What is Topotecan Actavis?
Topotecan Actavis is a powder for the preparation of a solution for infusion (drip into a vein), containing the active substance topotecan.
Topotecan Actavis is a "generic drug". This means that Topotecan Actavis 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 Actavis used for?
Topotecan Actavis is an anticancer medicine.
It is indicated for monotherapy in patients with small cell lung cancer, when the carcinoma is recurrent (in case of recurrence). 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 Actavis used?
Treatment with Topotecan Actavis 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 Actavis to be administered depends on the type of tumor treated as well as the weight and height of the patient. For lung cancer, Topotecan Actavis 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, Topotecan Actavis 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 complete information, see the summary of product characteristics (also included in the EPAR).
How does Topotecan Actavis work?
The active substance in Topotecan Actavis, 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 Actavis also affects non-cancer cells, thus causing undesirable effects.
How has Topotecan Actavis been studied?
Since Topotecan Actavis is a generic medicine, the pharmaceutical company has presented data already published in the medical literature on topotecan. No further studies were necessary as Topotecan Actavis 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 Actavis?
Because Topotecan Actavis is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Topotecan Actavis been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of the European Union, Topotecan Actavis proved 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 Topotecan Actavis be given marketing authorization.
More information on Topotecan Actavis:
On July 24, 2009, the European Commission issued PTC ehf to Actavis Group. a marketing authorization for Topotecan Actavis, valid throughout the European Union.
The full EPAR for Topotecan Actavis can be found here.
Last update of this summary: 06-2009.
