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Aranesp®
darbepoetin alfa
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Aranesp (darbepoetin alfa). It does not contain all the available information.
It does not take the place of talking to your doctor, nurse or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using Aranesp against the benefits he/she expects it will have for you.
If you have any concerns about using this medicine, ask your doctor, nurse or pharmacist.
Read this leaflet carefully before you start Aranesp and keep it with the medicine. You may need to read it again.
What Aranesp is used for
Aranesp is used to treat anaemia in cancer patients who are receiving chemotherapy. Anaemia is when your blood does not contain enough red blood cells.
Anaemia can occur as a result of chemotherapy medicines used to treat cancer. Some chemotherapy medicines can affect the bone marrow's ability to make red blood cells. When your red blood cell count falls too low, you become anaemic. Some affects of anaemia can include tiredness, dizziness, increased heart beat, depression, anorexia, nausea, feeling cold and pale skin colour.
Aranesp is a recombinant erythropoietic protein produced by special mammalian cells. Your doctor has given you Aranesp to treat the anaemia caused by the chemotherapy medicines used to treat your cancer. It will reduce your need for blood transfusions. Aranesp will help your bone marrow to produce more red blood cells, like your natural erythropoietin. The active ingredient of Aranesp is darbepoetin alfa that works in exactly the same way as the natural hormone erythropoietin.
It will take your body a short time to make red blood cells, so it will be about 4 weeks before you notice any effect.
Anaemia can occur as a result of cancer. Aranesp should not be used to treat anaemia that results from cancer.
Your doctor may have prescribed Aranesp for another reason. Ask your doctor if you have any questions about why Aranesp has been prescribed for you.
Before you use Aranesp
When you must not use Aranesp
Do not use Aranesp if you have:
- High blood pressure that is not controlled by other medicines.
- Allergies to other erythropoietin products, Aranesp, medicines made using mammalian cells, or to any of the other ingredients in Aranesp listed at the end of this leaflet.
Symptoms of a severe allergic reaction may include:
- Drop in blood pressure (faintness), fast pulse, difficulty breathing and sweating
- Swelling of the face, lips, mouth tongue or throat.
- Shortness of breath
- Skin rash, including rash over the whole body
- Hives
Talk to your doctor, nurse or pharmacist if you have any questions about this information.
Talk to your doctor, nurse or pharmacist if you have any questions about this information.
Do not give Aranesp to a child. There is not enough information at present to recommend using Aranesp in children.
Do not use Aranesp after the expiry date (Exp.) stamped on the pack. If you use Aranesp after the expiry date has passed, it may not work as well.
Do not use Aranesp if the packaging is torn or shows signs of tampering.
Before you start to use Aranesp
You must tell your doctor if:
- You have or have had any medical conditions, especially the following:
- Blood clotting diseases.
- Epilepsy (fits or seizures).
- Any other illness or health problems. A number of conditions such as infections and vitamin deficiencies may affect how well you respond to Aranesp.
- An allergy to latex. The needle shield on the pre-filled pen and the needle cover on pre-filled syringe contain a derivative of latex.
- You are pregnant or intend to become pregnant.
- You are breastfeeding or planning to breastfeed.
It is not known whether Aranesp passes into breast milk.
If you have not told your doctor about any of the above, tell him/her before you use Aranesp.
Taking other medicines
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any medicines you buy without a prescription from your pharmacy, supermarket or health food shop.
How to use Aranesp
Following blood tests, your doctor has decided you need Aranesp. Your doctor will work out the correct amount of Aranesp for you and tell you how much you must take.
While you are taking Aranesp, your doctor will take blood samples to measure how your anaemia is responding and may change the strength if necessary.
Your doctor will check your blood pressure regularly.
In some cases your doctor may recommend that you take iron supplements.
Aranesp can be injected either:
- under the skin (subcutaneous injection) using either the pre-filled pen or the pre-filled syringe; or
- Into a vein (intravenous injection) using the pre-filled syringe.
You can give yourself a subcutaneous injection after you have received training from your doctor or nurse. Intravenous injections are given by a doctor or nurse.
Aranesp is given by injection, once a week or in some cases once every three weeks. Your doctor will decide which injection frequency, strength of Aranesp and injection method is best for you.
Carefully follow all directions given to you by your doctor, pharmacist or nurse. They may differ from the information in this leaflet.
If you do not understand the instructions, ask your doctor, pharmacist or nurse for help.
