Consumer Medicine Information
ACLASTA®
5mg / 100ml solution for infusion
Zoledronic acid
What is in this leaflet
This leaflet answers some common questions about Aclasta.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine. You can also download the most up-to-date leaflet from www.medsafe.govt.nz
Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you having Aclasta against the benefits they expect it will have for you.
If you have any concerns about having this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What Aclasta is used for
The active ingredient in Aclasta is zoledronic acid, which belongs to a group of medicines called bisphosphonates.
Aclasta is used to treat pagets' disease of the bone, osteoporosis in men, treatment and prevention of osteoporosis in postmenopausal women, treatment and prevent of osteoporosis caused by treatment with steroid medicines, or to prevent additional fractures in patients who have recently had a hip fracture.
In Paget's disease, the bone material breaks down too much, new bone material grows too quickly, and in a disordered way. The bone material produced is weaker than normal. If the disease is not treated, bones may become deformed and painful, and may break. Aclasta works by returning the bone remodelling process to normal, and restoring strength to the bone.
Osteoporosis is a disease which causes bones to become less dense, gradually making them weaker, more brittle and likely to break. This is common in women after menopause, when a woman's ovaries stop producing the female hormone, oestrogen, which keeps bones healthy.. Broken bones may result from injury or simple falls. Breaks may occur during normal everyday activity, such as lifting, or from minor injury that would not ordinarily fracture normal bone. Fractures in people with osteoporosis usually occur at the hip, spine or wrist. These can lead not only to pain, but also to considerable deformity and disability, such as stooped posture from curvature of the spine, and loss of mobility.
Aclasta works by strengthening bones, making them less likely to break. Since it works for a long time, you will not need another dose for a year.
Ask your doctor if you have any questions about why this medicine has
been prescribed for you.
Your doctor may have prescribed it for another reason.
Aclasta is only available with a doctor's prescription. It is not addictive.
There is not enough information to recommend the use of this medicine for children or adolescents.
Before you have Aclasta
When you must not have it
You must not have Aclasta if you have an allergy to:
- zoledronic acid (the active ingredient in Aclasta) or any of the other ingredients list at the end of this leaflet.
- any other bisphosphonate medicine.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
If you are not sure whether you are allergic to other bisphosphonate
medicines, talk to your doctor.
Other bisphosphonate medicines have been shown to cause breathing
difficulties in people with asthma who are allergic to aspirin.
Do not have Aclasta if you have low levels of calcium in your blood.
Your doctor may do a blood test to check your calcium levels before you
have Aclasta.
Do not have Aclasta if you are pregnant.
There is no information on use of this medicine in pregnancy.
Do not breast-feed while you are having treatment with Aclasta.
It is not known if the active ingredient, zoledronic acid, passes into the
breast milk and could affect your baby.
Do not have Aclasta after the expiry date printed on the pack or if the
packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist.
If you are not sure whether you should be given this medicine, talk to your doctor.
Before you have it
Tell your doctor if
- you are being treated with Zometa, which contains the same active ingredient as in Aclasta
- you have been treated with another bisphosphonate medicine prior to Aclasta
- you have a kidney problem. This medicine is not suitable for some people with a kidney problem.
- you are on diuretic therapy (commonly called 'fluid tablets')
- you have a calcium deficiency or a vitamin D deficiency
- you are unable to take daily calcium or vitamin D supplements
- you have had some or all of your parathyroid or thyroid glands in your neck surgically removed
- you have had sections of your intestine removed
- you have or have had pain, swelling or numbness of the jaw or loosening of a tooth
- you are under dental treatment or will undergo dental surgery. Your doctor will check your oral health before you start treatment with Aclasta. Discuss with him or her any planned dental surgery such as a tooth extraction. Tell your dentist that you are being treated with Aclasta.
- you have or have had uveitis or iritis (inflammatory conditions of the eye).
Taking other medicines
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Aclasta can interfere with each other. These include:
- medicines that may have side effects on your kidneys
- aminoglycoside medicines used to treat severe infections.
You may need to take different amounts of these medicines or you may need to take different medicines. Your doctor or pharmacist has more information.
How Aclasta is given
Follow all directions given to you by your doctor, nurse and pharmacist
carefully.
These directions may differ from the information contained in this
leaflet.
If you do not understand the instructions, ask your doctor, nurse or pharmacist for help before treatment starts.
How it will be given
Aclasta will be given to you by infusion into a vein by your doctor or nurse once a year. The infusion will take at least 15 minutes.
If you had a recent hip fracture after a fall from a standing position or lower, a dose of 50,000 to 125,000 IU of vitamin D will be given to you orally or via the intramuscular route by your doctor or nurse prior to the first Aclasta infusion.
Make sure you drink enough fluids before and after the treatment with Aclasta as directed by your doctor.
Two glasses of fluid (such as water) before and after the infusion are usually enough. This will help to prevent dehydration.
You may eat normally on the day you are treated with Aclasta.
How much is given
A 100mL infusion will last at least 15 minutes.
