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pemetrexed ditromethamine vial (pemetrexed for injection)
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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 ditromethamine vial Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed for Injection is indicated:
- In combination with...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage for Non-Squamous NSCLC
- The recommended dose of Pemetrexed for Injection when administered with cisplatin for...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
For injection: 100 mg, 500 mg or 1 gram pemetrexed as a white to light-yellow or green-yellow lyophilized powder in single-dose vials for reconstitution.
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Contraindications
4 CONTRAINDICATIONS
Pemetrexed for 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 for Injection can cause severe...
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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 for Injection overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of Pemetrexed for Injection overdosage. It is not...
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Description
11 DESCRIPTION
Pemetrexed is a folate analog metabolic inhibitor. The drug substance, pemetrexed ditromethamine, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d] pyrimidin-5-yl)...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Pemetrexed for 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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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Pemetrexed for Injection is a white-to-light yellow or green-yellow lyophilized powder...
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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 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:
*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.
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.