What is Potactasol - topotecan?
Potactasol is a medicine that contains the active substance topotecan. It is available as a concentrate for the preparation of a solution for infusion (drip into a vein).
Potactasol is a "generic medicine". This means that Potactasol is similar to a 'reference medicine' already authorized in the European Union (EU) called Hycamtin.
What is Potactasol - topotecan used for?
Potactasol is an anticancer medicine. It is indicated as a unique therapy for the treatment of patients suffering from:
- metastatic ovarian carcinoma (ie that has spread to other parts of the body). It is used after the negative outcome of at least one other treatment;
- small cell lung cancer, when the carcinoma is recurrent (in case of reappearance). It is used when further treatment with the original therapeutic regimen is not recommended.
The medicine is also used in combination with cisplatin (another anticancer medicine) in the treatment of women with cervical cancer, in case of relapse after radiotherapy or in the case where the disease is at an advanced stage (stage IVB: the carcinoma has spread beyond the cervix).
How is Potactasol - topotecan used?
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 specialized cancer ward. Before treatment it is necessary to carry out an examination of the levels of white blood cells, platelets and hemoglobin in the blood, to ensure that these levels are above the minimum levels set. If the level of white blood cells remains particularly low, the dose may be adjusted or other drugs may be administered.
The dose of Potactasol to be administered depends on the type of tumor treated as well as the weight and height of the patient. If used on its own for ovarian cancer, it is given by intravenous injection for 30 minutes. For ovarian and lung cancer, Potactasol should be given every day for five days with an interval of three weeks between the start of each cycle. Treatment can continue until the disease progresses.
In cervical cancer, if the drug is used in combination with cisplatin, Potactasol is given by infusion on days 1, 2 and 3 (with cisplatin on day 1). This treatment scheme is repeated every 21 days for six cycles or until the disease progresses.
For further details, please refer to the summary of product characteristics, also included with the EPAR.
How does Potactasol - topotecan work?
The active substance in Potactasol, topotecan, is an anticancer medicine belonging to the group of "topoisomerasic inhibitors". It blocks an enzyme, topoisomerase I, which is involved in DNA duplication. When the enzyme is blocked, the DNA strands break off. In this way, cancer cells cannot divide and end up dying. Potactasol also affects non-cancer cells, thus causing side effects.
How has Potactasol - topotecan been studied?
The company presented data on topotecan derived from the scientific literature. No further studies were necessary because Potactasol is a generic medicine, given by infusion and containing the same active substance as the reference medicine, Hycamtin.
What are the benefits and risks of Potactasol - topotecan?
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.
Why has Potactasol - topotecan been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with European Union requirements, Potactasol has been shown to be comparable to Hycamtin. It is therefore the opinion of the CHMP that, as in the case of Hycamtin, the benefits outweigh the identified risks. The Committee therefore recommended that Potactasol be given marketing authorization.
Further information on Potactasol - topotecan
On 6 January 2011, the European Commission issued to Actavis Group PTC ehf. a marketing authorization for Potactasol, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
The full EPACT for Potactasol can be consulted on the Agency's website. For more information on Potactasol therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
