Topotecan Eagle

PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED

What is Topotecan Eagle?

Topotecan Eagle is a medicine that contains the active substance topotecan. It is available as a concentrate for solution for infusion (drip into a vein).

Topotecan Eagle is a "generic hybrid medicine". This means that it is similar to a "reference medicine" containing the same active ingredient. While the reference medicine, Hycamtin, is available as a powder for concentrate, Topotecan Eagle is already available as a concentrate.

Furthermore, Topotecan Eagle has a different dosage (higher) than that of Hycamtin.

What is Topotecan Eagle used for?

Topotecan Eagle is an anticancer medicine. It is indicated for monotherapy in patients with small cell lung cancer, when the carcinoma is recurrent (has reappeared). It is used when further treatment with the original therapeutic regimen is not recommended.

It 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: carcinoma occurs). it is spread beyond the cervix).

The medicine can only be obtained with a prescription.

How is Topotecan Eagle used?

Treatment with Topotecan Eagle 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 patient's blood, to ensure that they are above the minimum levels set. In the event that the level of white blood cells remains particularly low, it may be necessary to adjust the doses or administer other drugs.

The dose of Topotecan Eagle to be used depends on the type of cancer treated as well as the weight and height of the patient. For lung cancer, Topotecan Eagle 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.

If used in combination with cisplatin for the treatment of cervical cancer, Topotecan Eagle is given by infusion on days 1, 2 and 3 (with cisplatin on day 1). This pattern is repeated every 21 days for six cycles or until the disease progresses.

For all information, refer to the summary of product characteristics, included with the EPAR.

How does Topotecan Eagle work?

The active substance in Topotecan Eagle, topotecan, is an anticancer medicine belonging to the group of "topoisomerase inhibitors". It blocks an enzyme, topoisomerase I, which is involved in DNA division. When the enzyme is blocked, the DNA strands break off. In this way, cancer cells cannot divide and end up dying. Topotecan Eagle also affects non-cancer cells, causing side effects.

How has Topotecan Eagle been studied?

The company presented data on topotecan from the scientific literature. No further studies in patients were necessary because Topotecan Eagle is given by infusion and contains the same active substance as the reference medicine, Hycamtin.

What are the benefits and risks of Topotecan Eagle?

Because Topotecan Eagle is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.

Why has Topotecan Eagle been approved?

The CHMP concluded that, in accordance with EU requirements, Topotecan Eagle has been shown to have comparable quality and to be bioequivalent to Hycamtin. Therefore, the CHMP considered that, as in the case of Hycamtin, the benefit exceeds the identified risk. The committee recommended that Topotecan Eagle be given marketing authorization.