Neulasta 6 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Neulasta 6 mg solution for injection

pegfilgrastim

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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Neulasta is and what it is used for
2. What you need to know before using Neulasta
3. How to use Neulasta
4. Possible side effects
5. How to store Neulasta
6. Contents of the pack and other information

1. What Neulasta is and what it is used for

Neulasta contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in the bacterium E. coli. Pegfilgrastim belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte colony-stimulating factor) produced by our body.

Neulasta is used to reduce the duration of neutropenia (low white blood cell count) and the incidence of febrile neutropenia (low white blood cell count and fever) that may occur as a result of cytotoxic chemotherapy (medicines that destroy rapidly dividing cells). White blood cells are important cells because they help fight infections. These cells are sensitive to the effects of chemotherapy, which can cause their numbers to decrease. If the number of white blood cells drops too low, there may not be enough to fight bacteria, increasing the risk of developing an infection.

Your doctor has prescribed Neulasta to stimulate your bone marrow (the part of the bone where blood cells are produced) to produce more white blood cells to help you fight infections.

2. What you need to know before using Neulasta

Do not use Neulasta

• if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Neulasta:

• if you experience an allergic reaction including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash, or itching in areas of the skin.
• if you are allergic to latex. The needle cap of the pre-filled syringe contains a latex derivative which may cause severe allergic reactions.
• if you are allergic to acrylic adhesives. The on-body injector uses an acrylic adhesive which may cause allergic reactions.
• if you develop cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• if you experience any one or a combination of the following adverse effects:

? swelling that may be associated with reduced urination, difficulty breathing, abdominal swelling and bloating, and a general feeling of fatigue.

These may be symptoms of a condition called "Capillary Leak Syndrome," which can cause blood to leak from small blood vessels into other parts of your body. See section 4.

• if you have pain in the upper left side of the abdomen or shoulder tip pain. This may be a sign of a spleen problem (splenomegaly).
• if you recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary edema), lung inflammation (pulmonary interstitial disease), or an abnormal chest X-ray result (pulmonary infiltration).
• if you are aware of any blood cell count disorders (e.g., increased white blood cell count or anemia) or a low platelet count, which may reduce the blood's ability to clot (thrombocytopenia). Your doctor may want to monitor you more closely.
• if you have sickle cell anemia. Your doctor may monitor your condition more closely.
• if you are a patient with breast cancer or lung cancer, treatment with Neulasta combined with chemotherapy and/or radiotherapy may increase the risk of developing a pre-leukemic blood disorder called myelodysplastic syndrome (MDS) or a blood neoplasm called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, easy bruising, or bleeding.
• if you have sudden signs of allergy such as skin rash, itching or hives, swelling of the face, lips, tongue, or other body parts, shortness of breath, wheezing, or difficulty breathing, which may indicate a severe allergic reaction.
• if you have symptoms of inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), which has rarely been reported in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, general malaise, back pain, and elevated inflammatory markers. Inform your doctor if you experience these symptoms.

Your doctor will perform regular blood and urine tests because Neulasta may damage the small filters in the kidneys (glomerulonephritis).

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Neulasta. Stop using Neulasta and seek immediate medical attention if you notice any of the symptoms described in section 4.

You should consult your doctor about the risk of developing blood cancer. If you have or may develop blood cancer, you should not use Neulasta unless your doctor advises otherwise.

Loss of response to pegfilgrastim

If you experience a loss of response or are unable to maintain a response to pegfilgrastim treatment, your doctor will investigate possible causes, including whether you have developed antibodies that may neutralize the activity of pegfilgrastim.

Other medicines and Neulasta

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine. Neulasta has not been used in pregnant women. It is important that you inform your doctor if:

• you are pregnant;
• you think you may be pregnant; or
• you are planning to have a baby.

Unless otherwise instructed by your doctor, you must discontinue breastfeeding while using Neulasta.

Driving and using machines

The effect of Neulasta on the ability to drive and operate machinery is negligible or none.

Neulasta contains sorbitol (E420) and sodium

This medicine contains 30 mg of sorbitol in each pre-filled syringe (equivalent to 50 mg/ml). This medicine contains less than 1 mmol of sodium (23 mg) per 6 mg dose; hence, it is essentially "sodium-free".

3. How to use Neulasta

Neulasta is indicated in patients over 18 years of age.

Follow exactly the administration instructions for Neulasta provided by your doctor. Consult your doctor or pharmacist if you have any doubts. The usual dose is one 6 mg subcutaneous injection (under the skin), which should be administered at the end of each chemotherapy cycle, starting no sooner than 24 hours after your last chemotherapy dose.

Self-injection of Neulasta

Your doctor may consider it more convenient for you to self-inject Neulasta. Your doctor or nurse will teach you how to do this. Do not attempt it unless you have been trained.

For further instructions on how to self-inject Neulasta, read section 6 at the end of this leaflet.

Do not shake Neulasta vigorously, as this could affect its activity.

If you use more Neulasta than you should

If you use more Neulasta than you should, inform your doctor, pharmacist, or nurse.

If you forget to use Neulasta

If you are self-injecting and have forgotten to administer your dose of Neulasta, contact your doctor to determine when you should inject the next dose.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Immediately inform your doctor if you experience any one or a combination of the following adverse effects:

• swelling which may be associated with reduced frequency of urination, difficulty breathing, abdominal swelling and a general feeling of fatigue. These symptoms usually develop very rapidly.

These may be symptoms of a condition occurring infrequently (affecting up to 1 in 100 people), called "capillary leak syndrome", which may cause blood to leak from small blood vessels into other areas of your body and which requires urgent medical attention.

