Pemetrexed Krka

Pemetrexed Krka is available as a powder that is made up into a solution for infusion (drip) into a vein. The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.

The recommended dose of Permetrexed Krka is 500 mg per square metre of body surface area (calculated using the patient’s height and weight). It is given once every three weeks as an infusion lasting 10 minutes. 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 Krka. When Pemetrexed Krka is given with cisplatin, an antiemetic medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.

Treatment should be delayed or stopped, or the dose reduced, in patients whose blood cell counts are low or who have certain other side effects. For more information, see the summary of product characteristics (also part of the EPAR).

For more information about using Pemetrexed Krka, see the package leaflet or contact your doctor or pharmacist.

The active substance in Pemetrexed Krka, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites’. In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes involved in producing nucleotides (the building blocks of DNA and RNA, the genetic material of cells). As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing. Pemetrexed is converted into its active form more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells. This slows down the division of cancer cells, while normal cells are only slightly affected.

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed Krka.

As for every medicine, the company provided studies on the quality of Pemetrexed Krka. There was no need for ‘bioequivalence’ studies to investigate whether Pemetrexed Krka is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Pemetrexed Krka is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

Because Pemetrexed Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Pemetrexed Krka has been shown to be comparable to Alimta. Therefore, the Agency’s view was that, as for Alimta, the benefit of Pemetrexed Krka outweighs the identified risk and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Krka have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Pemetrexed Krka are continuously monitored. Side effects reported with Pemetrexed Krka are carefully evaluated and any necessary action taken to protect patients.

Pemetrexed Krka received a marketing authorisation valid throughout the EU on 22 May 2018.

Information on the reference medicine can also be found on the Agency’s website.