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Grastofil (filgrastim) – Package leaflet - L03AA02

Updated on site: 07-Oct-2017

Medication nameGrastofil
ATC CodeL03AA02
Substancefilgrastim
ManufacturerApotex Europe BV

PACKAGE LEAFLET: INFORMATION FOR THE USER

Grastofil 30 MU/0.5 mL (0.6 mg/mL) solution for injection or infusion in pre-filled syringe filgrastim

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side-effects you may get. See the end of section 4 for how to report side effects.

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, nurse or pharmacist.

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.

In this leaflet

1.What Grastofil is and what it is used for

2.What you need to know before you use Grastofil

3.How to use Grastofil

4.Possible side effects

5.How to store Grastofil

6.Contents of the pack and other information

1. What Grastofil is and what it is used for What Grastofil is

Grastofil contains the active ingredient filgrastim. Grastofil is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of medicines called cytokines. Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine. Grastofil works by stimulating the bone marrow to produce more white blood cells.

A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection. Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells that help fight infection.

What Grastofil is used for

Your doctor has prescribed Grastofil for you to help your body make more white blood cells. Your doctor will tell you why you are being treated with Grastofil.

Grastofil can be used:

to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;

to increase the number of white blood cells after a bone marrow transplant to help prevent infections;

to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections;

in patients with advanced HIV infection which will help reduce the risk of infections;

before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment. These can be taken from you or from a donor. The stem cells will then go back into the bone marrow and produce blood cells.

2.What you need to know before you use Grastofil

Do not use Grastofil

if you are allergic (hypersensitive) to 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 Grastofil.

Please tell your doctor before starting treatment if you have:

osteoporosis (bone disease),

sickle cell anaemia, as filgrastim may cause sickle cell crisis.

Please tell your doctor immediately during treatment with Grastofil, if you:

get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder (these may be symptoms of an enlarged spleen (splenomegaly), or possibly rupture of the spleen),

notice unusual bleeding or bruising (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot).

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 as these could be signs of a severe allergic reaction.

experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.

Loss of response to filgrastim

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

Your doctor may want to monitor you closely, see section 4 of the package leaflet.

If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome (MDS)). You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done. If you develop or are likely to develop cancers of the blood, you should not use Grastofil, unless instructed by your doctor.

If you are a stem cell donor, you must be aged between16 and 60 years.

Take special care with other products that stimulate white blood cells

Grastofil is one of a group of products that stimulate the production of white blood cells. Your healthcare professional should always record the exact product you are using.

Other medicines and Grastofil

You should not receive Grastofil in the 24 hours before and the 24 hours after receiving chemotherapy.

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

Pregnancy and breast-feeding

Grastofil has not been tested in pregnant or breast-feeding women.

It is important to tell your doctor if you:

are pregnant;

think you may be pregnant, or

are planning to have a baby.

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

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

Ask your doctor or pharmacist for advice before taking any medicine

Driving and using machines

Grastofil should not affect your ability to drive and use machines. However, it is advisable to wait and see how you feel after taking Grastofil and before driving or operating machinery.

Important information about some of the ingredients of Grastofil

Grastofil contains sorbitol. If you have been told by your doctor that you have a reaction to some sugars, contact your doctor before taking this medicine.

Grastofil contains less than 1 mmol sodium (0.035 mg) per dose, i.e. essentially ‘sodium-free’.

The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause an allergic reaction.

3.How to use Grastofil

Always use this medicine exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.

The usual dose of Grastofil varies depending on your illness and weight. Your doctor will tell you how much Grastofil you should take.

Dosage

Grastofil and neutropenia (low number of a type of white blood cells) associated with chemotherapy

The usual dose is 0.5 million units (5 micrograms) per kilogram of bodyweight each day. For example, if you weigh 60 kilograms your daily dose will be 30 million units (300 micrograms). Your treatment with Grastofil will usually last for about 14 days. In some disease types, however, longer treatment lasting up to about one month may be required.

Grastofil and bone marrow transplantation

The usual starting dose is 1 million units (10 micrograms) per kilogram of bodyweight each day given as an infusion. For example, if you weigh 60 kilograms your daily dose will be 60 million units (600 micrograms). You will normally receive your first dose of Grastofil at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant. Your doctor may then test your blood to see how well the treatment is working and how long it should last.

