What is Pemetrexed Hospira UK Limited and what is it used for?
Pemetrexed Hospira UK Limited is a cancer medicine used to treat two types of lung cancer:
- the malignant pleural mesothelioma (a tumor of the lining of the lungs, usually caused by exposure to asbestos): in this condition the medicine is used in combination with cisplatin in patients who have not undergone chemotherapy before and in whom the tumor cannot be removed by surgery;
- advanced non-small cell lung cancer of the type known as "non squamous": in this condition the medicine is used in combination with cisplatin in patients not previously treated or in monotherapy in patients who have previously undergone a cancer treatment. It can also be used as a maintenance therapy in patients who have undergone platinum-based chemotherapy.
Pemetrexed Hospira UK Limited contains the active substance pemetrexed. It is a "generic medicine". This means that Pemetrexed Hospira UK Limited contains the same active substance and acts in the same way as 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.
How is Pemetrexed Hospira UK Limited used?
Pemetrexed Hospira UK Limited 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 calculated based on the patient's height and weight and administered with a 10-minute infusion once every three weeks. To reduce side effects, patients should be given a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin) and injections of vitamin B12 during treatment with Pemetrexed Hospira UK Limited. When Pemetrexed Hospira UK Limited is given with cisplatin, patients should take an "anti-emetic" medicine (to prevent vomiting) and fluids (to prevent dehydration) before or after the cisplatin dose.
Treatment should be postponed or suspended, or the dose reduced, in patients with abnormalities in blood counts or certain other side effects. For more information, see the summary of product characteristics (included with EPAR).
How does Pemetrexed Hospira UK Limited work?
The active substance in Pemetrexed Hospira UK Limited is a cytotoxic medicine (a medicine that kills cells that are dividing, 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 by preventing the cells from dividing and multiplying. 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. It follows that the division of tumor cells is reduced, while normal cells are affected only in mild form.
What benefit has Pemetrexed Hospira UK Limited shown during the studies?
Studies on the benefits and risks of the active substance for approved uses have already been carried out for the reference medicine, Alimta, and should not be repeated for Pemetrexed Hospira UK Limited. As with any medicine, the company has provided quality studies of Pemetrexed Hospira UK Limited.
No bioequivalence studies were needed to verify whether Pemetrexed Hospira UK Limited was absorbed similarly to the reference medicine to produce the same level of active substance in the blood. The reason is that Pemetrexed Hospira UK Limited is given by infusion into a vein, so the active ingredient enters the bloodstream directly.
Because Pemetrexed Hospira UK Limited is a generic medicine, its benefits and risks are considered to be the same as those of the reference medicine.
What are the risks associated with Pemetrexed Hospira UK Limited?
Because Pemetrexed Hospira UK Limited is a generic medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Pemetrexed Hospira UK Limited been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Hospira UK Limited 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 UK Limited in the EU.
What measures are being taken to ensure the safe and effective use of Pemetrexed Hospira UK Limited?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Hospira UK Limited have been included in the summary of product characteristics and the package leaflet.
More information on Pemetrexed Hospira UK Limited
The full EPAR for Pemetrexed Hospira UK Limited can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Pemetrexed Hospira UK Limited, 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.
