Pelmeg 6 mg solution for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pelmeg 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; do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Pelmeg is and what it is used for

Pelmeg 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.

Pelmeg is used in adult patients 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 following cytotoxic chemotherapy (medicines that destroy rapidly dividing cells). White blood cells are important cells that help fight infections. These cells are sensitive to the effects of chemotherapy, which can cause their numbers to drop. If the number of white blood cells becomes too low, there may not be enough cells available to combat bacteria, increasing the risk of developing 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, helping you fight infections.

2. What you need to know before using Pelmeg

Do not use Pelmeg

• if you are allergic to pegfilgrastim, filgrastim, proteins produced in E. coli, or any of the other components of this medicine.

Warnings and precautions

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

• 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.

• if you experience 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 frequency of urination, 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," which causes blood to leak from small blood vessels into other areas 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 (interstitial lung disease), or abnormal chest X-ray findings (pulmonary infiltration).
• if you are aware of any abnormalities in blood cell counts (e.g., increased white blood cell count or anemia) or a reduced platelet count, which may decrease the blood's ability to clot (thrombocytopenia). Your doctor may wish 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 Pelmeg combined with chemotherapy and/or radiotherapy may increase the risk of developing a pre-cancerous 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 rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing. These may be signs of a severe allergic reaction.
• if you have symptoms of inflammation of the aorta (the large blood vessel that carries 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 increased inflammatory markers. Inform your doctor if you experience these symptoms.

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

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

You should discuss with your doctor the risk of developing blood cancer. If you have or may develop blood cancer, you should not use Pelmeg 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 neutralizing antibodies to pegfilgrastim.

Other medicines and Pelmeg

Inform 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. Pelmeg has not been studied in pregnant women. It is important that you inform your doctor if:

• you are pregnant;
• you think you might be pregnant; or
• you are planning to become pregnant.

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

Unless your doctor advises otherwise, you should discontinue breastfeeding while using Pelmeg.

Driving and using machines

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

Pelmeg contains sorbitol (E 420) and sodium acetate

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; hence, it is essentially "sodium-free".

3. How to use Pelmeg

Pelmeg is indicated in adults 18 years of age and older.

Always follow exactly the instructions for administration of this medicine provided by your doctor. In case of doubt, consult your doctor or pharmacist again. The usual dose is one 6 mg subcutaneous injection (under the skin) using a pre-filled syringe, to be administered at the end of each chemotherapy cycle, at least 24 hours after the last dose of chemotherapy.

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

Self-injection of Pelmeg

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

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

If you use more Pelmeg than you should

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

If you forget to inject Pelmeg

If you have forgotten to administer a dose of Pelmeg, contact your doctor to determine when you should administer 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 that may be associated with reduced frequency of urination, 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 condition that occurs infrequently (affecting up to 1 in 100 people), called "capillary leak syndrome," which causes blood to leak from small blood vessels into other areas of your 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;
• 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, 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;
• respiratory 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 could 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 patients):

• inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), see section 2;
• bleeding in the lungs (pulmonary haemorrhage);
• Stevens-Johnson syndrome, which may appear as concentric or circular red 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 Pelmeg 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 included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pelmeg

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 following EXP. The expiry date refers to the last day of the month indicated.

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

Pelmeg may be kept outside the refrigerator at room temperature (provided 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 (not exceeding 30°C), it must be used within 4 days or discarded.

Do not freeze. Pelmeg may still be used if it has been accidentally frozen for two periods of less than 72 hours each.

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

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

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

6. Contents of the pack and other information

Composition of Pelmeg

• 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 (E 420), polysorbate 20 and water for injections. See section 2.

Nature and contents of the container

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

Each pack contains 1 pre-filled glass syringe with a stainless steel needle and a needle cap. The syringe is supplied with an automatic needle protection device.

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

PharmaKorell GmbH

Schleissheimer Strasse 373,

80935 Munich

Germany

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

The Netherlands

Date of the most recent revision of this package leaflet:

Other sources of information

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