Zometa 4 mg/5 ml concentrate for solution for infusion
Zoledronic acid
Read all of this leaflet carefully before you are given Zometa.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- If any of the side effects gets serious, or if you notice side effects not listed in this leaflet, please
tell your doctor, nurse or pharmacist.
In this leaflet
- 1. What Zometa is and what it is used for
- 2. Before you are given Zometa
- 3. How Zometa is used
- 4. Possible side effects
- 5. How to store Zometa
- 6. Further information
What Zometa Is And What It Is Used For
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:
To treat bone metastases (spread of cancer from the primary cancer site to the bone) and to prevent associated/related bone complications, e.g. fractures.
To reduce the amount of calcium in the blood in cases where it is too high due to the presence of a tumour. Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased. This condition is known as tumour-induced hypercalcaemia (TIH).
Before You Are Given Zometa
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:
- if you are breast-feeding.
- if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the group of substances to which Zometa belongs), or any of the other ingredients of Zometa.
Before you are given Zometa, tell your doctor:
- if you have or have had a liver problem.
- if you have or have had a kidney problem.
- if you have or have had a heart problem.
- if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
- if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zometa.
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 Zometa Is Used
- Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
- Carefully follow all the other instructions given to you by your doctor, nurse or pharmacist.
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.
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:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency cannot be estimated from the available data.
Tell your doctor about any of the following side effects as soon as possible:
Very common:
- Low level of phosphate in the blood.
Common:
- Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache. In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
- Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
- Conjunctivitis, as reported with other bisphosphonates (the group of substances to which Zometa belongs).
- Blood tests indicating changes in kidney function (higher levels of creatinine), including severe kidney impairment. Such changes are also known to occur with other medicinal products of this kind. In addition, some cases of kidney disease have been reported.
- Low level of red blood cells (anaemia).
- Low level of calcium in the blood.
Uncommon:
- Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis). Tell your doctor and dentist immediately if you experience such symptoms.
- Hypersensitivity reactions.
- Low blood pressure.
- Chest pain.
- Skin reactions (redness and swelling) at the infusion site, rash, itching.
- High blood pressure, shortness of breath, dizziness, sleep disturbances, tingling or numbness of the hands or feet, diarrhoea.
- Low counts of white blood cells and blood platelets.
- Low level of magnesium and potassium in the blood. Your doctor will monitor this and take any necessary measures.
Rare:
- Slow heart beat.
- Confusion.
Very rare:
- Fainting due to low blood pressure.
- Severe bone, joint and/or muscle pain, occasionally incapacitating.
- Painful redness and/or swelling of the eye.
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 To Store Zometa
Your doctor, nurse or pharmacist knows how to store Zometa properly (see section 6).
Further Information
What Zometa contains
- The active substance of Zometa is zoledronic acid.
- The other ingredients are: mannitol, sodium citrate, water for injections.
What Zometa looks like and contents of the pack
Zometa is supplied as a liquid concentrate in a vial. One vial contains 4 mg of zoledronic acid.
Each pack contains the vial with concentrate. Zometa is supplied as packs containing 1, 4 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
This leaflet was last approved in January 2010
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