Grasustek - 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 Grasustek is and what it is used for

• 2. What you need to know before you use Grasustek

• 3. How to use Grasustek

• 4. Possible side effects

• 5. How to store Grasustek

• 6. Contents of the pack and other information

1. What Grasustek is and what it is used for

Grasustek is for use in adults aged 18 and over.

Grasustek 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.

Grasustek 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 Grasustek 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.

2. What you need to know before you use Grasustek

Do not use Grasustek

• if you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, 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 Grasustek:

• 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, Grasustek 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 those symptoms.

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

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Grasustek. Stop using Grasustek 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 Grasustek, unless instructed by your doctor.

Loss of response to pegfilgrastim

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.

Other medicines and Grasustek

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

Pregnancy, breast-feeding and fertility

Ask your doctor or pharmacist for advice before taking any medicine. Grasustek has not been tested in pregnant women. It is important to tell your doctor if you:

are pregnant or breast-feeding think you may be pregnant or are planning to have a baby

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

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

Driving and using machines

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

Grasustek contains sorbitol (E420) and sodium

This medicine contains 30 mg sorbitol in each 6 mg dose, 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 Grasustek

Always use Grasustek exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual 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 Grasustek yourself

Your doctor may decide that it would be more convenient for you to inject Grasustek 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 Grasustek, please read the section at the end of this leaflet.

Do not shake Grasustek vigorously as this may affect its activity.

If you use more Grasustek than you should

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

If you forget to inject Grasustek

If you have forgotten a dose of Grasustek, 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 may have 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.

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).
• 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)

• 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 Grasustek 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 Grasustek

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 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).

You may take Grasustek 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 freeze. Grasustek 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.

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 to protect the environment.

6. Contents of the pack and other information

What Grasustek 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).

What Grasustek looks like and contents of the pack

Grasustek is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 ml).

Each pack contains 1 glass pre-filled syringe with an attached stainless-steel needle and needle cap. The syringes are provided with an automatic needle safety guard.

Marketing Authorisation Holder

Juta Pharma GmbH,

Gutenbergstr. 13,

24941Flensburg,

Germany

Manufacturer

Juta Pharma GmbH,

Gutenbergstr. 13,

24941 Flensburg,

Germany

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

Magyarország Aramis Pharma Kft 1095 Mester u. 28 Budapest Hungary Tel:+36–1–299–1051	Polska Alvogen Pharma Sp. Z o.o. Ul Kniaznina 4a lok 7 01–607 Warsaw, Poland Tel: + 48 22 460 92 00
Romania Alvogen Romania SRL 44B, Theodor Pallady Blvd. 3rd district, 032266 Bucharest, Romania Tel: +40 21 318 0377	Österreich Vertrieb G.L.Pharma GmbH Schlossplatz 1, 8502 Lannach, Osterreich Tel: +43 3136 82577
Česká republika EGIS Praha, spol. s r.o., Praha1-Staré Město,Ovocný trh 1096/8, PSČ 11000 Tel: +420 227 129 111	Slovenská republika EGIS Slovakia spol. s r.o., Prievozská 4D, 821 09 Bratislava Tel: +421 2 32409422
Eesti Apteegikaubanduse Hulgimüük OÜ (Auxilia Pharma) Karamelli 6, 11317 Tallinn Tel: +372 605 0005	Deutschland medac GmbH Theaterstr. 6 22880 Wedel, Deutschland Tel: +49 4103 / 8006–777
Italia medac Pharma S.r.l. Via Viggiano 90, 00178 Rome Italien Tel: +39 06 51 59 121	Sverige, Danmark, Norge medac GmbH Malmöhusvägen 1 211 18 Malmö Schweden Tel: +46 0340 64 54 70
Suomi/Finland medac GmbH Hirsalantie 11 02420 Jorvas Finland	Lietuva SIA „Unikmed Baltija“ Gertrudos g. 33/35–2, LV-1011, Ryga, Latvija Tel.: +371 64 412–474

Tel: +358 10 420 4000

Latvija SIA Unikmed Baltija Gertrudes iela 33/35–2, LV-1011, Riga, Latvija Talr.: +371 64 412–474

Slovenija Distribucija G.L.Pharma GmbH Schlossplatz 1, 8502 Lannach, Avstrija Tel: +43 3136 82577

Belgie / Belgique / Belgien, España, France, Ireland, Kúnpog, Luxembourg / Luxemburg, Malta, Nederland, Portugal, United Kingdom (Northern Ireland)

Juta Pharma GmbH

Tel: +49(0)461995799–0

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Instructions for use:

Important

Before you use a Grasustek 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.

• Grasustek is given as an injection into the tissue just under the skin (subcutaneous use).

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

inject.

X 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.

X Do not attempt to activate the pre-filled syringe prior to injection.

X Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled

syringe.

X 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 minutes be

On a clean

X Do n< X Do n<

X Do n< Keep pre-

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

well-lit work surface, place the new pre-filled syringe and the other supplies.

ot try to warm the syringe by using a heat source such as hot water or microwave.

ot leave the pre-filled syringe exposed to direct sunlight.

ot shake the pre-filled syringe.

illed syringes out of the sight and reach of children.

B.

Warning/Precaution: Check to ensure there is no loose fragment or fluid inside the pack. In case of doubt DO NOT open this pack and take another pack instead.

Open the blister by peeling back the top layer all the way off the blister as shown.

\ \ \B lister

\ Toplayer

X.

____~

C.

Warning/Precaution: DO NOT lift the product by the plunger or needle cover.

Remove the pre-filled syringe from blister as shown.

Warning/Precaution: DO NOT twist the needle cover or touch the needle or plunger.

Pull the needle cover straight off as shown and handle the guard to avoid injuries or bending the needle.

After the injection is complete, one of the below alternatives can be followed:

• -Remove the needle from the injection site and release the plunger until the entire needle is covered by the guard.

• -Release the plunger until the needle is covered and then remove the syringe from the injection site