PELMEG 6 mg INJECTABLE SOLUTION IN PRE-FILLED SYRINGE

2. What you need to know before you use Pelmeg

Do not use Pelmeg

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

Warnings and precautions

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

• if you experience an allergic reaction that includes weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and itching.
• 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 side effects:

• swelling that may be associated with decreased frequency of urination, difficulty breathing, abdominal swelling and a feeling of fullness and a general feeling of tiredness.

These may be symptoms of a condition called "capillary leak syndrome" that causes blood to leak 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 tip of the shoulder. This may be a sign of a problem with the spleen (splenomegaly).
• if you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), inflammation of the lungs (interstitial lung disease) or an abnormal chest X-ray (pulmonary infiltration).
• if you are aware of any changes in your blood cell count (e.g. increased white blood cell count or anemia) or a decrease in your platelet count, which can reduce the ability of your blood to clot (thrombocytopenia). Your doctor may want to monitor you more closely.
• if you have sickle cell anemia. Your doctor may monitor your condition more closely.
• if you are a cancer patient, the combined treatment of Pelmeg with chemotherapy and/or radiotherapy may increase the risk of developing a pre-cancerous hematological condition called myelodysplastic syndrome (MDS) or a hematological malignancy called acute myeloid leukemia (AML). Symptoms may include tiredness, 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), this 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 perform regular blood and urine tests as Pelmeg may damage the small filters inside the kidneys (glomerulonephritis).

With the use of Pelmeg, serious skin reactions (Stevens-Johnson syndrome) have been reported. Stop using Pelmeg and seek medical attention immediately 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 develop or may develop blood cancer, you should not use Pelmeg, unless your doctor advises you to.

Loss of response to pegfilgrastim

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

Other medicines and Pelmeg

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking 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 may be pregnant; or
• you plan to become pregnant.

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

Unless your doctor tells you otherwise, you must stop breastfeeding if you use Pelmeg.

Driving and using machines

Pelmeg has no or negligible influence on the ability to drive and use machines.

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, i.e. it is essentially "sodium-free".

3. How to use Pelmeg

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

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again. The usual dose is a single subcutaneous injection of 6 mg (under the skin) using a pre-filled syringe, which should be administered at the end of each chemotherapy cycle at least 24 hours after your 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 inject Pelmeg yourself. Your doctor or nurse will teach you how to do this. Do not attempt to do it if you have not been taught.

For further instructions on how to inject 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, tell 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 decide when you should inject the next dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• swelling that may be associated with decreased frequency of urination, difficulty breathing, abdominal swelling and a feeling of fullness and a general feeling of tiredness. These symptoms usually develop rapidly.

These may be symptoms of a condition called "capillary leak syndrome" that causes blood to leak from small blood vessels into other parts of your body and requires urgent medical attention.

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

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

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

• injection site pain;
• general pain and pain in the joints and muscles;
• some changes in your blood may occur, which will be detected by regular blood tests. You may have an increased white blood cell count for a short period. You may have a decreased platelet count, which can cause bruising.

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

• allergic reactions, including redness and flushing, rash, and skin inflammation with itching;
• severe allergic reactions, including anaphylaxis (weakness, low blood pressure, difficulty breathing, facial swelling);
• enlargement of the spleen;
• splenic rupture. Some cases of splenic rupture were fatal. It is important that you contact your doctor immediately if you notice pain in the upper left abdomen or in the 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, purple-colored lesions on the extremities and sometimes on the face and neck, accompanied by fever) have been reported, but may be related to other factors;
• cutaneous vasculitis (inflammation of the skin blood vessels);
• damage to the small filters inside the kidneys (glomerulonephritis);
• redness at the injection site;
• bloody cough (hemoptysis).
• hematological disorders (myelodysplastic syndrome [MDS] or acute myeloid leukemia [AML]).

Rare side effects(may affect up to 1 in 1,000 patients):

• inflammation of the aorta (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 red, circular, or concentric 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 medical attention immediately. See section 2.

Reporting of side effects

If you experience 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 via the national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton and on the label of the pre-filled syringe after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (2°C - 8°C).

Pelmeg can be stored at room temperature (below 30°C) for a maximum of 4 days. Once a pre-filled syringe has been removed from the refrigerator and reached room temperature (below 30°C), it must be used within 4 days or discarded.

Do not freeze. Pelmeg can 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Pelmeg Composition

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

Product Appearance and Container Contents

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

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

Marketing Authorization 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

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