Grastofil and severe chronic neutropenia (low number of a type of white blood cells)

The usual starting dose is between 0.5 million units (5 micrograms) and 1.2 million units (12 micrograms) per kilogram bodyweight each day in a single or divided dose. Your doctor may then test your blood to see how well your treatment with Grastofil is working and to find the dose that is best for you. Long-term treatment with Grastofil is required for reduction in neutropenia.

Grastofil and neutropenia (low number of a type of white blood cells) in patients with HIV infection

The usual starting dose is between 0.1 million units (1 micrograms) and 0.4 million units (4 micrograms) per kilogram bodyweight each day. Your doctor may test your blood at regular intervals to see how well the Grastofil treatment is working. Once the number of white cells in your blood has returned to normal it may be possible to reduce the dose frequency to less than once per day. Long term treatment with Grastofil may be required to maintain a normal number of white cells in your blood.

Grastofil and peripheral blood stem cell transplantation (stem cells collected from the blood to use in bone marrow transplantation)

If you are donating stem cells for yourself, the usual dose is 0.5 million units (5 micrograms) to 1 million units (10 micrograms) per kilogram bodyweight each day. Grastofil treatment will last for up to 2 weeks. Your doctor will monitor your blood to determine the best time to collect the stem cells. If you are acting as a stem cell donor for another person, the usual dose is 1 million units (10 micrograms) per kilogram bodyweight each day. Grastofil treatment will last for 4 to 5 days. Your doctor will perform regular blood tests to determine the best time to collect the stem cells.

Method of administration

Grastofil is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection). It can also be given as a daily slow injection into the vein (known as an intravenous infusion).

If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections. Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Grastofil). Do not attempt to self-administer without this training. Some of the information you require is given at the end of this leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.

How long will I have to take Grastofil?

You will need to take Grastofil until your white blood cell count is normal. Regular blood tests will be taken to monitor the number of white blood cells in your body. Your doctor will tell you how long you will need to take Grastofil.

Use in children

Grastofil is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia). The dosing in children receiving chemotherapy is the same as for adults.

Instructions for injecting Grastofil

This section contains information on how to give yourself an injection of Grastofil.

Important: do not try to give yourself an injection unless you have received training from your doctor or nurse.

Grastofil is injected into the tissue just under the skin. This is known as a subcutaneuous injection.

Equipment that you need

To give yourself a subcutaneous injection you will need:

a new pre-filled syringe of Grastofil; and

alcohol wipes or similar.

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

1.Remove the syringe from the refrigerator. Leave the syringe at room temperature for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes. This will make the injection more comfortable. Do not warm Grastofil in any other way (for example, do not warm it in a microwave or in hot water).

2.Do not shake the pre-filled syringe.

3.Do not remove the needle cover until you are ready to inject.

4.Wash your hands thoroughly.

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

How do I prepare my Grastofil injection?

Before you inject Grastofil you must do the following:

1.To avoid bending the needle, gently pull the cover from the needle without twisting.

2.Do not touch the needle or push the plunger.

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

4.The Grastofil syringe has a scale on the syringe barrel. Hold the syringe with the needle pointing up. Push the plunger up slowly to the number (given in mL) that matches the dose of Grastofil which your doctor has prescribed.

5.You can now use the pre-filed syringe,

Where should I give my injection?

The best places to inject are the top of the thighs and the abdomen. If someone else is injecting you, they can also use the back of your arms.

You may change the injection site if you notice the area is red or sore.

How do I give my injection?

1.Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.

2.Put the needle fully into the skin as shown by your nurse or doctor.

3.Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, pull the needle out and re-insert it in another place.

4.Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.

5.Remove the needle and let go of your skin.

6.If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub the injection site. If needed, you may cover the injection site with a plaster.

7.Only use each syringe for one injection. Do not use any Grastofil that may be left in the syringe.

Remember: if you have any problems, please ask your doctor or nurse for help and advice.

If you use more Grastofil than you should

If you use more Grastofil than you should, contact your doctor or pharmacist as soon as possible.

If you forget to use Grastofil

If you have missed an injection, contact your doctor as soon as possible.

Do not take a double dose to make up for a forgotten injection. 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 or pharmacist.

4.Possible side effects

Tell your doctor immediately during treatment:

if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face, lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).

Hypersensitivity is common in patients with cancer;

if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS). ARDS is uncommon in patients with cancer;

if you get left upper belly (abdominal) pain, pain below the left rib cage or pain at the tip of your shoulder; as there may be a problem with your spleen (enlargement of your spleen (splenomegaly) or rupture of spleen).

if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria). Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).

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

oswelling 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 condition (may affect up to 1 in 100 people) called Capillary Leak Syndrome which causes the blood to leak from the small blood vessels into your body and needs urgent medical attention.

if you experience kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received filgrastim. Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.

