Aclasta (zoledronic acid)

How does it work?

Aclasta infusion contains the active ingredient zoledronic acid, which is a type of medicine called a bisphosphonate. Bisphosphonates are medicines that reduce the turnover of bone.

Bone is not a static structure. It is continually shaped, reformed and rebuilt by cells called osteoblasts and osteoclasts. These cells continously deposit and remove calcium and phophorous, stored in a protein network that makes up the structure of the bone. Old bone is broken down by the osteoclasts and new bone is formed by the osteoblasts.

In Paget's disease of bone the normal metabolism of bone is disturbed. There is an increase in bone breakdown by the osteoclasts and increased and irregular formation of new bone by the osteoblasts. The normal bone marrow also becomes replaced with blood vessels and fibrous tissue. In this disease there are often no symptoms for many years, but over time the bones can become enlarged, deformed, painful, weak and prone to breaking. The enlarged and deformed bones can also put pressure on nerves, causing pain and muscle weakness.

In women at the menopause, blood levels of the female hormone oestrogen start to decrease. This results in an increase in bone breakdown by the osteoclasts, which can lead to a loss of bone density. Bone loss is particularly rapid for the first ten years after the menopause and it may lead to the development of osteoporosis - a condition in which the bones become weak and brittle and break (fracture) more easily.

Zoledronic acid works by binding very tightly to the bone and preventing the calcium being removed by the osteoclasts. This stops the osteoclasts from breaking down the bone. The reduced bone turnover helps to reduce deformity and keep the bones strong and less likely to break.

Zoledronic acid is given as a single dose for treating Paget's disease of bone. It is given via a drip into a vein (intravenous infusion) over at least 15 minutes. For the treatment of postmenopausal osteoporosis zoledronic acid is given as a single dose once a year.

As this medicine slows bone turnover and so prevents calcium being reabsorbed from the bones into the blood, it can cause the amount of calcium in your blood to fall too low. Your doctor may ask you to take calcium and vitamin D supplements before you have your infusion and for at least ten days after it to prevent this. Calcium and vitamin D are also needed for strong bones and your doctor may ask you to continue to take supplements of these if your dietary intake is too low, or you are at risk of deficiency.

What is it used for?

Bone disease called Paget's disease, in which there is excessive breakdown of bone and increased and irregular formation of bone, causing the bones to become enlarged, deformed, painful, weak and prone to breaking.

Treatment of osteoporosis in postmenopausal women with high risk of fracture.

Warning!

Your doctor may want you to have a blood test before your infusion to check the level of calcium in your blood. After you have had your infusion, your doctor may also want you to have further blood tests to monitor the level of calcium in your blood. Your calcium level may drop in the first 10 days after your infusion and your doctor may prescribe you calcium and vitamin D supplements to prevent this. (Vitamin D is needed by the body to help it absorb calcium.) If the amount of calcium in your blood falls too low, this may cause symptoms such as muscle spasms, numbness, or tingling sensations, especially in the area around the mouth. Tell your doctor if you get any of these symptoms.

It is important that you drink enough fluid both before and after your infusion to prevent dehydration. Follow your doctors instructions.

The class of medicines that zoledronic acid belongs to (bisphosphonates) has been associated with a condition called osteonecrosis of the jaw. The majority of cases of this condition have been in cancer patients treated with bisphosphonates by injection into a vein and many of these patients were also having treatment with chemotherapy or corticosteroids. However, the risk may also be increased by poor oral hygiene, dental problems, teeth extractions and oral surgery. For this reason, your doctor may want you to have a dental examination and, if necessary, appropriate preventive dentistry, before you start treatment with this medicine. Discuss this with your doctor. It is important to look after your mouth and teeth as much as possible while you are receiving this medicine. Invasive dental procedures such as tooth extraction or surgery should be avoided if possible. If you need to see a dentist during treatment, make sure they know you are receiving this medicine.

Use with caution in

Decreased kidney function.

Dehydration.

People receiving treatment with diuretic medicines.

Disorders of the parathyroid gland (gland that produces hormones responsible for regulating calcium metabolism).

Vitamin D deficiency.

Not to be used in

Allergy to other bisphosphonate medicines.

People with a low level of calcium in their blood (hypocalcaemia).

Children and adolescents.

Pregnancy.

Breastfeeding.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine during pregnancy has not been established. It should not be used during pregnancy. Seek medical advice from your doctor.

It is not known if this medicine passes into breast milk. It should not be given to women who are breastfeeding. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Flu-like symptoms.

High temperature (fever).

Disturbances of the gut, such as diarrhoea, indigestion, nausea and vomiting.

Headache.

Dizziness.

Bone pain.

Pain in the muscles or joints.

Pain in the extremities, eg hands and feet.

Low blood calcium level (hypocalcaemia).

Shortness of breath.

Lethargy.

Fatigue.

Weakness or loss of strength (asthenia).

Anorexia.

Insomnia (inability to sleep).

Redness, swelling or pain at the infusion site.

Rash.

Increased blood creatinine levels.

Inflammation of the membrane lining the eye (conjunctivitis).

Inflammation of the coloured part of the eye (iritis).

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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