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pemetrexed ditromethamine vial (pemetrexed for injection)

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pemetrexed ditromethamine 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 for Injection is indicated:

  • In combination with...
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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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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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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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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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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 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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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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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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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 for Injection is a white-to-light yellow or green-yellow lyophilized powder...

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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 labeling may have been updated. For most recent prescribing information, please visit www.pfizer.com.

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

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