Pelgraz 6 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pelgraz 6 mg solution for injection in pre-filled syringe

pegfilgrastim

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Pelgraz is and what it is used for

Pelgraz 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.

Pelgraz 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 cells available to combat bacteria, resulting in an increased risk of developing an infection.

Your doctor has prescribed Pelgraz to stimulate your bone marrow (the part inside the bone where blood cells are produced) to produce more white blood cells, helping you fight infections.

2. What you need to know before using Pelgraz

Do not use Pelgraz

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

Warnings and precautions

Tell your doctor, pharmacist, or nurse before using Pelgraz if:

• you experience an allergic reaction including weakness, low blood pressure, difficulty breathing, facial swelling (anaphylaxis), redness and flushing, skin rash, or itching in areas of the skin.

• you are allergic to latex. The needle cap of the pre-filled syringe contains a latex derivative which may cause severe allergic reactions.

• you experience cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).

• you experience one or a combination of the following adverse effects:

  • swelling that may be associated with reduced frequency of urination, difficulty breathing, abdominal swelling and fullness, 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 areas of your body. See section 4.

• you have pain in the upper left part of your abdomen or shoulder tip pain. This may be a sign of spleen problems (splenomegaly).

• you recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), lung inflammation (pulmonary interstitial disease), or an abnormal chest X-ray result (pulmonary infiltration).

• you have any known 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.

• you have sickle cell anemia. Your doctor may monitor your condition more closely.

• you have breast cancer or lung cancer, as combined treatment with Pelgraz, chemotherapy, and/or radiotherapy may increase the risk of developing a pre-cancerous blood disorder called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, easy bruising, or bleeding.

• you develop sudden signs of allergy such as rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other body parts, shortness of breath, wheezing, or difficulty breathing, which may be signs of a severe allergic reaction.

• symptoms of inflammation of the aorta (the large blood vessel carrying blood from the heart to 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 (e.g., C-reactive protein and white blood cell count). Inform your doctor if you experience these symptoms.

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

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelgraz. Stop using Pelgraz 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 Pelgraz unless your doctor advises otherwise.

Loss of response to pegfilgrastim

If you experience a loss of response or fail 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.

Children and adolescents

The safety and efficacy of Pelgraz in children and adolescents have not yet been established. Consult your doctor or pharmacist before taking any medicine.

Other medicines and Pelgraz

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. Pelgraz 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 become pregnant.

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

Unless your doctor advises otherwise, you should stop breastfeeding while using Pelgraz.

Driving and using machines

The influence of Pelgraz on the ability to drive and use machines is negligible or none.

Pelgraz contains sorbitol (E420) and sodium

This medicine contains 30 mg of sorbitol per unit volume, 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 Pelgraz

Pelgraz is indicated for patients over 18 years of age.

Follow exactly the administration instructions for Pelgraz 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), administered using a pre-filled syringe, to be given at the end of each chemotherapy cycle, starting no sooner than 24 hours after your last dose of chemotherapy.

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

Self-injection of Pelgraz

Your doctor may consider it more convenient for you to self-inject Pelgraz. Your doctor or nurse will teach you how to do this. Do not attempt it unless you have received specific training from your doctor or nurse.

Instructions on how to self-inject Pelgraz are provided below; however, proper treatment of your condition requires close and continuous cooperation with your doctor.

If you are unsure about how to administer the injection yourself or have any doubts, seek help from your doctor or nurse.

How do I administer the Pelgraz injection myself?

You will need to inject the medication into the tissue beneath the skin. This is called a subcutaneous injection.

Equipment you will need

To administer a subcutaneous injection yourself, you will need:

• a pre-filled syringe of Pelgraz;
• alcohol swab.

What should I do before administering a subcutaneous injection of Pelgraz?

1. Remove the pre-filled syringe from the refrigerator.
2. Do not remove the needle cap from the syringe until you are ready to administer the injection.
3. Check the expiration date on the label of the pre-filled syringe (EXP). Do not use it if the date has passed, if it has been stored outside the refrigerator for more than 15 days, or if it is expired.
4. Check the appearance of Pelgraz. It should be a clear, colourless liquid. Do not use it if particles are visible.
5. To make the injection more comfortable, allow the pre-filled syringe to sit for 30 minutes to reach room temperature, or gently hold the syringe in your hand for a few minutes. Do not heat Pelgraz in any other way (for example, do not use a microwave or warm water).
6. Wash your hands thoroughly.
7. Find a comfortable, well-lit place and have all necessary items ready (the pre-filled syringe and the alcohol swab).

How do I prepare my Pelgraz injection?

Before injecting Pelgraz, you must do the following:

Never use a pre-filled syringe that has been dropped on a hard surface.

Step 1: Check the integrity of the system

1. Ensure the system is intact and undamaged. Do not use the medication if it appears damaged (if the syringe or needle shield is broken), has loose components, or if the needle shield is in the open position as shown in Image 9, as this indicates the system has already been activated. In general, the medication should not be used if it does not match Image 1. If so, the medication must be discarded in a container for hazardous biological waste.

Image 1

Step 2: Remove the needle shield

1. Remove the needle shield as shown in Image 2. Hold the needle shield with one hand, with the needle pointing away from you, without touching the syringe plunger. Remove the needle shield with the other hand. After removal, discard the protective cap in a container for hazardous biological waste.
2. You may notice a small air bubble in the pre-filled syringe. Do not remove the air bubble before injection. Injecting the solution with an air bubble is not harmful.
3. The pre-filled syringe is now ready for use.

Image 2

Where should I administer the injection?

The most suitable injection sites are:

• the upper thighs, and
• the abdomen, except the area around the navel (see Image 3).

