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U.S. Department of Health and Human Services

Safety

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Alimta (pemetrexed disodium) Injection, Powder, Lyophilized, For Solution for Intravenous Use September 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008 and June 2012

 

June 2012

Summary View

 

ADVERSE REACTIONS

Additional Clinical Trials Experience
  • include information regarding cases of esophagitis in clinical trials

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


 

September 2008

Summary View

 

Sections Modified

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Non-Small Cell Lung Cancer (NSCLC) — Combination with Cisplatin (new subsection)
    • Non-Small Cell Lung Cancer (NSCLC) — Single-Agent
      • ...No clinically relevant differences in adverse reactions were seen in patients based on histology...
  • Postmarketing Experience
    • Injury, poisoning, and procedural complications (new subsection)
    • Respiratory (new subsection)

USE IN SPECIFIC POPULATIONS

  • Geriatric Use
    • In the initial treatment non-small cell lung cancer clinical trial...

PATIENT COUNSELING INFORMATION

  • FDA Approved Patient Labeling - Patients should be instructed to read the patient package insert carefully.

PATIENT PACKAGE INSERT

  • What is Alimta?
    • Non-small cell lung cancer...
  • How is Alimta given?
    • If you are being treated with Alimta and cisplatin for the initial treatment of either mesothelioma or non-small cell lung cancer...
    • If you are being treated because your non-small cell lung cancer has returned...