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pemetrexed disodium (solution) vial (pemetrexed for injection)
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pemetrexed disodium (solution) vial Quick Finder
1 INDICATIONS AND USAGE
1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed Injection is indicated:
- In combination with cisplatin...
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...
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 (...
4 CONTRAINDICATIONS
Pemetrexed Injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed [see Adverse Reactions (6.1)].
...5 WARNINGS AND PRECAUTIONS
5.1 Myelosuppression and Increased Risk of Myelosuppression without Vitamin Supplementation
Pemetrexed can cause severe myelosuppression...
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Myelosuppression [see Warnings and...
7 DRUG INTERACTIONS
Effects of Ibuprofen on Pemetrexed
Ibuprofen increases exposure (AUC) of pemetrexed [see...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
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...
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-...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Pemetrexed Injection is a folate analog metabolic inhibitor that disrupts folate-dependent metabolic processes...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity studies have been conducted with pemetrexed. Pemetrexed was...
14 CLINICAL STUDIES
14.1 Non-Squamous NSCLC
Initial Treatment in Combination with Cisplatin...
15 REFERENCES
- "OSHA Hazardous Drugs." OSHA.
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Pemetrexed Injection is a clear, colorless to pale yellow ready-to-dilute solution in a...
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Premedication...
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