What is Pemetrexed Hospira and what is it used for?
Pemetrexed Hospira is an anticancer medicine used to treat two types of lung cancer:
- malignant pleural mesothelioma (a cancer of the tunic lining the lungs, usually caused by exposure to asbestos), in which the medicine is used in combination with cisplatin in patients who have not previously undergone 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 Hospira is a "generic medicine". This means that Pemetrexed Hospira 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 Hospira contains the active substance pemetrexed.
How is Pemetrexed Hospira used?
Pemetrexed Hospira 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 is 500 mg per square meter of body surface area (calculated based on the patient's weight and height). It 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 Hospira. When Pemetrexed Hospira 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, please refer to the summary of product characteristics (included with EPAR).
How does Pemetrexed Hospira work?
The active substance in Pemetrexed Hospira, 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" (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 Hospira been studied?
The company presented data on pemetrexed from the scientific literature. No further studies were needed because Pemetrexed Hospira 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 Hospira?
Because Pemetrexed Hospira is a generic medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Pemetrexed Hospira been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Hospira 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 Hospira in the EU.
What measures are being taken to ensure the safe and effective use of Pemetrexed Hospira?
A risk management plan has been developed to ensure that Pemetrexed Hospira 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 Hospira, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Pemetrexed Hospira
For more information about treatment with Pemetrexed Hospira, 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.
