Ristempa
pegfilgrastim
pegfilgrastim
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.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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.
What Ristempa is and what it is used for
What you need to know before you use Ristempa
How to use Ristempa
Possible side effects
How to store Ristempa
Medicinal product no longer authorised
Contents of the pack and other information
Ristempa 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.
Ristempa 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 Ristempa 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.
if you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine.
Talk to your doctor, pharmacist or nurse before using Ristempa:
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
have an allergy to latex. The needle cap on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions
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.
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)
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)
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
have sickle cell anaemia. Your doctor may monitor your condition more closely.
Medicinal product no longer authorised
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.
Your doctor will check your blood and urine regularly as Ristempa can harm the tiny filters inside your kidneys (glomerulonephritis).
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 Ristempa, unless instructed by your doctor.
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ask your doctor or pharmacist for advice before taking any medicine. Ristempa has not been tested in pregnant 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 Ristempa treatment, please inform your doctor. You may be encouraged to enrol in Amgen’s Pregnancy Surveillance programme. Local representative contact details are provided in section 6 of this leaflet.
Unless your doctor directs you otherwise, you must stop breast feeding if you use Ristempa.
If you are nursing during Ristempa treatment, you may be encouraged to enrol in Amgen’s Lactation Surveillance programme. Local representative contact details are provided in section 6 of this leaflet.
Ristempa has no or negligible effect on the ability to drive or use machines.
Ristempa contains sorbitol (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains less than 1 mmol (23 mg) sodium per 6 mg dose, i.e. essentially ‘sodium-free’
Ristempa is for use in adults aged 18 and over.
Medicinal product no longer authorised
Always take Ristempa exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. 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.
Do not shake Ristempa vigorously as this may affect its activity.
Your doctor may decide that it would be more convenient for you to inject Ristempa 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 Ristempa, please read the section at the end of this leaflet.
If you use more Ristempa than you should contact your doctor, pharmacist or nurse.
If you have forgotten a dose of Ristempa, you should contact your doctor to discuss when you should inject the next dose
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Please tell your doctor immediately if you have any of the following or combination of the following side effects:
swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These
symptoms generally develop in a rapid fashion.
These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
bone pain. Your doctor will tell you what you can take to ease the bone pain.
nausea and headaches.
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.
allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch.
Medicinal product no longer authorised
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.
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.
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 (2C – 8C).
You may take Ristempa out of the refrigerator and keep it at room temperature (not above 30C) for no longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30C) it must either be used within 3 days or disposed of.
Do not freeze. Ristempa 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.
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.
Ristempa is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Medicinal product no longer authorised
Each pack contains 1 pre-filled syringe of type I glass with an attached stainless steel needle and needle cap. The syringes are provided either with or without a blister wrapping.
Amgen Europe B.V. Minervum 7061
4817 ZK Breda
The Netherlands
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda The Netherlands
Amgen Technology (Ireland) Unlimited Company
Pottery Road Dun Laoghaire Co Dublin Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
s.a. Amgen n.v.
Tel/Tél: +32 (0)2 7752711
Amgen Switzerland AG Vilniaus filialas
Tel: +370 5 219 7474
Амджен България ЕООД Тел.: +359 (0)2 424 7440
s.a. Amgen Belgique/Belgien
Tel/Tél: +32 (0)2 7752711
Amgen s.r.o.
Tel: +420 221 773 500
Amgen Kft.
Tel.: +36 1 35 44 700
Amgen filial af Amgen AB, Sverige
Tlf: +45 39617500
Amgen B.V.
The Netherlands
Tel: +31 (0)76 5732500
Amgen B.V.
Tel: +31 (0)76 5732500
Amgen Switzerland AG Vilniaus filialas
Tel: +372 5125 501
Amgen AB
Tel: +47 23308000
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ.: +30 210 3447000
Amgen GmbH
Tel: +43 (0)1 50 217
Medicinal product no longer authorised
Amgen S.A.
Tel: +34 93 600 18 60
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000
Amgen S.A.S.
Tél: +33 (0)9 69 363 363
Amgen Biofarmacêutica, Lda. Tel: +351 21 4220550
Amgen d.o.o.
Tel: +385 (1) 562 57 20
Amgen România SRL Tel: +4021 527 3000
Amgen Limited United Kingdom
Tel: +44 (0)1223 420305
AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767
Vistor hf.
Sími: +354 535 7000
Amgen S.r.l.
Tel: +39 02 6241121
Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland
Puh/Tel: +358 (0)9 54900500
Papaellinas & Co Ltd Τηλ.: +357 22741 741
Amgen AB
Tel: +46 (0)8 6951100
Amgen Switzerland AG Rīgas filiāle Tel: +371 292 84807
Amgen Limited
Tel: +44 (0)1223 420305
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This section contains information on how to give yourself an injection of Ristempa. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse, or pharmacist. If you have questions about how to inject, please ask your doctor, nurse, pharmacist for assistance.
You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.
Medicinal product no longer authorised
To give yourself a subcutaneous injection you will need:
a pre-filled syringe of Ristempa; and
alcohol wipes or similar.
Remove from the refrigerator.
Do not shake the pre-filled syringe.
Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.
Check the appearance of Ristempa. It must be a clear and colourless liquid. If there are particles in it, you must not use it.
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Ristempa in any other way (for example, do not warm it in a microwave or in hot water).
Wash your hands thoroughly.
Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Before you inject Ristempa you must do the following:
Hold the syringe barrel and gently take the cap from the needle without twisting. Pull straight as shown in pictures 1 and 2. Do not touch the needle or push the plunger.
You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.
You can now use the pre-filled syringe.
The most suitable places to inject yourself are:
the top of your thighs; and
the abdomen, except for the area around the navel.
Medicinal product no longer authorised
If someone else is injecting you, they can also use the back of your arms.
Clean your skin by using an alcohol wipe.
Pinch (without squeezing) the skin using your thumb and forefinger. Insert the needle into the skin.
Push the plunger down with a slow constant pressure. Push the plunger all the way down as far as it will go to inject all the liquid.
After injecting the liquid, remove the needle and let go of your skin.
If you notice a spot of blood at the injection site dab with a cotton ball or tissues. Do not rub the injection site. If needed, you may cover the injection site with a plaster.
Do not use any Ristempa that is left in the syringe.
Only use each syringe for one injection. If you have any problems, please ask your doctor or nurse for help and advice.
Do not put the cap back on used needles.
Keep used syringes out of the sight and reach of children.
Medicinal product no longer authorised
The used syringe should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.