What is it?

Topotecan Actavis is a powder to be made up into a solution for infusion (drip into a vein). It contains the active substance topotecan.
Topotecan Actavis is a ?generic medicine?. This means that Topotecan Actavis is similar to a ?reference medicine? already authorised in the European Union (EU) called Hycamtin. For more information on generic medicines, see the question-and-answer document here.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Topotecan Actavis is an anticancer medicine.
It is used on its own to treat patients with small cell lung cancer, when the cancer has relapsed (come back). It is used when giving the original treatment again is not recommended.
It is also used together with cisplatin (another anticancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
The medicine can only be obtained with a prescription.

How is it 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 specialised cancer ward. The patient?s blood levels of white blood cells, platelets and haemoglobin should be checked before treatment, to ensure that they are above set minimum levels. The doses may need to be adjusted or other medicines given to the patients, when the level of white blood cells remains particularly low.
The dose of Topotecan Actavis to be used depends on the type of cancer that it is being used to treat and the patient?s weight and height. For lung cancer, Topotecan Actavis is given every day for five days with a three-week interval between the start of each course. Treatment may continue until the disease gets worse.
When used with cisplatin in cervical cancer, Topotecan Actavis is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1). This is repeated every 21 days for six courses or until the disease gets worse.
For full details, see the Summary of Product Characteristics (also part of the EPAR).

How does it work?

The active substance in Topotecan Actavis, topotecan, is an anticancer medicine that belongs to the group ?topoisomerase inhibitors?. It blocks an enzyme called topoisomerase I, which is involved in the division of DNA. When the enzyme is blocked, the DNA strands break. This prevents the cancer cells from dividing and they eventually die. Topotecan Actavis also affects non-cancer cells, which causes side effects.

How has it been studied?

Because Topotecan Actavis is a generic medicine, the company has provided data from the published literature on topotecan. No additional studies were needed as Topotecan Actavis is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.

What benefits has it shown during the studies?

Because Topotecan Actavis is a generic medicine, its benefit and risk are taken as being the same as those of the reference medicine.

What is the risk associated?

Because Topotecan Actavis is a generic medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Topotecan Actavis has been shown to be comparable to Hycamtin. Therefore, the CHMP?s view was that, as for Hycamtin, the benefit outweighs the identified risk. The Committee recommended that Topotecan Actavis be given marketing authorisation.

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