Author: Pharmathen S.A.


Long information

What is it?

Iasibon is a medicine that contains the active substance ibandronic acid. It is available as a concentrate that is made up into a solution for infusion (drip into a vein) and as white, round tablets (50 mg).

Iasibon is a ?generic medicine?. This means that Iasibon is similar to a ?reference medicine? already authorised in the European Union (EU) called Bondronat. 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?

Iasibon is used in the following ways:

as an infusion or as a tablet to prevent skeletal events fractures broken bones or bone complications requiring treatment in patients with breast cancer and bone metastases when the cancer has spread to the bone

as an infusion to treat hypercalcaemia high levels of calcium in the blood caused by tumours.

The medicine can only be obtained with a prescription.

How is it used?

Iasibon treatment should only be started by a doctor who has experience in the treatment of cancer.

In the prevention of skeletal events, Iasibon is either given as a 6-mg infusion lasting at least 15 minutes every three to four weeks, or as one tablet once a day. The tablets must always be taken after the patient has not eaten anything for at least six hours overnight and at least 30 minutes before the first food or drink of the day. They must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and they should not be chewed, sucked or crushed. The patient must not lie down for one hour after taking the tablet. Patients with moderate or severe kidney problems should receive Iasibon infusions at a lower dose over an hour, or the tablets every two days or every week.

In the treatment of hypercalcaemia caused by tumours, Iasibon is given as an infusion of either 2 or 4 mg, depending on how severe the hypercalcaemia is. The infusion will normally bring the blood calcium level down to normal levels within a week.

How does it work?

The active substance in Iasibon, ibandronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue. This leads to less bone loss. The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.

Patients with tumours can have high levels of calcium in their blood, released from the bones. By preventing the breakdown of bones, Iasibon also helps to reduce the amount of calcium released into the blood.

How has it been studied?

Because Iasibon is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Bondronat. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What benefits has it shown during the studies?

Because Iasibon 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 Iasibon 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, Iasibon has been shown to have comparable quality and to be bioequivalent to Bondronat. Therefore, the CHMP?s view was that, as for Bondronat, the benefit outweighs the identified risk. The Committee recommended that Iasibon be given marketing authorisation.

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