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pemetrexed disodium (solution) 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 disodium (solution) vial Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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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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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5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression and Increased Risk of Myelosuppression without Vitamin Supplementation

Pemetrexed can cause severe myelosuppression...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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7 DRUG INTERACTIONS

Effects of Ibuprofen on Pemetrexed

Ibuprofen increases exposure (AUC) of pemetrexed [see...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

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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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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity studies have been conducted with pemetrexed. Pemetrexed was...

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14 CLINICAL STUDIES

14.1 Non-Squamous NSCLC

Initial Treatment in Combination with Cisplatin...

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15 REFERENCES

  1. "OSHA Hazardous Drugs." OSHA.
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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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17 PATIENT COUNSELING INFORMATION

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

Premedication...

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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Manufactured by: Zydus Hospira Oncology Private Ltd....

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