ARANESP 30 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- if you get any side effects, talk to your doctor, pharmacist or nurse. this includes any possible side effects not listed in this leaflet (see section 4).

What is 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 pack and other information

1. what aranesp is and what it is used for

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.

2. what you need to know before you 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 which is not being controlled with other medicines prescribed by your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Aranesp

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

• – high blood pressure which is being controlled with medicines prescribed by your doctor;

• – sickle cell anaemia;

• – epileptic fits (seizures);

• – convulsions (fits or seizures);

• – liver disease;

• – significant lack of response to medicines used to treat anaemia;

• – an allergy to latex (the needle cap on the pre-filled pen contains a derivative of latex); or

• – hepatitis C.

Special warnings:

• – If you have symptoms which include unusual tiredness and a lack of energy this could mean you have pure red cell aplasia (PRCA), which has been reported in patients. PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia. If you experience these symptoms you should contact your doctor who will determine the best course of action to treat your anaemia.

• – Take special care with other products that stimulate red blood cell production: Aranesp is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does. Your healthcare professional should always record the exact product you are using.

• – If you are a patient with chronic renal failure, and particularly if you do not respond properly to Aranesp, your doctor will check your dose of Aranesp because repeatedly increasing your dose of Aranesp if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.

• – Your doctor should try to keep your haemoglobin between 10 and 12 g/dL. Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin concentrations could put you at risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.

• – If you have symptoms which include severe headache, drowsiness, confusion, problems with your eyesight, nausea, vomiting or fits (seizures), it could 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 blood cell growth factor and in some circumstances may have a negative impact on your cancer. Depending on your individual situation a blood transfusion may be preferable. Please discuss this with your doctor.

• – Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.

• – Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment. SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications.

If you develop a serious rash or another of these skin symptoms, stop taking Aranesp and contact your doctor or seek medical attention immediately.

Other medicines and Aranesp

Tell your doctor or pharmacist if you are using, have recently used or might use any 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.

Using Aranesp with food and drink

Food and drink do not affect Aranesp.

Pregnancy and breast-feeding

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 to tell your doctor if you:

• are pregnant;
• think you may be pregnant; or
• plan to get pregnant.

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.

Aranesp contains sodium

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

3. how to use aranesp

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

For all adult and paediatric patients > 1 year of age with chronic renal failure, Aranesp pre-filled pen is given as a single injection, under your skin (subcutaneous).

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

• 0.75 micrograms once every two weeks, or
• 0.45 micrograms once weekly.

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

For all adult and paediatric patients > 1 year of age with chronic renal failure, once your anaemia is corrected you will continue to receive Aranesp given as a single injection, either once a week or once every two weeks. For all adults and paediatric patients > 11 years of age not on dialysis, Aranesp could also be given as an injection once monthly.

Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose once every four weeks as necessary in order to maintain long term control of your anaemia.

Your doctor will use the lowest effective dose to control the symptoms of your anaemia.

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

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:

• 500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your

body weight); or

• 2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight.

Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary. Your treatment will continue until approximately four weeks after the end of your 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 Aranesp than you should

You could have serious problems if you use more Aranesp than you need, such as very high blood pressure. 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 use Aranesp

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

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

If you stop using Aranesp

If you want to stop using Aranesp, you should discuss it with 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 experienced by some patients taking Aranesp:

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 area injected
• Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

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

Not known: frequency cannot be estimated from available data

• Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy)

Cancer patients

Very common: may affect more than 1 in 10 people

• Allergic reactions

Common: may affect up to 1 in 10 people

• High blood pressure (hypertension)
• Blood clots (thrombosis)
• Pain around the area injected
• Rash and/or redness of the skin
• Fluid retention (oedema)

Uncommon: may affect up to 1 in 100 people

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

All patients

Not known: frequency cannot be estimated from available data

• Serious allergic reactions which may include:
• Sudden life-threatening allergic reactions (anaphylaxis)
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
• Shortness of breath (allergic bronchospasm)
• Skin rash
• Hives (urticaria)
• Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Aranesp if you develop these symptoms and contact your doctor or seek medical attention immediately (see 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store

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 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 this medicine if you notice the pre-filled pen contents are cloudy or there are particles in it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information- the active substance is darbepoetin alfa, r-huepo (erythropoietin produced by genetechnology). the pre-filled pen contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.

• – The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.

What Aranesp looks like and contents of the pack

Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled pen.

Aranesp (SureClick) is available in packs containing 1 or 4 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Amgen Limited

216 Cambridge Science Park

Milton Road

Cambridge

CB4 0WA

United Kingdom

Manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

Manufacturer

Amgen Technology (Ireland) Unlimited Company

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Amgen Limited

Tel: +44 (0)1223 420305

This leaflet was last revised in

Instructions for use

It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.

There are additional educational materials available to train you on how to self administer Aranesp pre-filled pen, a dummy demonstration device and a poster-size instructions for use for patients/caregivers with diminished eyesight.

Guide to parts

Before use

Red start button

Important: Needle is inside the yellow safety guard.

Important

Step 1: Prepare

Remove one pre-filled pen from the carton.

Carefully lift the pre-filled pen straight up out of the carton.

Put the original carton with any unused pre-filled pens back in the refrigerator.

Leave the pre-filled pen at room temperature for at least 30 minutes before injecting.

D Do not put the pre-filled pen back in the refrigerator once it has reached room temperature.

D Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.

D Do not leave the pre-filled pen in direct sunlight.

D Do not shake the pre-filled pen.

D Do not remove the grey cap from the pre-filled pen yet.

B Inspect the pre-filled pen.

Make sure the medicine in the window is a clear and colourless liquid.

• Check that it is the correct dose that your healthcare provider has prescribed.
• You may see the plunger in the inspection window at a different location, depending upon the strength.

D Do not use the pre-filled pen if the medicine is cloudy or discoloured or contains flakes or particles.

D Do not use the pre-filled pen if any part appears cracked or broken.

D Do not use the pre-filled pen if the grey cap is missing or not securely attached.

D Do not use the pre-filled pen if the expiry date printed after EXP on the label has passed.

In all cases, use a new pre-filled pen and contact your healthcare provider.

C Gather all the materials needed for your injection.

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place the:

• New pre-filled pen
• Alcohol wipes
• Cotton ball or gauze pad
• Plaster
• Sharps disposal container

Upper arm

Stomach area (abdomen)

Thigh

You can use:

• Y our thigh.
• Your stomach area (abdomen), except for a 5 cm (2-inch) area right around your navel.
• The outer area of upper arm (only if someone else is giving you the injection).

Clean the injection site with an alcohol wipe. Let your skin dry.

D Do not touch this area again before injecting.

• Choose a different site each time you give yourself an injection. If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.

D Do not inject into areas where the skin is tender, bruised, red, or hard.

• Avoid injecting into raised, thick, red, or scaly skin patches or lesions, or areas with scars or stretch marks.

Important: Follow your healthcare provider’s in­structions about selecting sites for injection appropriate to you and about changing the site for each injection.

Step 2: Get ready

Pull the grey cap straight off, only when you are ready to inject. Do not leave the grey cap off for more than five minutes. This can dry out the medicine.

It is normal to see a drop of liquid at the end of the needle or yellow safety guard.

D Do not twist or bend the grey cap.

D Do not put the grey cap back onto the pre-filled pen.

D Do not remove the grey cap from the pre-filled pen until you are ready to inject.

If you are unable to inject, please contact your healthcare provider immediately.

Stretch or pinch your injection site to create a firm surface.

Stretch method

Stretch your skin firmly by moving your thumb and fingers in opposite directions, creating an area about 5 cm (2-inches) wide.

OR

Pinch method

Pinch your skin firmly between your thumb and fingers, creating an area about 5 cm (2-inches) wide.

Important: It is important to keep your skin stretched or pinched while injecting.

Step 3: Inject

Keep stretching or pinching your skin. With the grey cap off, place the pre-filled pen on your skin at 90 degrees.

Important: Do not touch the red start button yet.

Firmly push the pre-filled pen down onto your skin until it stops moving. The safety guard retracts when pushed onto a firm injection site.

Important: You must push the pre-filled pen all the way down but do not touch the red start button until you are ready to inject.

When you are ready to inject, press the red start button.

Keep pushing the pre-filled pen down on your skin. Your injection could take about 15 seconds.

Window turns yellow when the injection is done

Note: After you remove the pre-filled pen from your skin, the needle will be automatically covered.

Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. Contact your healthcare provider immediately.

Examine the injection site.

• If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed.

Dispose of the used pre-filled pen and grey cap.

Put the used pre-filled pen in the sharps disposal container immediately after use.

D Do not reuse the pre-filled pen.

D Do not recycle the pre-filled pen or sharps disposal container or throw them into household rubbish.

Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal.

Important: Always keep the sharps disposal container out of the sight and reach of children.

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