Label: information for the user

Aranesp 10 micrograms injectable solution in pre-filled syringe

Aranesp 15 micrograms injectable solution in pre-filled syringe

Aranesp 20 micrograms injectable solution in pre-filled syringe

Aranesp 30 micrograms injectable solution in pre-filled syringe

Aranesp 40 micrograms injectable solution in pre-filled syringe

Aranesp 50 micrograms injectable solution in pre-filled syringe

Aranesp 60 micrograms injectable solution in pre-filled syringe

Aranesp 80 micrograms injectable solution in pre-filled syringe

Aranesp 100 micrograms injectable solution in pre-filled syringe

Aranesp 130 micrograms injectable solution in pre-filled syringe

Aranesp 150 micrograms injectable solution in pre-filled syringe

Aranesp 300 micrograms injectable solution in pre-filled syringe

Aranesp 500 micrograms injectable solution in pre-filled syringe

darbepoetina alfa (darbepoetin alfa)

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Your doctor has prescribed Aranesp (an erythropoiesis-stimulating agent) for the treatment of your anemia. Anemia occurs when the blood does not contain enough red blood cells, and symptoms can include fatigue, weakness, and shortness of breath.

Aranesp works exactly like the natural hormone erythropoietin. Erythropoietin is produced in the kidneys and helps the bone marrow to produce more red blood cells. The active substance of Aranesp is darbepoetina alfa, produced by genetic technology in Chinese Hamster Ovary (CHO-K1) cells.

If you have chronic kidney disease

Aranesp is used to treat symptomatic anemia associated with chronic kidney disease (kidney failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin, which often leads to anemia.

As your body will need some time to produce more red blood cells, it may take about four weeks before you notice any effect. Your normal dialysis routine will not affect Aranesp's ability to treat anemia.

If you are receiving chemotherapy

Aranesp is used to treat symptomatic anemia in adult patients with non-myeloid tumors treated with chemotherapy.

One of the main side effects of chemotherapy is that it makes the bone marrow stop producing enough red blood cells. Towards the end of chemotherapy treatment, especially if you have received a lot of chemotherapy, the red blood cell count may decrease, causing anemia.

No use Aranesp:

• If you are allergic to darbepoetin alfa or any of the other components of this medication (listed in section 6).
• If you have high blood pressure that is not being treated with other prescription medications by your doctor.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Aranesp.

Inform your doctor if you have or have had:

• High blood pressure being treated with prescription medications by your doctor;
• Sickle cell anemia;
• Seizures (attacks);
• Convulsions (spasms and attacks);
• Liver disease;
• You do not respond to medications used to treat anemia;
• Allergy to latex (the cap of the pre-filled syringe contains a latex derivative); or
• Heptatitis C.

Special Precautions:

• If you experience symptoms such as excessive fatigue and lack of energy, it may be due to a condition called pure red cell aplasia (PRCA) that has been observed in some patients. PRCA means that your body has reduced or stopped producing red blood cells, leading to severe anemia. If you experience these symptoms, contact your doctor, who will determine the best way to treat your anemia.

• Be cautious with other medications that stimulate red blood cell production: Aranesp belongs to a group of medications that stimulate red blood cell production like human erythropoietin proteins. Your doctor should always keep a record of the exact medication you are using.

• If you are a patient with chronic renal insufficiency and especially if you do not respond correctly to Aranesp, your doctor will review the Aranesp dose, as repeated increases in the Aranesp dose may increase the risk of having a heart or blood vessel problem and may increase the risk of myocardial infarction, stroke, and death.

• Your doctor will try to keep your hemoglobin levels between 10 and 12 g/dl. Your doctor will check that your hemoglobin does not exceed a certain level, as high hemoglobin concentrations may put you at risk of having a heart or blood vessel problem and may increase the risk of myocardial infarction, stroke, and death.

• If you experience symptoms that include severe headache, numbness, confusion, vision problems, nausea, vomiting, or seizures (convulsions), it may mean that you have very high blood pressure. If you experience these symptoms, you should contact your doctor.

• If you are a cancer patient, you should know that Aranesp can act as a growth factor for blood cells and that in some circumstances it may have a negative effect on your cancer. Depending on your individual situation, it may be preferable to have a blood transfusion. Please discuss this with your doctor.

• The use of this medication in healthy individuals may cause heart or blood vessel problems that can be fatal.

• Cases of severe skin reactions associated with epoetin treatment have been reported, including Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (TEN). SSJ/TEN may initially appear as red spots similar to a bull's-eye or circular spots frequently with central blisters on the torso. Additionally, ulcers may occur in the mouth, throat, nose, genitals, and eyes (red eyes and swelling). These severe eruptions are often preceded by fever or flu-like symptoms. The eruptions may progress to widespread skin peeling and potentially fatal complications. If you experience a severe eruption or other skin symptoms, stop taking Aranesp and inform your doctor or seek immediate medical attention.

