What is Bondronat?
Bondronat is a medicine that contains the active substance ibandronic acid and is available in concentrated form to prepare a solution for infusion (drip into a vein) and in 50 mg tablets.
What is Bondronat used for?
Bondronat 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 Bondronat used?
Treatment with Bondronat should be started by a doctor who has experience in the treatment of cancer.
In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat is administered as a 6 mg infusion lasting at least 15 minutes every 3-4 weeks or as a tablet once daily. The tablet should always be taken in the morning after an overnight fast of at least 6 hours and before taking any food or drink; Fasting should therefore be continued for at least 30 minutes after taking. The tablet should be taken with a full glass of water in an upright or sitting position. The patient cannot go to bed before one hour has elapsed from taking the tablet.
In the treatment of tumor-induced hypercalcaemia, Bondronat should be administered as a 2 or 4 mg infusion, depending on whether the hypercalcaemia is moderate (less than 3 mmol / l) or severe (greater than 3 mmol / l). Treatment usually returns blood calcium levels to normal within seven days.
How does Bondronat work?
The active substance in Bondronat is ibandronic acid, a bisphosphonate, which works by inhibiting the action of osteoclasts, the cells in the body that are involved in breaking down bone tissue. The result is a reduction in bone loss.
Cancer patients may have high blood levels of calcium, which is released from the bones. By preventing the decomposition of bones, ibandronic acid helps to reduce the levels of calcium released in the blood. The reduction in bone loss also helps to make bones less prone to breaking, with an advantage in terms of preventing fractures in patients with cancer. breast and bone metastases.
How has Bondronat been studied?
Bondronat was studied in the treatment of cancer hypercalcaemia in 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 was investigated in three studies involving 1 312 patients, one injection study (466 patients) and two tablet administration studies (846 patients). In all three studies, Bondronat was compared with 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 (spine), non-vertebral fractures and any bone complications requiring radiotherapy or surgery.
What benefit has Bondronat shown during the studies?
Bondronat was effective in the treatment of cancer-induced hypercalcaemia. One-half to two-thirds of patients responded to a 2 mg dose of Bondronat, with blood calcium levels returning to normal. Approximately three-quarters of the patients 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 skeletal related events by approximately 40% compared to placebo.
What is the risk associated with Bondronat?
The most common side effect associated with Bondronat (seen in more than 1 in 10 patients) is pyrexia (increased body temperature). For the full list of 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 as well as in patients sensitive to other bisphosphonates. Bondronat should not be given to children. Bondronat, like all bisphosphonates, may 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 Bondronat's benefits outweigh its risks in the prevention of 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 the granting of a marketing authorization for Bondronat.
Other information about Bondronat:
The European Commission granted Roche Registration Limited a marketing authorization valid throughout the European Union for Bondronat on 25 June 1996. This authorization was renewed on 25 June 2001 and 25 June 2006.
For the full version of Bondronat's EPAR click here.
Last update of this summary: 04-2008.
The information on Bondronat - ibandronic acid published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
