Aclasta

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.

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.

You may need to read it again.

The active ingredient in Aclasta is zoledronic acid, which belongs to a group of medicines called bisphosphonates.

Aclasta is used to treat osteoporosis in postmenopausal women and in men, to prevent additional fractures in men or women who have recently had a hip fracture, or to treat or prevent osteoporosis in men and women caused by treatment with steroid medicines such as prednisone. Aclasta is also used to treat Paget's disease of 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. It also occurs in men and women with increasing age. 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.

Paget's disease is a chronic disorder which may affect various bones of the skeleton. Bone is a living tissue and, just like other parts of the body, it is constantly being renewed. This process is called bone remodelling. In Paget's disease, the bone material breaks down more quickly than usual, and new bone material grows more quickly than usual and in a disordered way. The new bone that is formed may be thicker but weaker than normal, which can cause pain and may lead to fractures (broken bones).

Aclasta works by slowing down bone resorption, which allows the bone-forming cells time to rebuild normal bone. This allows bone remodelling to go back to normal and protects the bones from being weakened.

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.

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.

Other bisphosphonate medicines have been shown to cause breathing difficulties in people with asthma who are allergic to aspirin.

Your doctor may do a blood test to check your calcium levels before you have Aclasta.

There is no information on use of this medicine in pregnancy.

It is not known if the active ingredient, zoledronic acid, passes into the breast milk and could affect your baby.

If it has expired or is damaged, return it to your pharmacist.

Some medicines and Aclasta can interfere with each other. These include:

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.

These directions may differ from the information contained in this leaflet.

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.

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.

A 100mL infusion will last at least 15 minutes.

These symptoms may mean the level of calcium in your blood has fallen too far.

Some people get short-lasting flu-like symptoms after having Aclasta. Paracetamol can provide some relief.

Your doctor may want you to have X-rays, bone density scans or blood tests from time to time to make sure Aclasta is working and to prevent unwanted side effects from happening.

Your doctor can discuss with you the risks of having it while you are pregnant.

A dental condition called jaw osteonecrosis has been reported, primarily in patients being treated with this type of medicine for other illnesses.

Aclasta has no known effect on the ability to drive or use machines but, as a general precaution, if you are travelling home by car after the infusion, arrange to have someone else drive.

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.

Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur.

The above side effects may be serious. You may need urgent medical attention.

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.

It is unlikely you will have to store Aclasta at home.

Heat and dampness can destroy some medicines.

A locked cupboard at least one-and-a-half metres above the floor is a good place to store medicines.

Each Aclasta vial is to be used for one injection only and then discarded.

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.

Each vial of Aclasta contains 5mg of zoledronic acid. Each vial also contains: