NEUPOGEN 30 MU (0.3MG/ML) SOLUTION FOR INJECTION

Active substance: FILGRASTIM

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Package leaflet: Information for the user

EN

Neupogen 30 MU (0.3 mg/ml)
solution for injection
filgrastim
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.
What is in this leaflet

1. What Neupogen is and what it is used for
2. What you need to know before you use Neupogen
3. How to use Neupogen
4. Possible side effects
5. How to store Neupogen
6. Contents of the pack and other information

Neupogen

EN

MCK001464

®

1. What Neupogen is and what it is used for

Neupogen is a white blood cell growth factor (granulocyte colony stimulating factor) and
belong 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. Neupogen works by encouraging the bone marrow to produce more white blood
cells.

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A reduction in the number of white blood cells (neutropenia) can occur for several reasons
and makes your body less able to fight infection. Neupogen stimulates the bone marrow to
produce new white cells quickly.

Neupogen 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;
• 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;
• 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.
2. What you need to know before you use Neupogen

Do not use Neupogen

• if you are allergic 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 Neupogen.
Please tell your doctor before starting treatment if you have:
• sickle cell anaemia, as Neupogen may cause sickle cell crisis.
• osteoporosis (bone disease).

f you are a patient with severe chronic neutropenia, you may be at risk of developing
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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
Neupogen, unless instructed by your doctor.

f you are a stem cell donor, you must be aged between16 and 60 years.
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Take special care with other products that stimulate white blood cells
Neupogen 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 Neupogen

T
ell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Pregnancy and breast-feeding
Neupogen has not been tested in pregnant women. It is important to tell your doctor if
you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may
decide that you should not use this medicine. Neupogen could affect your ability to become
pregnant or stay pregnant.
You must not use this medicine if you are breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines

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

Neupogen contains sodium and sorbitol
N
eupogen contains less than 1 mmol (23 mg) sodium per 0.3 mg/ml, i.e. essentially sodium free.

N
eupogen contains sorbitol (E420), if you have been told by your doctor that you have a
reaction to some sugars, contact your doctor before taking this medicinal product.



3. How to use Neupogen
Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse
or pharmacist if you are not sure.
How is Neupogen given and how much should I take?

N
eupogen 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). The usual dose varies depending on your illness and weight.
Your doctor will tell you how much Neupogen you should take.

How long will I have to take Neupogen?
You will need to take Neupogen 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 Neupogen.
Use in children

N
eupogen 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.

If you use more Neupogen than you should

If you think you have had more than you should, contact your doctor as soon as possible.
If you forget to use Neupogen

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

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.


4. Possible side effects
Please 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 (splenomegaly). This is very
common in severe chronic neutropenia patients, common in HIV patients and uncommon
in normal stem cell donors.
• 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).

A very frequent side effect of Neupogen 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 or
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 cell 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 Neupogen):
in cancer patients
• changes in blood chemistry
• increase of certain enzymes in the blood
• decreased appetite
• headache
• pain in your 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)
• generalised 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)
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
• enlargement 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 Neupogen):
in cancer patients
• allergic reaction (drug hypersensitivity)
• low blood pressure (hypotension)

• pain when 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
• decrease of 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

in HIV patients
• enlargement of the spleen (splenomegaly)
Uncommon side effects (seen in more than 1 in 1000 people taking Neupogen):
in cancer patients
• 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
a fever (Sweets syndrome)
• inflammation of the blood vessels in the skin (cutaneous vasculitis)
• worsening of rheumatoid arthritis
• unusual change in the urine
• pain
• 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
in normal stem cell donors
• rupture of the spleen
• 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
in severe chronic neutropenia patients
• excess protein in the urine (proteinuria)
• rupture of the spleen

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side
effects not listed in this leaflet.
5. How to store Neupogen

Keep this medicine out of the sight and reach of children.

S
tore in a refrigerator (2°C – 8°C).
Accidental freezing will not harm Neupogen.

Do not use this medicine after the expiry date which is stated on the vial label and carton
after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice discolouration, cloudiness or particles, it should be a
clear, colourless liquid.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines no longer required. These measures will help protect the
environment.
6. Contents of the pack and other information

What Neupogen contains

• The active substance is filgrastim 30 million units in a 1 ml vial (0.3 mg/ml).
• The other ingredients are sodium acetate, sorbitol (E420), polysorbate 80, water for
injections.
What Neupogen looks like and contents of the pack
Neupogen is a clear colourless solution for injection (injection)/concentrate for solution for
infusion (sterile concentrate) in a vial.

Neupogen is available in packs of one or five vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Manufacturer:
Amgen Technology Ireland (ADL)
Pottery Road
Dun Laoghaire
Co Dublin
Ireland
This medicine is marketed in the European Economic Area under the name Neupogen,
except in Cyprus, Greece and Italy where it is called Granulokine.


This leaflet was last revised in July 2013.

D
etailed information on this medicine can be found on the following web sites:
• For UK residents, the Medicines and Healthcare products Regulatory Agency (MHRA)
www.mhra.gov.uk.
• For residents of Ireland, the Irish Medicines Board www.imb.ie.

Local representative of the marketing authorisation holder:
United Kingdom
Amgen Limited
240 Cambridge Science Park
Cambridge
CB4 0WD
United Kingdom
Tel: 01223 420305

Ireland
Amgen Limited
240 Cambridge Science Park
Cambridge
CB4 0WD
United Kingdom
Tel: +44 (0)1223 420305

Neupogen is available on the Royal National Institute of the Blind (RNIB)
Medicines Information Line who can provide this leaflet in a number of
physical formats including large/clear print, Braille and audio CD.
You can also listen to this leaflet when you call the Medicines
Information Line.
The RNIB Medicines Information Line is free to use and available
24 hours a day, 7 days a week. Please call them on 0800 198 5000.
The following information is intended for medical or healthcare professionals only:
When being used as a concentrate for solution for infusion, Neupogen should be diluted in
20 ml of 5% glucose solution. Please see the Summary of Product Characteristics for full
details.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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