EXJADE 250 mg dispersible tablets Deferasirox - United Kingdom[英国药品]

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EXJADE 250 mg dispersible tablets Deferasirox

2013-10-30 22:38:42 来源: 作者: 【大中小】浏览:645次评论:0条

For doctors

What is it and how is it used?

What EXJADE is
EXJADE contains an active substance called deferasirox. It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload).

What EXJADE is used for
EXJADE is used to treat iron overload caused by blood transfusions.

Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes). However, repeated blood transfusions can cause a build-up of excess iron. This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions. Over time, the excess iron can damage important organs such as the liver and heart. Medicines called iron chelators are used to remove the excess iron and reduce the risk of it causing organ damage.

EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.

EXJADE is also used when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.

How EXJADE works
EXJADE traps and removes excess iron which is then excreted mainly in the stools.

Monitoring your EXJADE treatment
You will have regular blood and urine tests during treatment. These will monitor the amount of iron in your body (blood level of ferritin) to see how well EXJADE is working. The tests will also monitor your kidney function (blood level of creatinine, presence of protein in the urine) and liver function (blood level of transaminases). Your doctor will take these tests into consideration when deciding on the dose of EXJADE most suitable for you.

You will get a booklet from your doctor which will help you to track your response to EXJADE. Your doctor will write your blood tests in this booklet at each visit. Keep the booklet safe and bring it with you each time you visit your doctor.

Your eyesight and hearing will be tested each year during treatment as a precautionary measure.

If you have any questions about how EXJADE works or why this medicine has been prescribed for you, ask your doctor.

What do you have to consider before using it?

Follow all the doctor’s instructions carefully. They may differ from the general information in this leaflet.

Do not take EXJADE

EXJADE is not recommended

Take special care with EXJADE

Taking other medicines
Antacids (medicines used to treat heartburn) containing aluminium should not be taken at the same time of day as EXJADE.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes in particular:

Additional tests may be required to monitor the blood levels of some of these medicines.

Older people (age 65 years and over)
EXJADE can be used by people aged 65 years and over at the same dose as for other adults. Elderly patients may experience more side effects than younger patients. They should be monitored closely by their doctor for side effects that may require a dose adjustment.

Children and adolescents (age 2 years to 17 years)
EXJADE can be used in adolescents and children aged 2 years and over. As the patient grows the doctor will adjust the dose.

Pregnancy and breast-feeding
EXJADE is not recommended during pregnancy unless clearly necessary. If you are pregnant or think that you may be, tell your doctor who will discuss with you whether you can take EXJADE during your pregnancy.

Breast-feeding is not recommended during treatment with EXJADE. Tell your doctor if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
If you feel dizzy after taking EXJADE, do not drive or operate any tools or machines until you are feeling normal again.

Important information about some of the ingredients of EXJADE
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How is it used?

Always take EXJADE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much EXJADE to take
The dose of EXJADE is related to body weight for all patients. Your doctor will calculate the dose you need and tell you how many tablets to take each day.
- The usual daily dose at the start of the treatment is 20 mg per kilogram body weight. A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
- Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose.
- The maximum recommended daily dose is 40 mg per kilogram body weight.

When to take EXJADE
- Take EXJADE once a day, every day, at about the same time each day.
- Take the tablets on an empty stomach.
- Then wait at least 30 minutes before eating any food.
Taking EXJADE at the same time each day will help you remember when to take your tablets.

How long to take EXJADE
Continue taking EXJADE every day for as long as your doctor tells you. This is a long-term treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 1: “Monitoring your EXJADE treatment”).

If you have questions about how long to take EXJADE, talk to your doctor.

If you take more EXJADE than you should
If you have taken too much EXJADE, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice straight away. Show them the pack of tablets. Medical treatment may be necessary.

If you forget to take EXJADE
If you miss a dose, take it as soon as you remember on that day. Take your next dose as scheduled. Do not take a double dose on the next day to make up for the forgotten tablet(s).

If you stop taking EXJADE
Do not stop taking EXJADE unless your doctor tells you to. If you stop taking it, the excess iron will no longer be removed from your body (see also above section “How long to take EXJADE”).

What are possible side effects?

Like all medicines, EXJADE can cause side effects, although not everybody gets them. Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects could become serious.
These side effects are uncommon, that is they may affect less than 1 in every 100 patients. - If you get blurred or cloudy eyesight,
- If you get reduced hearing,
tell your doctor as soon as possible.

Some side effects are very common.
These side effects may affect more than 1 in every 10 patients.
- Disturbance in renal function tests.

Some side effects are common.
These side effects may affect between 1 and 10 in every 100 patients.
- Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating, constipation, indigestion
- Rash
- Headache
If any of these affects you severely, tell your doctor.

Other side effects are uncommon. These side effects may affect less than 1 in every 100 patients. Dizziness Fever Sore throat Swelling of arms or legs Change in the colour of the skin Anxiety Sleep disorder Tiredness If any of these affects you severely, tell your doctor.

Frequency not known (cannot be estimated from the available data).
- A decrease in the number of cells involved in blood clotting (thrombocytopenia), or in all kinds of blood cells (pancytopenia)
- Hair loss
- Rash, reddening of the skin, blistering of lips, eyes or mouth, skin peeling, sore throat (signs of severe skin reaction)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children. Do not use EXJADE after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Do not use any pack that is damaged or shows signs of tampering.

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For doctors

What is it?

Exjade is a medicine that contains the active substance deferasirox. It is available as round, white dispersible tablets that are mixed with a liquid to make up a suspension that the patient can drink. Each tablet contains 125 mg, 250 mg or 500 mg of deferasirox.

What is it used for?

Exjade is used to treat a condition called chronic iron overload (an excess of iron in the body), which results from having repeated blood transfusions.

How is it used?

Treatment with Exjade should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload due to frequent transfusions. Only patients who have no problems with their kidneys can be treated with Exjade. The treatment starts once the patient has received about 100 ml of packed red blood cells per kilogram body weight, or once there are signs of iron overload (when the levels in the blood of ferritin, the protein in the body that stores iron, are over 1 mg per litre). The treatment usually starts using a dose of 20 mg per kilogram body weight. Starting doses of 10 or 30 mg/kg can also be used, depending on the frequency of the patient’s transfusions. These doses are then adjusted as needed, every three to six months, according to the response.

Exjade is taken every day, preferably at the same time each day, on an empty stomach (at least 30 minutes before food). The number of tablets of each strength that make up a dose is calculated based on the patient’s weight. The tablets are dispersed by stirring them in a glass of water or fruit juice to make a suspension for the patient to drink.

How does it work?

When patients receive repeated transfusions to correct anaemia, the transfused red cells bring iron into the body. As the body does not have a natural way of removing excess iron, it can build up and, over time, damage important organs such as the heart or liver. The active substance in Exjade, deferasirox, is an ‘iron chelator’. It binds to iron in the body to form a compound called a ‘chelate’ that can be excreted by the body, mainly in the stools. This helps to correct the iron overload and prevent damage due to excess iron.

How has it been studied?

The effects of Exjade were first tested in experimental models before being studied in humans. The main study of effectiveness compared Exjade with deferoxamine in 591 patients with beta thalassaemia major. About half of the patients were under the age of 16, and 56 were less than six years old. The doctor and patients knew which medicine they were using because Exjade is given by mouth but deferoxamine is given by subcutaneous infusion (very slow injection under the skin) overnight. The effectiveness was measured by looking at the level of iron contained in the liver before and after one year of treatment with the medicines.
An additional study looked at the effectiveness of Exjade in 184 patients who could not be treated with deferoxamine, including patients with beta thalassaemia major and with other types of anaemia.

What benefits has it shown during the studies?

At the end of the main study, 53% of the patients receiving Exjade had shown a sufficient response to treatment, compared with 66% of the patients receiving deferoxamine. This indicates that Exjade may not have been as effective as the comparator medicine. However, when looking at the 381 patients who had particularly high levels of iron in their liver at the beginning of the study and who received comparable amounts of Exjade or deferoxamine, the two medicines were as effective as each other. There were too few patients in this study aged below six years to demonstrate the safety and effectiveness of Exjade in this age group.
In the additional study, more than half of the patients who could not be treated with deferoxamine had responded to treatment with Exjade after a year, including patients aged between two and five years.

What is the risk associated?

The most common side effect with Exjade (seen in more than 1 patient in 10) is increased blood creatinine (a marker of kidney problems). For the full list of all side effects reported with Exjade, see the Package Leaflet.
Exjade should not be used in people who may be hypersensitive (allergic) to deferasirox or any of the other ingredients, or in people whose creatinine clearance (a measure of the ability of the kidney to remove creatinine from the blood) is below 60 ml per minute. It should not be used in combination with other iron chelators.
It is very important that the patient’s kidneys and liver are checked with blood tests before treatment with Exjade is started, and regularly during treatment. The dose should be reduced or treatment interrupted if a patient develops kidney or liver problems. Exjade is not recommended for patients with severe liver problems as it has not been tested in this group.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Exjade’s benefits are greater than its risks for the treatment of chronic iron overload due to frequent blood transfusions in patients with beta thalassaemia major, and due to blood transfusions when deferoxamine therapy is contraindicated or inadequate. The Committee recommended that the medicine be given marketing authorisation.

How has it been studied?

The company responsible for making Exjade available must prepare an education pack for doctors, which is distributed whenever the medicine is launched. This pack will ensure that doctors know about the need to monitor the patient’s health, especially kidney function, when they prescribe the medicine. The company will also prepare a similar pack for patients.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Exjade to Novartis Europharm Limited on 28 August 2006.

The summary of opinion of the Committee for Orphan Medicinal Products for Exjade is available here.

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Name

EXJADE 250 mg dispersible tablets

Composition

Each dispersible tablet contains 250 mg deferasirox.

Excipient: Each dispersible tablet contains 272 mg lactose.

For a full list of excipients, see section 6.1.

Pharmaceutical Form

Dispersible tablet

Off-white, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other).

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