekly.
Child: ≥3 years Same as adult dose.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Dose adjustments for methotrexate doses <100 mg/m2: Dose adjustments for methotrexate doses <100 mg/m2: Dose |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Oral
Burkitt's lymphoma
Adult: Stages 1-2: Recommended dose: 10-25 mg daily for 4-8 days. Stage 3: In combination with other antitumour agents: 0.625-2.5 mg/kg daily. In all stages, therapy usually consists of several courses interposed with 7-10 days rest periods.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Oral
Choriocarcinoma
Adult: 15-30 mg daily for a 5-day course, may repeat course for 3-5 times as necessary with at least 1 week rest periods between courses until toxicity subsides.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Oral
Trophoblastic neoplasm
Adult: 15-30 mg daily for a 5-day course, may repeat course for 3-5 times as necessary with at least 1 week rest periods between courses until toxicity subsides.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Oral
Mycosis fungoides
Adult: Recommended dose: 2.5-10 mg daily. Alternatively, 5-50 mg once weekly or 15-37.5 mg twice weekly, or 25 mg once weekly increased to 50 mg once weekly. Dose reduction or discontinuation is based on patient response and haematologic monitoring. Treatment regimen, protocols, and guidelines may vary among countries (refer to detailed product guideline).
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Intravenous
Breast cancer
Adult: In combination with cyclophosphamide and fluorouracil: 40 mg/m2 on days 1 and 8 every 4 weeks.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Reconstitution: Dilute with 5% dextrose or 0.9% NaCl solution to a concentration of ≤25 mg/mL or 50 mg/mL, may dilute further in 5% dextrose or 0.9% NaCl solution.
Intravenous
Osteosarcoma
Adult: In combination with other chemotherapeutic agents and with leucovorin rescue: Initially, 8-12 g/m2 infused over 4 hours. Treatment regimen, protocols, and guidelines n may vary among countries (refer to detailed product guideline).
Reconstitution: Dilute with 5% dextrose or 0.9% NaCl solution to a concentration of ≤25 mg/mL or 50 mg/mL, may dilute further in 5% dextrose or 0.9% NaCl solution.
Intramuscular
Choriocarcinoma
Adult: 15-30 mg daily for a 5-day course, may repeat course for 3-5 times as necessary with at least 1 week rest periods between courses until toxicity subsides.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Intramuscular
Trophoblastic neoplasm
Adult: 15-30 mg daily for a 5-day course, may repeat course for 3-5 times as necessary with at least 1 week rest periods between courses until toxicity subsides.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Intramuscular
Mycosis fungoides
Adult: 50 mg once weekly or 25 mg twice weekly, Alternatively, 5-50 mg once weekly or 15-37.5 mg twice weekly. Dose reduction or discontinuation is based on patient response and haematologic monitoring. Treatment regimen, protocols, and guidelines may vary among countries (refer to detailed product guideline).
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Parenteral
Acute lymphoblastic leukaemia
Adult: As maintenance: 20-30 mg/m2 via IM inj twice weekly or 2.5 mg/kg via IV inj every 14 days. If relapse occur, may repeat the initial induction regimen.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Reconstitution: IV: Dilute with 5% dextrose or 0.9% NaCl solution to a concentration of ≤25 mg/mL or 50 mg/mL, may dilute further in 5% dextrose or 0.9% NaCl solution.
Parenteral
Psoriasis
Adult: In patient with severe, uncontrolled case, unresponsive to conventional therapy: Test dose: 5-10 mg 1 week prior to therapy. Then, 10-25 mg weekly via IM or IV inj, adjusted according to patient response.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Reconstitution: IV: Dilute with 5% dextrose or 0.9% NaCl solution to a concentration of ≤25 mg/mL or 50 mg/mL, may dilute further in 5% dextrose or 0.9% NaCl solution.
Intrathecal
Meningeal leukaemia
Adult: 12 mg once weekly, repeated usually until CSF cell count returns to normal, at this point, 1 additional dose is recommended. For prophylactic use, refer to local protocols or guidelines.
Child: ≥3 years Same as adult dose.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<30 | For methotrexate dose <100 mg/m2: Contraindicated. |
30-59 | Dose adjustment for methotrexate dose <100 mg/m2: Use 50% of the dose. |
<60 | For methotrexate dose >100 mg/m2: Contraindicated. |
Approx 60 | Dose adjustment for methotrexate dose >100 mg/m2: Use 63% of the dose. |
Approx 80 | Dose adjustment for methotrexate dose >100 mg/m2: Use 75% of the dose. |
Reconstitution: Dilute with preservative-free 0.9% NaCl, lactated Ringer's or Elliot's B solution to a final volume of up to 12 mL or according to local protocol. Usual final concentration: 1 mg/mL up to approx 2-4 mg/mL.
Subcutaneous
Rheumatoid arthritis
Adult: Initially, 7.5 mg once weekly, adjust dose gradually according to individual response and tolerability.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<10 | Contraindicated. |
10-50 | Use 50% of the dose. |
Subcutaneous
Polyarticular juvenile idiopathic arthritis
Child: 2-16 years Initially, 10 mg/m2 once weekly, gradually adjust up to 20-30 mg/m2 once weekly. Max: 25 mg.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<10 | Contraindicated. |
10-50 | Use 50% of the dose. |
Subcutaneous
Psoriasis
Adult: In patient with severe, uncontrolled case, unresponsive to conventional therapy: Initially, 10-25 mg once weekly, gradually adjust dose according to patient response.
Elderly: Dose reduction may be necessary.
Renal impairment:
CrCl (ml/min) | Dosage Recommendation |
<10 | Contraindicated. |
10-50 | Use 50% of the dose. |