Label Changes for:
Alimta (pemetrexed disodium) Injection, Powder, Lyophilized, For Solution for Intravenous Use
Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
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.|
- 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...