What are possible side effects?
Like all medicines, Zometa can cause side effects, although not everybody gets them. The most common ones are usually mild and will probably disappear after a short time.

The frequency of possible side effects listed below is defined using the following convention:

Tell your doctor about any of the following side effects as soon as possible:

Very common:

Common:

Uncommon:

Rare:

Very rare:

Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis. It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

How should it be stored?
Your doctor, nurse or pharmacist knows how to store Zometa properly (see section 6).

↑ back to table of contents ↑
For doctors
What is it?
Zometa is a medicine that contains the active substance zoledronic acid. It is available as a powder and solvent, and as a concentrate, which are made up into a solution for infusion (drip into a vein).

What is it used for?
Zometa can be used to prevent bone complications in adults with advanced cancer that is affecting the bone. This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood). Zometa can also be used to treat the hypercalcaemia caused by tumours.
The medicine can only be obtained with a prescription.

How is it used?
Zometa must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
The usual dose of Zometa is one infusion of 4 mg over at least 15 minutes. When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys. It is not recommended for patients with severe kidney problems.

How does it work?
The active substance in Zometa, zoledronic 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, Zometa also helps to reduce the amount of calcium released into the blood.

How has it been studied?
Zometa has been studied in over 3,000 adults with bone metastases in three main studies looking at its ability to prevent bone damage. Zometa was compared with placebo (a dummy treatment) in two of the studies, and with pamidronate (another bisphosphonate) in the third. The main measure of effectiveness was the number of patients who developed at least one new ‘skeletal event’ over 13 months. This included any bone complications needing treatment with ra