Very common adverse effects (may affect more than 1 in 10 people):

• bone pain. Your doctor will advise you on what you may take to relieve the pain.
• nausea and headache.

Common adverse effects (may affect up to 1 in 10 people):

• with use of the on-body injector, rashes, pruritus, and urticaria (contact dermatitis/local skin reactions) have been observed.
• pain at the injection site.
• with use of the on-body injector, reactions at the application site may occur, including redness, bleeding, bruising, pain, and discomfort.
• generalised pain and joint and muscle pain.
• some changes in your blood may occur, which will be detected through periodic blood tests. The number of white blood cells may increase temporarily. The number of platelets may decrease, which could lead to bruising.

Uncommon adverse effects (may affect up to 1 in 100 people):

• allergic-type reactions, including flushing and redness/flushing, skin rash, and itchy skin inflammation.
• severe allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
• enlargement of the spleen.
• rupture of the spleen. Some cases of spleen rupture have been fatal. It is important that you contact your doctor immediately if you experience pain in the upper left side of your abdomen or left shoulder, as these may be related to a problem with your spleen.
• respiratory problems. If you have cough, fever, and difficulty breathing, consult your doctor.
• cases of Sweet's syndrome (painful, inflamed, purple-colored skin lesions on the limbs and sometimes on the face and neck, accompanied by fever) have occurred, but these may be related to other factors.
• cutaneous vasculitis (inflammation of the skin blood vessels).
• damage to the small filters within the kidneys (glomerulonephritis).
• redness at the injection site.
• coughing up blood (haemoptysis).
• haematological disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]).

Rare adverse effects (may affect up to 1 in 1,000 people):

• inflammation of the aorta (the blood vessel carrying blood from the heart to the rest of the body), see section 2.
• lung bleeding (pulmonary haemorrhage).
• Stevens-Johnson syndrome, which may appear as concentric red spots or circular lesions, often with central blisters, on the trunk, skin peeling, and ulcers in the mouth, throat, nose, genital area, and eyes; and may be preceded by fever and flu-like symptoms. Stop using Neulasta if you develop these symptoms and contact your doctor or seek immediate medical attention. See section 2.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Neulasta

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

Do not use this medicine after the expiry date stated on the carton and on the syringe label after EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Neulasta may be kept outside the refrigerator at room temperature (provided it does not exceed 30°C) for up to 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not exceeding 30°C), it must be used within 3 days or discarded.

Do not freeze. Neulasta may be used if accidental freezing occurs for a period of less than 24 hours.

Keep the container in the outer packaging to protect it from light.

Do not use this medicine if you notice that the solution is not completely clear or contains particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Neulasta

• The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.
• The other components are sodium acetate, sorbitol (E420), polysorbate 20, and water for injections. See section 2.

Presentation of the product and contents of the pack

Neulasta is a clear, colourless injectable solution in a pre-filled syringe (6 mg/0.6 ml).

Each pack contains 1 glass pre-filled syringe with a stainless steel needle and a needle cap.

The pre-filled syringe (packaged with or without blister) may also be supplied with an automatic needle protection device.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder and Manufacturer:

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

Marketing Authorisation Holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

Manufacturer

Amgen Technology (Ireland) Unlimited Company

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

Instructions for self-injecting Neulasta from a pre-filled syringe

This section contains information on how to self-administer Neulasta. It is important that you do not attempt to inject yourself unless you have received specific training on how to do so from your doctor, nurse, or pharmacist. If you have any doubts about how to administer the injection, consult your doctor, nurse, or pharmacist.

How should you or the person administering Neulasta pre-filled syringe use it?

The injection must be given into the tissue beneath the skin. This is known as a subcutaneous injection.

Equipment needed for administration

To administer a subcutaneous injection, you will need:

• one pre-filled syringe of Neulasta; and
• an alcohol swab or similar.

What should you do before administering a subcutaneous injection of Neulasta?

1. Remove the pre-filled syringe from the refrigerator.

2. Do not shake the pre-filled syringe.

3. Do not remove the cap from the syringe until you are ready to administer the injection.

4. Check the expiry date (EXP) on the label of the pre-filled syringe. Do not use it if the date has passed.

5. Check the appearance of Neulasta. It should be a clear, colourless liquid. Do not use it if you see particles.

6. To make the injection more comfortable, allow the pre-filled syringe to warm to room temperature for 30 minutes or hold it in your closed hand for a few minutes. Do not heat Neulasta in any other way (for example, do not place it in a microwave or in hot water).

7. Wash your hands thoroughly.

8. Find a comfortable, well-lit area and place all necessary items within easy reach.

How to prepare the Neulasta injection?

Before injecting Neulasta, you must do the following:

1. There may be a small air bubble in the pre-filled syringe. It is not necessary to remove it before the injection. Injecting the solution with an air bubble is not harmful.

2. You may now use the pre-filled syringe.

Where should you administer the injection?

How to administer the injection

1. Clean the skin using a cotton ball with alcohol.

2. Pinch (without squeezing tightly) the skin using your thumb and index finger. Insert the needle into the skin.

3. Press the plunger head with a gentle, steady pressure. Continue pressing the plunger head until all the liquid in the syringe has been injected.

4. After injecting the solution, remove the needle and release the skin.

5. If you see a small amount of blood at the injection site, wipe it away with a cotton ball or gauze. Do not rub the injection site. If needed, you may cover the injection site with a bandage.

6. Do not use any remaining Neulasta left in the syringe.

Remember

Use each syringe for a single injection only. If you have any difficulties, do not hesitate to ask your doctor or nurse for help and advice.

Disposal of used syringes

• Do not recap used needles.

• Keep used syringes out of sight and out of reach of children.

• Used syringes must be disposed of according to local regulations. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.