How does it work?

Zometa infusion contains the active ingredient zoledronic acid,which is a type of medicine called a bisphosphonate. Bisphosphonates aremedicines 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 cellscontinously deposit and remove calcium and phophorous, stored in a proteinnetwork that makes up the structure of the bone. Old bone is broken down by theosteoclasts and new bone is formed by the osteoblasts.

Biphosphonates work by binding very tightly to the bone tissueand preventing the calcium being removed by the osteoclasts. This stops theosteoclasts from breaking down the bone.

Cancers involving the bone, for example breast or prostatecancer that has spread to the bone, or bone marrow cancer (multiple myeloma),can cause excessive bone breakdown. This causes areas of bone weakness that canlead to bone pain and fractures. Zoledronic acid can be used in thesesituations to bind to the bone and prevent it being broken down.

Zoledronic acid also has some anti-cancer effect on thecancerous cells in the bone, which helps reduce the growth of the cancer in thebones. This can help prevent the cancer from pressing on nerves, particularlyin the spine, and reduce the need for surgery or radiotherapy on thebones.

When the osteoclasts remove calcium from the bones, the calciumthen seeps into the blood. The excessive breakdown of bone that occurs whencancer spreads to the bones can therefore lead to high levels of calcium in theblood. This can cause symptoms such as nausea, tiredness and confusion. Aszoledronic acid prevents the calcium being removed from the bone, it can beused to treat high levels of calcium in the blood that are a result of cancer.

As the medicine slows bone turnover and so prevents calciumbeing reabsorbed from the bones into the blood, it can cause the amount ofcalcium in your blood to fall too low. Your doctor may therefore ask you totakecalcium andvitamin D supplements to prevent this. (Vitamin D isneeded by the body to help it absorb calcium.)

What is it used for?

• Preventing bone complications (such as fractures, bone complications requiring radiotherapy or surgery, compression of nerves in the spine, or high blood calcium levels) in people with advanced cancer involving the bones, for example breast cancer or prostate cancer that has spread to the bones, or bone marrow cancer (multiple myeloma).
• Reducing high levels of calcium in the blood (hypercalcaemia) caused by tumours.

How is it given?

• Zometa infusion isgiven via a drip into a vein (intravenous infusion) over at least 15 minutes.
• For preventing bone complications of cancer, the drip is given every three to four weeks.
• Zometa infusion is given as a single dose to lower high bloodcalcium levels that are the result of tumours.

Warning!

• You will need to have regular blood tests while you are having treatment with this medicine, in order to check your kidney function and the level of calcium and other minerals in your blood. This is particularly important if you have any existing problems with your kidneys, or you are also taking diuretic medicines or other medicines that can affect the kidneys.
• It is important that you drink enough fluid both before and after your infusion to prevent dehydration. However, it is important to follow your doctors instructions regarding this, particularly if you have a heart condition or are at risk of heart failure. If you are unable to take fluids by mouth your doctor may need to give you a drip to rehydrate you.
• The class of medicines that zoledronic acid belongs to (bisphosphonates) has been associated with a rare 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 people were also having treatment with chemotherapy or corticosteroids. The risk may also be increased by poor oral hygiene, dental problems such as gum disease or poorly fitting dentures, teeth extractions, oral surgery and smoking. For this reason, you should 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 having treatment with this medicine. You should have regular check-ups with your dentist and get advice straight away if you have any problems with your mouth or teeth. When you see a dentist during treatment, make sure they know you are having this medicine. Invasive dental procedures such as tooth extraction or surgery should be avoided if possible.
• Some people being treated with bisphosphonates (mainly people having long-term treatment for osteoporosis) have experienced an unusual fracture of their thigh bone. For this reason it is important to let your doctor know if you get any pain in your thighs, hips or groin while you are having treatment with this medicine. These symptoms could be an early indication of a possible fracture.

Use with caution in

• Elderly people.
• Decreased kidney function.
• Dehydration.

Not to be used in

• People who are allergic to other bisphosphonate medicines.
• People with a low level of calcium in their blood (hypocalcaemia).
• People with severely decreased kidney function.
• Pregnancy.
• Breastfeeding.
• This medicine is not recommended for children and adolescents under 18 years of age.

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

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

Pregnancy and breastfeeding

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

• The safety of this medicine for use 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 individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• High temperature (fever).
• Flu-like symptoms.
• Headache.
• Anaemia.
• Inflammation of the membrane lining the eye (conjunctivitis).
• Loss of appetite.
• Feeling sick and vomiting.
• Bone pain.
• Pain in the muscles or joints.
• Muscle cramps.
• Decreased kidney function.
• Low blood calcium or phosphate level (hypocalcaemia or hypophosphataemia).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Feeling weak.
• Swollen ankles caused by fluid retention.
• Pain, swelling or redness at the infusion site.
• Decreased numbers of white blood cells or platelets in the blood.
• Sleep disturbance.
• Anxiety.
• Dizziness.
• Pins and needles or numb sensations.
• Taste disturbance.
• Tremor.
• Sleepiness.
• Blurred vision.
• Other forms of eye inflammation.
• Changes in blood pressure.
• Irregular heartbeat (atrial fibrillation).
• Cough.
• Shortness of breath.
• Gut disturbances such as diarrhoea, constipation, abdominal pain or indigestion.
• Dry or sore mouth.
• Skin reactions such as rash, sweating or itching.
• Osteonecrosis of the jaw (see warning section above).
• Kidney failure.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Unusual fractures of the thigh bone (see warning section above).
• Confusion.
• Slow heart rate.

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

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

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines while being treated with this one, to make sure that thecombination is safe.

This medicine should be used with caution in people who aretaking medicines that can affect kidney function, for example aminoglycoside antibioticssuch as gentamicin or diuretics such asfurosemide, or thalidomide. Medicines that affect kidney function could increase the chance of side effects from this medicine.

There may an increased chance of the amount of calcium in the blood falling too low if aminoglycoside antibiotics such as gentamicin are used in combination with this medicine.

Other medicines containing the same active ingredient