Fulphila 6 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fulphila 6 mg solution for injection in pre-filled syringe

Pegfilgrastim

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet; 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 must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Fulphila is and what it is used for

Fulphila 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 the human body.

Fulphila 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 because they 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 Fulphila 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.

Fulphila is indicated in patients over 18 years of age.

2. What you need to know before using Fulphila

Do not use Fulphila

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

Warnings and precautions

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

• if you experience an allergic reaction including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash, or itching in areas of the skin.
• if you develop cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• if you experience one or a combination of the following side effects:
  • swelling that may be associated with reduced 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.

• if you have pain in the upper left side of your 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 (pulmonary interstitial disease), or an abnormal chest X-ray (pulmonary infiltration).
• if you are aware of any abnormalities in your blood cell counts (e.g., increased white blood cells or anemia) or a decrease in platelet count, which may reduce 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 have breast cancer or lung cancer, treatment with Fulphila in combination 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 develop 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 elevated inflammatory markers. Inform your doctor if you experience these symptoms.

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

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

Loss of response to Fulphila

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 antibodies that may neutralize the activity of pegfilgrastim.

Children and adolescents

The use of Fulphila is not recommended in children and adolescents, as there is insufficient data on its safety and efficacy.

Other medicines and Fulphila

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Fulphila has not been used in pregnant women. Therefore, your doctor may decide that you should not use this medicine.

If you become pregnant while being treated with Fulphila, inform your doctor.

Unless otherwise instructed by your doctor, you should stop breastfeeding if you are using Fulphila.

Driving and using machines

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

Fulphila contains sorbitol and sodium

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 dose, i.e., essentially "sodium-free."

3. How to use Fulphila

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 6 mg subcutaneous injection (under the skin) delivered with a pre-filled syringe, to be administered at the end of each chemotherapy cycle, starting 24 hours after the last dose of chemotherapy.

Self-injection of Fulphila

Your doctor may consider it more convenient for you to inject Fulphila yourself. Your doctor or nurse will teach you how to do this. Do not attempt it if you have not been trained.

For further instructions on how to self-inject Fulphila, read the accompanying instructions. Do not shake Fulphila vigorously, as this may affect its activity.

If you use more Fulphila than you should

If you use more Fulphila than you should, contact your doctor, pharmacist, or nurse.

If you forget to use Fulphila

If you have forgotten to administer your dose of Fulphila, contact your doctor to determine when you should receive the next injection.

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 will experience them.

Inform your doctor immediately 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 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 out of 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 people)

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

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

• 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 for a short period of time. The number of platelets may decrease, which could lead to bruising.
• chest pain.

Uncommon adverse effects (may affect up to 1 in 100 people)

• allergic-type reactions, including redness and flushing/flushing, rash, and itchy skin inflammation.
• severe allergic reactions, including anaphylaxis (weakness, low blood pressure, difficulty breathing, facial swelling).
• sickle cell crisis in patients with sickle cell anemia.
• 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 this could indicate a problem with the 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 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.
• coughing up blood (hemoptysis).
• hematological disorders (MDS or AML).

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

• inflammation of the aorta (the large blood vessel that carries blood from the heart to the rest of the body), see section 2.
• lung bleeding (pulmonary hemorrhage).
• 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 Fulphila 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 effects, talk to your doctor, pharmacist, or nurse, even if they are adverse effects 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 Fulphila

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

Do not use this medicine after the expiry date stated on the carton, blister, and label of the syringe following EXP. The expiry date refers to the last day of the month indicated.

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

Do not freeze. Fulphila may be used if accidental freezing occurs for less than 24 hours.

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

Fulphila may be kept outside the refrigerator at room temperature (provided it does not exceed 30 °C) for up to 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not exceeding 30 °C), it must be used within 3 days or discarded.

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

Medicines must 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 Fulphila

• 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, “Fulphila contains sorbitol and sodium acetate”.

Nature of the medicinal product and contents of the pack

Fulphila is a clear, colourless injectable solution (injection) contained in a glass pre-filled syringe with a stainless steel needle and a needle cap. The syringe is provided packaged in a blister.

Each pack contains 1 pre-filled syringe.

Marketing Authorisation Holder

Biosimilar Collaborations Ireland Limited
Unit 35/36
Grange Parade,
Baldoyle Industrial Estate,
Dublin 13
DUBLIN
Ireland
D13 R202

Manufacturer

Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne
Dublin
D09 C6X8
Ireland

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

Date of the most recent review of this leaflet: {MM/YYYY}.

Other sources of information

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