Overview

Pemetrexed Baxter is 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 or metastatic (meaning it has spread to other parts of the body) ‘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 a platinum-based chemotherapy.

Pemetrexed Baxter is a ‘generic medicine’. This means that Pemetrexed Baxter contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Alimta. For more information on generic medicines, see the question-and-answer document here.

Pemetrexed Baxter contains the active substance pemetrexed.

Pemetrexed Baxter 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.

Pemetrexed Baxter is given once every three weeks as an infusion (drip) into a vein 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 Baxter.

Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.

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

The active substance in Pemetrexed Baxter, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells). In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides’ (the building blocks of DNA and RNA). As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying. The conversion of pemetrexed into its active form occurs 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 results in the division of cancer cells being reduced, 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 Baxter.

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

Because Pemetrexed Baxter 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 Baxter has been shown to have comparable quality and to be bioequivalent to Alimta. Therefore, the Agency’s view was that, as for Alimta, the benefits of Pemetrexed Baxter outweigh the identified risks 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 Baxter have been included in the summary of product characteristics and the package leaflet.

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

Pemetrexed Baxter received a marketing authorisation valid throughout the EU on 09 December 2022.

Pemetrexed Baxter : EPAR - Medicine Overview

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Pemetrexed Baxter : EPAR - Risk management plan summary

Product information

Pemetrexed Baxter : EPAR - Product Information

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Pemetrexed Baxter : EPAR - All authorised presentations

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Product details

Name of medicine
Pemetrexed Baxter
Active substance
pemetrexed disodium heptahydrate
International non-proprietary name (INN) or common name
pemetrexed
Therapeutic area (MeSH)
  • Carcinoma, Non-Small-Cell Lung
  • Mesothelioma
Anatomical therapeutic chemical (ATC) code
L01BA04

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

Non-small cell lung cancer
Pemetrexed Baxter 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 (see section 5.1).

Pemetrexed Baxter 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 (see section 5.1).

Pemetrexed Baxter 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 (see section 5.1).

Authorisation details

EMA product number
EMEA/H/C/005848

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
Baxter Holding B.V.

Baxter Holding B.V.
Kobaltweg 49
3542 CE
Utrecht
Netherlands

Opinion adopted
13/10/2022
Marketing authorisation issued
09/12/2022

Assessment history

Pemetrexed Baxter : EPAR - Public Assessment Report

CHMP summary of positive opinion for Pemetrexed Baxter

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