Active Substance: ibandronic acid
Common Name: ibandronic acid
ATC Code: M05BA06
Marketing Authorisation Holder: Roche Registration Ltd.
Active Substance: ibandronic acid
Authorisation Date: 1996-06-25
Therapeutic Area: Neoplasm Metastasis Hypercalcemia Breast Neoplasms Fractures, Bone
Pharmacotherapeutic Group: Drugs for treatment of bone diseases
Bondronat is indicated for:
- prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases;
- treatment of tumour-induced hypercalcaemia with or without metastases.
What is Bondronat?
Bondronat is a medicine that contains the active substance ibandronic acid. It is available as a concentrate that is made up into a solution for infusion (drip) into a vein and as tablets (50 mg).
What is Bondronat used for?
Bondronat is used in adults in the following ways:
- as an infusion or as a tablet to prevent â€˜skeletal eventsâ€™ (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
- as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
The medicine can only be obtained with a prescription.
How is Bondronat used?
Bondronat treatment should only be started by a doctor who has experience in the treatment of cancer.
In the prevention of skeletal events, Bondronat is either given as a 6-mg infusion lasting at least 15 minutes every three to four weeks, or as one tablet once a day. The tablets must always be taken after the patient has not eaten anything for at least six hours overnight and at least 30 minutes before the first food or drink of the day. They must be taken with a full glass of plain water. (In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used.) Tablets should be taken while standing or sitting up, and they should not be chewed, sucked or crushed. The patient must not lie down for one hour after taking the tablet. Patients with moderate or severe kidney problems should receive Bondronat infusions at a lower dose over an hour, or the tablets every two days or every week.
In the treatment of hypercalcaemia caused by tumours, Bondronat is given over 2 hours as an infusion of either 2 or 4 mg, depending on how severe the hypercalcaemia is. The infusion will normally bring the blood calcium level down to normal levels within a week.
How does Bondronat work?
The active substance in Bondronat, 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.
How has Bondronat been studied?
In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat has been compared with placebo (a dummy treatment) 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 has also been studied in the treatment of hypercalcaemia 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.
What benefit has Bondronat shown during the studies?
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 was also effective in treating hypercalcaemia 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.
What is the risk associated with Bondronat?
The most common side effects with Bondronat infusions are a rise in body temperature, hypocalcaemia (low blood calcium levels), asthenia (weakness) and headache. The most common side effects with the tablets are hypocalcaemia and dyspepsia (heartburn). For the full list of all side effects reported with Bondronat, see the package leaflet.
Bondronat must not be used in people who are hypersensitive (allergic) to ibandronic acid or any of the other ingredients. It must not be used in people with hypocalcaemia. 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.
Why has Bondronat been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Bondronatâ€™s benefits are greater than its risks and recommended that it be given marketing authorisation.
Other information about Bondronat
The European Commission granted a marketing authorisation valid throughout the European Union for Bondronat on 25 June 1996.
Source: European Medicines Agency
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