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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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Call (800) 438-1985

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Report Adverse Event
Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.
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.