What is Topotecan Hospira?
Topotecan Hospira is a concentrate for the preparation of a solution for infusion (drip into a vein). It contains the active ingredient topotecan.
Topotecan Hospira is a "generic medicine". This means that Topotecan Hospira is similar to a 'reference medicine' already authorized in the European Union (EU) called Hycamtin.
What is Topotecan Hospira used for?
Topotecan Hospira is indicated for monotherapy in patients with 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 Hospira used?
Treatment with Topotecan Hospira 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 Hospira to be administered depends on the type of cancer treated as well as the weight and height of the patient. For lung cancer, Topotecan Hospira 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 Hospira 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 Hospira work?
The active substance in Topotecan Hospira, 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. Topotecan Hospira also affects non-cancer cells, thus causing undesirable effects
How has Topotecan Hospira been studied?
The company presented data on topotecan derived from the scientific literature. No further studies were necessary as Topotecan Hospira 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 Olanzapine Ribavirin Three Rivers?
Because Topotecan Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's
Why has Topotecan Hospira been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with the requirements of the European Union, Topotecan Hospira 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 therefore recommended that Topotecan Hospira be given marketing authorization.
More information on Topotecan Hospira
On 10 June 2010, the European Commission granted Hospira UK Limited a marketing authorization for Topotecan Hospira, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
For the full EPAR of Topotecan Hospira, click here. For more information about treatment with Topotecan Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 04/2010.
