Methotrexate

METHOTREXATE- methotrexate solution
Hikma Pharmaceuticals USA Inc.

WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS

  • Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Injection is contraindicated in pregnancy. Advise females and males of reproductive potential to use effective contraception [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.3)].
  • Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.2)].
  • Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis. Use only preservative-free Methotrexate Injection for treatment of neonates or low-birth weight infants and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available [see Dosage and Administration (2.1) and Warnings and Precautions (5.3)].
  • Other serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, kidneys, liver, nervous system, gastrointestinal tract, lungs, and skin. Withhold or discontinue Methotrexate Injection as appropriate [see Warnings and Precautions (5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 5.10, 5.11)].

1 INDICATIONS AND USAGE

1.1 Acute Lymphoblastic Leukemia

Methotrexate Injection is indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy regimen.

1.2 Meningeal Leukemia: Prophylaxis and Treatment

Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients.

1.3 Non-Hodgkin Lymphoma

Methotrexate Injection is indicated for the treatment of adults and pediatric patients with Non-Hodgkin lymphoma.

1.4 Osteosarcoma

Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen.

1.5 Breast Cancer

Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen.

1.6 Squamous Cell Carcinoma of the Head and Neck

Methotrexate Injection is indicated for the treatment of adults with squamous cell carcinoma of the head and neck as a single-agent.

1.7 Gestational Trophoblastic Neoplasia

Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen.

1.8 Rheumatoid Arthritis

Methotrexate Injection is indicated for the treatment of adults with rheumatoid arthritis (RA).

1.9 Polyarticular Juvenile Idiopathic Arthritis

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

1.10 Psoriasis

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

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Safety Information

  • Use only preservative-free Methotrexate Injection for treatment of neonates or low-birth weight infants and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4)].
  • Verify pregnancy status in females of reproductive potential before starting Methotrexate Injection [see Contraindications (4) and Warnings and Precautions (5.1)].
  • For patients switching between a methotrexate product administered orally and Methotrexate Injection, consider potential differences in bioavailability.

2.2 Recommended Monitoring and Concomitant Therapies for Intermediate- and High-Dose Regimens

To decrease the risk of severe adverse reactions [see Warnings and Precautions (5)]:

  • Administer leucovorin rescue in patients receiving Methotrexate Injection doses of 500 mg/m2 or greater (e.g., high-dose).
  • Consider leucovorin rescue for patients receiving Methotrexate Injection doses between 100 mg/m2 to less than 500 mg/m2 (e.g., intermediate-dose).
    Refer to the leucovorin Prescribing Information for additional information.
  • For high-dose Methotrexate Injection regimens, follow the supportive care and monitoring instructions below. Also consider for patients receiving intermediate-dose Methotrexate Injection regimens.
    • Monitor serum creatinine, electrolytes, at baseline and at least daily during therapy
    • Administer intravenous fluids starting before the first dose and continuing throughout treatment to maintain adequate hydration and urine output
    • Alkalinize urine starting before the first dose and continuing throughout treatment to maintain a urinary pH of 7 or higher
    • Monitor methotrexate concentrations at least daily and adjust hydration and leucovorin dosing as needed
  • Administer glucarpidase in patients who have toxic plasma methotrexate concentrations (>1 micromole per liter) and delayed methotrexate clearance due to impaired renal function (refer to the glucarpidase Prescribing Information for additional information)

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