Fulphila - patient leaflet, side effects, dosage

- 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.

What is in this leaflet

• 1. What Fulphila is and what it is used for

• 2. What you need to know before you use 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 bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.

Fulphila is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.

Your doctor has given you Fulphila to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.

Fulphila is for use in adults aged 18 and over.

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 using Fulphila:

• – if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch.

• – if you experience a cough, fever and difficulty breathing. This can be a sign of Acute

Respiratory Distress Syndrome (ARDS).

• – if you have any of the following or combination of the following side effects:

• swelling or puffiness, which may be associated with passing water less frequently,

difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.

These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body. See section 4.

• – if you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a problem with your spleen (splenomegaly).

• – if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration).

• – if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia). Your doctor may want to monitor you more closely.

• – if you have sickle cell anaemia. Your doctor may monitor your condition more closely.

• – if you are a patient with breast cancer or lung cancer, Fulphila in combination with chemotherapy and/or radiation therapy may increase your risk of a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukaemia (AML). Symptoms may include tiredness, fever, and 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 trouble breathing, these could be signs of a severe allergic reaction.

• – if you have symptoms of inflammation of the aorta (the large blood vessel which transports

blood from the heart to the body); this has been reported rarely in cancer patients and healthy donors. The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor if you experience these symptoms.

Your doctor will check your blood and urine regularly as Fulphila can harm the tiny filters inside your kidneys (glomerulonep­hritis).

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

You should talk to your doctor about your risks of developing cancers of the blood. If you develop or are likely to develop cancers of the blood, you should not use Fulphila, unless instructed by your doctor.

Loss of response to Fulphila

If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim’s ac­tivity.

Children and adolescents

Fulphila is not recommended for use in children and adolescents due to insufficient data on safety and effectiveness.

Other medicines and Fulphila

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

If you become pregnant during Fulphila treatment, please inform your doctor.

Unless your doctor directs you otherwise, you must stop breast-feeding if you use Fulphila.

Driving and using machines

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

Fulphila contains sorbitol and sodium

This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.

This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free’.

3. How to use Fulphila

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.

Injecting Fulphila yourself

Your doctor may decide that it would be more convenient for you to inject Fulphila yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.

For further instructions on how to inject yourself with Fulphila, please read the attached instructions for use.

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 inject Fulphila

If you have forgotten a dose of Fulphila, you should contact your doctor to discuss 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.

Please tell your doctor immediately if you have any of the following or combination of the following side effects:

• – swelling or puffiness, which may be associated with passing water less frequently, difficulty

breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally develop in a rapid fashion.

These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.

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

• – bone pain. Your doctor will tell you what you can take to ease the bone pain.

• – nausea and headaches.

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

• – pain at the site of injection.

• – general aches and pains in the joints and muscles.

• – some changes may occur in your blood, but these will be detected by routine blood tests. Your white blood cell count may become high for a short period of time. Your platelet count may become low which might result in bruising.

• – chest pain.

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

• – allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch.

• – serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).

• – sickle cell crises in patients with sickle cell anaemia.

• – increased spleen size.

• – spleen rupture. Some cases of splenic rupture were fatal. It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.

• – breathing problems. If you have a cough, fever and difficulty breathing please tell your doctor.

• – Sweet’s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role.

• – cutaneous vasculitis (inflammation of the blood vessels in the skin).

• – damage to the tiny filters inside your kidneys (glomerulonep­hritis).

• – redness at the site of injection.

• – coughing up blood (haemoptysis).

• – Blood disorders (myelodysplastic syndrome [MSD] or acute myeloid leukaemia [AML]).

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

• – inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.

• – bleeding from the lung (pulmonary haemorrhage).

• – Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Fulphila if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

Reporting of side effects

If you get 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. How to store 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, on the blister and on the syringe label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

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

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

You may take Fulphila out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.

Do not use this medicine if you notice it is cloudy or there are particles in it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fulphila contains

• – The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL of solution.

• – The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.

See section 2 “Fulphila contains sorbitol and sodium”.

