What is Bondronat?
Bondronat 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 as 50 mg tablets.
What is Bondronat used for?
Bondronat 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 Bondronat used?
Treatment with Bondronat should be established by a doctor experienced in treating cancer.
In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat should be administered by infusion of 6 mg lasting at least 15 minutes every 3-4 weeks or via a tablet once a day. The tablet should always be taken in the morning after an overnight fast of at least 6 hours and before taking food or drink; fasting should therefore be continued for at least 30 minutes after intake. The tablet should be taken with a full glass of water in an upright position or sitting. The patient cannot lie down until an hour has elapsed after taking the tablet.
In the treatment of tumor hypercalcaemia, Bondronat is given as an infusion of 2 or 4 mg, depending on whether hypercalcaemia is moderate (less than 3 mmol / l) or severe (greater than 3 mmol / l). Usually the treatment brings back the calcium levels in the blood to normal within seven days.
How does Bondronat work?
The active ingredient of Bondronat 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.
Patients with tumors may have high blood levels of calcium, which is released from the bones. By preventing the breakdown of bones, ibandronic acid helps to reduce the levels of calcium released into the blood. Reducing bone loss also helps make the bones less prone to breakage, with an advantage in terms of preventing fractures in patients with breast cancer and bone metastases.
How has Bondronat been studied?
Bondronat has been studied in the treatment of cancer hypercalcaemia through three four-week studies involving a total of 343 patients. Bondronat was not compared with other treatments. The main measure of effectiveness was the change in blood calcium levels.
The efficacy of Bondronat in the prevention of skeletal events in patients with breast cancer and bone metastases has been the subject of three studies involving 1 312 patients, an injection administration study (466 patients) and two on tablet administration (846 patients). In all three studies, Bondronat was compared with a placebo (a dummy treatment) over 96 weeks. The main measure of effectiveness was based on the number of new bone complications. These included fractures of the vertebrae (of the spine), non-vertebral fractures and any bone complication requiring radiotherapy or surgical treatment.
What benefit has Bondronat shown during the studies?
Bondronat was effective in the treatment of cancer-induced hypercalcaemia. A proportion of patients between half and two thirds responded to a dose of 2 mg Bondronat, with a return to normal of blood calcium levels. About three quarters of the patients responded to the 4 mg dose.
Bondronat was more effective than placebo based on the number of bone complications. In patients treated with Bondronat by injection or tablets the onset of new bone complications was delayed compared to patients treated with placebo (50-76 weeks versus 33-48 weeks). Bondronat reduced the risk of related skeletal events by approximately 40% compared to placebo.
What is the risk associated with Bondronat?
The most common side effect with Bondronat (seen in more than 1 patient in 10) is pyrexia (increased body temperature). For the full list of all side effects reported with Bondronat, see the Package Leaflet.
Bondronat should not be used in patients who may be hypersensitive (allergic) to ibandronic acid or any of the other ingredients, or to patients who are sensitive to other bisphosphonates. Bondronat should not be given to children. Bondronat, like all bisphosphonates, can pose a risk of osteonecrosis (death of bone tissue) in the jaw.
Why has Bondronat been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Bondronat outweigh the risks in preventing skeletal events (fractures due to disease, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases and for the treatment of tumor hypercalcaemia with or without metastases. The committee recommended that Bondronat be given marketing authorization.
More information on Bondronat:
On 25 June 1996, the European Commission granted a marketing authorization valid throughout the European Union for Bondronat to Roche Registration Limited. This authorization was renewed on June 25, 2001 and June 25, 2006.
The full EPAR for Bondronat can be found here.
Last update of this summary: 04-2008.