A very frequent side effect of Grastofil use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics). In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands and soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints. Very commonly seen in normal stem cells donors is increase in white blood cells (leukocytosis) and decrease of platelets which reduces the ability of blood to clot (thrombocytopenia), these will be monitored by your doctor.

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

Very common side effects (seen in more than 1 in 10 people who take Grastofil): in cancer patients

changes in blood chemistry

increase of certain enzymes in the blood

decreased appetite

headache

pain in the mouth and throat (oropharyngeal pain)

cough

diarrhoea

vomiting

constipation

nausea

skin rash

unusual hair loss or thinning (alopecia)

pain in your muscles or bones (musculoskeletal pain)

generalized weakness (asthenia)

tiredness (fatigue)

soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucosal inflammation)

shortness of breath (dyspnoea)

pain

in normal stem cell donors

decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)

increase in white blood cells (leukocytosis)

headache

pain in your muscles or bones (musculoskeletal pain)

in severe chronic neutropenia patients

enlargement of the spleen (splenomegaly)

low red blood cell count (anaemia)

changes in blood chemistry

increase of certain enzymes in the blood

headache

nose bleeds (epistaxis)

diarrhoea

enlargment of the liver (hepatomegaly)

skin rash

pain in your muscles or bones (musculoskeletal pain)

joint pain (arthralgia)

in HIV patients

pain in your muscles or bones (musculoskeletal pain)

Common side effects (seen in more than 1 in 100 people taking Grastofil): in cancer patients

allergic reaction (drug hypersensitivity)

low blood pressure (hypotension)

pain while passing urine (dysuria)

chest pain

coughing up blood (haemoptysis)

in normal stem cell donors

increase of certain enzymes in the blood

shortness of breath (dyspnoea)

enlargement of the spleen (splenomegaly)

in severe chronic neutropenia patients

rupture of the spleen

decrease in platelets which reduces the ability of blood to clot (thrombocytopenia)

changes in blood chemistry

inflammation of the blood vessels in the skin (cutaneous vasculitis)

unusual hair loss or thinning (alopecia)

disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)

blood in the urine (haematuria)

injection site pain

damage to the tiny filters inside your kidneys (glomerulonephritis)

in HIV patients

enlargement of the spleen (splenomegaly)

Uncommon side effects (seen in more than 1 in 1000 people taking Grastofil): in cancer patients

rupture of the spleen

enlargement of the spleen (splenomegaly)

severe pain in the bones, chest, gut or joints (sickle cell crisis)

rejection of transplanted bone marrow (graft versus host disease)

pain and swelling of the joints, similar to gout (pseudogout)

severe lung inflammation causing difficulty in breathing (acute respiratory distress syndrome)

lungs do not function as they should, causing breathlessness (respiratory failure)

swelling and/or fluid in the lungs (pulmonary oedema)

inflammation of the lungs (interstitial lung disease)

abnormal x-rays of the lungs (lung infiltration)

plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with fever (Sweets syndrome)

inflammation of the blood vessels in the skin (cutaneous vasculitits)

worsening of rheumatoid arthritis

unusual change in urine

liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)

bleeding from the lung (pulmonary haemorrhage)

a change in how your body regulates fluids within your body and may result in puffiness

damage to the tiny filters inside your kidneys (glomerulonephritis)

in normal stem cell donors

rupture of the spleen

severe pain in the bones, chest, gut or joints (sickle cell crisis)

sudden life-threatening allergic reaction (anaphylactic reaction)

changes in blood chemistry

bleeding in the lung (pulmonary haemorrhage)

coughing up blood (haemoptysis)

abnormal x-rays of the lung (lung infiltration)

lack of absorption of oxygen in the lung (hypoxia)

increase of certain enzymes in the blood

worsening of rheumatoid arthritis

damage to the tiny filters inside your kidneys (glomerulonephritis)

in severe chronic neutropenia patients

severe pain in the bones, chest, gut or joints (sickle cell crisis)

excess protein in the urine (proteinuria)

in HIV patients

severe pain in the bones, chest, gut or joints (sickle cell crisis)

Not known side effects (cannot be estimated from the available data):

damage to the tiny filters inside your kidneys (glomerulonephritis)

Reporting of side effects

If you get any side effects, talk to your doctor 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.

Store in a refrigerator (2°C - 8°C). Do not freeze.

5.How to store Grastofil

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP. The expiry date refers to the last day of the month.

