What is Zoledronic acid Actavis?
Zoledronic acid Actavis is a medicine that contains the active substance zoledronic acid (4 mg). It is available as a concentrate for solution for infusion (drip into a vein).
Zoledronic acid Actavis is a "generic medicine". This means that Zoledronic acid Actavis is similar to a 'reference medicine' already authorized in the European Union (EU) called Zometa.
What is Zoledronic acid Actavis used for?
Zoledronic acid Actavis can be used in adults to prevent bone complications in adults with advanced bone cancer. This includes fractures (bone breakage), vertebral compressions (when the spinal cord is compressed by the bone), bone disorders that require radiotherapy (treatment with radiation) or surgery and hypercalcaemia (high levels of calcium in the blood). Zoledronic acid Actavis can also be used to treat hypercalcaemia caused by tumors.
The medicine can only be obtained with a prescription.
How is Zoledronic acid Actavis used?
Zoledronic acid Actavis should only be used by a doctor experienced in the use of this type of medicine administered intravenously.
The normal dose of Zoledronic acid Actavis is an infusion of 4 mg in at least 15 minutes. When used to prevent bone complications, the infusion can be repeated every 3-4 weeks, and patients must also take calcium and vitamin D supplements. A lower dose is recommended for patients with bone metastases (when the cancer has spread to 'bone) if they have mild to moderate kidney problems. It is not recommended in patients with severe kidney problems.
How does Zoledronic acid Actavis work?
The active substance in Zoledronic acid Actavis is a bisphosphonate. It blocks the action of the osteoclasts, the body's cells responsible for breaking down the bone tissue, thereby reducing bone loss. This reduction helps make the bones less prone to breakage, with an advantage in terms of preventing fractures in cancer patients with bone metastases.
Patients with tumors may have high levels of calcium in the blood, which is released from the bones. By inhibiting bone decomposition, Zoledronic acid Actavis helps to reduce the levels of calcium released into the blood.
What studies have been performed on Zoledronic acid Actavis?
The company presented data on zoledronic acid taken from the scientific literature. No further studies were necessary as Zoledronic acid Actavis is a generic medicine, given by infusion and containing the same active substance as the reference medicine, Zometa.
What are the risks and benefits of Zoledronic acid Actavis?
Because Zoledronic acid Actavis is a generic medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Zoledronic acid Actavis been approved?
The CHMP concluded that, in accordance with the requirements of the European Union, Zoledronic acid Actavis has been shown to have qualities comparable to Zometa. Therefore, the CHMP considered that, as in the case of Zometa, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Zoledronic acid Actavis.
Further information on Zoledronic acid Actavis
On 20 April 2012, the European Commission issued a marketing authorization for Actavis zeltronic acid, valid throughout the European Union.
For more information on Zoledronic acid Actavis therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 03-2012.
