What is Iasibon - ibandronic acid?
Iasibon is a medicine that contains the active substance ibandronic acid and is available in concentrated form to make a solution for infusion (drip into a vein) and in white round tablets (50 mg).
Iasibon is a 'generic medicine' which means it is similar to a 'reference medicine' already authorized in the European Union (EU) called Bondronat.
What is Iasibon used for - ibandronic acid?
Iasibon is used:
- as an infusion or as a tablet to prevent 'skeletal events' (bone fractures or complications requiring treatment) in patients with breast cancer or bone metastases (spread of cancer to bone);
- 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 used - ibandronic acid?
Treatment with Iasibon should be started by a doctor who has experience in treating cancer.
In the prevention of skeletal events, Iasibon is administered as an infusion of 6 mg over a period of at least 15 minutes to be given every 3-4 weeks or as one tablet per day. The tablets should always be taken in the morning after fasting for at least 6 hours. not less than 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 go to bed before one "hour" after taking the tablet. For patients with moderate to severe kidney problems, Iasibon is given as an infusion over a 'one hour' by reducing the dose or as one tablet every two days or once a week.
For the treatment of tumor-related hypercalcaemia, Iasibon is given as a 2 or 4 mg infusion, depending on the severity of the hypercalcaemia. The infusion usually returns blood calcium levels to normal within a week.
How does Iasibon - ibandronic acid work?
The active ingredient in Iasibon is ibandronic acid, a bisphosphonate, which works by inhibiting the action of osteoclasts, the cells in the body that are involved in the breakdown of bone tissue. The result is a reduction in bone loss. reduced bone loss contributes to making bones less prone to breaking, with an advantage in terms of fracture prevention in cancer patients with bone metastases.
Cancer patients may have high blood levels of calcium which is released from the bones. By preventing bone breakdown, Iasibon also helps reduce the levels of calcium released in the blood.
How has Iasibon - ibandronic acid been studied?
As Iasibon is a generic medicine, the studies in patients were limited to verifying its bioequivalence 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?
Because Iasibon is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks associated with it are considered to be 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 EU requirements, Iasibon has been shown to be qualitatively comparable and bioequivalent to Bondronat and therefore considered that, as in the case of Bondronat, the the benefits outweigh the risks identified. The committee recommended the granting of a marketing authorization for Iasibon.
Other information about Iasibon - ibandronic acid
On January 21, 2011, the European Commission issued Pharmathen S.A. a "Marketing Authorization" for Iasibon, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
Last update of this summary: 11-2010.
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