6 mg solution for injection in a pre-filled syringe of
pegfilgrastim

1. What Fulphila is and what it is used for

Fulphila contains the active substance pegfilgrastim. Pegfilgrastim is a protein that is produced using biotechnology in a bacterium called E. coli. It belongs to a group of proteins called cytokines and it is very similar to a natural protein (granulocyte colony-stimulating factor) that is produced in the 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 concomitant fever) which may be due to the use of cytotoxic chemotherapy (drugs that destroy fast-growing cells). The white blood cells are important because they help your body fight infection. These blood cells are very sensitive to chemotherapy and this treatment can lead to a decrease in their number in the body. About the number of white blood cells drops to a low level, there may not be enough left in the body to fight bacteria, and then you may become more susceptible to infection.

Your doctor has given you Fulphila to help your bone marrow (the part of the skeleton where blood cells are formed) to form more white blood cells that help your body fight infection.

Fulphila is intended for adults who are 18 years or older.

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 cautions

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

  • if you suffer from an allergic reaction, which may manifest as a feeling of weakness, drop in blood pressure, difficulty breathing, swelling of the face ( anaphylaxis ), redness and swelling, rash, and areas of skin with itching.
  • if you have a cough, fever, and difficulty breathing. This may be a sign of acute respiratory distress syndrome.
  • if you experience any of the following side effects: swelling or fluid retention, which may occur while urinating less frequently than usual, difficulty breathing; swollen abdomen and a feeling of satiety; general feeling of tiredness. This can be a symptom of a condition called capillary leakage syndrome, which causes blood to leak from the small blood vessels. See section 4.
  • if you experience pain in the upper abdomen on the left side of the tip of the left shoulder blade. This may be a sign of splenomegaly.
  • if you have recently had a serious lung infection ( pneumonia ), fluid in the lungs ( pulmonary edema ), inflammation of the lungs (interstitial lung disease), or abnormal chest X-ray results (lung infiltration).
  • if you know you have altered blood cell count (eg increased white blood cell count or anemia ) or decreased platelet count, which reduces the blood’s ability to clot ( thrombocytopenia ). Your doctor may want to check this more often than usual.
  • if you have sickle cell anemia. Your doctor may want to check this more often than usual.
  • if you experience sudden signs of allergy, such as a rash, itching or hives, 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.
  • Inflammation of the carotid artery (the large blood vessel that carries blood from the heart to the body) has been reported with the frequency “rare” in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Tell your doctor if you experience these symptoms.

You will be given regular blood and urine samples as Fulphila can damage the small filters in your kidneys ( glomerulonephritis ).

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

Talk to your doctor about the risk of developing blood cancer. If you develop or are at high risk of developing blood cancer, do not use Fulphila unless your doctor tells you to.

Impaired treatment response to Fulphila

If you stop responding to treatment with pegfilgrastim or if the response to treatment decreases, your doctor will investigate the reasons for this. Your doctor will, among other things, check if you have developed antibodies that neutralize the activity of pegfilgrastim.

Children and young people

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

Other drugs and Fulphila

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

Pregnancy, breastfeeding, and fertility

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. Your doctor may therefore decide not to use this medicine.

If you become pregnant during treatment with Fulphila, talk to your doctor.

If you do not receive any other instructions from your doctor, you must stop breast-feeding if you are taking Fulphila

Fulphila contains sorbitol and sodium acetate

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

Fulphila contains excipients

This medicine contains 30 mg sorbitol in each prefilled syringe equivalent to 50 mg/ml.

This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.

3. How to use Fulphila

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

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

Do not shake Fulphila vigorously as this may affect its effect.

How to give yourself the injection with Fulphila

Your doctor may decide that you should inject Fulphila yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if your doctor or nurse has not shown you how to do it.

For more information on how to give yourself the injection you with Fulphila at the end of this leaflet.

If you use more Fulphila then you should 

If you take more Fulphila then you should contact a doctor, pharmacist, or nurse.

If you forget to use Fulphila

If you have missed your 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 product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

If you get any of these side effects, talk to your doctor straight away:

  • swelling or fluid retention, which may occur while urinating less frequently than usual, difficulty breathing, a swollen abdomen and a feeling of satiety, and a general feeling of tiredness. These symptoms often develop rapidly.

These symptoms may be signs of a less common condition (may affect up to 1 in 100 people) called capillary leakage syndrome, which causes blood to leak from small blood vessels into the body. This condition must be treated immediately.

A very common side effect is (can occur in more than 1 in 10)

  • skeletal pain. Your doctor may recommend what you can take to relieve skeletal pain.
  • headache and nausea.

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

  • injection site pain.
  • general joint and muscle pain.
  • some changes in blood values ​​may occur, but these are detected during routine blood tests. Your white blood cells may increase for a limited period of time. The number of platelets can decrease which can lead to bruising.
  • chest pain.