How to inject using the Aranesp® SureClick™ (pre-filled pen)
This section contains information on how to give yourself an injection using the Aranesp SureClick (pre-filled pen). It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Equipment :
To give yourself a subcutaneous injection you will need:
- a new Aranesp pre-filled pen
- a puncture-resistant sharps container
Do the following before you give yourself a subcutaneous injection of Aranesp
- Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
- Remove the pre-filled pen from the refrigerator.
- Do not shake the pre-filled pen.
- Do not remove the grey needle shield from the pre-filled pen until you are ready to inject.
- Check that it is the correct strength that your doctor has prescribed.
- Check the expiry date on the pre-filled pen label (Exp.). Do not use it if the date has passed the last day of the month shown.
- Check the appearance of Aranesp through the inspection window. It must be a clear colourless liquid. If it is cloudy or there are particles in it, you must not use it.
- For a more comfortable injection, leave at room temperature for approximately 30 minutes. Do not warm Aranesp in any other way (for example, do not warm it in a microwave or in hot water). Do not leave the pre-filled pen exposed to direct sunlight.
- Wash and dry your hands.
Where to inject
The best injection sites (see pictures below) are:
- your abdomen, except for the area around the navel (belly button) or
- the top and side of your thighs.
Change the place that you inject each time so you do not become sore in one area. If someone else is injecting you, they can also use the back of your arms.
How to inject into the abdomen using Aranesp SureClick (pre-filled pen)
Remove the grey needle shield.
Important skin pinch technique
- The skin pinch technique will create a firm site for the injection. If a firm site is not used, the pre-filled pen may not inject properly.
- Choose a site at least 5 cm away from the navel.
- Pinch the skin of the abdomen firmly between the thumb and fingers creating a space at least 3 cm wide (twice the width of the tip of the pre-filled pen). Maintain a firm skin pinch for the entire procedure.
A: Angle
Centre the pre-filled pen in the area of the pinched skin at a right angle (90 degrees) and push firmly against the skin. Hold down.
Press the pre-filled pen firmly enough against the skin so that the yellow safety cover is fully retracted. This will be possible without excessive pressure.
B: Button
Maintain a firm skin pinch use your thumb to (1) press - you will hear a "click" - and (2) release the red button on top. Do not lift the pre-filled pen. Do not keep your thumb on the red button after you have pressed it. The Aranesp is now being injected under your skin.
C: CLICK!
After the second "click" (or a count of 15) lift the pre-filled pen from the injection site. Your Aranesp has now been fully injected.
Check the inspection window. It should be yellow. Consult your doctor, nurse or pharmacist if you have any questions.
The yellow safety cover will move down over the needle and lock into place. The inspection window will be yellow, confirming the injection is complete.
If you experience difficulties choose a more firm injection site.
If you notice a spot of blood at the injection site dab away with a cotton ball or tissues.
Do not rub the injection site. If needed, you may cover the injection site with a bandaid or similar.
You cannot reuse the Aranesp SureClick pre-filled pen.
Do not put the grey needle shield back on the used pre-filled pen. Put the used pre-filled pen in the puncture-resistant sharps container.
How to inject into the thigh or back of the arm using Aranesp SureClick (pre-filled pen)
Remove the grey needle shield.
A: Angle
Grasp the pre-filled pen in your hand, ensuring that you are holding it towards the upper half of the pen (see picture).
Place the pre-filled pen on the injection site at a right angle (90 degrees) and push firmly against the skin. Hold down (see picture).
Press the pre-filled pen firmly enough against the skin so that the yellow safety cover is fully retracted (see picture). This will be possible without excessive pressure.
B: Button
While holding the pre-filled pen in place, use your thumb to (1) press - you will hear a "click" - and (2) release the red button on top. Do not keep your thumb on the red button after you have pressed it. Do not lift the pre-filled pen. The Aranesp is now being injected under your skin.
C: CLICK!
After the second "click" (or count of 15) lift the pre-filled pen from the injection site. Your Aranesp has been fully injected.
Check the inspection window. It should be yellow. Consult your doctor, nurse or pharmacist if you have any questions.
The yellow safety cover will move down over the needle and lock into place. The inspection window will be yellow, confirming the injection is complete.
If you experience difficulties choose a more firm injection site.
If you notice a spot of blood at the injection site dab away with a cotton ball or tissues.
Do not rub the injection site. If needed, you may cover the injection site with a bandaid or similar.
You cannot reuse the Aranesp SureClick pre-filled pen.
Do not put the grey needle shield back on the used pre-filled pen. Put the used pre-filled pen in the puncture-resistant sharps container.
How to inject using the Aranesp pre-filled syringe
This section contains information on how to give yourself an injection of Aranesp using the pre-filled syringe.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Equipment:
To give yourself a subcutaneous injection you will need:
- a new pre-filled syringe.
