What Xgeva is used for and how to use it
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Xgeva – Consumer Medicine Information

Manufacture: Amgen
Country: United States
Condition: Hypercalcemia of Malignancy, Osteoporosis
Class: Miscellaneous bone resorption inhibitors
Form: Liquid solution, Subcutaneous (SC)
Ingredients: denosumab, glacial acetic acid, sodium hydroxide for pH adjustment, sorbitol (E420), water for injections

Xgeva 120mg/1.7ml solution for injection vials

When used in bone metastases in people with cancer

Xgeva (Exgeevah) is a medicine which is used in bone metastases in people with cancer and giant cell tumour of bone. Xgeva contains denosumab. It is supplied by AMGEN Ltd.

Your medicine

Xgeva is a monoclonal antibody that affects bone metabolism. It is used to treat people who have cancer that has spread to their bones. People who are having Xgeva are usually given calcium and vitamin D supplements.

New bone tissue is constantly added to the bones that make up the skeleton and old tissue is constantly taken away (resorbed). These processes are carried out by special cells. In some medical conditions, such as when cancer has spread to the bones, this process is imbalanced and the loss of bone is speeded up. This means that gradually bones become weaker and are prone to breaks or fractures.

Xgeva works by reducing the activity of the cells that take away old bone. This helps stop the bone maintenance process from becoming imbalanced and slows the rate at which bone is resorbed.

Xgeva is also used to treat giant cell tumour of bone, which cannot be treated by surgery or where surgery is not the best option, in adults and adolescents whose bones have stopped growing.

Other information about Xgeva:

  • it is essential to maintain good oral hygiene during your treatment with Xgeva

Xgeva is usually given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber or someone involved in your medical care.

When to take your medicine

Your prescriber will advise you when you need to have your injections. Xgeva is usually only given once every four weeks. It is a good idea to make a note of the date that your next injection is due so that you do not miss any of your appointments.

How to take your medicine

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

Taking too much of your medicine

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

In the case of Xgeva, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

Stopping your medicine

The person in charge of your care will make the decision about when you should stop this medicine. If you experience any problems while having this medicine, talk to someone who is involved in your medical care.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or call 111.

Looking after your medicine

As Xgeva will be given to you as an injection, it will usually be stored by the medical team.

This medicine will usually be given to you by a health professional. If you have any concerns about this medicine or about the process of taking it you should speak to your doctor, nurse or to the health professional who looks after you.

Whether this medicine is suitable for you

Xgeva is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

  • are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine
  • have kidney problems
  • have liver problems
  • are on dialysis
  • have fructose intolerance
  • have certain type of bone problem
  • have rheumatoid arthritis
  • have had recent oral surgery that has not completely healed
  • have a dental or jaw problem requiring surgery
  • have risk factors for developing osteonecrosis of the jaw such as cancer? radiotherapy treatment to the head and neck? smoking? dental disease? infections? poor oral hygiene? invasive dental procedures such as tooth extraction or dental implants? are elderly or have had treatment with biphosphonates
  • have certain types of metabolic problems or have risk factors for metabolic problems such as low levels of vitamin D or calcium

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for someone who is under the age of 18 years.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects

Over time it is possible that Xgeva can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Xgeva has become unsuitable, it is important that the prescriber is contacted immediately.

Side effects

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side­effects you will have from taking a particular medicine, or whether you will have any side­effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who have Xgeva

  • breathing difficulties
  • diarrhoea
  • muscle, bone or joint pain

Common: More than 1 in 100 people who have Xgeva

  • increased sweating
  • metabolic problems some of these metabolic problems may be fatal. You or your carer should seek medical advice if you have paraesthesia, muscle stiffness, twitching, spasms, muscle cramps, tetany, seizures, mental health problems or coma
  • osteonecrosis of the jaw seek immediate medical advice if you have dental problems such as loose teeth, pain or swelling
  • tooth extraction

Rare: More than 1 in 10,000 people who have Xgeva

  • bone fractures seek medical advice if you have any symptoms such as thigh, hip or groin pain
  • hypersensitivity reactions including anaphylactic reactions

If you feel unwell or if you have concerns about a side­effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call 111.

Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following types of medicine may interact with Xgeva:

  • cytotoxics
  • angiogenesis inhibitors
  • corticosteroids
  • bisphosphonates
  • other medicines containing denosumab
  • chemotherapy

If you are taking Xgeva and one of the above types of medicines, make sure your prescriber knows about it.

Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Xgeva.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

Like all medicines Xgeva can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.

Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Xgeva:

  • there are no specific foods that you must exclude from your diet when having Xgeva

Alcohol

Alcohol can interact with certain medicines.

In the case of Xgeva:

  • there are no known interactions between alcohol and Xgeva

Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Xgeva:

  • the use of this medicine during pregnancy is not recommended
  • Xgeva is a medicine which has implications for pregnancy. You must not become pregnant while you are having it, and for at least five months after you stop having this medicine. If you could become pregnant, you must use effective contraception or abstain from penetrative sex. You must contact your prescriber if you become pregnant, or think you have become pregnant, while having Xgeva

If you become pregnant or think you have become pregnant while taking this medicine you should contact your prescriber.

Breast feeding

Certain medicines can pass into breast milk and may reach your baby through breast­feeding.

In the case of Xgeva:

  • women who are having Xgeva should not breast­feed

Before you have your baby you should discuss breast­feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast­feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast­feed. You should not stop this medicine without taking advice from your doctor.

Ingredients of your medicine

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Xgeva contains:

  • denosumab
  • glacial acetic acid
  • sodium hydroxide for pH adjustment
  • sorbitol (E420)
  • water for injections

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Xgeva before, do not have Xgeva. Talk to your prescriber, pharmacist or nurse as soon as possible.