Grastofil can be removed from the refrigerator and left at room temperature (not above 25) for a single period of up to 15 days that ends within the labelled expiry date. Once Grastofil has been out at room temperature it should not be put back into the refrigerator. Any Grastofil syringes that have been out of the refrigerator for longer than 15 days should not be used and should be disposed of in accordance with local requirements.

Keep the pre-filled syringe in the carton in order to protect from light.

Do not use Grastofil if you notice it is cloudy, or there is discoloration or there are particles in it.

Do not put the cover back on used needles, as you may accidentally prick yourself. 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 pack and other information

What Grastofil contains

The active substance is filgrastim. Each pre-filled syringe contains 30 MU (300 micrograms) filgrastim in 0.5 mL, corresponding to 0.6 mg/mL.

The other ingredients are acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80 and water for injections.

What Grastofil looks like and contents of the pack

Grastofil is a clear colourless solution for injection or infusion in a pre-filled syringe with an injection needle marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel. Each pre-filled syringe contains 0.5 mL of solution.

Grastofil is available in packs containing 1 and 5 pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Tel: +31 (0)71 565 77 77

Fax: +31 (0)71 565 23 33

Manufacturer

Apotex Nederland B.V. Bio Science park Archimedesweg 2 2333 CN Leiden Netherlands

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

België/Belgique/Belgien

Lietuva

Eurogenerics SA/NV

STADA Arzneimittel AG

Telephone +32/2.479.78.78

Telephone +49/6101.603.0

България

Luxembourg/Luxemburg

STADA Arzneimittel AG

Eurogenerics SA/NV

Telephone +49/6101.603.0

Telephone +32/2.479.78.78

Česká republika

Magyarország

STADA Pharma CZ s.r.o.

STADA Arzneimittel AG

Telephone +420/257-888.111

Telephone +49/6101.603.0

Danmark

Malta

STADA Nordic ApS

PharmaMt Ltd.

Telephone +45/44.85.99.99

Telephone +356/21337008

Deutschland

Nederland

cell pharm GmbH

Centrafarm BV

Telephone +49/6101.30.42.0

Telephone +31/7650.81.000

Eesti

Norge

STADA Arzneimittel AG

STADA Arzneimittel AG

Telephone +49/6101.603.0

Telephone +49/6101.603.0

Ελλάδα

Österreich

Rafarm AEBE

STADA Arzneimittel Gesellschaft m.b.H.

Κορίνθου 12, Ν. Ψυχικό, 15451, Αθήνα

Telephone +43/1-367.85.85.0

Telephone +30/2106776550

 

España

Polska

Laboratorio STADA S.L.

STADA Poland Sp. z.oo.

Telephone +34/93-473.88.89

Telephone +48/22 -737.79.20

France

Portugal

EG LABO-Laboratoires Eurogenerics SAS

Apotex Europe B.V.

Telephone +33/1-46.94.86.86

Telephone (31) 71. 565.77. 77

Hrvatska

România

STADA d.o.o

STADA Arzneimittel AG

Telephone+385/1.3764.111

Telephone +49/6101.603.0

Ireland

Slovenija

CLONMEL Healthcare Ltd.

STADA d.o.o.

Telephone + 353/52.61.77.777

Telephone + 386/1-589.67.10

Ísland

Slovenská republika

STADA Arzneimittel AG

STADA PHARMA Slovakia s.r.o.

Telephone +49/6101.603.0

Telephone +421/2-5262.1933

Italia

Suomi/Finland

CRINOS S.p.A.

STADA Nordic ApS, Suomen sivuliike

Telephone +39/02-89.421721

Telephone +358/207.416.888

Κύπρος

Sverige

STADA Arzneimittel AG

STADA Nordic ApS

Telephone +49/6101.603.0

Telephone +45/44.85.99.99

Latvija

United Kingdom

STADA Arzneimittel AG

Thornton & Ross Ltd.

Telephone +49/6101.603.0

Tel:+44/1484-842.217

http://www.ema.europa.eu

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The following information is intended for medical or healthcare professionals only:

In order to improve traceability of granulocyte-colony stimulating factors, the product name (Grastofil) and batch number of the administered product should be clearly recorded in the patient file

If required, Grastofil may be diluted in 5% glucose. Dilution to a final concentration less than 0.2 MU (2 µg) per mL is not recommended at any time.

The solution should be visually inspected prior to use. Only clear solutions without particles should be used.

