ARANESP  4 solution for injection 60 mcg. 0.3 ml.

What is Aranesp and what it is used
Your doctor has prescribed Aranesp ( anti- anemic drug) to treat your anemia. Anemia is a shortage of red blood cells in the blood, some of the symptoms are fatigue , weakness and shortness of breath .
Aranesp works in the same way as the natural hormone erythropoietin. Erythropoietin is produced in the kidneys and stimulates the bone marrow to produce more red blood cells. The active substance of Aranesp is darbepoetin alfa , which is produced by gene technology into cells of Chinese hamster ovary (CHO-K1).

If you suffer from chronic renal failure
Aranesp is used for symptomatic treatment of anemia associated with chronic renal failure in adults and children . In renal insufficiency, renal not produce enough of the natural hormone erythropoietin , which often causes anemia .
Since the body needs some time to start to produce more red blood cells will feel the effect in about four weeks. The regular course of dialysis does not interfere with Aranesp to treat your anemia.

If you are receiving chemotherapy
Aranesp is used for the treatment of symptomatic anemia in adult cancer patients with non-myeloid formations which have been subjected to chemotherapy .
One of the major side effects of chemotherapy , the bone marrow stops required to produce blood cells. At the end of chemotherapy , especially if it was prolonged , the number of red blood cells may decrease and cause anemia.

2 . What you should 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 diagnosed high blood pressure that is not controlled with other medications prescribed by your doctor .
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Aranesp. Please tell your doctor if you suffer or have suffered from :
high blood pressure that is controlled by medication prescribed by your doctor ;
sickle cell anemia ;
seizures (fits) ;
convulsions ( seizures or fits ) ;
liver disease ;
significant refractoriness to drugs used to treat anemia ;
known allergy to latex ( the needle cover of the prefilled syringe contains a derivative of latex) ;
hepatitis C.
Special warnings :
If you have symptoms, including unusual tiredness and lack of energy, this may mean that you have a clean aplaziya red blood cells ( PRCA ) that e observed in patients . PRCA means that the body has stopped or reduced the production of red blood cells, which causes severe anemia . If you experience these symptoms , you should contact your doctor who will determine the best way to treat your anemia.
Take special care with other products that stimulate red blood cell production. Aranesp is a first group of products that stimulate the production of red blood cells , such as human erythropoietin protein . Your healthcare professional should always record the exact product you are using.
Your doctor will try to keep your hemoglobin between 10 and 12 g / dl. Your doctor will monitor your hemoglobin does not exceed a certain level as high hemoglobin concentrations could put you at risk of heart problems or blood vessels and increase the risk of heart attack (myocardial infarction) , stroke ( stroke) and death .
If you suffer from chronic renal failure are at an increased risk of serious problems with your heart or blood vessels ( cardiovascular events ) if your hemoglobin remain too high.
If you have symptoms , which include severe headache , drowsiness , confusion, vision problems , nausea , vomiting, or seizure (convulsions ), this 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 be aware that Aranesp may act as a growth factor for blood cells and in certain circumstances can have a negative impact on your cancer. Depending on the individual history, blood transfusion may be preferable . Please discuss this with your doctor.
Misuse of the product by healthy people may lead to life-threatening disorders of the heart or blood vessels.
Other medicines and Aranesp
Tell your doctor or pharmacist if you are using or have recently used it is possible to use other drugs.
Cyclosporine and tacrolimus (medicines that suppress the immune system ) can be influenced by the amount of red blood cells in your blood. It is important to tell your doctor if you are taking any of these medicines .

Aranesp with food and drink
Food and beverages will impact on Aranesp.

Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.

Aranesp has not been tested on pregnant women. It is important to tell your doctor if:
you are pregnant ;
think you may be pregnant ;
planning to become pregnant .
Not known whether darbepoetin alfa is excreted in human milk . You should stop breast-feeding if you use Aranesp.

Driving and using machines
Aranesp does not affect your ability to drive or operate machinery .

Aranesp sodium
This product contains sodium, less than 1 mmol ( 23 mg) per dose , i.e. essentially sodium .

3 . How to use Aranesp
Always use this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
After blood tests , your doctor has determined that you need Aranesp, as the level of your hemoglobin is 10 g / dl or less. Your doctor will tell you how much and how often you should take Aranesp, to maintain hemoglobin levels between 10 and 12 g / dl. This can vary depending on whether you are an adult or child.

How to inject Aranesp alone
Your doctor may decide that it is better you yourself or the one carer to inject Aranesp. Your doctor or nurse will show you how to do the injections in prefilled syringe. Do not try to do the injections if you are not trained (s). Never inject Aranesp intravenously alone.

If you suffer from chronic renal failure
All adults and pediatric patients aged> 11 years with chronic renal failure , Aranesp is administered as a single injection under the skin ( subcutaneously) or into a vein (intravenously ) .

