What is it?

Potactasol is a medicine that contains the active substance topotecan. It is available as a concentrate to be made up into a solution for infusion (drip into a vein).

Potactasol is a ?generic medicine?. This means that Potactasol 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?

Potactasol is an anticancer medicine. It is used on its own to treat patients with:

metastatic cancer of the ovary when the cancer has spread to other parts of the body. It is used after at least one other treatment has failed

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 Potactasol 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 Potactasol to be used depends on the type of cancer that it is being used to treat and the patient?s weight and height. When Potactasol is used on its own for ovarian cancer, it is given by intravenous infusion over 30 minutes. For both ovarian and lung cancer, Potactasol 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, Potactasol 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 Potactasol, 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. Potactasol also affects non-cancer cells, which causes side effects.

How has it been studied?

The company has provided data from the published literature on topotecan. No additional studies were needed as Potactasol 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 Potactasol is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine?s.

What is the risk associated?

Because Potactasol is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine?s.

Why has it been approved?

The CHMP concluded that, in accordance with EU requirements, Potactasol 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 Potactasol be given marketing authorisation.

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