Methotrexate (Page 2 of 8)

2.6 Dosage Modifications for Adverse Reactions

Discontinue methotrexate tablets for:

  • Anaphylaxis or other severe hypersensitivity reactions [see Warnings and Precautions (5.2)]
  • Lymphoproliferative disease [see Warnings and Precautions (5.13)]

Withhold, dose reduce or discontinue methotrexate tablets as appropriate for:

  • Myelosuppression [see Warnings and Precautions (5.3)]

Withhold or discontinue methotrexate tablets as appropriate for:

  • Severe gastrointestinal toxicity [see Warnings and Precautions (5.4)]
  • Hepatotoxicity [see Warnings and Precautions (5.5)]
  • Pulmonary toxicity [see Warnings and Precautions (5.6)]
  • Severe dermatologic reactions [see Warnings and Precautions (5.7)]
  • Severe renal toxicity [see Warnings and Precautions (5.8)]
  • Serious infections [see Warnings and Precautions (5.11)]
  • Neurotoxicity [see Warnings and Precautions (5.12)]

3 DOSAGE FORMS AND STRENGTHS

Tablets: Yellow, oval-shaped, scored tablet debossed with stylized b/572 on one side.

4 CONTRAINDICATIONS

Methotrexate tablets are contraindicated in:

  • Pregnant women receiving methotrexate tablets for treatment of non-neoplastic diseases [see Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.3)].
  • Patients with a history of a severe hypersensitivity reactions, including anaphylaxis, to methotrexate [see Warnings and Precautions (5.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Embryo-Fetal Toxicity

Based on published reports and its mechanism of action, methotrexate can cause fetal harm, including fetal death, when administered to a pregnant woman. Methotrexate is contraindicated for use in pregnant women receiving methotrexate for the treatment of non-malignant diseases. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with methotrexate and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during methotrexate treatment and for 3 months after the final dose [see Contraindications (4), Use in Specific Populations (8.1, 8.3)].

5.2 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, can occur with methotrexate [see Contraindications (4), Adverse Reactions (6.1)].

If anaphylaxis or other serious hypersensitivity reaction occurs, immediately and permanently discontinue methotrexate [see Dosage and Administration (2.6)].

5.3 Myelosuppression

Methotrexate suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia [see Adverse Reactions (6.1)].

Obtain blood counts at baseline, periodically during treatment, and as clinically indicated. Monitor patients for clinical complications of myelosuppression. Withhold, dose reduce, or discontinue methotrexate taking into account the importance of methotrexate treatment in the context of the severity of the disease being treated, the severity of the adverse drug reaction, and availability of alternative therapy [see Dosage and Administration (2.6)].

5.4 Gastrointestinal Toxicity

Diarrhea, vomiting, nausea, and stomatitis occurred in up to 10% of patients receiving methotrexate for treatment of non-neoplastic diseases. Hemorrhagic enteritis and fatal intestinal perforation have been reported [see Adverse Reactions (6.1, 6.2)]. Patients with peptic ulcer disease or ulcerative colitis are at a greater risk of developing severe gastrointestinal adverse reactions [see Drug Interactions (7.1)].

Withhold or discontinue methotrexate for severe gastrointestinal toxicity taking into account the importance of methotrexate treatment in the context of the severity of the disease being treated, the severity of the adverse drug reaction, and availability of alternative therapy [see Dosage and Administration (2.6)].

5.5 Hepatotoxicity

Methotrexate can cause severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure [see Adverse Reactions (6.1)]. The safety of methotrexate in patients with hepatic disease is unknown.

The risk of hepatotoxicity is increased with heavy alcohol consumption. In patients with psoriasis, fibrosis or cirrhosis may occur in the absence of symptoms or abnormal liver tests; the risk of hepatotoxicity appears to increase with total cumulative dose and generally occurs after receipt of a total cumulative dose of 1.5 g or more.

Monitor liver tests at baseline, periodically during treatment and as clinically indicated. Withhold or discontinue methotrexate taking into account the importance of methotrexate treatment in the context of the severity of the disease being treated, the severity of the adverse drug reaction, and availability of alternative therapy [see Dosage and Administration (2.6)].

5.6 Pulmonary Toxicity

Pulmonary toxicity, including acute or chronic interstitial pneumonitis and irreversible or fatal cases, can occur with methotrexate [see Adverse Reactions (6.1, 6.2)].

Monitor patients for pulmonary toxicity and withhold or discontinue methotrexate taking into account the importance of methotrexate treatment in the context of the severity of the disease being treated, the severity of the adverse drug reaction, and availability of alternative therapy [see Dosage and Administration (2.6)].

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