How long treatment will last
Each dose of Aclasta lasts one year. Your doctor will check your condition and may prescribe further treatment.
If you have too much (overdose)
Immediately telephone your doctor or the National Poisons Information Centre (telephone 0800 POISON or 0800764766), or go to the Accident and Emergency department at your nearest hospital if you think that an overdose has happened. Do this even if there are no signs of discomfort or poisoning.
Tell your doctor if you have any of the following symptoms:
- muscle spasms
- numbness or tingling sensation, especially around the mouth
- shortness of breath.
These symptoms may mean the level of calcium in your blood has fallen too far.
While you are being given Aclasta
Things you must do
Take paracetamol for the first three days if your doctor has told you
to.
Some people get short-lasting flu-like symptoms after having Aclasta.
Paracetamol can provide some relief.
Take calcium and vitamin D supplements if your doctor has told you to.
Most people do not get enough calcium and vitamin D in their diet and
supplements are needed to help strengthen your bones.
Keep all of your doctor's appointments so that your progress can be
checked.
Your doctor may want you to have X-rays, bone density scans or urine tests
from time to time to make sure Aclasta is working and to prevent unwanted side
effects from happening.
Tell your doctor immediately if you become pregnant while having
treatment with this medicine.
Your doctor can discuss with you the risks of having it while you are
pregnant.
Tell your doctor and dentist immediately about any dental symptoms
including persistent pain and/or non-healing sores of the mouth or jaw.
A dental condition called jaw osteonecrosis has been reported, primarily
in patients being treated with Aclasta or other bisphosphonates for other
illnesses.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being treated with Aclasta.
Tell any other doctor, dentist or pharmacist who treats you that you are having Aclasta.
Things to be careful of
Be careful driving or operating machinery until you know how Aclasta
affects you.
Aclasta has no known effect on the ability to drive or use machines but,
as a general precaution, if you are driving home after the infusion, arrange
to have someone else drive.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are having Aclasta.
All medicines can have side effects. Sometimes they are serious, most of
the time they are not. You may need medical attention if you get some of the
side effects.
Do not be alarmed by the following list of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
- short-lasting fever, sometimes with flu-like symptoms, headache, sickness, chills, pain or aching in the muscles, bones or joints
- redness, swelling or pain where the needle for the infusion was inserted
- upset stomach, indigestion, gastritis abdominal pain, loss of appetite, taste disturbance, thirst
- nausea, vomiting or diarrhoea, constipation
- dry mouth, toothache or sore throat
- lack of energy, weakness, dizziness, pain in your back, arms or legs, swollen or stiff joints,, muscle weakness or spasm
- swollen fingers or lower legs due to fluid build-up
- swollen, red, painful or itchy eyes (conjunctivitis) or sensitivity of the eyes to light, blurred vision,
- palpitations (feeling of fast or irregular heartbeat), which may be accompanied by dizziness and breathlessness
- pain in chest muscles and rib cage
- difficulty sleeping.
- frequent unrination
- anaemia (low iron levels)
- increased protein levels in the blood
- increased perspiration, night sweats
- reduced alertness and awareness
- anxiety
- decreased skin sensitivity
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following after you have Aclasta:
- signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath
- signs that the level of calcium in your blood may have fallen too far, such as muscle spasms, numbness or tingling sensation, especially around the mouth, shortness of breath
- persistent pain and/or non-healing sores of the mouth, or jaw, swelling or numbness of the jaw or loosening of a tooth. These symptoms could be a sign of a jaw-bone problem known as jaw osteonecrosis.
The above side effects may be serious. You may need urgent medical attention.
Tell your doctor or pharmacist if you notice anything that is making you
feel unwell.
Other side effects not listed above may also occur in some people. Some of
these (e.g. effects on kidney function and on the level of calcium in the
blood) can only be found by laboratory testing.
After having Aclasta
Storage
It is unlikely you will have to store Aclasta at home.
If you do have to store it:
- Store the medicine in a cool dry place at room temperature
- Do not store Aclasta or any other medicine in the bathroom or near a sink
- Do not leave it in the car or on a window sill.
Heat and dampness can destroy some medicines.
Keep the medicine where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.
Each Aclasta vial is to be used for one infusion only and then discarded.
Disposal
If you no longer need Aclasta or it has passed its expiry date, return any unused medicine to your pharmacist.
Product description
What it looks like
Aclasta solution for infusion is supplied in a transparent plastic vial containing 100mL of a clear, colourless solution. Aclasta is supplied as packs containing one vial.
Ingredients
Each vial of Aclasta contains 5mg of zoledronic acid. The vials also contain mannitol, sodium citrate and water for injections.
Sponsor
Aclasta is supplied in New Zealand by:
Novartis New Zealand Limited
Private Bag 65904
Mairangi Bay
Auckland
Building G, 5 Orbit Drive
Rosedale
Auckland 0632
Telephone 0800 652 422
Date of preparation
This leaflet was prepared on 8 October 2009 based on the current data sheet for this product.
® = Registered trademark