FULPHILA 6 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Fulphila and what is it used for

Fulphila contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in the bacteria E. coli. Pegfilgrastim belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor) that our body produces.

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 can occur as a result of 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 decrease. If the number of white blood cells becomes too low, there may not be enough to fight off bacteria, which can lead to a higher risk of infection.

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

Fulphila is indicated in patients over 18 years of age.

2. What you need to know before you use 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 starting Fulphila:

• if you experience an allergic reaction that includes weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness, and itching 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 side effects:
• • swelling that may be associated with decreased urine output, difficulty breathing, swelling, and a feeling of fullness in the abdomen, and a general feeling of tiredness.

These may be symptoms of a condition called "capillary leak syndrome" and can cause 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 infiltrate).
• 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 Fulphila with chemotherapy and/or radiotherapy may increase the risk of developing a pre-cancerous hematological disorder called myelodysplastic syndrome (MDS) or a hematological malignancy 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), 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 regularly perform blood and urine tests, as Fulphila may damage the small filters within the kidneys (glomerulonephritis).

With the use of pegfilgrastim, serious skin reactions (Stevens-Johnson syndrome) have been reported. Stop using Fulphila and seek medical attention immediately if you observe any of the symptoms described in section 4.

You should discuss with your doctor the risk of developing blood cancer. If you present or may present blood cancer, you should not use Fulphila, unless your doctor advises you to.

Loss of response to Fulphila

If you experience a loss of response or if it is not possible to maintain the response to treatment with pegfilgrastim, your doctor will investigate the 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 not enough data available on its safety and efficacy.

Other medicines and Fulphila

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 during treatment with Fulphila, inform your doctor.

Unless your doctor tells you otherwise, you must stop breastfeeding if you use 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, which is equivalent to 50 mg/ml.

This medicine contains less than 1 mmol of sodium (23 mg) per 6 mg dose, which is essentially "sodium-free".

3. How to use Fulphila

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is a single subcutaneous injection of 6 mg (under the skin) with a pre-filled syringe, and should be administered at the end of each chemotherapy cycle, at least 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 it. Do not attempt to do it if you have not been taught.

For further instructions on how to inject Fulphila yourself, read the attached 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 decide when you should inject the next dose.

If you have any other 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 urine output, difficulty breathing, swelling, and a feeling of fullness in the abdomen, and a general feeling of tiredness. These symptoms usually develop very quickly.

These may be symptoms of a condition called "capillary leak syndrome" that can cause 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 people)

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

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

• 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 by regular blood tests. The number of white blood cells may increase for a short period. The number of platelets may decrease, which can cause bruising.
• chest pain.

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

• allergic reactions, including redness, flushing, rash, and itching of the skin.
• 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.
• 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 left shoulder tip, as this could be related to a problem with the spleen.
• respiratory problems. If you have a cough, fever, and difficulty breathing, consult your doctor.
• cases of Sweet's syndrome (painful, inflamed, purple-colored lesions on the limbs 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 blood vessels in the skin).
• damage to the small filters within the kidneys (glomerulonephritis).
• redness at the injection site.
• bleeding from the lungs (hemoptysis).
• hematological disorders (MDS or AML).

Rare side 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.
• bleeding from 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 Fulphila and seek medical attention immediately if you develop these symptoms. 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 Fulphila

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, blister, and label of the pre-filled syringe after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (2°C to 8°C).

Do not freeze. Fulphila may be used if it has been accidentally frozen for a period of less than 24 hours.

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

Fulphila may be stored at room temperature (below 30°C) for a maximum of 3 days. Once a pre-filled syringe has been removed from the refrigerator and reaches room temperature (below 30°C), it must be used within 3 days or discarded.

Do not use this medicine if you notice that the solution is not entirely clear 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. Package Contents and Additional Information

Fulphila Composition

• The active ingredient is pegfilgrastim. Each prefilled 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 injectable preparations. See section 2 "Fulphila contains sorbitol and sodium acetate".

Product Appearance and Package Contents

Fulphila is a clear and colorless injectable solution (injection) contained in a glass prefilled syringe with a stainless steel needle and a needle cap. The syringe is provided in a blister pack.

Each package contains 1 prefilled syringe.

Marketing Authorization 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

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

Date of the last revision of this prospectus: {MM/AAAA}.

Other sources of information

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

---------------------------------------------------------------------------------------------------------------------