Methotrexate

METHOTREXATE- methotrexate tablet
Major Pharmaceuticals

WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS

Methotrexate tablets can cause embryo-fetal toxicity, including fetal death. For non- neoplasticdiseases, methotrexate tablets are contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].
Methotrexate tablets are contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [Contraindications (4), Warnings and Precautions (5.2)].
Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue methotrexate tablets as appropriate [Warnings and Precautions (5.3, 5.4,5.5, 5.6, 5.7, 5.8)].

1 INDICATIONS AND USAGE

1.1 Neoplastic Diseases

Methotrexate tablets are indicated for the:

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 as part of a metronomic combination chemotherapy regimen

1.2 Rheumatoid Arthritis

Methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis.

1.3 Polyarticular Juvenile Idiopathic Arthritis

Methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).

1.4 Psoriasis

Methotrexate tablets are indicated for the treatment of adults with severe psoriasis.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Safety Information

Verify pregnancy status in females of reproductive potential before starting methotrexate tablets [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] .

Instruct patients and caregivers to take the recommended dosage as directed, because medication errors have led to deaths [see Warnings and Precautions (5.9)].

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.

Methotrexate tablets are 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 methotrexate tablets are 20 mg/m2 orally once weekly, as part of a combination chemotherapy maintenance regimen. After initiating methotrexate tablets, 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 methotrexate tablets are 25 to 75 mg orally once weekly when administered as a single agent or 10 mg/m2 orally twice weekly as part of a combination chemotherapy regimen.

Relapsed or Refractory Non-Hodgkin Lymphomas

The recommended dosage of methotrexate tablets are 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 methotrexate tablets are 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 methotrexate adverse reactions [see Warnings and Precautions ( 5.10 )] .

2.4 Recommended Dosage for Polyarticular Juvenile Idiopathic Arthritis

The recommended starting dosage of methotrexate tablets are 10 mg/m2 orally once weekly with escalation to achieve optimal response. Dosages of more than 30 mg/m2 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 methotrexate adverse reactions [see Warnings and Precautions ( 5.10 )] .

2.5 Recommended Dosage for Psoriasis

The recommended dosage of methotrexate tablets are 10 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 methotrexate adverse reactions [see Warnings and Precautions (5.10)].

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 )]

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