Potactasol
Authorised
This medicine is authorised for use in the European Union
topotecan
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Potactasol. 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 Potactasol.
Potactasol is a medicine that contains the active substance topotecan. It is available as a powder to be made up into a solution for infusion (drip) into a vein.
Potactasol is a ‘generic medicine’. This means that Potactasol is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Hycamtin.
Potactasol is a cancer medicine. It is used on its own to treat patients with:
- metastatic cancer of the ovary (when the cancer has spread to other parts of the body). It is used after at least one other treatment has failed;
- small cell lung cancer, when the cancer has relapsed (come back). It is used when giving the original treatment again is not recommended.
It is also used together with cisplatin (another cancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (the cancer has spread beyond the cervix).
The medicine can only be obtained with a prescription.
Treatment with Potactasol should only be given under the supervision of a doctor experienced in the use of chemotherapy. Infusions should be carried out in a specialised cancer ward.
The dose of Potactasol to be used depends on the type of cancer that it is being used to treat and the patient’s weight and height. When Potactasol is used on its own for ovarian cancer, it is given by infusion over 30 minutes. For both ovarian and lung cancer, Potactasol is given every day for five days with a three-week interval between the start of each course. Treatment may continue until the disease gets worse.
When used with cisplatin in cervical cancer, Potactasol is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1). This is repeated every 21 days for six courses or until the disease gets worse.
Doses of Potactasol may need to be adjusted or treatment delayed, depending on side effects. For full details, see the summary of product characteristics, also part of the EPAR.
The active substance in Potactasol, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors’. It blocks an enzyme called topoisomerase I, which is involved in the division of DNA. When the enzyme is blocked, the DNA strands break. This prevents the cancer cells from dividing and they eventually die. Potactasol also affects non?cancer cells, which causes side effects.
The company has provided data from the published literature on topotecan. No additional studies were needed as Potactasol is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Because Potactasol 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 CHMP concluded that, in accordance with EU requirements, Potactasol has been shown to be comparable to Hycamtin. Therefore, the CHMP’s view was that, as for Hycamtin, the benefit outweighs the identified risk. The Committee recommended that Potactasol be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Potactasol to on 06 January 2011.
For more information about treatment with Potactasol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: IG1612
31/05/2023
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).
Product details
- Name of medicine
- Potactasol
- Active substance
- topotecan
- International non-proprietary name (INN) or common name
- topotecan
- Therapeutic area (MeSH)
- Uterine Cervical Neoplasms
- Small Cell Lung Carcinoma
- Anatomical therapeutic chemical (ATC) code
- L01CE01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Topotecan monotherapy is indicated for the treatment of:
- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy
- patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
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