This is a summary of the European public assessment report (EPAR) for Docetaxel Kabi. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Docetaxel Kabi.
- What is Docetaxel Kabi?
Docetaxel Kabi is a medicine that contains the active substance docetaxel. It is available as a concentrate to be made up into a solution for infusion (drip into a vein).
Docetaxel Kabi is a ‘generic medicine’. This means that Docetaxel Kabi is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Taxotere.
- What is Docetaxel Kabi used for?
Docetaxel Kabi is used to treat the following types of cancer:
- breast cancer. Docetaxel Kabi can be used on its own after other treatments have failed. It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
- non-small-cell lung cancer. Docetaxel Kabi can be used on its own after other treatments have failed. It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer;
- prostate cancer, when the cancer does not respond to hormonal treatment. Docetaxel Kabi is used with prednisone or prednisolone (anti-inflammatory medicines);
- gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer. Docetaxel Kabi is used with cisplatin and 5-fluorouracil (other anticancer medicines);
- head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Docetaxel Kabi is used with cisplatin and 5-fluorouracil.
For full details, see the summary of product characteristics (also part of the EPAR).
The medicine can only be obtained with a prescription.
- How is Docetaxel Kabi used?
Docetaxel Kabi should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Docetaxel Kabi is given as a one-hour infusion every three weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated. Docetaxel Kabi is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3). An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Kabi infusion. For more information, see the summary of product characteristics.
- How does Docetaxel Kabi work?
The active substance in Docetaxel Kabi, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the ability of cells to destroy the internal ‘skeleton’ that allows them to divide and multiply. With the skeleton still in place, the cells cannot divide and they eventually die. Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
- How has Docetaxel Kabi been studied?
The company provided data from published literature on docetaxel. The company also showed that the Docetaxel Kabi solution for infusion has comparable quality to that of Taxotere. No additional studies were needed as Docetaxel Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
- What are the benefits and risks of Docetaxel Kabi?
Because Docetaxel Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
- Why has Docetaxel Kabi been approved?
The CHMP concluded that, in accordance with EU requirements, Docetaxel Kabi has been shown to be comparable to Taxotere. Therefore, the CHMP’s view was that, as for Taxotere, the benefit outweighs the identified risk. The Committee recommended that Docetaxel Kabi be given marketing authorisation.
- Other information about Docetaxel Kabi
The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Kabi on 22 May 2012.
For more information about treatment with Docetaxel Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 25/01/2016 .
15/12/2015 Docetaxel Kabi -EMEA/H/C/002325 -IB/0012
- 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.
Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
- operable node-positive breast cancer;
- operable node-negative breast cancer.
For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.
Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.
Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.
Non-small-cell lung cancer
Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.
Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Head and neck cancer
Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Docetaxel Kabi : EPAR - Procedural steps taken and scientific information after authorisation||SV = svenska||27/11/2012||25/01/2016|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Docetaxel Kabi : EPAR - Public assessment report||SV = svenska||18/06/2012|
|CHMP summary of positive opinion for Docetaxel Kabi||SV = svenska||16/03/2012|