- a puncture-resistant sharps container.
Do the following before you give yourself a subcutaneous injection of Aranesp:
- Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
- Remove the pre-filled syringe from the refrigerator.
- Do not shake the pre-filled syringe.
- Do not remove the needle cover from the pre-filled syringe until you are ready to inject.
- Check that it is the correct strength that your doctor has prescribed.
- Check the expiry date on the pre-filled syringe label (Exp.). Do not use it if the date has passed the last day of the month shown.
- Check the appearance of Aranesp. It must be a clear, colourless liquid. If it is cloudy or there are particles in it, you must not use it.
- For a more comfortable injection, leave at room temperature for approximately 30 minutes. Do not warm Aranesp in any other way (for example, do not warm it in a microwave or in hot water). Do not leave the pre-filled syringe exposed to direct sunlight.
- Wash and dry your hands.
How to prepare the Aranesp injection (pre-filled syringe)
Before you inject Aranesp you must do the following:
- Gently pull the needle cover from the needle. Do not touch the needle or plunger.
- Hold the syringe with the needle pointing up to see if it has any air bubbles inside. If there are, gently press the plunger until all the air (but none of the liquid) has been removed.
- You can now use the pre-filled syringe.
Where to inject
The best injection sites (see picture) are:
- your abdomen, except for the area around the navel (belly button) or
- the top and side of your thighs.
Change the place that you inject each time so you do not become sore in one area. If someone else is injecting for you, they can also use the back of your arms.
How to give your injection
- Pinch the skin between your thumb and forefinger, without squeezing it.
- Put the needle fully into the skin at an angle of about 45 degrees to 90 degrees (up to right angle).
- After the needle is in, pull back the plunger very slightly. If blood comes into the syringe, the needle has entered a blood vessel. Remove the needle. Select another site and reinsert the needle.
- Inject the liquid slowly and evenly, always keeping your skin pinched.
- After injecting the liquid, remove the needle and let go of your skin.
- If you notice a spot of blood at the injection site dab away with a cotton ball or tissues. Do not rub the injection site. If needed, you may cover the injection site with a bandaid or similar.
You cannot reuse the Aranesp pre-filled syringe.
Do not put the grey needle cover back on the used pre-filled syringe. Put the used pre-filled syringe in the puncture-resistant sharps container.
While you are using Aranesp
How much Aranesp to inject
Your doctor has prescribed the strength of Aranesp that is best for you. You need to inject the full contents of the syringe.
When to inject Aranesp
You will need to give yourself an injection once a week or in some cases once every three weeks. Your doctor will decide which injection frequency is best for you.
If you forget to use Aranesp
If you have forgotten to inject Aranesp, contact your doctor or nurse to discuss when you should next inject.
If you inject too much Aranesp (overdose)
You should have no serious problems if you inject more Aranesp than you need. However, you should contact your doctor, nurse or pharmacist if this happens.
Things you must do
Always follow your doctor's instructions carefully.
If you are about to start taking a new medicine, tell your doctor, nurse and pharmacist that you are using Aranesp.
If you become pregnant while you area using Aranesp, tell your doctor.
Things you must not do
Do not use Aranesp to treat any other complaint unless your doctor says so.
Do not give Aranesp to anyone else, even if their symptoms seem similar to yours.
Side Effects
Tell your doctor as soon as possible if you have any problems while using Aranesp, even if you do not think the problems are connected with Aranesp or are not listed in this leaflet. Like other medicines, Aranesp may cause side effects. Some side effects may be serious and need medical attention. Other side effects are minor and are likely to be temporary. Some of the side effects listed below may be due to your cancer or the chemotherapy used to treat the cancer rather than Aranesp.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
If any of the following happens, stop injecting Aranesp and go straight to the hospital, as you may need urgent medical attention:
- Serious allergic reaction:
- Drop in blood pressure (faintness), fast pulse, difficulty breathing and sweating
- Swelling of the face, lips, mouth tongue or throat.
- Shortness of breath
- Skin rash, including rash over the whole body
- Hives - Signs of a sudden rise in blood pressure such as sudden, stabbing, migraine-like headaches, confusion or seizures.
- Signs of a stroke such as tingling of the extremities, slight weakness on one side of the body, speech difficulties, double vision, dizziness, headache and imbalance.
- Signs of a heart attack such as chest pain.
- Pain in the legs or arms, with or without swelling.
These symptoms may be serious and could possibly become life-threatening if not treated promptly.
