Select therapeutic use:

Arthritis/rheumatic disorders:

Indications for Methotrexate Tablets:

Treatment of adults with rheumatoid arthritis (RA) or children with polyarticular juvenile idiopathic arthritis (pJIA).

Adult:

Initially 7.5mg as a single dose once weekly, or a course of three 2.5mg doses at 12-hr intervals once weekly; max 20mg/week. Give with folic or folinic acid to reduce adverse reactions.

Children:

<2yrs: not established. ≥2yrs: initially 10mg/m2 once weekly; adjust dose gradually to achieve optimal response; max 20mg/m2 per week. Give with folic or folinic acid to reduce adverse reactions.

Contraindications:

Pregnancy in patients with non-neoplastic diseases.

Boxed Warning:

Embryo-fetal toxicity. Hypersensitivity reactions. Severe adverse reactions.

Warnings/Precautions:

Be fully familiar with this drug's toxicity before use. Obtain baseline and monitor CBCs for myelosuppression, and hepatic, renal and pulmonary function; reduce dose, interrupt, or discontinue if needed. Monitor for neurotoxicity, dermatologic toxicity. Avoid excessive sun exposure. Increased risk of serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor and treat promptly. Peptic ulcer disease. Ulcerative colitis. Increased risk of hepatotoxicity with alcoholism or receiving total cumulative dose (≥1.5g). Update immunizations according to current guidelines prior to initiation. Permanently discontinue if anaphylaxis, other serious hypersensitivity or severe dermatologic reactions occur. Evacuate significant third-space accumulations prior to administration. Renal or hepatic impairment. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Pharmacologic Class:

DMARD (folic acid antagonist).

Interactions:

Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, proton pump inhibitors, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, neomycin. May be antagonized by folic acid. Increased risk of leukoencephalopathy with prior cranial radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).

Adverse Reactions:

Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness; myelosuppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, dermatologic reactions, secondary malignancies, tumor lysis syndrome, infertility.

Note:

Formerly known under the brand name Rheumatrex.

How Supplied:

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Leukemias, lymphomas, and other hematologic cancers:

Indications for Methotrexate Tablets:

Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. Treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen. Treatment of adults with relapsed or refractory non-Hodgkin lymphomas (NHL) as part of a metronomic combination chemotherapy regimen.

Adult:

ALL: initially 20mg/m2 once weekly; adjust subsequent dosing based on ANC and platelet count. Mycosis fungoides (as single agent): 25–75mg once weekly; (as part of combination regimen): 10mg/m2 twice weekly. Relapsed/refractory NHL: 2.5mg 2–4 times weekly; max 10mg/week.

Children:

ALL: initially 20mg/m2 once weekly; adjust subsequent dosing based on ANC and platelet count.

Contraindications:

Pregnancy in patients with non-neoplastic diseases.

Boxed Warning:

Embryo-fetal toxicity. Hypersensitivity reactions. Severe adverse reactions.

Warnings/Precautions:

Be fully familiar with this drug's toxicity before use. Obtain baseline and monitor CBCs for myelosuppression, and hepatic, renal and pulmonary function; reduce dose, interrupt, or discontinue if needed. Monitor for neurotoxicity, dermatologic toxicity. Avoid excessive sun exposure. Increased risk of serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor and treat promptly. Peptic ulcer disease. Ulcerative colitis. Increased risk of hepatotoxicity with alcoholism or receiving total cumulative dose (≥1.5g). Update immunizations according to current guidelines prior to initiation. Permanently discontinue if anaphylaxis, other serious hypersensitivity or severe dermatologic reactions occur. Evacuate significant third-space accumulations prior to administration. Renal or hepatic impairment. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Pharmacologic Class:

DMARD (folic acid antagonist).

Interactions:

Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, proton pump inhibitors, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, neomycin. May be antagonized by folic acid. Increased risk of leukoencephalopathy with prior cranial radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).

Adverse Reactions:

Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness; myelosuppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, dermatologic reactions, secondary malignancies, tumor lysis syndrome, infertility.

Note:

Formerly known under the brand name Rheumatrex.

How Supplied:

Contact supplier

Psoriasis:

Indications for Methotrexate Tablets:

Treatment of adults with severe psoriasis.

Adult:

Initially 10–25mg once weekly until adequate response; adjust gradually to achieve optimal response; max 30mg/week. Give with folic or folinic acid to reduce adverse reactions.

Children:

Not established.

Contraindications:

Pregnancy in patients with non-neoplastic diseases.

Boxed Warning:

Embryo-fetal toxicity. Hypersensitivity reactions. Severe adverse reactions.

Warnings/Precautions:

Be fully familiar with this drug's toxicity before use. Obtain baseline and monitor CBCs for myelosuppression, and hepatic, renal and pulmonary function; reduce dose, interrupt, or discontinue if needed. Monitor for neurotoxicity, dermatologic toxicity. Avoid excessive sun exposure. Increased risk of serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor and treat promptly. Peptic ulcer disease. Ulcerative colitis. Increased risk of hepatotoxicity with alcoholism or receiving total cumulative dose (≥1.5g). Update immunizations according to current guidelines prior to initiation. Permanently discontinue if anaphylaxis, other serious hypersensitivity or severe dermatologic reactions occur. Evacuate significant third-space accumulations prior to administration. Renal or hepatic impairment. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Pharmacologic Class:

DMARD (folic acid antagonist).

Interactions:

Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, proton pump inhibitors, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, neomycin. May be antagonized by folic acid. Increased risk of leukoencephalopathy with prior cranial radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).

Adverse Reactions:

Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness; myelosuppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, dermatologic reactions, secondary malignancies, tumor lysis syndrome, infertility.

Note:

Formerly known under the brand name Rheumatrex.

How Supplied:

Contact supplier