What Fulphila looks like and contents of the pack

Fulphila is a clear, colourless solution for injection in a glass pre-filled syringe with an attached stainless steel needle and needle cap. The syringe is provided with a blister wrapping.

Each pack contains 1 pre-filled syringe.

Marketing Authorisation Holder

Mylan S.A.S.

117 allée des Parcs

69800 Saint-Priest

France

Manufacturer

McDermott Laboratories t/a Mylan Dublin Biologics

Newenham Court, Northern Cross, Malahide Road

17 Dublin

Ireland

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352,

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Mylan EPD bvba/sprl Tél/Tel: + 32 (0)2 658 61 00	Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288
Etnrapua MaňnaH EOOfl Ten: +359 2 44 55 400	Luxembourg/Lu­xemburg Mylan EPD bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Česká republika Mylan Healthcare CZ s.r.o. Tel: + 420 222 004 400	Magyarorszag Mylan EPD Kft Tel: + 36 1 465 2100
Danmark Viatris ApS Tlf: + 45 28116932	Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74
Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800	Nederland Mylan Healthcare BV Tel: +31 (0)20 426 3300
Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 052	Norge Viatris AS Tel: + 47 66 75 33 00
EXXáSa BGP nPOIONTA M.E.n.E. Tql: +30 210 9891 777	Österreich Mylan Österreich GmbH Tel: +43 1 86390
España Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 712	Polska Mylan Healthcare Sp. z o.o Tel: + 48 22 546 64 00
France Mylan Medical SAS Tel: +33 1 56 64 10 70	Portugal Mylan, Lda. Tel: + 351 21 412 72 56
Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599	Romania BGP Products SRL Tel: + 40 372 579 000
Ireland Mylan Ireland Limited Tel: +353 1 8711600	Slovenija Mylan Healthcare d.o.o. Tel: + 386 1 236 31 80

Ísland

Icepharma hf

Símí: +354 540 8000

Slovenská republika

Mylan s.r.o.

Tel: +421 2 32 199 100

Instructions for injecting with the Fulphila pre-filled syringe

This section contains information on how to give yourself an injection of Fulphila. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.

How do you, or the person injecting you, use Fulphila pre-filled syringe?

You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.

Equipment that you need

To give yourself a subcutaneous injection you will need:

• – a pre-filled syringe of Fulphila; and

• – alcohol wipes or similar.

What should I do before I give myself a subcutaneous injection of Fulphila?

• 1. Remove the syringe from the refrigerator.

• 2. Do not shake the pre-filled syringe.

• 3. Do not remove the needle cap from the syringe until you are ready to inject.

• 4. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.

• 5. Check the appearance of Fulphila. It must be a clear and colourless liquid. If there are particles in it, you must not use it.

• 6. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm the syringe in any other way (for example, do not warm it in a microwave or in hot water).

• 7. Wash your hands thoroughly.

• 8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.

How do I prepare my Fulphila injection?

Before you inject Fulphila you must do the following:

• 1. Hold the syringe barrel and gently take the cap from the needle without twisting. Pull straight as shown in pictures 1 and 2. Do not touch the needle or push the plunger.

• 2. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.

• 3. You can now use the pre-filled syringe.

Where should I give my injection?

The most suitable places to inject yourself are:

• the top of your thighs; and
• the abdomen, except for the area around the navel.

If someone else is injecting you, they can also use the back of your arms.

How do I give my injection?

• 1. Clean your skin by using an alcohol wipe.

• 2. Pinch (without squeezing) the skin using your thumb and forefinger. Insert the needle into the skin.

• 3. Push the plunger down with a slow constant pressure. Push the plunger all the way down as far as it will go to inject all the liquid.

• 4. After injecting the liquid, remove the needle and let go of your skin.

• 5. If you notice a spot of blood at the injection site, dab with a cotton ball or tissues. Do not rub the injection site. If needed, you may cover the injection site with a plaster.

• 6. Do not use any Fulphila that is left in the syringe.

Remember

Only use each syringe for one injection. If you have any problems, please ask your doctor or nurse for help and advice.

Disposing of used syringes

• Do not put the cap back on used needles.
• Keep used syringes out of the sight and reach of children.
• The used syringe should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.