diotherapy or surgery, any fractures or any spinal compression.
Zometa has also been compared with pamidronate in two main studies involving a total of 287 adults with hypercalcaemia caused by tumours. The main measure of effectiveness was the number of patients whose calcium levels had returned to normal within 10 days after treatment.
What benefits has it shown during the studies?
In the first two studies of patients with bone metastases, the number of patients who developed a new skeletal event was lower with Zometa (33 to 38%) than with placebo (44%). In the third study, Zometa was as effective as pamidronate: 44% of the patients receiving Zometa had at least one skeletal event, compared with 46% of those receiving pamidronate.
In patients with hypercalcaemia, Zometa was more effective than pamidronate. Looking at the results of the two studies together, 88% of the patients receiving Zometa had normal calcium levels within 10 days after treatment, compared with 70% of those receiving pamidronate.
What is the risk associated?
The most common side effect with Zometa (seen in more than 1 patient in 10) is hypophosphataemia (low blood phosphate levels). For the full list of all side effects reported with Zometa, see the Package Leaflet.
Zometa should not be used in people who may be hypersensitive (allergic) to zoledronic acid, other bisphosphonates or any of the other ingredients. Zometa should not be used in pregnant or breast-feeding women.
Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Zometa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union to Novartis Europharm Limited for Zometa on 20 March 2001. The marketing authorisation is valid for an unlimited period.
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Name
Zometa 4 mg/5 ml concentrate for solution for infusion
Composition
One vial with 5 ml concentrate contains 4 mg zoledronic acid (anhydrous).
One ml concentrate contains zoledronic acid (as monohydrate) corresponding to 0.8 mg zoledronic acid (anhydrous).
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Concentrate for solution for infusion
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