Prospect: information for the user

Pelmeg 6 mg injectable solution in pre-filled syringe

pegfilgrastim

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read the entire prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects that do not appear in this prospect. See section 4.

1. What Pelmeg is and for what it is used

2. What you need to know before starting to use Pelmeg

3. How to use Pelmeg

4. Possible adverse effects

5. Storage of Pelmeg

6. Contents of the package and additional information

Pelmeg contains the active ingredient pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in the bacteriaE. 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.

Pelmeg is used in adult patients to reduce the duration of neutropenia (low count of white blood cells) and the incidence of febrile neutropenia (low count of white blood cells and fever) that may be caused by cytotoxic chemotherapy (medicines that destroy rapidly dividing cells). White blood cells are important cells that contribute to fighting infections. These cells are sensitive to the effects of chemotherapy, which can cause their number to decrease. If the number of white blood cells decreases significantly, there may not be enough to fight bacteria, which implies a higher risk of contracting an infection.

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

No use Pelmeg

• If you are allergic to pegfilgrastim, filgrastim, proteins produced inE. coli, or any of the other components of this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Pelmeg:

• If you experience an allergic reaction that includes weakness, decreased blood pressure, difficulty breathing, facial swelling (anaphylaxis), redness and flushing, skin rash, and itching in areas of the skin;
• If you experience cough, fever, and difficulty breathing. This may be a sign of acute respiratory distress syndrome (ARDS);
• If you experience any or a combination of the following adverse effects:

• Swelling that may be associated with urinating less frequently, difficulty breathing, abdominal swelling, and a feeling of fullness, and a general feeling of fatigue.

These may be symptoms of a condition called "capillary leak syndrome" that causes blood to escape from small blood vessels into other parts of your body. See section 4;

• If you have pain in the upper left abdomen or pain in the shoulder tip. This may be a sign of a problem with the spleen (splenomegaly);
• If you recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), inflammation of the lungs (interstitial lung disease), or an abnormal result on chest X-rays (pulmonary infiltration);
• If you are aware of any alteration in blood cell count (for example, an increase in the number of white blood cells or anemia) or a decrease in 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 closely monitor your disease;
• If you are a breast cancer or lung cancer patient, the combined treatment of Pelmeg with chemotherapy and/or radiation therapy may increase the risk of developing a pre-cancerous hematological condition called myelodysplastic syndrome (MDS) or a hematological neoplasm called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, easy bruising, or bleeding;
• If you experience sudden signs of allergy, such as skin rash, itching, or urticaria, facial swelling, lips, tongue, or other body parts, shortness of breath, wheezing, or difficulty breathing. These may be signs of a severe allergic reaction;
• If you experience symptoms of aorta inflammation (the large blood vessel that carries blood from the heart to the rest of the body), which rarely has been reported in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, general discomfort, back pain, and increased inflammatory markers. Inform your doctor if you experience these symptoms.

Your doctor will perform regular blood and urine tests since Pelmeg may damage the small filters within the kidneys (glomerulonephritis).

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

You should consult with your doctor about the risk of developing blood cancer. If you develop or may develop blood cancer, do not use Pelmeg, except if your doctor advises you to.

Loss of response to pegfilgrastim

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

Other medications and Pelmeg

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication. Pelmeg has not been studied in pregnant women. It is essential that you inform your doctor if:

• You are pregnant;
• You think you may be pregnant; or
• You intend to become pregnant.

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

Unless your doctor advises you otherwise, you should stop breastfeeding if you use Pelmeg.

Driving and operating machinery

The influence of Pelmeg on the ability to drive and operate machinery is negligible or insignificant.

Pelmeg contains sorbitol (E420) and sodium acetate

This medication contains 30 mg of sorbitol in each pre-filled syringe equivalent to 50 mg/ml.

This medication contains less than 1 mmol of sodium (23 mg) per 6 mg; this is essentially "sodium-free".

Pelmeg is indicated for adults 18 years of age or older.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. The usual dose is a subcutaneous injection of 6 mg (under the skin) using a preloaded syringe, which should be administered at the end of each chemotherapy cycle at least 24 hours after your last chemotherapy dose.

Do not shake Pelmeg strongly as it may affect its activity.

Pelmeg Self-Administration

Your doctor may consider it more convenient for you to administer Pelmeg yourself. Your doctor or nurse will teach you how to do it. Do not attempt it if you have not been taught.

For more information on how to administer Pelmeg yourself, read the section at the end of this leaflet.

If you use more Pelmeg than you should

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

If you forgot to administer Pelmeg

If you have forgotten to administer a dose of Pelmeg, contact your doctor to decide when you should administer the next dose.

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

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

Inform your doctor immediately if you experience any or a combination of the following side effects:

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

These may be symptoms of a rare disease (which can affect up to 1 in 100 people) called "capillary leak syndrome" that causes blood to escape from small blood vessels into other parts of your body and requires urgent medical attention.

Very common side effects(can affect more than 1 in 10 patients):

• bone pain. Your doctor will inform you about what you can take to alleviate the pain;
• nausea and headache.

Common side effects(can affect up to 1 in 10 patients):

• pain at the injection site;
• general pain and pain in the joints and muscles;
• some changes in your blood may occur, which will be detected through periodic blood tests. You may experience an increase in white blood cells for a short period of time. You may experience a decrease in platelets, which can cause bruising.

Uncommon side effects(can affect up to 1 in 100 patients):

• allergic reactions, including redness and flushing/hives, appearance of rashes, and skin inflammation with itching;
• severe allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling);
• enlargement of the spleen;
• spleen rupture. Some cases of spleen rupture were fatal. It is essential to contact your doctor immediately if you notice pain in the upper left abdomen or left shoulder, as it may be related to a spleen problem;
• respiratory problems. If you have a cough, fever, and difficulty breathing, consult your doctor. Cases of Sweet syndrome (painful, inflamed, violaceous lesions on the extremities and, in some cases, on the face and neck, accompanied by fever) have been reported, but they may be related to other factors;
• cutaneous vasculitis (inflammation of skin blood vessels);
• damage to the small filters within the kidneys (glomerulonephritis);
• redness at the injection site;
• coughing up blood (hemoptysis);
• hematological disorders (myelodysplastic syndrome [MDS] or acute myeloid leukemia [AML]).

Rare side effects(can affect up to 1 in 1000 patients):

• aortic inflammation (the large blood vessel that carries blood from the heart to the rest of the body), see section 2;
• bleeding in the lungs (pulmonary hemorrhage);
• Stevens-Johnson syndrome, which can appear as concentric or circular red patches often with central blisters on the trunk, exfoliation, ulcers in the mouth, throat, nose, genitals, and eyes; and may be preceded by fever and flu-like symptoms. Stop using Pelmeg if you develop these symptoms and contact your doctor or seek immediate medical attention. See section 2.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the syringe label after CAD. The expiration date is the last day of the month indicated.

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

Pelmeg can be out of the refrigerator at room temperature (as long as it does not exceed 30°C) for a maximum of 4 days. Once a syringe has been removed from the refrigerator and has reached room temperature (which does not exceed 30°C), it must be used within 4 days or discarded.

Do not freeze. Pelmeg can be used if it is accidentally frozen for two periods of less than 72 hours each.

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

Do not use this medication if you observe that the solution is cloudy or contains particles.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help toprotectthe environment.

Composition of Pelmeg

• The active ingredient 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), polisorbate 20, and water for injection. See section 2.

Appearance of the product and contents of the pack

Pelmeg is a transparent and colourless injectable solution in a pre-filled syringe (6 mg/0.6 ml).

Each pack contains one pre-filled syringe of glass with a stainless steel needle and a needle cap. The syringe is supplied with an automatic needle guard.

Marketing authorisation holder

Mundipharma Corporation (Ireland) Limited,

United Drug House Magna Drive, Magna Business Park,

Citywest Road, Dublin 24,

Ireland

Manufacturer

PharmaKorell GmbH

Georges-Köhler-Str. 2,

79539 Lörrach

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:February 2023.

Other sources of information

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