What is it and how is it used?
The active substance in Zometa is zoledronic acid, which belongs to a group of substances called bisphosphonates. Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change. It is used:
What do you have to consider before using it?
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with Zometa and will check your response to treatment at regular intervals.
You should not be given Zometa:
Before you are given Zometa, tell your doctor:
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important that you tell your doctor if you are also taking:
– Aminoglycosides (medicines used to treat severe infections), since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low. – Thalidomide or any other medicines which may harm your kidneys.
Patients aged 65 years and over
Zometa can be given to people aged 65 years and over. There is no evidence to suggest that any extra precautions are needed.
Use in children
There have been 2 studies on the use of Zometa in children with severe osteogenesis imperfecta (a genetic disorder, also called “brittle bone disease”). However, it has not been established whether these children will benefit from Zometa treatment.
Pregnancy and breast-feeding
You should not be given Zometa if you are pregnant. Tell your doctor if you are or think that you may be pregnant.
You must not be given Zometa if you are breast-feeding.
Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Driving and using machines
The effects of Zometa on driving, using machines and performing other tasks that need your full attention have not been studied. However, there have been very rare cases of drowsiness with the use of Zometa. You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
How is it used?
How much Zometa is given
– The usual single dose given is 4 mg.
– If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
How Zometa is given
– Zometa is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D supplements to be taken each day.
How often you will be given Zometa
– If you are being treated for bone metastases, you will be given one infusion of Zometa every three to four weeks.
– If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zometa.
If you are given more Zometa than you should be
If you have received doses higher than those recommended, you must be carefully monitored by your doctor. This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment. If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
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).
