Difference between revisions of "Pemetrexed (Alimta)"
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* 8/19/2004: Accelerated approval as a single-agent for the treatment of patients with locally advanced or metastatic [[non-small cell lung cancer]] after prior chemotherapy. ''(New disease entity) | * 8/19/2004: Accelerated approval as a single-agent for the treatment of patients with locally advanced or metastatic [[non-small cell lung cancer]] after prior chemotherapy. ''(New disease entity) | ||
| − | ===[[Non-small cell lung cancer, | + | ===[[Non-small cell lung cancer, nonsquamous]]=== |
| − | * 9/26/2008: Accelerated approval for [[Non-small cell lung cancer, | + | * 9/26/2008: Accelerated approval for [[Non-small cell lung cancer, nonsquamous|nonsquamous non-small cell lung cancer]] initial treatment in combination with [[Cisplatin (Platinol) | cisplatin]]. |
| − | * 9/26/2008: Accelerated approval for [[Non-small cell lung cancer, | + | * 9/26/2008: Accelerated approval for [[Non-small cell lung cancer, nonsquamous|nonsquamous non-small cell lung cancer]] as a single-agent after prior chemotherapy. |
| − | * 7/2/2009: Converted to regular approval and additional indication for [[Non-small cell lung cancer, | + | * 7/2/2009: Converted to regular approval and additional indication for [[Non-small cell lung cancer, nonsquamous|nonsquamous non-small cell lung cancer]]: Maintenance treatment of patients whose disease has not progressed after four cycles of [[Regimen_classes#Platinum-based_regimen|platinum-based]] first-line chemotherapy. |
**Limitation: "not indicated for the treatment of patients with squamous cell non-small cell lung cancer." | **Limitation: "not indicated for the treatment of patients with squamous cell non-small cell lung cancer." | ||
| − | * 6/4/2018: Accelerated approval in combination with pembrolizumab and carboplatin for first-line treatment of metastatic [[Non-small cell lung cancer, | + | * 6/4/2018: Accelerated approval in combination with pembrolizumab and carboplatin for first-line treatment of metastatic [[Non-small cell lung cancer, nonsquamous|non-squamous NSCLC]] |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
Revision as of 16:12, 1 May 2022
General information
Class/mechanism: Folate analog, antimetabolite. Pemetrexed inhibits the activity of several folate-dependent enzymes involved in the synthesis of thymidine and purine nucleotides, such as thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT).[1][2]
Route: IV
Extravasation: neutral
Supportive care examples:[1]
- Patients should take daily folic acid (example dose: 1mg PO daily) while on therapy and at least 5 doses in the 7 days before starting Pemetrexed (Alimta) therapy.
- Vitamin B12 1000mcg should be given during the week before the first dose of Pemetrexed (Alimta) and then every 3 cycles thereafter.
- Dexamethasone 4mg PO twice per day the day before, the day of, and day after Pemetrexed (Alimta) helps to reduce the incidence and severity of cutaneous reactions.
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Brief patient counseling information can be found in the Pemetrexed (Alimta) package insert[1]
- Pemetrexed (Alimta) patient drug information (Chemocare)[3]
- Pemetrexed (Alimta) patient drug information (UpToDate)[4]
History of changes in FDA indication
Mesothelioma
- 2/4/2004: Initial approval in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery.
- 9/26/2008: Indication revised for mesothelioma in combination with cisplatin.
Non-small cell lung cancer
- 8/19/2004: Accelerated approval as a single-agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy. (New disease entity)
Non-small cell lung cancer, nonsquamous
- 9/26/2008: Accelerated approval for nonsquamous non-small cell lung cancer initial treatment in combination with cisplatin.
- 9/26/2008: Accelerated approval for nonsquamous non-small cell lung cancer as a single-agent after prior chemotherapy.
- 7/2/2009: Converted to regular approval and additional indication for nonsquamous non-small cell lung cancer: Maintenance treatment of patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
- Limitation: "not indicated for the treatment of patients with squamous cell non-small cell lung cancer."
- 6/4/2018: Accelerated approval in combination with pembrolizumab and carboplatin for first-line treatment of metastatic non-squamous NSCLC
History of changes in EMA indication
- 9/20/2004: Initial marketing authorization as Alimta.
Also known as
- Generic name: pemetrexed disodium
- Brand names: Alimta, Antifol, Armisarte, Kabipem, Pemetero, Pemetra, Pemetrex, Pemex, Pemfexy, Pemgem, Pemibenz, Pemnat, Pexotra