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Methotrexate Vial Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

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

1 INDICATIONS AND USAGE

1.1 Acute Lymphoblastic Leukemia

1.2 Meningeal Leukemia: Prophylaxis and Treatment

1.3 Non-Hodgkin Lymphoma

1.4 Osteosarcoma

1.5 Breast Cancer

1.6 Squamous Cell Carcinoma of the Head and Neck

1.7 Gestational Trophoblastic Neoplasia

1.8 Rheumatoid Arthritis

1.9 Polyarticular Juvenile Idiopathic Arthritis

1.10 Psoriasis

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Safety Information

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

2.3 Recommended Dosage for Acute Lymphoblastic Leukemia

2.4 Recommended Dosage for Meningeal Leukemia: Prophylaxis and Treatment

2.5 Recommended Dosage for Non-Hodgkin Lymphoma

2.6 Recommended Dosage for Osteosarcoma

2.7 Recommended Dosage for Breast Cancer

2.8 Recommended Dosage for Squamous Cell Carcinoma of Head and Neck

2.9 Recommended Dosage for Gestational Trophoblastic Neoplasia

2.10 Recommended Dosage for Rheumatoid Arthritis

2.11 Recommended Dosage for Polyarticular Juvenile Idiopathic Arthritis

2.12 Recommended Dosage for Psoriasis

2.13 Dosage Modifications for Adverse Reactions

2.14 Administration and Handling Information

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Embryo-Fetal Toxicity

5.2 Hypersensitivity Reactions

5.3 Risks of Serious Adverse Reactions due to Benzyl Alcohol-Preservative

5.4 Myelosuppression

5.5 Serious Infections

5.6 Renal Toxicity

5.7 Hepatotoxicity

5.8 Neurotoxicity

5.9 Gastrointestinal Toxicity

5.10 Pulmonary Toxicity

5.11 Dermatologic Reactions

5.12 Folic Acid Supplementation

5.13 Secondary Malignancies

5.14 Tumor Lysis Syndrome

5.15 Immunization and Risks Associated with Live Vaccines

5.16 Infertility

5.17 Increased Risk of Adverse Reactions Due to Third Space Accumulation

5.18 Increased Risk of Soft Tissue and Bone Toxicity with Concomitant Radiotherapy

5.19 Risk of Serious Adverse Reactions with Medication Errors

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on Methotrexate

7.2 Effects of Methotrexate on Other Drugs

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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