25, 40, 60, 100, 200, 300 mcg injection solution in the vial 
darbepoetin alfa

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Aranesp is and what it is used for 
2. What you need to know before you use Aranesp 
3. How to use Aranesp 
4. Possible side effects 
5. How to store Aranesp 
6. Contents of the packaging and other information 

1. What Aranesp is and what it is used for

Your doctor has given you Aranesp (an anti-anemic, anemia ) to treat your anemia. Anemia means that the blood does not contain enough red blood cells, which can give rise to symptoms such as fatigue, weakness, and shortness of breath.

Aranesp works in exactly the same way as the natural hormone et erythropoietin. Erythropoietin is produced in the kidneys and stimulates the bone marrow to make more red blood cells. The active substance in Aranesp is darbepoetin alfa, which is produced using genetic engineering in Chinese hamster egg cells (CHO ‑ K1).

If you have chronic kidney failure

Aranesp is used to treat symptomatic anemia in chronic kidney failure in adults and children. In renal failure, the kidneys do not produce enough of the natural hormone erythropoietin, which in many cases can cause anemia .

Because it takes some time for the body to produce more red blood cells, it will take about four weeks before you notice any effect. The treatment of anemia with Aranesp will not be affected by your normal dialysis routine.

If you are receiving treatment with chemotherapy

Aranesp is used to treat symptomatic anemia in adult patients with certain cancers treated with chemotherapy.

One of the most common side effects of chemotherapy is that it prevents the bone marrow from producing enough blood cells. Towards the end of your chemotherapy treatment, especially if you have received a lot of chemotherapy, the number of red blood cells in your blood may decrease, which means that you will be anemic.

What you need to know before using Aranesp

Do not use Aranesp

  • if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in section 6).
  • if you have been diagnosed with high blood pressure that is not under the control of medicines prescribed by your doctor.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Aranesp.

You should inform your doctor if you are currently suffering from or have suffered from:

  • high blood pressure that is under the control of medicines prescribed by your doctor,
  • sicklecellanemi ,
  • epileptic seizures,
  • seizures (seizures),
  • liver disease,
  • significant lack of treatment response to drugs used in anemia treatment, or
  • hepatitis C.


Special warnings:

  • If you have symptoms that include abnormal fatigue and lack of energy, it may mean that you have anti-erythropoietin antibody-mediated erythroblastopenia (PRCA), a condition that has been reported during treatment. PRCA means that the body has stopped or reduced the production of red blood cells, leading to severe anemia. If you experience these symptoms, consult your doctor who will decide which measures are best for treating your anemia.
  • Take special care with other drugs that stimulate the production of red blood cells: Aranesp belongs to a group of drugs that stimulate the production of red blood cells in the same way as the human protein et erythropoietin does. Your doctor should always write down exactly which medicine you are using.
  • If you have chronic kidney failure, and especially if you do not respond satisfactorily to Aranesp, your doctor will monitor your Aranesp dose. The reason for this is that if you do not respond to treatment, repeated increases in Aranesp- does increase the risk of cardiovascular problems and increase the risk of heart attack, stroke, and death.
  • Your doctor should try to keep your hemoglobin value between 10 and 12 g / dl. Your doctor will check that your hemoglobin value does not exceed a certain level, as high hemoglobin concentrations may increase the risk of heart or blood vessel problems, and may increase the risk of heart attack, stroke, and death.
  • If you have symptoms in the form of severe headache, drowsiness, confusion, vision problems, nausea, vomiting, or seizures, it may mean that you have very high blood pressure. If you experience such symptoms, consult a doctor.
  • If you have cancer, you should know that Aranesp can act as a growth factor for blood cells, which in some cases can have a negative effect on your cancer. Depending on your individual situation, a blood transfusion may be preferable. Discuss this with your doctor.
  • Abuse in healthy people can lead to life-threatening problems with the heart or blood vessels.
  • Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with epoetin. Stevens-Johnson syndrome and toxic epidermal necrolysis can begin as reddish-purple target-like or round spots on the torso, often with blisters in the middle. Sores in the mouth, throat, nose, genitals, and eyes (red and swollen eyes) may also occur. These severe skin reactions are often preceded by fever and/or flu-like symptoms. The rash can develop into widespread areas with scaly skin and life-threatening complications. If you get a severe rash or any of these skin symptoms, stop taking Aranesp, and contact a doctor or hospital immediately.

Other medicines and Aranesp

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ciclosporin and tacrolimus (medicines that lower the immune system) are affected by the number of red blood cells in the blood. It is important that you tell your doctor if you are taking any of these medicines.

Aranesp with food and drink

Food and drink do not affect Aranesp.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

  • is pregnant,
  • think you may be pregnant or
  • planning to get pregnant.

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

Driving and using machines

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

Aranesp contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.

How to use Aranesp

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

After checking your blood levels, your doctor has decided that you need Aranesp because your hemoglobin level is 10 g / dl or lower. To maintain your hemoglobin level between 10 and 12 g / dl, your doctor will tell you how much and how often to use Aranesp. This can vary depending on whether you are an adult or a child.

You will receive the injections from healthcare professionals.

If you have chronic kidney failure

All adult patients and children (≥ 1 year) with chronic renal failure are given Aranesp as an injection by healthcare professionals either under the skin ( subcutaneously ) or into a vein ( intravenously ).

