This information is produced and provided originally by the European Medicines Agency (EMA). We only provide general information and advice from medical professionals should be followed. It is very important to consult more information about the drug, such as side-effects, benefits, indications, approval and so forth. More information concerning the use of this drug is available on the EMA website at www.ema.europa.eu. This information was last updated by EMA in April 2013. It is always important to consult the leaflet information.
Ibandronic acid is the active substrate in Bondronat® (Roche Registration limited).
Bondronat® is used in the following ways:
As an infusion or as a tablet to prevent ‘skeletal events’ (fractures or bone complications requiring treatment) in patients with breast cancer and bone metastases.
As an infusion to treat hypercalcemia caused by tumours.
The medicine can only be obtained with a prescription.
Ibandronic acid® is also the active substance in Ibandronic acid® Teva (Teva Pharma B.V.). It’s use is identical to that of Bondronat®.
What is it?
The active substance in Bondronat® and Ibandronic acid® Teva, 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, Bondronat® also helps to reduce the amount of calcium released into the blood.
Does it work?
In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat® has been compared with placebo in three main studies lasting two years: one with the infusions in 466 patients and two with the tablets in a total of 846 patients. The main measure of effectiveness was based on the number of new bone complications. These included spine fractures, fractures outside the spine and any bone complications that needed treatment with radiotherapy or surgery.
Bondronat® was more effective than placebo in preventing bone complications. It took longer for patients on Bondronat® infusions or tablets to develop a new bone complication (50 to 76 weeks) than for patients on placebo (33 to 48 weeks). Bondronat® reduced the risk of having a skeletal event by about 40% compared with placebo.
Bondronat® has also been studied in the treatment of hypercalcemia caused by tumours in three four-week studies involving a total of 343 patients. Bondronat® was not compared with any other treatments in these studies. The main measure of effectiveness was the change in blood calcium levels.
Bondronat® was also effective in treating hypercalcemia caused by tumours. About a half to two-thirds of the patients responded to a 2-mg dose of Bondronat, with blood calcium levels returning to within the normal range. About three-quarters responded to a 4-mg dose.
Because Ibandronic acid® Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicines. Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Its benefit is taken as being the same as the reference medicines’.
Is it safe?
The most common side effect with Bondronat® infusions (seen in more than 1 patient in 10) is fever. The most common side effects with the tablets (seen in between 1 and 10 patients in 100) are hypocalcemia, heartburn, nausea, abdominal pain, oesophagitis (inflammation of the oesophagus), and weakness. For the full list of all side effects reported with Bondronat, see the Package Leaflet.
Because Ibandronic acid® Teva is a generic medicine and is bioequivalent to the reference medicines, its risk is taken as being the same as the reference medicines’.
Bondronat® and Ibandronic acid® Teva should not be used in people who may be hypersensitive to ibandronic acid® or any of the other ingredients. It must not be used in people with hypocalcaemia, and should be used with caution in patients who are sensitive to other bisphosphonates. The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit upright for at least an hour. Bondronat® and Ibandronic Avid Teva should not be used in children.
To get more professional information about this drug (EMA information) click here.
Boniva (brand name)
Bondronate (brand name)