What is Pemetrexed Fresenius Kabi and what is it used for?
Pemetrexed Fresenius Kabi is an anticancer medicine used to treat two types of lung cancer:
- malignant pleural mesothelioma (a cancer of the lining of the lungs, usually caused by exposure to asbestos), in which the medicine is used in combination with cisplatin in patients who have not previously been treated with chemotherapy and in whom the tumor cannot be removed by surgery;
- advanced non-small cell lung cancer, of the type known as "non-squamous", in which the medicine is used in combination with cisplatin in previously untreated patients or as monotherapy in patients who have previously undergone cancer treatment . It can also be used as a maintenance therapy in patients who have undergone platinum-based chemotherapy.
Pemetrexed Fresenius Kabi is a "generic medicine". This means that Pemetrexed Fresenius Kabi is similar to a 'reference medicine' already authorized in the European Union (EU) called Alimta. For more information on generic medicines, see the questions and answers by clicking here.
Pemetrexed Fresenius Kabi contains the active ingredient pemetrexed.
How is Pemetrexed Fresenius Kabi used?
Pemetrexed Fresenius Kabi is available as a powder for solution for infusion (drip into a vein). The medicine can only be obtained with a prescription and should only be administered under the supervision of a doctor experienced in the use of chemotherapy.
The recommended dose should be calculated based on the patient's height and weight and is given as a 10-minute infusion once every three weeks. To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin) and receive injections of vitamin B12 during treatment with Pemetrexed Fresenius Kabi. When Pemetrexed Fresenius Kabi is given with cisplatin, patients should take an "anti-emetic" medicine (to prevent vomiting) and fluids (to prevent dehydration) before or after taking the cisplatin dose.
Treatment should be postponed or suspended, or the dose reduced, in patients with changes in blood counts or other side effects. For more information, see the summary of product characteristics (included with EPAR).
How does Pemetrexed Fresenius Kabi work?
The active substance in Pemetrexed Fresenius Kabi, pemetrexed, is a cytotoxic medicine (a medicine that destroys active dividing cells, such as cancer cells) belonging to the group of "antimetabolites". In the body, pemetrexed is converted into an active form that blocks the activity of enzymes involved in the production of "nucleotides" (the building blocks of DNA and RNA, the genetic material of cells). As a result, the active form of pemetrexed slows the formation of DNA and RNA and avoids cell division and multiplication. The conversion of pemetrexed into its active form occurs more rapidly in tumor cells than in normal ones; for this reason, in tumor cells there are higher concentrations than the active form of the medicine and a more prolonged action. The division of cancer cells is therefore reduced, while normal cells are only partially affected.
What benefit has Pemetrexed Fresenius Kabi shown during the studies?
The company presented data on pemetrexed from the scientific literature. No further studies were needed because Pemetrexed Fresenius Kabi is a generic medicine given by infusion and contains the same active substance as the reference medicine, Alimta.
Because Pemetrexed Fresenius Kabi is a generic medicine, its benefits and risks are considered to be the same as the reference medicine's.
What are the risks associated with Pemetrexed Fresenius Kabi?
Because Pemetrexed Fresenius Kabi is a generic medicine, its benefits and risks are considered to be the same as the reference medicine's.
Why has Pemetrexed Fresenius Kabi been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Fresenius Kabi has been shown to be comparable to Alimta. Therefore, the CHMP considered that, as in the case of Alimta, the benefits outweigh the identified risks and recommended to approve the use of Pemetrexed Fresenius Kabi in the EU.
What measures are being taken to ensure the safe and effective use of Pemetrexed Fresenius Kabi?
Recommendations and precautions for the safe and effective use of Pemetrexed Fresenius Kabi that health professionals and patients should take are included in the summary of product characteristics and the package leaflet.
More information on Pemetrexed Fresenius Kabi
For the full EPAR and the summary of the Pemetrexed Fresenius Kabi risk management plan, see the Agency website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports.
For more information about treatment with Pemetrexed Fresenius Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website.
