Pemetrexed Actavis

What is Pemetrexed Actavis and what is it used for?

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

malignant pleural mesothelioma (a tumor of the lining of 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 previously untreated or monotherapy patients in patients who have previously been treated antitumor. It can also be used as a maintenance therapy in patients who have undergone platinum-based chemotherapy.

Pemetrexed Actavis is a "hybrid medicine". This means that Pemetrexed Actavis is similar to a 'reference medicine' already authorized in the European Union (EU) called Alimta, but is available in a different form. While Alimta is available as a powder to be reconstituted in a solution for infusion (drip into a vein), Pemetrexed Actavis is available as a concentrated liquid for the preparation of a solution for infusion.

Pemetrexed Actavis contains the active substance pemetrexed.

How is Pemetrexed Actavis used?

Pemetrexed Actavis is available as a concentrate for solution for intravenous infusion. 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 anticancer medicines.

The recommended dose is 500 mg per square meter of body surface area (calculated based on the patient's height and weight), which 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 Actavis. When Pemetrexed Actavis is given with cisplatin, patients should also take an "anti-emetic" (to prevent vomiting) and fluid (to prevent dehydration) before or after the dose of cisplatin.

Treatment should be postponed or suspended, or the dose reduced, in patients with changes in blood counts or reported certain other side effects. For more information, please refer to the summary of product characteristics (included with EPAR).

How does Pemetrexed Actavis work?

The active substance in Pemetrexed Actavis, pemetrexed, is 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 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.

How has Pemetrexed Actavis been studied?

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

What are the benefits and risks of Pemetrexed Actavis?

Because Pemetrexed Actavis is a hybrid medicine given by infusion and contains the same active substance as the reference medicine, its benefits and risks are assumed to be the same as the reference medicine.

Why has Pemetrexed Actavis been approved?

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

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

A risk management plan has been developed to ensure that Pemetrexed Actavis 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 Actavis, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information is available in the summary of the risk management plan.