What is Iasibon - ibandronic acid?
Iasibon is a medicine containing the active substance ibandronic acid and is available in concentrated form for the preparation of a solution for infusion (drip into a vein) and into white round tablets (50 mg).
Iasibon is a "generic medicine", which means that it is similar to a "reference medicine" already authorized in the European Union (EU) called Bondronat.
What is Iasibon - ibandronic acid used for?
Iasibon is used:
- as an infusion or tablet to prevent "skeletal events" (fractures or bone complications requiring treatment) in patients with breast cancer or bone metastases (spread of bone cancer);
- as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by cancer.
The medicine can only be obtained with a prescription.
How is Iasibon - ibandronic acid used?
Treatment with Iasibon should be established by a doctor experienced in treating cancer.
In the prevention of skeletal events, Iasibon is administered by infusion of 6 mg over at least 15 minutes to be given every 3-4 weeks or by one tablet per day. The tablets should always be taken in the morning after fasting for at least 6 hours and at least 30 minutes from the first food intake (solid or liquid) of the day with a full glass of tap water (not mineral water) while standing or sitting and without chewing, sucking or crushing them. The patient cannot lie down until an hour has elapsed after taking the tablet. For patients with moderate to severe kidney problems, Iasibon should be given as an infusion over an hour by reducing the dose or using a tablet every two days or once a week.
For the treatment of tumor hypercalcaemia, Iasibon is given by infusion of 2 or 4 mg, depending on the severity of hypercalcaemia. Usually the infusion brings blood calcium levels back to normal within a week.
How does Iasibon - ibandronic acid work?
The active ingredient of Iasibon is ibandronic acid, a bisphosphonate, which acts by inhibiting the action of osteoclasts, the cells in the body that are involved in the decomposition of bone tissue. The result is a reduction in bone loss. Reduced bone loss helps make bones less prone to breakage, with an advantage in terms of preventing fractures in cancer patients with bone metastases.
Patients with tumors may have high blood levels of calcium that is released from the bones. By preventing the breakdown of bones, Iasibon also helps reduce the levels of calcium released into the blood.
What studies have been carried out on Iasibon - ibandronic acid?
Because Iasibon is a generic medicine, studies in patients have been limited to checking that it is bioequivalent with the reference medicine Bondronat. Two drugs are bioequivalent if, once in the body, they deliver the same levels of active ingredient.
What are the benefits and risks of Iasibon - ibandronic acid?
Since Iasibon is a generic medicine and is bioequivalent to the reference medicine, it is believed that the benefits and risks associated with it are the same as the reference medicine.
Why has Iasibon - ibandronic acid been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in line with the requirements in the EU, it was shown that Iasibon is qualitatively comparable and bioequivalent to Bondronat and therefore considered that, as in the case of Bondronat, the advantages are greater than the risks identified. The committee recommended that Iasibon be given marketing authorization.
More information on Iasibon - ibandronic acid
On 21 January 2011, the European Commission issued a marketing authorization valid for Iasibon, valid throughout the European Union, to Pharmathen SA. The marketing authorization is valid for five years, after which it can be renewed.
Last update of this summary: 11-2010.
