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pemetrexed disodium (solution) vial (pemetrexed for injection)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
pemetrexed disodium (solution) vial Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed Injection is indicated:
- In combination with cisplatin...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage for Non-Squamous NSCLC
- The recommended dose of Pemetrexed Injection when administered with cisplatin for initial treatment...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Pemetrexed Injection is a clear colorless to pale yellow ready-to-dilute solution available in single-dose vials as follows:
- 100 mg/4 mL (25 mg/mL)
- 500 mg/20 mL (...
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Contraindications
4 CONTRAINDICATIONS
Pemetrexed Injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed [see Adverse Reactions (6.1)].
...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Myelosuppression and Increased Risk of Myelosuppression without Vitamin Supplementation
Pemetrexed can cause severe myelosuppression...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Myelosuppression [see Warnings and...
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Drug Interactions
7 DRUG INTERACTIONS
Effects of Ibuprofen on Pemetrexed
Ibuprofen increases exposure (AUC) of pemetrexed [see...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
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Overdosage
10 OVERDOSAGE
No drugs are approved for the treatment of Pemetrexed Injection overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of Pemetrexed Injection overdosage. It is not known...
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Description
11 DESCRIPTION
Pemetrexed is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium (2.5 H2O), has the chemical name N-[[4-[2-(2-Amino-4-oxo-4,7-...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Pemetrexed Injection is a folate analog metabolic inhibitor that disrupts folate-dependent metabolic processes...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity studies have been conducted with pemetrexed. Pemetrexed was...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Non-Squamous NSCLC
Initial Treatment in Combination with Cisplatin...
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References
15 REFERENCES
- "OSHA Hazardous Drugs." OSHA.
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Pemetrexed Injection is a clear, colorless to pale yellow ready-to-dilute solution in a...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Premedication...
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Report Adverse Event
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
*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 to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
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.
(800)-332-1088.