Methotrexatedosage

Instruct patients and caregivers to take the recommended dosage as directed, because medication errors have led to deaths. Verify pregnancy status in females of reproductive potential before starting TREXALL.

ALL: The recommended dosage is 20 mg/m 2 orally once weekly as a part of a combination chemotherapy maintenance regimen.

Mycosis fungoides: The recommended dosage is 25 mg to 75 mg orally once weekly as monotherapy; 10 mg/m 2 orally twice weekly as part of combination chemotherapy. Relapsed or refractory non-Hodgkin lymphoma: The recommended dosage is 2.5 mg orally two to four times per week as part of metronomic combination chemotherapy.

Rheumatoid Arthritis: The recommended starting dosage is 7.5 mg orally once weekly; adjust dose to achieve an optimal response pJIA: The recommended starting dosage is 10 mg/m 2 orally once weekly; adjust dose to achieve an optimal response Psoriasis: The recommended dosage is 10 to 25 mg orally once weekly until adequate response is achieved.

2.1 Important

Dosage and Safety Information Verify pregnancy status in females of reproductive potential before starting TREXALL. Instruct patients and caregivers to take the recommended dosage as directed, because medication errors have led to deaths. When switching the dosing regimen from oral administration to intravenous, intramuscular, or subcutaneous administration, an alternative dosing regimen may be necessary. Do not administer to patients who are unable to swallow a tablet. TREXALL is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

2.2 Recommended

Dosage for Neoplastic Diseases Acute Lymphoblastic Leukemia The recommended starting dosage of TREXALL is 20 mg/m 2 orally once weekly, as part of a combination chemotherapy maintenance regimen. After initiating TREXALL, periodically monitor absolute neutrophil count (ANC) and platelet count and adjust the dose to maintain ANC at a desirable level and for excessive myelosuppression. Mycosis Fungoides The recommended dosage of TREXALL is 25 mg to 75 mg orally once weekly when administered as a single agent or 10 mg/m 2 orally twice weekly as part of a combination chemotherapy regimen. Relapsed or Refractory Non-Hodgkin Lymphomas The recommended dosage of methotrexate tablets is 2.5 mg orally 2 to 4 times per week (maximum 10 mg per week) as part of a metronomic combination chemotherapy regimen.

2.3 Recommended

Dosage for Rheumatoid Arthritis The recommended starting dosage of TREXALL is 7.5 mg orally once weekly with escalation to achieve optimal response. Dosages of more than 20 mg once weekly result in an increased risk of serious adverse reactions, including myelosuppression. When responses are observed, the majority occurred between 3 and 6 weeks from initiation of treatment; however, responses have occurred up to 12 weeks after treatment initiation. Administer folic acid or folinic acid to reduce the risk of TREXALL adverse reactions.

2.4 Recommended

Dosage for Polyarticular Juvenile Idiopathic Arthritis The recommended starting dosage of TREXALL is 10 mg/m 2 orally once weekly with escalation to achieve optimal response. Dosages of more than 30 mg/m 2 once weekly result in an increased risk of serious adverse reactions, including myelosuppression. When responses are observed, the majority occurred between 3 and 6 weeks from initiation of treatment; however, responses have occurred up to 12 weeks after treatment initiation. Administer folic acid or folinic acid to reduce the risk of TREXALL adverse reactions.

2.5 Recommended

Dosage for Psoriasis The recommended dosage of TREXALL is 10 mg to 25 mg orally once weekly until an adequate response is achieved. Adjust the dose gradually to achieve optimal clinical response; do not exceed a dose of 30 mg per week. Once optimal clinical response has been achieved, reduce the dosage to the lowest possible dosing regimen. Administer folic acid or folinic acid supplementation to reduce the risk of TREXALL adverse reactions.

2.6 Dosage Modifications for

Adverse Reactions Discontinue TREXALL for: Anaphylaxis or other severe hypersensitivity reactions Lymphoproliferative disease Withhold, dose reduce or discontinue TREXALL as appropriate for: Myelosuppression Withhold or discontinue TREXALL as appropriate for: Severe gastrointestinal toxicity Hepatotoxicity Pulmonary toxicity Severe dermatologic reactions Severe renal toxicity Serious infections Neurotoxicity