AREDIA DRY POWDER 15, 30, 60 and 90 mg
(pamidronate disodium)
What you need to know about Aredia Dry Powder
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.
If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
This medicine will usually be referred to just as Aredia in this leaflet.
In this leaflet:
- 1. What Aredia is and what it’s used for
- 2. Things to consider before you start to take Aredia
- 3. How to take Aredia
- 4. Possible side effects
- 5. How to store Aredia
- 6. Further information
What Aredia is and what it’s used for
The Aredia pack includes vials containing the Aredia powder, and ampoules containing Water for Injections. These are used to make up the injection solution.
The active ingredient in Aredia is called pamidronate disodium. This is one of a group of medicines called biphosphonates which can help to regulate the amount of calcium in the blood.
High blood calcium levels (hypercalcaemia) occur in a number of conditions, including some types of cancer. Often, hypercalcaemia is caused by the release of calcium from bones. Aredia sticks to bones and helps to reduce the release of calcium into the blood. If untreated, hypercalcaemia can cause symptoms such as nausea, tiredness and confusion.
Aredia is used to treat high blood calcium levels caused by some cancers. In some patients with cancer, it is also used to treat bone disease and to help relieve bone pain.
Aredia is also used to treat Paget’s disease.
Things to consider before you take Aredia
Some people MUST NOT take Aredia. Talk to your doctor if:
- you think you may be allergic to Aredia or any other biphosphonate, or to the other ingredients of Aredia powder (these are listed at the end of the leaflet).
- you are pregnant or breastfeeding.
Aredia is not suitable for treating children.
You should also ask yourself these questions before taking Aredia:
- Do you suffer from any kidney disease?
- Do you suffer from any heart problems?
- Do you have any liver problems?
- Have you ever had thyroid problems?
- Are you likely to suffer from calcium or Vitamin D deficiency?
- Have you had any problems with your teeth or jaw?
- Are you suffering from a feverish illness e.g. flu or something similar?
If the answer to any of these questions is YES, tell your doctor or nurse because Aredia might not be the right medicine for you.
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell the doctor or nurse if you are taking any of the following:
- Other medicines for high calcium levels such as calcitonin
- Other biphosphonates
- Other medicines that may affect the kidneys (Your doctor or nurse will know which drugs these are.)
- Thalidomide (used to treat some cancers).
Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Other special warnings
- Because treatment with Aredia may affect your jaw bone, you must make sure that your dentist knows that you are having Aredia before you have any dental treatment or surgery.
- You must make sure that you do not become dehydrated while you are being treated with Aredia. Talk to your doctor to make sure you are aware how much you must drink.
- Whilst you are being treated with Aredia, your doctor will want to check your progress by carrying out a number of tests e.g. blood tests and kidney function tests. Remind your doctor you are taking Aredia before he/she does any tests. Aredia may affect the results.
Will there be any problems with driving or using machinery?
If you feel sleepy or dizzy after being treated with Aredia, do not drive or use machinery until these effects wear off.
How to take Aredia
Your doctor will have decided on the right dose depending on your condition.
A doctor or nurse will prepare the injection by dissolving Aredia powder in the water provided and then diluting this solution with a special infusion fluid. The made-up solution must be stored in a refrigerator and used with 24 hours.
Aredia is given by very slow injection into a vein (intravenous infusion). The infusion will take from one to several hours depending on the dose. Your doctor will decide how many infusions you need and how often they will be given.
Dosage guidelines are as follows:
For hypercalcaemia
15-90 mg given as a single or several infusions.
For bone diseases and bone pain
90 mg every 4 weeks. In some patients the dose may be given every 3 weeks at the same time as chemotherapy.
For Paget’s disease
180 mg given as either 30 mg once a week for 6 weeks, or 60 mg every other week for 6 weeks
Your doctor may also give you a test dose of 30 mg to see how you respond to the treatment.
Your doctor may also have prescribed treatment with Calcium and Vitamin D at the same time as Aredia.
