Bondronat

ibandronic acid

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

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 white, oblong tablets (50 mg).

What is Bondronat used for?

Bondronat is used in the following ways:

• as an infusion or as a tablet to prevent ‘skeletal events’ (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 initiated 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 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 tablet must always be taken after the patient has eaten nothing for at least six hours overnight and at least 30 minutes before the first food or drink of the day, with a full glass of plain water while standing or sitting. 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 tumour-induced hypercalcaemia, Bondronat is given as an infusion of 2 or 4 mg, depending on whether the patient’s hypercalcaemia is moderate (below 3 mmol/l) or severe (above 3 mmol/l). This will normally bring the blood calcium level down to normal levels within seven days.

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 effect with Bondronat infusions (seen in more than 1 patient in 10) is pyrexia (fever). The most common side effects with the tablets (seen in between 1 and 10 patients in 100) are hypocalcaemia (low blood calcium levels), dyspepsia (heartburn), nausea (feeling sick), abdominal pain (stomach ache), oesophagitis (inflammation of the oesophagus, the tube that leads from the mouth to the stomach) and asthenia (weakness). For the full list of all side effects reported with Bondronat, see the Package Leaflet.

Bondronat should not be used in people who may be hypersensitive (allergic) 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 should not be used in children.

Why has Bondronat been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Bondronat’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. The marketing authorisation holder is to Roche Registration Limited. The marketing authorisation is valid for an unlimited period.

This EPAR was last updated on 13/09/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

26/07/2011  Bondronat -EMEA/H/C/000101 -WS/0144

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

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.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents