Ferriprox 100 mg/ml oral solution Deferiprone - United Kingdom[英国药品]

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Ferriprox 100 mg/ml oral solution Deferiprone

2014-04-21 19:05:51 来源: 作者: 【大中小】浏览:371次评论:0条

For doctors

What is it and how is it used?

Ferriprox contains the active substance deferiprone. Ferriprox is a medicine that removes iron from the body.

Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.

What do you have to consider before using it?

Take special care with Ferriprox
- the most serious side effect that may occur while taking Ferriprox is a very low white blood cell (neutrophil) count. This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken Ferriprox in clinical studies. Because white blood cells help to fight infection, a low neutrophil count may place you at risk of developing a serious and potentially life-threatening infection. To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) performed regularly, as frequently as every week, while you are being treated with Ferriprox. It is very important for you to keep all of these appointments. Please refer to the patient/carer reminder card attached to this leaflet. Report immediately to your doctor any symptoms of infection such as fever, sore throat or flu-like symptoms.
- if you are HIV positive or if your kidney and liver function is impaired, your doctor may recommend additional tests.

Your doctor will also ask you to come in for tests to monitor body iron load. In addition he or she also might ask you to undergo liver biopsies.

Taking other medicines
Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Ferriprox”). Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take aluminium-based antacids while taking Ferriprox.

Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or if you are trying to become pregnant. This medicine could seriously harm your baby. You must use effective contraception while you are taking Ferriprox. Ask your doctor which method is best for you. If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.

Do not use Ferriprox if you are breast-feeding. Please refer to the patient/carer reminder card attached to this leaflet.

Driving and using machines
Not relevant.

Important information about some of the ingredients of Ferriprox
Ferriprox oral solution contains Sunset Yellow (E110) which may cause allergic reactions.

How is it used?

Always take Ferriprox exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The amount of Ferriprox that you take will depend on your weight. The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg/day. The total daily dose should not exceed 100 mg/kg/day. Use the measuring cup to measure the volume prescribed by your doctor. Take your first dose in the morning. Take your second dose midday. Take your third dose in the evening. Ferriprox can be taken with or without food however, you may find it easier to remember to take Ferriprox if you take it with your meals.

If you take more Ferriprox than you should
There are no reports of acute overdose with Ferriprox. If you have accidentally taken more than the prescribed dose, you should contact your doctor.

If you forget to take Ferriprox
Ferriprox will be most effective if you do not miss any doses. If you do miss one dose take it as soon as you remember and take your next dose at its regularly scheduled time. If you miss more than one dose do not take a double dose to make up for forgotten individual doses, just continue with your normal schedule. Do not change your daily dose without first talking to your doctor.

What are possible side effects?

Like all medicines, Ferriprox can have side effects, although not everybody gets them.

The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count. This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken Ferriprox in clinical studies. A low white blood cell count can be associated with a

serious and potentially life-threatening infection. Report immediately to your doctor any symptoms of infection such as: fever, sore throat or flu-like symptoms.

Very common side effects (affects more than 1 user in 10):

If you experience nausea or vomiting, it may help to take your Ferriprox with some food. Discoloured urine is a very common effect and is not harmful.

Common side effects (affects 1 to 10 users in 100):

Events of joint pain and swelling ranged from mild pain in one or more joints to severe disability. In most cases, the pain disappeared while patients continued taking Ferriprox.

In post-marketing experience with Ferriprox, neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years. They recovered from these symptoms after Ferriprox discontinuation.

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 Ferriprox after the expiry date which is stated on the carton and the label after EXP. After first opening use within 35 days. Do not store above 30ºC.
Store in the original package in order to protect from light.

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For doctors

What is it?

Ferriprox is a medicine that contains the active substance deferiprone. It is available as white, capsule-shaped tablets (500 and 1,000 mg) and as an oral solution (100 mg/ml).

What is it used for?

Ferriprox is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major. This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body. Ferriprox is used when deferoxamine (the standard treatment for iron overload) cannot be used or is inadequate.

The medicine can only be obtained with a prescription.

How is it used?

Ferriprox treatment should be started and maintained by a doctor who has experience in the treatment of patients with thalassaemia.

The usual dose of Ferriprox is 75 mg per kilogram body weight each day, divided into three separate doses. If the tablets are used, each dose is adjusted to the nearest half tablet. If the oral solution is used, the dose is adjusted to the nearest 2.5 ml. Doses above 100 mg/kg a day are not recommended because of a potentially increased risk of side effects. The doctor may adjust the dose of Ferriprox depending on the patient’s response, which should be measured every two to three months with blood tests. The doctor may interrupt treatment if iron levels in the body get too low.

Patients taking Ferriprox, or their carers, must be given a reminder card that reminds the patient how to take the medicine safely.

For more information, see the summary of product characteristics (also part of the EPAR).

How does it work?

Patients with thalassaemia major need frequent blood transfusions. When patients receive repeated transfusions, the transfused red cells bring iron into the body. However, the body does not have a natural way of removing excess iron, so it builds up. Over time, the excess iron can damage important organs such as the heart or liver. The active substance in Ferriprox, deferiprone, is an ‘iron chelator’. It attaches to iron in the body to form a compound that can be excreted by the body, mainly in the urine, and to a lesser extent in the stools. This helps to correct the iron overload and prevent damage due to excess iron.

How has it been studied?

Ferriprox was originally studied in three studies involving 247 patients over six years of age with thalassaemia major, with the main study comparing Ferriprox with deferoxamine in 71 patients over two years. The study was ‘open label’, meaning that the doctor and patients knew which medicine they were using, because Ferriprox was given by mouth, whereas deferoxamine was given by subcutaneous infusion (a very slow injection under the skin) overnight. A later study compared treatment alternating Ferriprox and deferoxamine (five days’ Ferriprox plus two days’ deferoxamine each week) with continuous treatment with deferoxamine on its own, in 60 patients over 12 months.

In all of the studies, the main measure of effectiveness was the change in the levels of ferritin in the blood. Ferritin is a protein that stores iron in the body. The blood ferritin level indicates how much iron is being stored in the body.

What benefits has it shown during the studies?

In the initial study comparing Ferriprox with deferoxamine, the average blood ferritin levels were similar in the two treatment groups. However, the average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.

In the alternating treatment study, the treatment schedule combining Ferriprox for five days with deferoxamine for two days reduced blood ferritin levels to the same extent as deferoxamine taken on its own. However, there were too few patients in the study to prove whether such a schedule is as effective as deferoxamine taken on its own or not.

What is the risk associated?

The most common side effects with Ferriprox (seen in more than 1 patient in 10) are reddish-brown urine (showing that iron is being excreted), nausea (feeling sick), abdominal pain (stomach ache) and vomiting. A less common but serious side effect is agranulocytosis (very low levels of granulocytes, a type of white blood cell). For the full list of all side effects reported with Ferriprox, see the package leaflet.

Ferriprox should not be used in people who may be hypersensitive (allergic) to deferiprone or any of the other ingredients. Ferriprox must not be used in people who have had neutropenia (low levels of neutrophils, a type of white blood cell) repeatedly or agranulocytosis. Ferriprox must also not be used with medicines that might cause neutropenia or agranulocytosis. Ferriprox must not be used in women who are pregnant or breast-feeding.

Why has it been approved?

The CHMP decided that Ferriprox’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Ferriprox on 25 August 1999. The marketing authorisation holder is Apotex Europe B.V. The marketing authorisation is valid for an unlimited period.

For more information about treatment with Ferriprox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2010.

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