To correct your anemia, your starting dose of Aranesp per kilogram of body weight will be either:

  • 0.75 micrograms once every two weeks or
  • 0.45 micrograms once a week.

For adult patients who are not treated with dialysis, 1.5 micrograms/kg once a month can also be used as the starting dose.

After the anemia has been corrected, Aranesp is given to adult patients and children ≥ 1 year of age with chronic renal failure as an injection either once a week or every other week. All adults and children ≥ 11 years of age who are not treated with dialysis also be given Aranesp as an injection once a month.

Your doctor will take regular blood tests to measure how your anemia is responding to treatment and may adjust your dose once every four weeks if necessary to maintain long-term control of your anemia.

Your doctor will use the lowest effective dose to get your anemia symptoms under control.

If you are not responding satisfactorily to Aranesp, your doctor will check your dose and tell you if you need to change your Aranesp dosage.

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

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

Your doctor may decide to change the route of administration (either under the skin or in a vein). If this changes, you will start with the same dose you have been given before and your doctor will take a blood test to make sure you are still getting the right treatment for the anemia.

If your doctor decides to change your treatment from r ‑ HuEPO (erythropoietin produced by genetic engineering) to Aranesp, your doctor will choose whether to give you your injection once a week or once every two weeks. The method of injection is the same as with r ‑ HuEPO but your doctor will tell you how much to take and when and can adjust dose one if necessary.

If you are receiving treatment with chemotherapy

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

To correct your anemia, your starting dose will be

  • 500 micrograms once every three weeks (6.75 micrograms Aranesp per kilogram body weight) or
  • 2.25 micrograms (once a week) Aranesp per kilogram of body weight.

Your doctor will take regular blood tests to measure how your anemia is responding to treatment and may adjust your dose if necessary. Your treatment will continue until approximately 4 weeks after the end of chemotherapy. Your doctor will tell you when to stop taking Aranesp.

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

If you use more Aranesp than you should 

You can get serious problems if you get more Aranesp than you need, such as very high blood pressure. If this happens, consult your doctor, nurse, or pharmacist. If you feel unwell in any way, contact your doctor, nurse, or pharmacist immediately.

If you miss a dose of Aranesp

Do not take a double dose to make up for a forgotten dose.

If you have missed a dose of Aranesp, contact your doctor to find out when to take the next dose.

If you stop using Aranesp

If you want to stop using Aranesp, talk to your doctor first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported in some patients taking Aranesp:

Patients with chronic renal failure

Very common: may affect more than 1 user in 10

  • High blood pressure ( hypertension )
  • Allergic reactions

Common: may affect up to 1 in 10 users

  • Stroke
  • Injection site pain
  • Skin rash and/or redness

Uncommon: may affect up to 1 in 100 people

  • Blood clot ( thrombosis )
  • Convulsions (seizures and epileptic seizures)
  • Bruising and bleeding at the injection site
  • Blood clots in a dialysis access

No known frequency: occurs an unknown number of users

  • Erythroblastopenia (PRCA) – ( anemia, unusual tiredness, lack of energy)

Cancer patients

Very common: may affect more than 1 user in 10

  • Allergic reactions

Common: may affect up to 1 in 10 users

  • High blood pressure ( hypertension )
  • Blood clot ( thrombosis )
  • Injection site pain
  • Skin rash and/or redness
  • Fluid retention ( edema )

Uncommon: may affect up to 1 in 100 people

  • Convulsions (seizures and epileptic seizures)
  • Bruising and bleeding at the injection site

All patients

No known frequency: occurs an unknown number of users

  • Severe allergic reactions which may include:
    • Sudden life-threatening allergic reactions ( anaphylaxis )
    • Swelling of the face, lips, mouth, tongue, or throat may cause difficulty in swallowing or breathing ( angioedema )
    • Shortness of breath (allergic bronchospasm )
    • Rash
    • Hives ( urticaria )
  • Severe skin rashes such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with epoetin treatment. These conditions can cause symptoms such as reddish-purple target-like or round spots on the torso, often with blisters in the middle, scaly skin, sores in the mouth, throat, nose, genitals, and eyes and may be preceded by fever and/or flu-like symptoms. Stop taking Aranesp if you experience these symptoms and contact a doctor or hospital immediately. See also section 2.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Aranesp

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiration date is the last day of the specified 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 vial in the outer carton. Sensitive to light.

After removing the Aranesp vial from the refrigerator and leaving it at room temperature for approximately 30 minutes before injection, it must either be used within seven days or discarded.

Do not use this medicine if the contents of the vial are cloudy or if 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is darbepoetin alfa, r ‑ HuEPO (erythropoietin produced by genetic engineering). The vial contains either 25, 40, 60, 100, 200, or 300 micrograms of darbepoetin alfa.
  • The other ingredients are sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, polysorbate 80, and water for injections.

What the medicine looks like and the contents of the pack

Aranesp is a clear, colorless, or slightly pearlescent solution for injection in a vial.

Aranesp is supplied in packs of 1 or 4 vials. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Amgen Europe BV

Minervum 7061

4817 ZK Breda

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine.

Muhammad Nadeem

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