Image 3

If someone else is administering the injection, the back of the upper arms may also be used (see Image 4).

Image 4

It is advisable to change the injection site each time to reduce the risk of local discomfort.

How do I administer the injection?

Disinfect the injection site using an alcohol swab and pinch the skin gently between your thumb and index finger (see Image 5).

Image 5

Step 3: Insert the needle

• With one hand, gently pinch the skin at the injection site;
• With the other hand, insert the needle at the injection site without touching the plunger rod head (at an angle of 45–90 degrees) (see Images 6 and 7).

Image 6

Image 7

Pre-filled syringe with needle safety shield

• Insert the needle completely into the skin as demonstrated by your nurse or doctor (see Image 6).
• Gently pull back on the plunger to check that you have not entered a blood vessel. If you see blood in the syringe, withdraw the needle and reinsert it at a different site.
• Inject only the dose prescribed by your doctor, following the instructions below.

Step 4: Injection

Place your thumb on the end of the plunger. Press the plunger rod and push firmly to ensure the syringe is completely emptied (see Image 8). Hold the skin firmly until administration is complete.

Image 8

Step 5: Protection against accidental needlestick injuries

The safety mechanism activates when the plunger is fully depressed:

• Without moving the syringe, slowly lift your thumb from the end of the plunger;
• The plunger will rise with your thumb and the spring will retract the needle from the injection site into the needle safety shield (see Image 9).

Image 9

Remember

If you experience any problems, consult your doctor or nurse for help and advice.

Disposal of used syringes

Dispose of the syringe as instructed by your doctor, pharmacist, or nurse.

If you use more Pelgraz than you should

If you use more Pelgraz than prescribed, contact your doctor, pharmacist, or nurse immediately.

If you forget to use Pelgraz

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

If you stop using Pelgraz

Your doctor will advise you when to stop using Pelgraz. It is common to undergo a series of treatment cycles with Pelgraz.

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

4. Possible adverse effects

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

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

• swelling that may be associated with urinating less frequently, difficulty breathing, abdominal swelling and a general feeling of fatigue. These symptoms usually develop very rapidly.

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

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

• bone pain. Your doctor will advise you on what you can take to relieve the pain.

• nausea and headache.

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

• pain at the injection site.

• general pain and joint and muscle pain.

• chest pain not caused by heart disease or heart attack.

• 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 patients):

• allergic-type reactions, including redness and flushing/feeling hot, 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 part of the abdomen or left shoulder, as these may be related to a problem with your spleen.

• breathing problems. If you have cough, fever, and difficulty breathing, consult your doctor.

• cases of Sweet’s syndrome (painful, inflamed, purplish 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.

• abnormal blood test results (lactate dehydrogenase, uric acid, and alkaline phosphatase).

• abnormal blood test results related to the liver (alanine aminotransferase, aspartate aminotransferase).

• coughing up blood (haemoptysis).

• haematological disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]).

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

• inflammation of the aorta (the large blood vessel carrying blood from the heart to the body) – see section 2.

• bleeding from the lung (pulmonary haemorrhage).

• Stevens-Johnson syndrome, which may appear as red, target-like or circular spots, often with central blisters, on the trunk, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. Stop using Pelgraz if you develop these symptoms and contact your doctor or seek immediate medical attention. See also 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 via the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pelgraz

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 label of the syringe after EXP. The expiry date refers to the last day of the month indicated.

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

Pelgraz may be kept at room temperature (not above 25°C ± 2°C) for a single period of up to 15 days. If Pelgraz is left at room temperature for more than 15 days, it must be discarded. For any questions regarding storage, consult your doctor, nurse, or pharmacist.

Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not negatively affect the stability of Pelgraz.

Keep the pre-filled syringe in its carton 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 dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pelgraz

• 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).

Nature of the product and contents of the pack

Pelgraz is a clear, colourless, injectable solution in a pre-filled syringe with an injection needle. Each pre-filled syringe contains 0.6 ml of solution.

Pelgraz is available in packs containing 1 pre-filled syringe, with a needle safety shield pre-attached, in an individual blister pack, and an alcohol swab.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6th floor,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder.

AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IS / LT / LV / LX / MT / NL / NO / PT / PL / RO / SE / SI / SK / ES

Accord Healthcare S.L.U. Tel: +34 93 301 00 64

IT

Accord Healthcare Italia

Tel: +39 02 94323700

EL

Win Medica Pharmaceutical S.A.

Tel: +30 210 7488 821

Date of the most recent revision of this leaflet: 06/2023

Other sources of information

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

This information is intended for healthcare professionals only:

Pelgraz contains no preservatives. Due to the potential risk of microbial contamination, Pelgraz syringes are for single use only.

Do not freeze. Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Pelgraz. If exposure exceeds 24 hours or if the product has been frozen more than once, Pelgraz must not be used.

To improve traceability of granulocyte colony-stimulating factors, the name of the medicinal product (Pelgraz) and the batch number of the administered syringe should be clearly recorded in the patient's medical record.

Use of the pre-filled syringe with needle safety shield

The needle safety shield covers the needle after injection to prevent needlestick injuries. This does not affect the normal functioning of the syringe. Press the plunger rod and push firmly at the end of the injection to ensure complete emptying of the syringe. Hold the skin firmly until the injection is complete. Keep the syringe still and slowly lift your thumb from the plunger head. The plunger rod will move upwards with your thumb, and the spring will retract the needle into the needle safety shield.

Do not use a pre-filled syringe if it has been dropped onto a hard surface.

Disposal

Any unused medicinal product and all materials that have come into contact with it must be disposed of in accordance with local regulations.