Biograstim
filgrastim
Filgrastim
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 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.
What Biograstim is and what it is used for
What you need to know before you use Biograstim
How to use Biograstim
Possible side effects
How to store Biograstim
Contents of the pack and other information
Information for injecting yourself
Medicinal product no longer authorised
The following information is intended for healthcare professionals only
Biograstim contains the active substance filgrastim. Filgrastim is a protein produced by biotechnology in bacteria called Escherichia coli. It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body. Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more blood cells, especially certain types of white cells. White cells are important as they help your body fight infection.
Your doctor has prescribed Biograstim for you to help your body make more white blood cells. Your doctor will tell you why you are being treated with Biograstim. Biograstim is useful in several different conditions, which are:
chemotherapy;
bone marrow transplantation;
severe chronic neutropenia (low white blood cell count);
neutropenia in patients with HIV infection;
peripheral blood stem cell mobilisation (for blood stem cell donation).
if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor, pharmacist or nurse before using Biograstim
if you experience a cough, fever and difficulty breathing. It could be a consequence of a pulmonary disorder (see section “4. Possible side effects”).
if you have sickle cell disease (an inherited disease characterised by sickle-shaped red blood cells).
if you get left upper abdominal pain or pain at the tip of your shoulder. It could be a consequence of a spleen disorder (see section “4. Possible side effects”).
if you have specific blood disorders (e.g. Kostman's syndrome, myelodysplastic syndrome, different types of leukaemia).
if you have osteoporosis. Your doctor might check your bone density regularly.
if you are suffering from any other illness, especially if you think you have an infection.
Talk to your doctor or nurse that you are treated with Biograstim if you are undergoing bone-imaging. You will need to have regular blood tests whilst being treated with Biograstim to count the number of
neutrophils and other white blood cells in your blood. This will tell your doctor how well the treatment is working and will also indicate if treatment needs to be continued.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Do not use Biograstim in the 24 hours before or the 24 hours after your chemotherapy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Medicinal product no longer authorised
Biograstim has not been tested in pregnant women. Therefore, your doctor may decide that you should not use this medicine.
It is unknown whether filgrastim passes over to the breast milk. Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding.
If you experience fatigue, do not drive or use any tools or machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free’.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The amount of Biograstim you need, will depend on the condition you are taking Biograstim for and on your bodyweight. Your doctor will tell you when to stop using Biograstim. It is quite normal to have a number of courses of Biograstim treatment.
Biograstim and chemotherapy
The usual dose is 0.5 million international units (MIU) per kilogram of bodyweight each day. For example, if you weigh 60 kg your daily dose will be 30 million international units (MIU). You will
normally receive your first dose of Biograstim at least 24 hours after your chemotherapy. Your treatment will usually last for about 14 days. In some disease types however, longer treatment lasting up to about one month may be required.
Biograstim and bone marrow transplantation
The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day. For example, if you weigh 60 kg your daily dose will be 60 million international units (MIU). You will normally receive your first dose of Biograstim at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion. Your doctor will test your blood daily to see how well the treatment is working and to find the dose that is best for you. The treatment will be discontinued when white cells in your blood reach a certain number.
Biograstim and severe chronic neutropenia
The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose. Your doctor will then test your blood to see how well your treatment is working and to find the dose that is best for you. Long-term treatment with Biograstim is required for neutropenia.
Biograstim and neutropenia in patients with HIV infection
The usual starting dose is between 0.1 and 0.4 million international units (MIU) per kilogram bodyweight each day. Your doctor will test your blood at regular intervals to see how well the treatment is working. Once the number of white cells in your blood have returned to normal it may be possible to reduce the dose frequency to less than once per day. Your doctor will continue to test your blood regularly and will recommend the best dose for you. Long-term treatment with Biograstim may be required to maintain a normal number of white cells in your blood.
