Dyrupeg 6 mg solution for injection in a 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 Dyrupeg is and what it is used for
2. What you need to know before you use Dyrupeg
3. How to use Dyrupeg
4. Possible side effects
5. How to store Dyrupeg
6. Contents of the pack and other information

• if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6).

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

• 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 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 a 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, Dyrupeg 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 severe allergic reaction.
• Inflammation of the aorta (the large blood vessel that transports blood from the heart to the body) 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 these symptoms.

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

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of pegfilgrastim. Stop using Dyrupeg 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 Dyrupeg 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 that neutralize pegfilgrastim’s activity.

Dyrupeg is not recommended for use in children and adolescents due to insufficient data on safety and effectiveness.

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

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.

Dyrupeg has not been tested in pregnant women. Therefore, your doctor may decide that you should not use this medicine. It is important to tell your doctor if you:

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

If you become pregnant during Dyrupeg treatment, please inform your doctor.

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

Dyrupeg 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 pre-filled syringe, that is to say, essentially ‘sodium-free.’

This medicine contains 0.02 mg of polysorbate 20 in each pre-filled syringe. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Your doctor may decide that it would be more convenient for you to inject Dyrupeg 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 Dyrupeg, please read the section at the end of this leaflet.

Do not shake Dyrupeg vigorously, as this may affect its activity.

If you use more Dyrupeg, then you should contact your doctor, pharmacist, or nurse.

If you are injecting yourself and have forgotten a dose of Dyrupeg, you should contact your doctor to discuss 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.

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 affects you can help provide more information on the safety of this medicine.

United Kingdom

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• 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 (E432) and water for injections. See section 2, “Dyrupeg contains sorbitol (E420), polysorbate 20 (E432), and sodium.”

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

Each pack contains one glass pre-filled syringe with a rubber plunger stopper, a plunger rod, an attached stainless-steel needle, and a needle cap. The syringe is provided in a blister tray.

The syringes are provided with an automatic needle guard.

Before you use a Dyrupeg pre-filled syringe with an 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.
• Dyrupeg is given as an injection into the tissue just under the skin (subcutaneous injection).

Do not remove the 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.

A Remove the pre-filled syringe from the blister 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 Warning/Precaution: Check to ensure there is no loose fragment or fluid inside the pack. In case of doubt, DO NOT open this pack; take another pack instead.

C Warning/Precaution: DO NOT lift the product by the plunger or needle cover. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the blister tray.

D Remove the pre-filled syringe from the blister tray as shown.

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.

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 the 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.

Warning/Precaution: DO NOT twist the needle cover or touch the needle or plunger. Pull the needle cover straight off as shown and handle the guard to avoid injuries or bending

C Pinch your injection site to create a firm surface.

Warning/Precaution: It is important to keep the skin pinched when injecting

A Hold the pinch. INSERT the needle into the skin.

Push the plunger while grasping the finger grips.

Warning/Precaution: 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. The entire dose has to be administered to trigger the guard.

Precaution: It is important to push down through the ‘snap’ to deliver the complete dose

C RELEASE your thumb. Then, LIFT the syringe of the skin.

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

Warning/Precaution: Do not put the needle cap back on used pre-filled syringes.

If the guard is not activated or only partially activated, discard the product - without replacing the needle cover.

Healthcare professionals only

The trade name of the administered product should be clearly recorded in the patient file.

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

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

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

Warnings:

Do not reuse the pre-filled syringe.

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.