Iasibon
Authorised
This medicine is authorised for use in the European Union
ibandronic acid
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Iasibon. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Iasibon.
Iasibon 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).
Iasibon is a ‘generic medicine’. This means that Iasibon is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Bondronat.
Iasibon 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.
Iasibon treatment should only be started by a doctor who has experience in the treatment of cancer.
In the prevention of skeletal events, Iasibon 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 should be used). The tablet should be taken while standing or sitting up, and it 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 Iasibon 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, Iasibon 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.
The active substance in Iasibon, 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, Iasibon also helps to reduce the amount of calcium released into the blood.
Because Iasibon is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Bondronat. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Because Iasibon is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The CHMP concluded that, in accordance with EU requirements, Iasibon has been shown to have comparable quality and to be bioequivalent to Bondronat. Therefore, the CHMP’s view was that, as for Bondronat, the benefit outweighs the identified risk. The Committee recommended that Iasibon be given marketing authorisation.
A risk management plan has been developed to ensure that Iasibon is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Iasibon, including the appropriate precautions to be followed by healthcare professionals and patients.
The European Commission granted a marketing authorisation valid throughout the European Union for Iasibon on 21 January 2011.
For more information about treatment with Iasibon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
EMA/VR/0000222634
28/08/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Iasibon
- Active substance
- ibandronic acid
- International non-proprietary name (INN) or common name
- ibandronic acid
- Therapeutic area (MeSH)
- Hypercalcemia
- Fractures, Bone
- Neoplasm Metastasis
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- M05BA06
Pharmacotherapeutic group
Drugs for treatment of bone diseasesTherapeutic indication
Concentrate for solution for infusion
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.
Film-coated Tablets
Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
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