Biograstim and peripheral blood stem cell mobilisation
Medicinal product no longer authorised
If you are donating stem cells for yourself, the usual dose is 0.5 million to 1 million international units (MIU) per kilogram bodyweight each day. Biograstim treatment will last for up to 2 weeks and in exceptional cases longer. 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 international units (MIU) per kilogram bodyweight each day. Biograstim treatment will last for 4 to 5 days.
This medicine is given by injection, either through an intravenous (IV) infusion (drip) or a subcutaneous (SC) injection (into the tissue just under the skin). 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. Do not attempt to self-administer without this training. Some of the information you require is given at the end of this package leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.
If you use more Biograstim than you should, contact your doctor or pharmacist as soon as possible.
Do not use a double dose to make up for a forgotten injection.
Before you stop using Biograstim, talk to your doctor.
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.
Allergic reactions such as skin rash, raised itchy areas of skin and serious allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported. If you think you are having this type of reaction, you must stop your Biograstim injection and get medical help immediately.
Increased spleen size and cases of spleen ruptures have been reported. Some cases of splenic rupture were fatal. It is important to 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.
Cough, fever and difficult or painful breathing can be signs of serious pulmonary side effects, such as pneumonia and acute respiratory distress syndrome, which may be fatal. If you have a fever or any of these symptoms, it is important to contact your doctor immediately.
It is important to contact 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.
Medicinal product no longer authorised
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.
If you have Sickle Cell Disease, make sure that you tell your doctor before you start taking Biograstim. Sickle cell crisis has happened in some patients with Sickle Cell Disease who have been given filgrastim.
As a very common (may affect more than 1 in 10 people) side effect, filgrastim may cause bone and muscle pain. Ask your doctor which medicine you can take to help with this.
In cancer patients
Very common (may affect more than 1 in 10 people):
elevated levels of some liver or blood enzymes; high blood levels of uric acid;
feeling sick; vomiting;
chest pain.
Common (may affect up to 1 in 10 people):
headache;
cough; sore throat;
constipation; loss of appetite; diarrhoea; mucositis, which is painful inflammation and ulceration of the mucous membranes lining the digestive tract;
hair loss; rash;
fatigue; generalised weakness.
Uncommon (may affect up to 1 in 100 people):
unspecified pain.
Rare (may affect up to 1 in 1,000 people):
vascular disorders, which can cause pain, redness and swelling in the limbs.
Very rare (may affect up to 1 in 10,000 people):
painful, raised, plum-coloured sores on the limbs and sometimes the face and neck with fever (Sweet's syndrome); inflammation of blood vessels, often with skin rash;
worsening of rheumatic conditions;
pains or difficulties in passing urine.
Not known (frequency cannot be estimated from the available data):
rejection of transplanted bone marrow;
transient low blood pressure;
pain and swelling of the joints, similar to gout. In normal stem cell donors
Very common (may affect more than 1 in 10 people):
rise in white blood cells; reduction in blood platelets, which increases risk of bleeding or bruising;
headache.
Common (may affect up to 1 in 10 people):
elevated levels of some blood enzymes.
Uncommon (may affect up to 1 in 100 people):
elevated levels of some liver enzymes; high blood levels of uric acid;
worsening of rheumatic conditions.
Medicinal product no longer authorised
Not known (frequency cannot be estimated from the available data):
cough; fever and difficulty breathing or coughing up blood. In severe chronic neutropenia patients
Very common (may affect more than 1 in 10 people):
reduction in red blood cells, which can make the skin pale and cause weakness or breathlessness;
low blood levels of glucose; elevated levels of some blood enzymes; high blood levels of uric acid;
nosebleed.
Common (may affect up to 1 in 10 people):
reduction in blood platelets, which increases risk of bleeding or bruising;
headache;
diarrhoea;
enlargement of the liver;
hair loss; inflammation of blood vessels, often with skin rash; pain at the site of injection; rash;
loss of calcium from the bones; joint pain.