For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL. Example: In a final injection volume of 20 mL, total doses of filgrastim less than 30 MU (300 µg) should be given with 0.2 mL of 200 mg/mL (20%) human albumin solution added.

When diluted in 5% glucose, Grastofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Grastofil 48 MU/0.5 mL (0.96 mg/mL) solution for injection or infusion in pre-filled syringe filgrastim

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side-effects you may get. See the end of section 4 for how to report side effects.

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, nurse or pharmacist.

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.

In this leaflet

1.What Grastofil is and what it is used for

2.What you need to know before you use Grastofil

3.How to use Grastofil

4.Possible side effects

5.How to store Grastofil

6.Contents of the pack and other information

1. What Grastofil is and what it is used for What Grastofil is

Grastofil contains the active ingredient filgrastim. Grastofil is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of medicines called cytokines. Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine. Grastofil works by stimulating the bone marrow to produce more white blood cells.

A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection. Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells that help fight infection.

What Grastofil is used for

Your doctor has prescribed Grastofil for you to help your body make more white blood cells. Your doctor will tell you why you are being treated with Grastofil.

Grastofil can be used

to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;

to increase the number of white blood cells after a bone marrow transplant to help prevent infections

to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections;

in patients with advanced HIV infection which will help reduce the risk of infections;

before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment. These can be taken from you or from a donor. The stem cells will then go back into the bone marrow and produce blood cells.

2. What you need to know before you use Grastofil

Do not use Grastofil

if you are allergic (hypersensitive) to 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 Grastofil:

Please tell your doctor before starting treatment if you have:

osteoporosis (bone disease),

sickle cell disease anaemia, as filgrastim can cause sickle cell crisis. Please tell your doctor immediately during treatment with Grastofil, if you:

get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder (these may be symptoms of an enlarged spleen (splenomegaly), or possibly rupture of the spleen),

notice unusual bleeding or bruising (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot).

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 as these could be signs of a severe allergic reaction.

experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.

Loss of response to filgrastim

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

Your doctor may want to monitor you closely, see section 4 of the package leaflet.

If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome (MDS)). You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done. If you develop or are likely to develop cancers of the blood, you should not use Grastofil, unless instructed by your doctor.

If you are a stem cell donor, you must be aged between16 and 60 years.

Take special care with other products that stimulate white blood cells

Grastofil is one of a group of products that stimulate the production of white blood cells. Your healthcare professional should always record the exact product you are using.

Other medicines and Grastofil

You should not receive Grastofil in the 24 hours before and the 24 hours after receiving chemotherapy.

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

Pregnancy and breast-feeding

Grastofil has not been tested in pregnant or breast-feeding women.

It is important to tell your doctor if you

are pregnant,

think you may be pregnant or

plan to have a baby

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

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

Ask your doctor or pharmacist for advice before taking any medicine

Driving and using machines

Grastofil should not affect your ability to drive and use machines. However, it is advisable to wait and see how you feel after taking Grastofil and before driving or operating machinery.

Important information about some of the ingredients of Grastofil

Grastofil contains sorbitol. If you have been told by your doctor that you have a reaction to some sugars, contact your doctor before taking this medicine.

Grastofil also contains less than 1 mmol sodium (0.035 mg) per dose, i.e. essentially ‘sodium-free’.

The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause an allergic reaction.

3. How to use Grastofil

Always use this medicine exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.

The usual dose of Grastofil varies depending on your illness and weight. Your doctor will tell you how much Grastofil you should take.

Dosage

Grastofil and neutropenia (low number of a type of white blood cells) associated with chemotherapy

The usual dose is 0.5 million units (5 micrograms) per kilogram of bodyweight each day. For example, if you weigh 60 kilograms your daily dose will be 30 million units (300 micrograms). Your treatment with Grastofil will usually last for about 14 days. In some disease types, however, longer treatment lasting up to about one month may be required.

Grastofil and bone marrow transplantation

The usual starting dose is 1 million units (10 micrograms) per kilogram of bodyweight each day given as an infusion. For example, if you weigh 60 kilograms your daily dose will be 60 million units (600 micrograms). You will normally receive your first dose of Grastofil at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant. Your doctor may then test your blood to see how well the treatment is working and how long it should last.

Grastofil and severe chronic neutropenia (low number of a type of white blood cells)

The usual starting dose is between 0.5 million units (5 micrograms) and 1.2 million units (12 micrograms) per kilogram bodyweight each day in a single or divided dose. Your doctor may then test your blood to see how well your treatment with Grastofil is working and to find the dose that is best for you. Long-term treatment with Grastofil is required for reduction in neutropenia.

