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

 

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.

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...