Tell your doctor, nurse or pharmacist if you experience any of the following:
- Light-headedness, headache, not being able to sleep, pins and needles, diminished sense of touch.
- Nausea (feeling sick), vomiting, diarrhoea, constipation, loss of appetite, stomach pain, indigestion.
- Pain in your joints, limbs, muscles or bones.
- Feeling of depression and anxiety.
- Difficulty in breathing, cough, chest or throat infection.
- Hair loss, rash.
- Redness, swelling, pain or itching at the site of injection.
Tell your doctor, nurse or pharmacist if you notice anything that worries you or that is making you feel unwell, even if it is not on this list. Other side effects not listed above may occur in some people.
Very rarely convulsions (fits or seizures) have been reported in patients with receiving Aranesp.
A condition called pure red cell aplasia (PRCA) has been rarely reported after months to years of treatment with recombinant forms of erythropoietin.
This condition is found mostly in patients with chronic kidney disease and means the absence of very young red blood cells in the bone marrow. If this condition develops, patients lose the good response they have been having to the treatment for anaemia. The cause of this is presently not known.
Tell your doctor if you experience more tiredness than usual.
Although PRCA is rare, you should know that you would have to stop injecting Aranesp and would need to have regular blood transfusions to treat your anaemia.
After using Aranesp
Storage
Keep your Aranesp in the refrigerator (between 2 and 8 °C), but not in the freezer. You can use Aranesp if it has been left out of the refrigerator, for no longer than 2 days at room temperature (up to 30 °C).
Do not use the Aranesp pre-filled syringe if you think that it has been frozen for longer than 2 days. You can use the Aranesp pre-filled syringe if accidentally left frozen for less than 2 days.
Always keep the Aranesp pre-filled pen and pre-filled syringe in the original box to protect it from light.
As with all medicines, you should keep Aranesp out of the reach and sight of children.
Disposal
Do not put the needle cover back on the used pre-filled syringe.
Do not put the grey needle shield back on the used pre-filled pen.
Put used pre-filled pens and pre-filled syringes into the puncture-resistant sharps container and keep it out of the reach and sight of children.
Dispose of the full puncture-resistant sharps container as instructed by your doctor, nurse or pharmacist.
Never put the used pre-filled pens or used pre-filled syringes into your normal household rubbish bin.
Product Description
What it looks like
Aranesp is a clear, colourless liquid available as:
- pre-filled pens containing from 20 to 150 microgram of darbepoetin alfa in each pre-filled pen. Aranesp SureClick is available in packs containing 1 pre-filled pen.
- pre-filled syringes containing from 10 to 150 microgram of darbepoetin alfa in each pre-filled syringe. Aranesp is available in packs containing 4 pre-filled syringes.
Ingredients
Active ingredient
The active ingredient in Aranesp is darbepoetin alfa.
Other ingredients
- Polysorbate 80
- Sodium phosphate monobasic
- Sodium phosphate dibasic
- Sodium chloride
- Water for Injection
The needle shield on the pre-filled pen and the needle cover on the pre-filled syringe contain a derivative of latex.
Aranesp does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Manufacturer
Aranesp is supplied in Australia by:
Amgen Australia Pty Ltd
Level 7, 123 Epping Road
North Ryde NSW 2113
ABN 31 051 057 428
Tel: (02) 9870 1333
Fax: (02) 9870 1344
Medical Information: 1800 803 638
Australian Registration Numbers
Pre-filled syringe:
Aranesp 10 microgram/0.4 mL
AUST R 77950
Aranesp 20 microgram/0.5 mL
AUST R 77952
Aranesp 30 microgram/0.3 mL
AUST R 77953
Aranesp 40 microgram/0.4 mL
AUST R 77954
Aranesp 50 microgram/0.5 mL
AUST R 77955
Aranesp 60 microgram/0.3 mL
AUST R 77956
Aranesp 80 microgram/0.4 mL
AUST R 77957
Aranesp 100 microgram/0.5 mL
AUST R 77958
Aranesp 150 microgram/0.3 mL
AUST R 77959
Pre-filled pen:
Aranesp 20 microgram/0.5 mL
AUST R 122853
Aranesp 40 microgram/0.4 mL
AUST R 122851
Aranesp 60 microgram/0.3 mL
AUST R 122849
Aranesp 80 microgram/0.4 mL
AUST R 122855
Aranesp 100 microgram/0.5 mL
AUST R 122852
Aranesp 150 microgram/0.3 mL
AUST R 122854
Aranesp® is a registered trademark of Amgen.
SureClick™ is a trademark of Amgen.
This leaflet was prepared in April 2008.
Published by MIMS/myDr July 2008
