Methotrexate

METHOTREXATE- methotrexate sodium tablet
REMEDYREPACK INC.

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

  • Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets is 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 is 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

is indicated for the: Methotrexate Tablets is 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

is indicated for the treatment of adults with rheumatoid arthritis. Methotrexate Tablets is indicated for the treatment of adults with rheumatoid arthritis.

1.3 Polyarticular Juvenile Idiopathic Arthritis

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

1.4 Psoriasis

is indicated for the treatment of adults with severe psoriasis. Methotrexate Tablets is indicated for the treatment of adults with severe psoriasis.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Safety Information

in females of reproductive potential before starting Methotrexate Tablets 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 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.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.Do not administer to patients who are unable to swallow a tablet.

Methotrexate Tablets is a cytotoxic drug. Follow applicable special handling and disposal procedures. Methotrexate Tablets 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 Methotrexate Tablets is 20 mg/m 2 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 is 25 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 Methotrexate Tablets 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.The recommended starting dosage of Methotrexate Tablets 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 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 is 10 mg/m orally once weekly with escalation to achieve optimal response. Dosages of more than 30 mg/m 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. The recommended starting dosage of Methotrexate Tablets 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.

or folinic acid to reduce the risk of methotrexate adverse reactions 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 is 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. or folinic acid supplementation to reduce the risk of methotrexate adverse reactions The recommended dosage of Methotrexate Tablets is 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)].

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