What if you have had too much Aredia? (Overdose)
If you think you have either been given or have taken too much Aredia tell your doctor or nurse straight away. If you think you have either been given it or have taken it too often, also tell your doctor or nurse straight away.
What if you miss a dose of Aredia?
If you miss one of your appointments, please let your doctor or nurse know immediately.
Possible side effects
Aredia is suitable for most people, but, like all medicines, it can sometimes cause side effects. The side effects are usually mild and disappear as treatment continues. It is sometimes not clear whether the symptoms are related to your illness or to your treatment.
A very common effect is a mild fever with flu like symptoms such as sore throat, shivering, high temperature or hot flushes, which occur at the start of treatment and last for 24-48 hours. Some patients notice an increase in bone pain soon after starting treatment. This usually improves after a few days. If it does not, tell your doctor.
Some side effects can be serious
Tell the doctor straight away if you notice:
- Bronchospasm with wheezing or coughing and difficulty in breathing, or swelling of your face, lips or hands.
- If you feel faint (you might have low blood pressure), have a rash, or experience itching or facial swelling.
These might be the result of an allergic reaction which is very rare (likely to affect fewer than 1 in 10,000 patients).
The side effects listed below have also been reported.
Up to 1 in 10 people have experienced:
- Pain, redness or swelling at the infusion site
- Skin rash or unexplained bruising/increased bleeding
- Joint or muscle pain
- Nausea, vomiting , loss of appetite, stomach pain, gastritis, constipation or diarrhoea
- Headache, sleeplessness, tiredness
- Conjunctivitis
- Tingling in hands and feet and muscle spasms (symptoms of low level of calcium)
- High blood pressure
- Low level of white blood cells (leucopenia) or red blood cells (anaemia)
- Changes in blood test results (including low potassium, low phosphate, low magnesium and raised serum creatinine levels or, very rarely, raised potassium or sodium levels).
Up to 1 in 100 people have experienced:
- Muscle cramps
- Dizziness, lethargy, feeling agitated, seizures
- Problems with vision, painful red eyes
- Low blood pressure
- Itching, indigestion
- Deterioration of kidney function (e.g. unexpected change in the amount of urine produced and/or its appearance), abnormal liver function tests or increases in serum urea
- Problems with teeth or jaw.
Up to 1 in 1,000 people have experienced:
A change in kidney function known as glomerulosclerosis, some of the symptoms of this condition may be, fluid retention, nausea and fatigue. Tell your doctor if you suspect that you might have these symptoms
Up to 1 in 10,000 people have experienced:
- Cardiac effects which may include a difficulty in breathing and fluid retention
- Worsening of an existing kidney problem e.g. blood in urine
- A flare-up of cold sores or shingles
- Confusion or visual hallucinations (seeing things that are not there).
If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor.
How to store Aredia
The vials of Aredia powder before they are made up into the injection should be stored below 30°C. The made-up solution must be stored in a refrigerator and used with 24 hours.
Any unused solution should be thrown away.
Keep out of the reach and sight of children.
Do not use Aredia after the expiry date which is printed on the outside of the pack.
If your doctor tells you to stop taking Aredia and you have been keeping some at home, please take any unused vials back to your pharmacist to be destroyed. Do not
throw them away with your normal household water or waste. This will help to protect the environment.
Further information
Aredia is available in clear glass vials containing either 15, 30, 60 or 90 mg of pamidronate disodium powder. The vials also contain the inactive ingredients mannitol and phosphoric acid.
Aredia packs contain 1, 2 or 4 vials of powder. Each pack also contains 1 ampoule of water (5 ml ampoules for 15 and 30 mg vials and 10 ml ampoules for 60 and 90 mg vials) for every Aredia vial.
Not all of the pack sizes are marketed.
The product licence holder is
Surrey
The manufacturer responsible for the release on to the market is
This leaflet was revised in January 2007.
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.
AREDIA is a registered Trade Mark
Copyright Novartis Pharmaceuticals UK Limited
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