NEULASTA Pre-Filled Syringe

• 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.

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

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

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

• if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch.
• if you have an allergy to latex. The needle cap on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions.
• if you experience a cough, fever and difficulty breathing. This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
• if you have any of the following or combination of the following side effects:
  • swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
  These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body. See section 4.
• if you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a problem with your spleen (splenomegaly).
• if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration).
• if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia). Your doctor may want to monitor you more closely.
• if you have sickle cell anaemia. Your doctor may monitor your condition more closely.
• if you are a patient with breast cancer or lung cancer, Neulasta in combination with chemotherapy and/or radiation therapy may increase your risk of a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukaemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding.
• if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing these could be signs of a severe allergic reaction.
• if you have symptoms of inflammation of aorta (the large blood vessel which transports blood from the heart to the body), this has been reported rarely in cancer patients and healthy donors. The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor if you experience those symptoms.

Your doctor will check your blood and urine regularly as Neulasta can harm the tiny filters inside your kidneys (glomerulonephritis).

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

You should talk to your doctor about your risks of developing cancers of the blood. If you develop or are likely to develop cancers of the blood, you should not use Neulasta, unless instructed by your doctor.

If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim’s activity.

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

Ask your doctor or pharmacist for advice before taking any medicine. Neulasta has not been tested in pregnant women. It is important to tell your doctor if you:

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

Unless your doctor directs you otherwise, you must stop breast-feeding if you use Neulasta.

Neulasta has no or negligible effect on the ability to drive or use machines.

This medicine contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg/mL. This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free’.

Your doctor may decide that it would be more convenient for you to inject Neulasta yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.

For further instructions on how to inject yourself with Neulasta, please read the section at the end of this leaflet.

Do not shake Neulasta vigorously as this may affect its activity.

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

If you are injecting yourself and have forgotten your dose of Neulasta, you should contact your doctor to discuss when you should inject the next dose.

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.

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

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

Neulasta is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL).

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

The pre-filled syringe (with or without blister wrapping) may also be provided with an automatic needle guard.

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

You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.

To give yourself a subcutaneous injection you will need:

• a pre-filled syringe of Neulasta; and
• alcohol wipes or similar.

1. Remove 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 inject.

4. 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.

5. Check the appearance of Neulasta. It must be a clear and colourless liquid. If there are particles in it, you must not use it.

6. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Neulasta in any other way (for example, do not warm it in a microwave or in hot water).

7. Wash your hands thoroughly.

8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.

Before you inject Neulasta you must do the following:

1. Hold the syringe barrel and gently take the cap from the needle without twisting. Pull straight as shown in pictures 1 and 2. Do not touch the needle or push the plunger.

2. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.

3. You can now use the pre-filled syringe.

The most suitable places to inject yourself are:

• the top of your thighs; and
• the abdomen, except for the area around the navel.

If someone else is injecting you, they can also use the back of your arms.

1. Clean your skin by using an alcohol wipe.

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

3. Push the plunger down with a slow constant pressure. Push the plunger all the way down as far as it will go to inject all the liquid.

4. After injecting the liquid, remove the needle and let go of your skin.

5. If you notice a spot of blood at the injection site, dab with a cotton ball or tissues. Do not rub the injection site. If needed, you may cover the injection site with a plaster.

6. Do not use any Neulasta that is left in the syringe.

Only use each syringe for one injection. If you have any problems, please ask your doctor or nurse for help and advice.

• Do not put the cap back on used needles.
• Keep used syringes out of the sight and reach of children.
• The used syringe should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Before you use a Neulasta pre-filled syringe with automatic needle guard, read this important information:

• It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
• Neulasta is given as an injection into the tissue just under the skin (subcutaneous injection).
• Tell your doctor if you have an allergy to latex. The needle cap on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions.

• Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
• Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new pre-filled syringe and call your doctor or healthcare provider.
• Do not attempt to activate the pre-filled syringe prior to injection.
• Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe.
• Do not attempt to remove the peelable label on the pre-filled syringe barrel before administering your injection.

Call your doctor or healthcare provider if you have any questions.

Step 1: Prepare

A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).

For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting. Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.

• Do not try to warm the syringe by using a heat source such as hot water or microwave.
• Do not leave the pre-filled syringe exposed to direct sunlight.
• Do not shake the pre-filled syringe.

• Keep pre-filled syringes out of the sight and reach of children.

B Open the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.

For safety reasons:

• Do not grasp the plunger.
• Do not grasp the grey needle cap.

C Inspect the medicine and pre-filled syringe.

• Do not use the pre-filled syringe if:
  • The medicine is cloudy or there are particles in it. It must be a clear and colourless liquid.
  • Any part appears cracked or broken.
  • The grey needle cap is missing or not securely attached.
  • The expiry date printed on the label has passed the last day of the month shown.

In all cases, call your doctor or healthcare provider.

Step 2: Get ready

A Wash your hands thoroughly. Prepare and clean your injection site.

You can use:

• Upper part of your thigh.
• Belly, except for a 5 cm (2-inch) area right around your belly button.
• 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.

• Do not touch the injection site before injecting.

• Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

B Carefully pull the grey needle cap straight out and away from your body.

C Pinch your injection site to create a firm surface.

• It is important to keep the skin pinched when injecting.

Step 3: Inject

A Hold the pinch. INSERT the needle into skin.

• Do not touch the cleaned area of the skin.

B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the way down through the snap.

It is important to push down through the “snap” to deliver your full dose.

C RELEASE your thumb. Then LIFT the syringe off skin.

After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.

• Do not put the grey needle cap back on used pre-filled syringes.

Step 4: Finish

A Discard the used pre-filled syringe and other supplies in a sharps disposal container.

Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Keep the syringe and sharps disposal container out of sight and reach of children.

• Do not reuse the pre-filled syringe.

• Do not recycle pre-filled syringes or throw them into household waste.

B 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.