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Aranesp 15 micrograms solution for injection in a pre-filled
2014-05-10 19:15:04 来源: 作者: 【 】 浏览:287次 评论:0

For doctors

 

What is it and how is it used?

Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.

Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is produced in your kidneys and encourages your bone marrow to produce more red blood cells. The active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).

If you have chronic renal failure

Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.

Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia.

If you are receiving chemotherapy

Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers (non-myeloid malignancies) who are receiving chemotherapy.

One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood cells. Towards the end of your chemotherapy course, particularly if you have had a lot of chemotherapy, your red blood cell count may fall making you anaemic.

What do you have to consider before using it?

DO NOT use Aranesp:

Take special care with Aranesp

Please tell your doctor if you are suffering or have suffered from:

Special warnings

pressure. This has been reported in patients with chronic renal failure treated with Aranesp. If you experience these symptoms you should contact your doctor.

Using other medicines

Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the number of red cells in your blood. It is important to tell your doctor if you are taking either of these medicines.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Aranesp with food and drink

Food and drink do not affect Aranesp.

Pregnancy and breast-feeding

Aranesp has not been tested in pregnant women. It is important to tell your doctor if you:

It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if you use Aranesp.

Driving and using machines

Aranesp should not affect your ability to drive or use machinery.

Important information about some of the ingredients of Aranesp

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.

How is it used?

Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dl or less. Your injection is to be given under the skin (subcutaneous), and so you may use the Aranesp pre-filled pen. Your doctor will tell you how much and how often you must take Aranesp in order to maintain a haemoglobin level between 10 and 12 g/dl. This may vary depending on whether you are an adult or a child.

Injecting Aranesp yourself

Your doctor has decided that the Aranesp pre-filled pen is the best way for you, a nurse, or a carer to inject Aranesp. Your doctor, nurse or pharmacist will show you how to inject yourself with the pre-filled pen. Do not try to inject yourself if you have not been trained. Never inject Aranesp into a vein yourself. The pre-filled pen is designed to inject the area under your skin only.

For instructions on use of the pre-filled pen, please read the section at the end of this leaflet.

If you have chronic renal failure

The Aranesp pre-filled pen is given as a single injection, either once a week, once every two weeks, or once every month.

In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will be either:

Once your anaemia is corrected, your doctor will continue to regularly check your blood and your dose may be adjusted further in order to maintain long-term control of your anaemia. Your doctor will inform you if your dose changes.

Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.

In some cases, your doctor may recommend that you take iron supplements.

Your doctor may decide to change the way that your injection is given (either under the skin or into a vein). If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.

If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.

If you are receiving chemotherapy

Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.

In order to correct your anaemia, your initial dose will be

In some cases, your doctor may recommend that you take iron supplements.

If you use more Aranesp than you should

You could have serious problems if you take more Aranesp than you need. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell in any way you should contact your doctor, nurse or pharmacist immediately.

If you forget to inject Aranesp

If you have forgotten a dose of Aranesp, you should contact your doctor to discuss when you should inject the next dose.

What are possible side effects?

Like all medicines, Aranesp may cause side effects, although not everybody gets them.

The following side effects have been experienced by some patients in clinical trials taking Aranesp:

Chronic renal failure patients

Very Common (seen in more than 10 in 100 people)

Common (seen in more than 1 in 100 people)

Rare (seen in more than 1 in 10,000 people)

Cancer patients

Very common (seen in more than 10 in 100 people)

Common (seen in more than 1 in 100 people)

The following side effects have been experienced by some patients after Aranesp has been marketed:

Very rare (seen in less than 1 in 10,000 people)

Frequency unknown

If you have any of these symptoms or you notice any side effects that are not mentioned in this leaflet, please tell your doctor, nurse or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Aranesp after the expiry date which is stated on the carton and on the pre-filled pen label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Do not freeze. Do not use Aranesp if you think it has been frozen.

Keep the pre-filled pen in the outer carton in order to protect from light.

When your pen has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.