Correcting anemia your initial dose of Aranesp per kilogram of body weight will be either :
0.75 micrograms once every two weeks ;
0.45 micrograms once a week.
For adult patients not on dialysis , it may also be used 1.5 micrograms / kg once a month as the starting dose .
All adult and pediatric patients aged> 11 years with chronic renal failure after correction of anemia will continue to receive Aranesp, given as a single injection once weekly or once every two weeks. If you are not on dialysis , Aranesp may also be given as an injection once a month.
Your doctor will monitor your blood counts regularly to determine how your anemia is influenced by treatment and may adjust your dose once every four weeks.
After correcting the anemic condition, your doctor will continue to monitor your blood counts and your dose may be further changed to long-term stabilization of anemia. Your doctor will tell you if your dose is changed .
Your blood pressure will also be checked regularly , especially in the initial phase of treatment.
In some cases , your doctor may recommend that you take iron supplements .
Your doctor may decide that it is necessary to change the way of injection (or under the skin or into a vein ) . If this changes , you will start treatment with the same dose taken so far, and your doctor will monitor your blood counts to make sure that your anemia responds correctly.
If your doctor decides to replace your treatment with r-HuEPO ( erythropoietin produced by gene technology) to Aranesp, it will decide whether you should receive Aranesp injection once weekly or once every two weeks. The method of injection is the same as r-HuEPO, but your doctor will determine how much to take and when , and may adjust your dose if needed.

If you are receiving chemotherapy
Aranesp is administered as a single injection, either once per week and once every three weeks under the skin .

The initial dose of Aranesp for the treatment of your anemia will be :
500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of body weight ) ;
2.25 micrograms of Aranesp ( once a week) per kilogram body weight .
Your doctor will monitor your blood counts regularly to determine whether they respond to treatment and may adjust your dose . Your treatment will last for approximately four weeks after the end of chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp.
In some cases, your doctor may recommend that you take iron supplements .

If you use more than the amount of Aranesp
If you use more Aranesp, than you should , you may have serious problems , such as very high blood pressure . You should tell your doctor, nurse or pharmacist if this happens . In case you do not feel well , you should immediately contact your doctor, nurse or pharmacist.

If you forget to use Aranesp
Do not take a double dose to make up for a missed dose.
If you forget to take a dose Aranesp, contact your doctor to discuss when you should inject the next dose.

If you stop using Aranesp
If you wish to stop the use of Aranesp, you must first discuss this with your doctor.

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

The following side effects have been experienced by some patients taking Aranesp:
Chronic renal failure
Very common : may affect more than 1 in 10 people :
High blood pressure ( hypertension) ;
Allergic reactions.
Common: may affect up to 1 in 10 people :
Stroke ;
Pain around the injection site ;
Rash and / or redness of the skin.
Uncommon: may affect up to 1 in 100 people :
Blood clots ( thrombosis ) ;
Convulsions (fits and seizures) .
Not known from the available data can not be estimated :
Pure red blood cells ( PRCA ) - ( anemia, unusual tiredness , lack of energy).
cancer patients
Very common : may affect more than 1 in 10 people :
Allergic reactions;
Fluid retention (edema) .
Common: may affect up to 1 in 10 people :
High blood pressure ( hypertension) ;
Blood clots ( thrombosis ) ;
Pain around the injection site ;
Rash and / or redness of the skin.
Uncommon: may affect up to 1 in 100 people :
Convulsions (fits and seizures) .
all patients
Not known from the available data can not be estimated :
Serious allergic reactions, which may include:
Sudden life-threatening allergic reactions ( anaphylaxis) ;
Swelling of face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema) ;
Shortness of breath ( allergic bronchospasm) ;
Skin rash ;
Hives (urticaria) .
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet .

5 . How to store Aranesp
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and label the pre-filled syringe after EXP :/ 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 suspect has been frozen .
Keep the pre- filled syringe in the outer carton to protect from light.
Once the pre-filled syringe is removed from the refrigerator and left at room temperature for about 30 minutes prior to injection , it must be used within 7 days or may be discarded.
Do not use this medicine if the contents of the pre-filled syringe is cloudy or contains particles.
Do not dispose of medications in 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 pack and other information
What does Aranesp
The active substance is darbepoetin alfa , r-HuEPO ( erythropoietin produced by gene technology).
The pre-filled syringe contains 10, 15 , 20, 30 , 40, 50, 60 , 80, 100, 130 , 150, 300 or 500 micrograms of darbepoetin alfa.
The other ingredients are sodium dihydrogen phosphate , disodium hydrogen phosphate , sodium chloride , polysorbate 80 and water for injections.

Aranesp looks like and contents of the pack
Aranesp is a clear, colorless or slightly pearly solution for injection in pre-filled syringe.
Aranesp is available in packs of 1 or 4 pre-filled syringes. The syringes are supplied either with (pack of 1 and 4 ) or without ( pack of 1 ) blister wrap.
Not all pack sizes may be market.