What is Ibandronic acid Accord?
Ibandronic acid Accord is a medicine that contains the active substance ibandronic acid. It is available as a concentrate (2 mg and 6 mg) for solution for infusion (drip into a vein).
Ibandronic acid Accord is a 'generic medicine'. This means that Ibandronic acid Accord is similar to a 'reference medicine' already authorized in the European Union (EU) called Bondronat.
What is Ibandronic acid Accord used for?
Ibandronic acid Accord is used for:
- prevent 'skeletal events' (bone fractures or complications requiring treatment) in patients with breast cancer and bone metastases (spread of cancer to the bone).
- treat hypercalcemia (high levels of calcium in the blood) caused by cancer.
The medicine can only be obtained with a prescription.
How is Ibandronic acid Accord used?
Treatment with Ibandronic acid Accord should be given by a doctor with experience in the treatment of cancer.
In the prevention of skeletal events in patients with breast cancer and bone metastases, Ibandronic acid Accord should be administered as a 6 mg infusion lasting at least 15 minutes every 3-4 weeks. Patients with moderate or severe kidney disease should receive infusions of Ibandronic acid Accord at a lower dose for a duration of one "hour.
In the treatment of tumor-induced hypercalcaemia Ibandronic acid Accord 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 Ibandronic acid Accord work?
The active substance in Ibandronic acid Accord, ibandronic acid, is a bisphosphonate. It blocks the action of osteoclasts, the body's cells responsible for breaking down bone tissue, thereby reducing bone loss. the bones less prone to breakage, with an advantage in terms of fracture prevention in cancer patients with bone metastases.
Patients with cancer may have high levels of calcium in the blood, which is released from the bones. By inhibiting the breakdown of bones, Ibandronic acid Accord helps reduce the levels of calcium released in the blood.
How has Ibandronic acid Accord been studied?
The company presented data on ibandronic acid from the scientific literature. No further studies were needed, as Ibandronic acid Accord is a generic medicine, given by infusion and contains the same active substance as the reference medicine, Bondronat.
What are the benefits and risks of Ibandronic acid Accord
Because Ibandronic acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Ibandronic acid Accord been approved?
The CHMP concluded that, in accordance with EU requirements, Ibandronic acid Accord has been shown to have comparable quality and to be bioequivalent to Bondronat. Therefore, the CHMP considered that, as in the case of Bondronat, the benefits outweigh the identified risks. and recommended the granting of a marketing authorization for Ibandronic acid Accord.
More information about Ibandronic acid Accord
On 11 November 2012, the European Commission issued a "Marketing Authorization" for Ibandronic acid Accord, valid throughout the European Union.
For the complete version of the EPAR of Ibandronic acid Accord, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Ibandronic acid Accord therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 11-2012.
The information on Ibandronic acid Accord 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.