Do not use Aranesp if you notice the pre-filled pen contents are cloudy or there are particles in it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

Aranesp is a solution for injection in a vial, a pre-filled syringe or a pre-filled pen. It contains the active substance darbepoetin alfa. Aranesp exists in various strengths, from 25 to 500 micrograms per millilitre.

What is it used for?

Aranesp is used to treat anaemia (low red blood cell counts) that is causing symptoms. It is used in two groups of patients:

adults and children with chronic renal failure long-term, progressive decrease in the ability of the kidneys to work properly

adults who are receiving chemotherapy for non-myeloid cancer cancer not originating in the bone marrow.

The medicine can only be obtained with a prescription.

How is it used?

Aranesp treatment should be initiated by a doctor who has experience in treating the types of anaemia mentioned above.

For patients with chronic renal failure, Aranesp can be injected into a vein or under the skin. It must be injected under the skin in patients receiving chemotherapy. The dose and frequency of injection depend on why Aranesp is being used, and are to be adjusted, according to the patient’s response, to obtain haemoglobin levels that remain within the recommended range (between 10 and 12 grams per decilitre). Haemoglobin is the protein in red blood cells that carries oxygen around the body. The lowest dose that provides adequate control of symptoms should be used.

Aranesp can be injected by the patient or their carer if they have been trained appropriately. For full details, see the package leaflet.

How does it work?

A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow. Erythropoietin is produced by the kidneys. In patients with chronic renal failure, anaemia can be caused by a lack of erythropoietin. In patients receiving chemotherapy, anaemia can be caused by the body not responding sufficiently to the erythropoietin it has naturally.

Darbepoetin alfa, the active substance in Aranesp, acts exactly like the natural erythropoietin made by the body to stimulate red blood cell production, but it is very slightly different in its structure. This means that darbepoetin alfa has a longer duration of action, and can be given less often than natural erythropoietin. The darbepoetin alfa in Aranesp is produced by a method known as ‘recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes the cell able to produce darbepoetin alfa.

How has it been studied?

Aranesp has been studied in patients with chronic renal failure in four studies involving over 1,200 patients, in which it was compared with recombinant human erythropoietin. The main measure of effectiveness was the increase in haemoglobin. Aranesp has also been studied in 124 children with chronic renal failure to check that it is absorbed in the same way as in adults.

Aranesp has also been compared with placebo (a dummy treatment) in two studies involving 669 patients receiving chemotherapy for cancer such as lung cancer, myeloma or lymphoma. The main measure of effectiveness was the reduction in number of patients who needed a blood transfusion.

What benefits has it shown during the studies?

Aranesp was as effective as human recombinant erythropoietin at increasing the haemoglobin levels in patients with chronic renal failure, and at keeping these levels maintained after they had been improved, whether given as an injection into a vein or under the skin.

In cancer patients receiving chemotherapy, fewer of the patients treated with Aranesp needed a blood transfusion than those given placebo.

What is the risk associated?

The most common side effects with Aranesp (seen in more than 1 patient in 10) are hypertension (high blood pressure) and oedema (fluid retention). For the full list of all side effects reported with Aranesp, see the package leaflet.

Aranesp should not be used in people who may be hypersensitive (allergic) to darbepoetin alfa or any of the other ingredients. It must not be used in patients who have poorly controlled high blood pressure.

Why has it been approved?

The CHMP decided that Aranesp’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 Aranesp to Amgen Europe B.V. on 8 June 2001. The marketing authorisation is valid for an unlimited period. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Aranesp, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2011.

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Name

 

Aranesp 15 micrograms solution for injection in a pre-filled
pen

 

Composition

 

Each pre-filled pen contains 15 micrograms of darbepoetin alfa in 0.375 ml (40 µg/ml).

Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).

Excipients:
Each pre-filled pen contains 1.42 mg of sodium in 0.375 ml.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Solution for injection (injection) in a pre-filled pen (SureClick).

Clear, colourless solution.

 

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