Pemetrexed Krka

pemetrexed

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An overview of Pemetrexed Krka and why it is authorised in the EU

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

  • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
  • advanced non-small-cell lung cancer of the kind known as ‘non-squamous’, where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment. It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.

Pemetrexed Krka contains the active substance pemetrexed. It is a ‘generic medicine’. This means that Pemetrexed Krka contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Alimta.

How is Permetrexed Krka used?

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.

How does Pemetrexed Krka work?

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.

How has Pemetrexed Krka been studied?

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.

What are the benefits and risks of Pemetrexed Krka?

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.

Why is Pemetrexed Krka authorised in the EU?

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.

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

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.

Other information about Pemetrexed Krka

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.

Name Language First published Last updated
Pemetrexed Krka : EPAR - Medicine overview BG = bălgarski 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview ES = español 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview CS = čeština 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview DA = dansk 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview DE = Deutsch 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview ET = eesti keel 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview EL = elliniká 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview FR = français 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview IT = italiano 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview LV = latviešu valoda 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview LT = lietuvių kalba 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview HU = magyar 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview MT = Malti 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview NL = Nederlands 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview PL = polski 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview PT = português 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview RO = română 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview SK = slovenčina 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview SL = slovenščina 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview FI = suomi 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview SV = svenska 2018-06-08  
Pemetrexed Krka : EPAR - Medicine overview HR = Hrvatski 2018-06-08  
Name Language First published Last updated
Pemetrexed Krka : EPAR - Risk-management-plan summary (English only) 2018-06-08  

This EPAR was last updated on 08/06/2018 .

Authorisation details

Product details

Product details for Pemetrexed Krka
NamePemetrexed Krka
Agency product numberEMEA/H/C/003958
Active substance

pemetrexed disodium

International non-proprietary name (INN) or common name

pemetrexed

Therapeutic area Carcinoma, Non-Small-Cell LungMesothelioma
Anatomical therapeutic chemical (ATC) code L01BA04
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Pemetrexed Krka
Marketing-authorisation holder

KRKA d.d.

Revision0
Date of issue of marketing authorisation valid throughout the European Union22/05/2018

Contact address:

KRKA d.d. 
Šmarješka cesta 6 
8501 Novo mesto 
Slovenia

Product information

Product information

22/05/2018  Pemetrexed Krka -EMEA/H/C/003958 --

Name Language First published Last updated
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  
Pemetrexed Krka : EPAR - Product Information EN = English 2018-06-08  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  
Pemetrexed Krka : EPAR - All Authorised presentations EN = English 2018-06-08  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Malignant pleural mesothelioma
Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.

Non-small cell lung cancer
Pemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Pemetrexed Krka : EPAR - Public assessment report EN = English 2018-06-08  
CHMP summary of positive opinion for Pemetrexed Krka EN = English 2018-03-23  

Authorised

This medicine is approved for use in the European Union

More information on Pemetrexed Krka