Pemetrexed medac

What is Pemetrexed medac used for and what is it used for?

Pemetrexed medac is a cancer medicine used to treat two types of lung cancer:

malignant pleural mesothelioma (a tumor of the tissue that coats the lungs, usually caused by exposure to asbestos), in which the medicine is used in combination with cisplatin in patients not previously receiving 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 patients not previously treated, or as monotherapy in patients previously treated with anticancer treatment . It can also be used as a maintenance therapy in patients who have undergone platinum-based chemotherapy.

Pemetrexed medac is a "generic medicine". This means that Pemetrexed medac 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 medac contains the active substance pemetrexed.

How is Pemetrexed medac used?

Pemetrexed medac is available as a powder for the preparation of a 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 is 500 mg per square meter of body surface area (calculated based on the patient's height and weight), and is administered with 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 medac. When Pemetrexed medac is given with cisplatin, patients should also take an "anti-emetic" (to prevent vomiting) and fluid (to prevent dehydration) before or after the cisplatin dose.

Treatment should be postponed or discontinued, or the dose should be reduced, in patients with changes in blood counts or with certain side effects of another nature. For more information, see the summary of product characteristics (included with EPAR).

How does Pemetrexed medac work?

The active substance of Pemetrexed medac is pemetrexed, a cytotoxic medicine (a medicine that kills cells in active division, 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 DNA and RNA formation and prevents 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 of the active form of the medicine and a longer duration of action. The division of cancer cells is therefore reduced, while normal cells are only partially affected.

What studies have been performed on Pemetrexed medac?

The company presented data on pemetrexed taken from the scientific literature. No further studies were needed because Pemetrexed medac is a generic medicine given by infusion and contains the same active substance as the reference medicine, Alimta.

What are the benefits and risks of Pemetrexed medac?

Because Pemetrexed medac is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Pemetrexed medac been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed medac was 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 medac in the EU.

What measures are being taken to ensure the safe and effective use of Pemetrexed medac?

A risk management plan has been developed to ensure that Pemetrexed medac is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed medac, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.