Fulphila 6 mg solution for injection in pre-filled syringe – patient leaflet, side effects, dosage

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 pegfilgrastim, please read the attached instructions for use.

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 [MDS] 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 Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard Or search for MHRA Yellow Card in the Google Play or Apple App Store. 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, the syringe is provided with an automatic needle guard.

Each pack contains 1 glass pre-filled syringe

Marketing Authorisation Holder

Biosimilar Collaborations Ireland Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Dublin

D13 R20R

Ireland

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:

This leaflet was last revised in July 2023

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Instructions for use:

Guide to parts Before use

After use

Important

Before you use a Fulphila pre-filled syringe with automatic needle guard, read this important information:

• It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
• Fulphila is given as an injection into the tissue just under the skin (subcutaneous injection).

Χ Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.

Χ Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new pre-filled syringe and call your doctor or healthcare provider.

Χ Do not attempt to activate the pre-filled syringe prior to injection. Χ Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe.

Χ Do not attempt to remove the peelable label on the pre-filled syringe barrel before administering your injection.

Call your doctor or healthcare provider if you have any questions.

Step 1: Prepare A. Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).

For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting. Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies. Χ Do not try to warm the syringe by using a heat source such as hot water or microwave. Χ Do not leave the pre-filled syringe exposed to direct sunlight.

Χ Do not shake the pre-filled syringe.

• Keep pre-filled syringes out of the sight and reach of children.

B. Open the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.

For safety reasons:

Χ Do not grasp the plunger.

Χ Do not grasp the grey needle cap.

C.

Inspect the medicine and pre-filled syringe.

Χ Do not use the pre-filled syringe if:

• The medicine is cloudy or there are particles in it. It must be a clear and colourless liquid.
• Any part appears cracked or broken.
• The grey needle cap is missing or not securely attached.

• The expiry date printed on the label has passed the last day of the month shown. In all cases, call your doctor or healthcare provider.

  Step 2: Get ready A. Wash your hands thoroughly. Prepare and clean your injection site.

You can use:

• Upper part of your thigh
• Belly, except for a 5 cm (2-inch) area right around your belly button.
• Outer area of upper arm (only if someone else is giving you the injection).

Clean the injection site with an alcohol wipe. Let your skin dry.

Χ Do not touch the injection site before injecting.

Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

B Carefully pull the grey needle cap straight out and away from your body.

C Pinch your injection site to create a firm surface.

It is important to keep the skin pinched when injecting.

Step 3: Inject A Hold the pinch. INSERT the needle into skin.

Χ Do not touch the cleaned area of the skin.

B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the way down through the snap.

It is important to push down through the “snap” to deliver your full dose.

C RELEASE your thumb. Then LIFT the syringe off skin.

After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.

Χ Do not put the grey needle cap back on used pre-filled syringes.

Healthcare professionals only The trade name of the administered product should be clearly recorded in the patient file.

Step 4: Finish

A Discard the used pre-filled syringe and other supplies in a sharps disposal container.

Medicines 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.

Keep the syringe and sharps disposal container out of sight and reach of children.

Χ Do not reuse the pre-filled syringe.

Χ Do not recycle pre-filled syringes or throw them into household waste.

B

Examine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed.