What is Topotecan Hospira?
Topotecan Hospira is a concentrate that is made up into a solution for infusion (drip into a vein). 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 cancer has come back (if it comes back). It is used when further treatment with the original regimen is not recommended.
The medicine is also used in combination with cisplatin (another anticancer medicine) to treat women with cervical cancer, if they come back after radiotherapy or if 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 administered under the supervision of a physician experienced in the use of chemotherapy. The infusions should be given in a specialized cancer department. 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 in. In the event that the level of white blood cells remains particularly low, a dose adjustment or administration of other drugs can be made.
The dose of Topotecan Hospira to be given depends on the type of tumor being treated as well as the patient's weight and height. For lung cancer, Topotecan Hospira is given 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 Hospira is given on days 1, 2 and 3 (with cisplatin on day 1). This treatment schedule is repeated every 21 days for six cycles or until disease progression.
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 that belongs to the group of 'topoisomerase 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 eventually die. Topotecan Hospira also affects non-cancer cells, thus causing undesirable effects.
How has Topotecan Hospira been studied?
The company presented data on topotecan from the scientific literature. No additional studies were needed because 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?
Since Topotecan Hospira is a generic medicine, the benefits and risks are assumed to be the same as the reference medicine.
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 has been shown to be comparable to Hycamtin. It is therefore the view of the CHMP that, as in the case of Hycamtin, the benefits are than the risks identified, the Committee therefore recommended the granting of a marketing authorization for Topotecan Hospira.
More information about 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 version of Topotecan Hospira, click here. For more information about therapy with Topotecan Hospira, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 04/2010.
The information on Topotecan Hospira published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
