What is Topotecan Teva?
Topotecan Teva is a concentrate for the preparation of a solution for infusion (drip into a vein). It contains the active ingredient topotecan.
Topotecan Teva is a "generic medicine". This means that Topotecan Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Hycamtin. For more information on generic medicines, see the questions and answers by clicking here.
What is Topotecan Teva used for?
Topotecan Teva 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).
The medicine can only be obtained with a prescription.
How is Topotecan Teva used?
Treatment with Topotecan Teva 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 Topotecan Teva to be administered depends on the type of tumor treated as well as the weight and height of the patient. Topotecan Teva is given as a 30-minute infusion every day, for five days, with a three-week interval 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, Topotecan Teva is given 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 complete information, see the summary of product characteristics (also included in the EPAR).
How does Topotecan Teva work?
The active substance in Topotecan Teva, 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. Thus the cancer cells cannot divide and end up dying. Topotecan Teva also affects non-cancer cells, thus causing undesirable effects.
How has Topotecan Teva been studied?
Since Topotecan Teva is a generic medicine, the pharmaceutical company has presented data already published in the medical literature on topotecan. No further studies were necessary because Topotecan Teva is a generic medicine, given by infusion and containing the same active substance as the reference medicine, Hycamtin.
What are the risks and benefits associated with Topotecan Teva?
Because Topotecan Teva is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Topotecan Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with European Union requirements, Topotecan Teva was 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 recommended the granting of a marketing authorization for Topotecan Teva.
More information on Topotecan Teva
On 21 September 2009, the European Commission granted Teva Pharma BV a marketing authorization for Topotecan Teva, valid throughout the European Union.
The full EPAR for Topotecan Teva can be found here.
The full EPAR of the reference medicine is also found on the Agency's website. Last update of this summary: 09-2009