Uncommon (may affect up to 1 in 100 people):
blood in the urine; protein in the urine.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
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 outer carton and on the pre-filled syringe after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
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. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is filgrastim. Each mL of solution for injection or infusion contains 60 million international units [MIU] (600 microgram) of filgrastim.
Biograstim 30 MIU/0.5 mL: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL solution.
Medicinal product no longer authorised
Biograstim 48 MIU/0.8 mL: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL solution.
The other ingredients are: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water for injections.
Biograstim is a solution for injection or infusion in a pre-filled syringe with or without safety device. Biograstim is a clear and colourless solution. Each pre-filled syringe contains either 0.5 mL or 0.8 mL of solution.
Biograstim is supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes. Not all pack sizes may be marketed.
AbZ-Pharma GmbH Graf-Arco-Straße 3
89079 Ulm
Germany
89079 Ulm
Germany
This section contains information on how to give yourself an injection of Biograstim. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
It is important that you dispose of used syringes in a puncture-proof container.
You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection. You will need to have your injections at about the same time every day.
To give yourself a subcutaneous injection you will need:
a pre-filled syringe of Biograstim;
alcohol wipes or similar;
a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely.
Try to self-inject at approximately the same time every day.
Take your Biograstim pre-filled syringe out of the refrigerator.
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.
Medicinal product no longer authorised
Check the appearance of Biograstim. 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 Biograstim in any other way (for example, do not warm it in a microwave or in hot water).
Do not remove the cover from the syringe until you are ready to inject.
Wash your hands thoroughly.
Find a comfortable, well-lit place and put everything you need where you can reach them (the Biograstim pre-filled syringe, alcohol wipes and the puncture-proof container).
Before you inject Biograstim you must do the following:
Hold the syringe and gently take the cover from the needle without twisting. Pull straight as shown in pictures 1 and 2. Do not touch the needle or push the plunger.
2You may notice a small air bubble in the pre-filled syringe. If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With the syringe pointing upwards, expel all air from the syringe by pushing the plunger upwards.
The syringe has a scale on the syringe barrel. Push the plunger up to the number (mL) on the syringe that matches the dose of Biograstim that your doctor prescribed.
Check again to make sure the correct dose of Biograstim is in the syringe.
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 (see picture 3).
4If someone else is injecting you, they can also use the back of your arms (see picture 4).
It is better to change the injection site every day to avoid the risk of soreness at any one site.
Medicinal product no longer authorised
Disinfect the injection site by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).
Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.
Inject the liquid slowly and evenly, always keeping your skin pinched.
Inject only the dose your doctor has told you.
After injecting the liquid, remove the needle and let go of your skin.
Only use each syringe for one injection. Do not use any Biograstim that is left in the syringe.
6If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Do not put the cover back on used needles.
Put used syringes into the puncture-proof container and keep this container out of the sight and reach of children.
Dispose of the full puncture-proof container as instructed by your doctor, nurse or pharmacist.
Never put the syringes that you have used into your normal household rubbish bin.
Biograstim does not contain any preservative. In view of the possible risk of microbial contamination, Biograstim syringes are for single use only.
Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim. Biograstim should not be diluted with sodium chloride solution. This medicinal product must not be
mixed with other medicinal products except those mentioned below. Diluted filgrastim may be
adsorbed to glass and plastic materials except diluted, as mentioned below.
If required, Biograstim may be diluted in glucose 50 mg/mL (5 %) solution for infusion. Dilution to a final concentration less than 0.2 MIU (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 MIU (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 MIU (300 μg) should be given with 0.2 mL of 200 mg/mL (20 %) human albumin solution added. When diluted in glucose 50 mg/mL (5 %) solution for infusion, Biograstim is compatible with glass and a variety of plastics including PVC, polyolefin
(a co-polymer of polypropylene and polyethylene) and polypropylene.
Medicinal product no longer authorised
After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.