Use of Aranesp with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Ciclosporin and tacrolimus (immunosuppressive medications) may be affected by the number of red blood cells. It is essential to inform your doctor if you are using any of these medications.

Use of Aranesp with food and beverages

Food and beverages do not affect Aranesp.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Aranesp has not been used in pregnant women. It is essential to inform your doctor if you:

The elimination of darbepoetin alfa by breast milk is unknown. If you are being treated with Aranesp, you should stop breastfeeding.

Driving and operating machinery

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

Aranesp contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

After blood tests, your doctor has decided that you need Aranesp since your hemoglobin level is equal to or less than 10 g/dl. Your doctor will tell you how much Aranesp you need and how often you should use it to maintain your hemoglobin level between 10 and 12 g/dl. This may vary depending on whether you are an adult or a child.

How to inject Aranesp yourself

Your doctor may decide that it is better for you or the people who care for you to inject Aranesp. Your doctor, nurse, or pharmacist will teach you how to put the injection with the preloaded syringe. Do not attempt to self-inject if you have not been taught how to do it.Never inject Aranesp yourself into a vein.

If you have chronic kidney failure

For all adult and pediatric patients ≥ 1 year of age with chronic kidney failure, Aranesp is administered in a single injection, either subcutaneously or intravenously.

To correct anemia, the initial dose of Aranesp per kilogram of body weight will be:

For adult patients not on dialysis, 1.5 micrograms/kg once a month may also be used as the initial dose.

For all adult and pediatric patients ≥ 1 year of age with chronic kidney failure, once anemia is corrected, Aranesp will continue to be administered in a single injection, either once a week or once every two weeks. For all adult and pediatric patients ≥ 11 years of age not on dialysis, Aranesp may also be administered as a monthly injection.

Your doctor will take regular blood tests to see how you are responding to anemia treatment and, if necessary, may adjust the dose every four weeks to maintain long-term control of your anemia.

Your doctor will use the most effective dose to control your anemia symptoms.

If you do not respond adequately to Aranesp, your doctor will review your dose and inform you if you need to change the Aranesp doses.

Your doctor will regularly measure your blood pressure, especially at the start of treatment.

In some cases, your doctor may recommend iron supplements.

Your doctor may decide to change the way you receive the injection (subcutaneously or intravenously). If this happens, you will start with the same dose you were receiving before and blood tests will be done to check that anemia is still being treated correctly.

If your doctor has decided to change your r-HuEPO (genetically engineered erythropoietin) treatment to Aranesp, they will choose between administering Aranesp once a week or once every two weeks. The administration route will be the same as with r-HuEPO, but your doctor will decide how much and when to administer it, and may adjust the dose you receive if necessary.

If you are receiving chemotherapy

Aranesp is administered subcutaneously in a single injection, once a week or once every three weeks.

To correct anemia, the initial dose of Aranesp will be:

Your doctor will regularly take blood samples to measure how you respond to anemia, and may adjust the dose as needed. Treatment will continue until approximately 4 weeks after the end of chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp.

In some cases, your doctor may recommend iron supplements.

If you use more Aranesp than you should

You may have serious problems if you administer more Aranesp than you should, such as very high blood pressure. Contact your doctor or pharmacist if this happens. If you do not feel well, contact your doctor or pharmacist immediately.

If you forgot to use Aranesp

Do not take a double dose to compensate for the missed doses.

If you forgot to inject a dose of Aranesp, contact your doctor to see when you should inject the next dose.

If you interrupt Aranesp treatment

If you want to stop using Aranesp, you must first discuss it with your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some patients have experienced the following side effects while using Aranesp:

Patients with chronic renal insufficiency

Very common:may affect more than 1 in 10 people

Common:may affect up to 1 in 10 people

Uncommon:may affect up to 1 in 100 people

Frequency not known:the frequency cannot be estimated from the available data

Patients with cancer

Very common:may affect more than 1 in 10 people

Common:may affect up to 1 in 10 people

Uncommon:may affect up to 1 in 100 people

All patients

Frequency not known:the frequency cannot be estimated from the available data

• Difficulty breathing (allergic bronchospasm)
• Rashes on the skin
• Hives (urticaria)
• Severe skin eruptions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported associated with treatment with epoetins. These may appear as red spots similar to a bullseye or circular patches frequently with central blisters on the torso, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes and may be preceded by fever or flu-like symptoms.

• Haematomas and bleeding at the injection site