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Methotrexate Vial

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Methotrexate Vial Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS

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1 INDICATIONS AND USAGE

1.1 Acute Lymphoblastic Leukemia

Methotrexate Injection is indicated for the treatment...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Safety Information

  • Use only...
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3 DOSAGE FORMS AND STRENGTHS

Injection: Methotrexate Injection is a clear, yellow solution and is supplied in single-dose vials (preservative-free) and multiple-dose vials (with preservative) in the following strengths:

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5 WARNINGS AND PRECAUTIONS

5.1 Embryo-Fetal Toxicity

Based on published reports and its mechanism of action,...

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6 ADVERSE REACTIONS

The following adverse reactions are described, or described in greater detail, in other sections:

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7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on Methotrexate

Drugs that Increase...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Methotrexate Injection...

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10 OVERDOSAGE

Manifestations

Overdosage, including fatal overdosage, has occurred with methotrexate [see...

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11 DESCRIPTION

Methotrexate is a folate analog metabolic inhibitor with the chemical name of N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid and a molecular weight...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Methotrexate has been evaluated in a number of animal studies for carcinogenic...

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15 REFERENCES

  1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
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16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Methotrexate Injection is a clear, yellow, sterile solution available with preservative...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Embryo-Fetal...

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Report Adverse Event
Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

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FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.