What is it and how is it used?
What Nivestim is
Nivestim contains the active substance filgrastim. 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.
What Nivestim is used for
Your doctor has prescribed Nivestim for you to help your body make more white blood cells. Your doctor will tell you why you are being treated with Nivestim.
Nivestim is useful in several different conditions which are:
What do you have to consider before using it?
Do not use Nivestim
Take special care with Nivestim
You may need to have regular blood tests whilst being treated with Nivestim to count the number of neutrophils and other white blood cells in your blood. This will tell your doctor how the treatment is working and will also indicate if treatment needs to be continued.
Using other medicines
You should not receive Nivestim in the 24 hours before and the 24 hours after receiving chemotherapy. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Filgrastim 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 your doctor may decide that you should not use this medicine. Filgrastim could affect your ability to become pregnant or stay pregnant.
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.
Driving and using machines
Filgrastim has negligible influence on the ability to drive and use machines. If the patient is experiencing fatigue, caution is advised when driving a car or operating machinery.
Important information about some of the ingredients of Nivestim
This medicine contains sorbitol (E420). If you have been told by your doctor that you have an intolerance to some sugars (fructose), contact your doctor before taking this medicine. This medicine also contains sodium less than 1mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
How is it used?
Always use Nivestim exactly as your doctor tells you to.
This medicine is given by injection, either through an intravenous infusion (drip) or by a subcutaneous 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 (see end of leaflet for self administration information). 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. The amount of Nivestim you need, will depend on the condition you are taking Nivestim for and on your bodyweight.
Nivestim and neutropenia associated with chemotherapy
The usual dose for adults and children is 0.5 million units (5 micrograms) per kilogram of bodyweight each day. For example, if you weigh 60 kg your daily dose will be 30 million units (300 micrograms). 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.
Nivestim and bone marrow transplantation
The normal starting dose is 1 million units (10 micrograms) per kilogram of bodyweight each day given as an infusion. For example, if you weigh 60 kg your daily dose will be 60 million units (600 micrograms). You will normally receive your first dose of Nivestim at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transplantation. Your doctor may then test your blood to tell how well your treatment is working and how long it should last.
Nivestim and severe chronic neutropenia
The normal starting dose is between 0.5 million (5 micrograms) and 1.2 million (12 micrograms) units per kilogram bodyweight each day in a single or divided dose. Your doctor may 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 Nivestim is required for neutropenia.
Nivestim and neutropenia in patients with HIV infection
The normal starting dose is between 0.1 (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 treatment is working and to decide on the dose necessary. 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. Long term treatment with Nivestim may be required to maintain a normal number of white cells in your blood.
Nivestim and peripheral blood stem cell transplantation
If you are donating stem cells for yourself, the usual dose is 0.5 million (5 micrograms) to 1 million units (10 micrograms) per kilogram bodyweight each day. Nivestim 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 per kilogram bodyweight each day. Nivestim treatment will last for 4 to 5 days.
If you use more Nivestim than you should
If you use more Nivestim than you should, contact your doctor or pharmacist as soon as possible.
If you forget to use Nivestim
If you have forgotten to inject a dose, speak to your doctor or pharmacist to find out when you should inject the next dose. Do not use a double dose to make up for a forgotten injection.
If you stop using Nivestim
Your doctor will tell you when to stop using Nivestim. It is quite normal to have a number of courses of Nivestim treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, Nivestim can cause side effects, although not everyone gets them.
Allergic-type reactions to filgrastim, including skin rash, raised areas of the skin that itch and anaphylaxis (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, stop your Nivestim injection and get medical help immediately.
Increased spleen size and very rare cases of spleen ruptures have been reported. Some cases of rupture of the spleen 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 painsince this may relate to a problem with your spleen.
It is also very important that you call your doctor if you think you may have an infection. There are many ways an infection may show itself. You should watch for a temperature of 37.8 °C or above, chills or other signs of infection, such as a rash, sore throat, diarrhoea, ear-ache, difficult or painful breathing or problems such as cough or wheezing. These symptoms could be signs of severe lung side effects, like pneumonia and respiratory distress syndrome in adults, which may be fatal. If you have a fever or any of these symptoms, contact your doctor immediately and go straight to your hospital.
If you have Sickle Cell Disease, make sure that you tell your doctor before you start taking Nivestim. Sickle cell crisis has happened in some patients with Sickle Cell Disease who have been given filgrastim.
The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Very common side effects
Common side effects
Uncommon side effects
Rare side effects
The side effects that may be experienced by you if you are acting as a stem cell donor for another person are:
Very common side effects
Common side effects
Uncommon side effects
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Nivestim 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 and transport refrigerated (2°C – 8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.
The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 7 days (but not above 25°C).
Do not use Nivestim if you notice it is cloudy or there are particles in it.
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.