Less common side effects are (may affect up to 1 in 100)

  • allergy-like reactions, including redness and swelling, rash, and raised itchy skin areas.
  • severe allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
  • sickle cell crisis in patients with sickle cell anemia.
  • increased spleen size.
  • anthrax. Some cases of anthrax were fatal. You must contact your doctor immediately if you experience pain in the upper left side of the abdomen or up against the left shoulder, as this may indicate problems with the spleen.
  • breathing problems. If you have a cough, fever, and difficulty breathing, consult a doctor.
  • Sweet’s syndrome (plum-colored, raised, painful skin changes on the arms and legs and sometimes on the face and neck with fever) have occurred, but other factors may be important.
  • cutaneous vasculitis ( inflammation of the blood vessels of the skin).
  • damage to the small filters in the kidneys ( glomerulonephritis ).
  • redness at the injection site.
  • hemorrhages (hemoptysis).

Rare side effects are (may affect up to 1 in 1000 users)

  • inflammation of the carotid artery (the large blood vessel that carries blood from the heart to the body), see section 2.
  • bleeding from the lungs ( pulmonary hemorrhage).
  • Stevens-Johnson syndrome can begin as reddish target-like or round spots on the torso, often with blisters in the middle. Skin peeling and sores in the mouth, throat, nose, genitals, and eyes may also occur. These reactions are often preceded by fever and flu-like symptoms. If you develop any of these symptoms, stop using Fulphila and contact your doctor immediately or seek medical attention. See also section 2.

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, blister, and syringe label after EXP. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C).

Do not freeze. Fulphila can be used if the solution has been inadvertently frozen for less than 24 hours at a time.

Store the packaging in the outer carton. Sensitive to light.

You can remove Fulphila from the refrigerator and store it at room temperature (maximum 30 ° C) for a maximum of 3 days. Once a syringe has been removed from the refrigerator and reached room temperature (maximum 30 ° C), it must be used within 3 days or discarded.

Do not use this medicine if it 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. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml solution.
  • The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20, and water for injections. See section 2 “Fulphila contains sorbitol and sodium acetate”.

What the medicine looks like and the contents of the pack

Fulphila is a clear, colorless solution for injection in a pre-filled glass syringe with a stainless steel needle and needle sleeve. The syringe is delivered in a blister pack. The syringe comes with an automatic needle guard.

Each pack contains 1 pre-filled glass syringe.

Marketing Authorisation Holder

Mylan SAS

117 Allée des Parcs

69800 Saint ‑ Priest

France

Manufacturer

McDermott Laboratories to Mylan Dublin Biologics

Newenham Court, Northern Cross, Malahide Road

17 Dublin

Ireland

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienMylan EPD bvba / sprlTel: + 32 (0) 2 658 61 00 LithuaniaBGP Products UABTel: +370 5 205 1288
BulgariaМайлан ЕООДTel: +359 2 44 55 400 Luxembourg / LuxemburgMylan EPD bvba / sprlTel: + 32 (0) 2 658 61 00(Belgium / Belgium)
Czech RepublicMylan Pharmaceuticals.sroTel: + 420 222 004 400 HungaryMylan EPD KftTel: + 36 1 465 2100
DenmarkMylan Denmark ApSTel: + 45 28116932 MaltaVJ Salomone Pharma LtdTel: + 356 21 22 01 74
GermanyMylan Healthcare GmbHTel: + 49‑ (0) 511 475 43 400 The NetherlandsMylan Healthcare BVTel: +31 (0) 20 426 3300
EestiBGP Products Switzerland GmbH Eesti subsidiaryTel: + 372 6363 052 NorwayMylan Healthcare Norge ASTel: + 47 66 75 33 00
GreeceBGP ΠΡΟΪΟΝΤΑ Μ.Ε.Π.Ε.:Ηλ: +30 210 9891 777 AustriaMylan Österreich GmbHTel: +43 1 86390
SpainMylan Pharmaceuticals, SLTel: + 34 900 102 712 PolandMylan Healthcare Sp. ZooTel: + 48 22 546 64 00
FranceMylan Medical SASTel: +33 1 56 64 10 70 PortugalMylan, Lda.Tel: + 351 21 412 72 56
CroatiaMylan Hrvatska dooTel: +385 1 23 50 599 RomaniaBGP Products SRLTel: + 40 372 579 000
IrelandMylan IrelandTel: +353 (0) 87 1694982 SloveniaGSP Proizvodi dooTel: + 386 1 236 31 85
IcelandBGP Products ApSTel: +45 28116932(Denmark) Slovak RepublicMylan sroTel: +421 2 32 199 100
ItalyMylan SpATel: + 39 02 612 46921 Finland / FinlandMylan Finland OYPuh / Tel: +358 20 720 9555
LatviaBGP Products SIATel: +371 676 055 80 United KingdomGenerics [UK] LtdTel: +44 1707 853000

Muhammad Nadeem

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