Grastofil and neutropenia (low number of a type of white blood cells) in patients with HIV infection

The usual starting dose is between 0.1 million units (1 micrograms) and 0.4 million units (4 micrograms) per kilogram bodyweight each day. Your doctor may test your blood at regular intervals to see how well the Grastofil treatment is working. Once the number of white cells in your blood has returned to normal it may be possible to reduce the dose frequency to less than once per day. Long term treatment with Grastofil may be required to maintain a normal number of white cells in your blood.

Grastofil and peripheral blood stem cell transplantation (stem cells collected from the blood to use in bone marrow transplantation)

If you are donating stem cells for yourself, the usual dose is 0.5 million units (5 micrograms) to 1 million units (10 micrograms) per kilogram bodyweight each day. Grastofil treatment will last for up to 2 weeks. Your doctor will monitor your blood to determine the best time to collect the stem cells. If you are acting as a stem cell donor for another person, the usual dose is 1 million units (10 micrograms) per kilogram bodyweight each day. Grastofil treatment will last for 4 to 5 days. Your doctor will perform regular blood tests to determine the best time to collect the stem cells.

Method of administration

Grastofil is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection). It can also be given as a daily slow injection into the vein (known as an intravenous infusion).

If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections. Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Grastofil). Do not attempt to self-administer without this training. Some of the information you require is given at the end of this leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.

How long will I have to take Grastofil?

You will need to take Grastofil until your white blood cell count is normal. Regular blood tests will be taken to monitor the number of white blood cells in your body. Your doctor will tell you how long you will need to take Grastofil.

Use in children

Grastofil is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia). The dosing in children receiving chemotherapy is the same as for adults.

Instructions for injecting Grastofil

This section contains information on how to give yourself an injection of Grastofil.

Important: do not try to give yourself an injection unless you have received training from your doctor or nurse.

Grastofil is injected into the tissue just under the skin. This is known as a subcutaneuous injection.

Equipment that you need

To give yourself a subcutaneous injection you will need:

a new pre-filled syringe of Grastofil; and

alcohol wipes or similar.

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

1.Remove the syringe from the refrigerator. Leave the syringe at room temperature for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes. This will make the injection more comfortable. Do not warm Grastofil in any other way (for example, do not warm it in a microwave or in hot water).

2.Do not shake the pre-filled syringe.

3.Do not remove the needle cover until you are ready to inject.

4.Wash your hands thoroughly.

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

How do I prepare my Grastofil injection?

Before you inject Grastofil you must do the following:

1.To avoid bending the needle, gently pull the cover from the needle without twisting.

2.Do not touch the needle or push the plunger.

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

4.The Grastofil syringe has a scale on the syringe barrel. Hold the syringe with the needle pointing up. Push the plunger up slowly to the number (given in mL) that matches the dose of Grastofil which your doctor has prescribed.

5.You can now use the pre-filled syringe.

Where should I give my injection?

The best places to inject are the top of the thighs and the abdomen. If someone else is injecting you, they can also use the back of your arms.

You may change the injection site if you notice the area is red or sore.

How do I give my injection?

1.Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.

2.Put the needle fully into the skin as shown by your nurse or doctor.

3.Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, pull the needle out and re-insert it in another place.

4.Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.

5.Remove the needle and let go of your skin.

6.If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub the injection site. If needed, you may cover the injection site with a plaster.

7.Only use each syringe for one injection. Do not use any Grastofil that may be left in the syringe.

Remember: if you have any problems, please ask your doctor or nurse for help and advice.

If you use more Grastofil than you should

If you use more Grastofil than you should, contact your doctor or pharmacist as soon as possible.

If you forget to use Grastofil

If you have missed an injection, contact your doctor as soon as possible.

Do not take a double dose to make up for a forgotten injection. 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 or pharmacist.

4. Possible side effects

Tell your doctor immediately during treatment:

if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face, lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).

Hypersensitivity is common in patients with cancer;

if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS). ARDS is uncommon in patients with cancer;

if you get left upper belly (abdominal) pain, pain below the left rib cage or pain at the tip of your shoulder; as there may be a problem with your spleen (enlargement of your spleen (splenomegaly) or rupture of spleen).

if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria). Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).

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

oswelling 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 condition (may affect up to 1 in 100 people) called Capillary Leak Syndrome which causes the blood to leak from the small blood vessels into your body and needs urgent medical attention.

if you experience kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received filgrastim. Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.

A very frequent side effect of Grastofil use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics). In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands and soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints. Very commonly seen in normal stem cells donors is increase in white blood cells (leukocytosis) and decrease of platelets which reduces the ability of blood to clot (thrombocytopenia), these will be monitored by your doctor.

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

Very common side effects (seen in more than 1 in 10 people who take Grastofil): in cancer patients

changes in blood chemistry

increase of certain enzymes in the blood

decreased appetite

headache

pain in the mouth and throat (oropharyngeal pain)

cough

diarrhoea

vomiting

constipation

nausea

skin rash

unusual hair loss or thinning (alopecia)

pain in your muscles or bones (musculoskeletal pain)

generalized weakness (asthenia)

tiredness (fatigue)

soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucosal inflammation)

shortness of breath (dyspnoea)

pain

in normal stem cell donors

decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)

increase in white blood cells (leukocytosis)

headache

pain in your muscles or bones (musculoskeletal pain)

in severe chronic neutropenia patients

enlargement of the spleen (splenomegaly)

low red blood cell count (anaemia)

changes in blood chemistry

increase of certain enzymes in the blood

headache

nose bleeds (epistaxis)

diarrhoea

enlargment of the liver (hepatomegaly)

skin rash

pain in your muscles or bones (musculoskeletal pain)

joint pain (arthralgia)

in HIV patients

pain in your muscles or bones (musculoskeletal pain)

Common side effects (seen in more than 1 in 100 people taking Grastofil): in cancer patients

allergic reaction (drug hypersensitivity)

low blood pressure (hypotension)

pain while passing urine (dysuria)

chest pain

coughing up blood (haemoptysis)

in normal stem cell donors

increase of certain enzymes in the blood

shortness of breath (dyspnoea)

enlargement of the spleen (splenomegaly)

in severe chronic neutropenia patients

rupture of the spleen

decrease in platelets which reduces the ability of blood to clot (thrombocytopenia)

changes in blood chemistry

inflammation of the blood vessels in the skin (cutaneous vasculitis)

unusual hair loss or thinning (alopecia)

disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)

blood in the urine (haematuria)

injection site pain

damage to the tiny filters inside your kidneys (glomerulonephritis)

in HIV patients

enlargement of the spleen (splenomegaly)

Uncommon side effects (seen in more than 1 in 1000 people taking Grastofil): in cancer patients

rupture of the spleen

enlargement of the spleen (splenomegaly)

severe pain in the bones, chest, gut or joints (sickle cell crisis)

rejection of transplanted bone marrow (graft versus host disease)

pain and swelling of the joints, similar to gout (pseudogout)

severe lung inflammation causing difficulty in breathing (acute respiratory distress syndrome)

lungs do not function as they should, causing breathlessness (respiratory failure)

swelling and/or fluid in the lungs (pulmonary oedema)

inflammation of the lungs (interstitial lung disease)

abnormal x-rays of the lungs (lung infiltration)

plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with fever (Sweets syndrome)

inflammation of the blood vessels in the skin (cutaneous vasculitits)

worsening of rheumatoid arthritis

unusual change in urine

liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)

bleeding from the lung (pulmonary haemorrhage)

a change in how your body regulates fluids within your body and may result in puffiness

damage to the tiny filters inside your kidneys (glomerulonephritis)

in normal stem cell donors

rupture of the spleen

severe pain in the bones, chest, gut or joints (sickle cell crisis)

sudden life-threatening allergic reaction (anaphylactic reaction)

changes in blood chemistry

bleeding in the lung (pulmonary haemorrhage)

coughing up blood (haemoptysis)

abnormal x-rays of the lung (lung infiltration)

lack of absorption of oxygen in the lung (hypoxia)

increase of certain enzymes in the blood

worsening of rheumatoid arthritis

damage to the tiny filters inside your kidneys (glomerulonephritis)

in severe chronic neutropenia patients

severe pain in the bones, chest, gut or joints (sickle cell crisis)

excess protein in the urine (proteinuria)

in HIV patients

severe pain in the bones, chest, gut or joints (sickle cell crisis)

Not known side effects (cannot be estimated from the available data):

damage to the tiny filters inside your kidneys (glomerulonephritis)

Reporting of side effects

If you get any side effects, talk to your doctor 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.

Store in a refrigerator (2°C - 8°C). Do not freeze.

5. How to store Grastofil

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP. The expiry date refers to the last day of the month.

Grastofil can be removed from the refrigerator and left at room temperature (not above 25) for a single period of up to 15 days that ends within the labelled expiry date. Once Grastofil has been out at room temperature it should not be put back into the refrigerator. Any Grastofil syringes that have been out of the refrigerator for longer than 15 days should not be used and should be disposed of in accordance with local requirements.

Keep the pre-filled syringe in the carton in order to protect from light.

Do not use Grastofil if you notice it is cloudy, or there is discoloration or there are particles in it.

Do not put the cover back on used needles, as you may accidentally prick yourself. 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 pack and other information

What Grastofil contains

The active substance is filgrastim. Each pre-filled syringe contains 48 MU (480 micrograms) filgrastim in 0.5 mL, corresponding to 0.96 mg/mL.

The other ingredients are acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80 and water for injections.

What Grastofil looks like and contents of the pack

Grastofil is a clear colourless solution for injection or infusion in a pre-filled syringe marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel, with an injection needle. Each pre-filled syringe contains 0.5 mL of solution.

Grastofil is available in packs containing 1 and 5 pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Tel: +31 (0)71 565 77 77

Fax: +31 (0)71 565 23 33

Manufacturer

Apotex Nederland B.V. Bio Science park Archimedesweg 2 2333 CN Leiden Netherlands

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

België/Belgique/Belgien

Lietuva

Eurogenerics SA/NV

STADA Arzneimittel AG

Telephone +32/2.479.78.78

Telephone +49/6101.603.0

България

Luxembourg/Luxemburg

STADA Arzneimittel AG

Eurogenerics SA/NV

Telephone +49/6101.603.0

Telephone +32/2.479.78.78

Česká republika

Magyarország

STADA Pharma CZ s.r.o.

STADA Arzneimittel AG

Telephone +420/257-888.111

Telephone +49/6101.603.0

Danmark

Malta

STADA Nordic ApS

PharmaMt Ltd.

Telephone +45/44.85.99.99

Telephone +356/21337008

Deutschland

Nederland

cell pharm GmbH

Centrafarm BV

Telephone +49/6101.30.42.0

Telephone +31/7650.81.000

Eesti

Norge

STADA Arzneimittel AG

STADA Arzneimittel AG

Telephone +49/6101.603.0

Telephone +49/6101.603.0

Ελλάδα

Österreich

Rafarm AEBE

STADA Arzneimittel Gesellschaft m.b.H.

Κορίνθου 12, Ν. Ψυχικό, 15451, Αθήνα

Telephone +43/1-367.85.85.0

Telephone +30/2106776550

 

España

Polska

Laboratorio STADA S.L.

STADA Poland Sp. z.oo.

Telephone +34/93-473.88.89

Telephone +48/22 -737.79.20

France

Portugal

EG LABO-Laboratoires Eurogenerics SAS

Apotex Europe B.V.

Telephone +33/1-46.94.86.86

Telephone (31) 71. 565.77. 77

Hrvatska

România

STADA d.o.o

STADA Arzneimittel AG

Telephone+385/1.3764.111

Telephone +49/6101.603.0

Ireland

Slovenija

CLONMEL Healthcare Ltd.

STADA d.o.o.

Telephone + 353/52.61.77.777

Telephone + 386/1-589.67.10

Ísland

Slovenská republika

STADA Arzneimittel AG

STADA PHARMA Slovakia s.r.o.

Telephone +49/6101.603.0

Telephone +421/2-5262.1933

Italia

Suomi/Finland

CRINOS S.p.A.

STADA Nordic ApS, Suomen sivuliike

Telephone +39/02-89.421721

Telephone +358/207.416.888

Κύπρος

Sverige

STADA Arzneimittel AG

STADA Nordic ApS

Telephone +49/6101.603.0

Telephone +45/44.85.99.99

Latvija

United Kingdom

STADA Arzneimittel AG

Thornton & Ross Ltd.

Telephone +49/6101.603.0

Tel:+44/1484-842.217

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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

The following information is intended for medical or healthcare professionals only:

In order to improve traceability of granulocyte-colony stimulating factors, the product name (Grastofil) and batch number of the administered product should be clearly recorded in the patient file

If required, Grastofil may be diluted in 5% glucose. Dilution to a final concentration less than 0.2 MU (2 µg) per mL is not recommended at any time.

The solution should be visually inspected prior to use. Only clear solutions without particles should be used.

For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per mL, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL. Example: In a final injection volume of 20 mL, total doses of filgrastim less than 30 MU (300 µg) should be given with 0.2 mL of 200 mg/mL (20%) human albumin solution added.

When diluted in 5% glucose, Grastofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.

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