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Nivestim (filgrastim) – Package leaflet - L03AA02

Updated on site: 08-Oct-2017

Medication nameNivestim
ATC CodeL03AA02
Substancefilgrastim
ManufacturerHospira UK Ltd  

Package leaflet: Information for the user

Nivestim 12 MU/0.2 ml solution for injection/infusion

Nivestim 30 MU/0.5 ml solution for injection/infusion

Nivestim 48 MU/0.5 ml solution for injection/infusion

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, 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 is in this leaflet:

1.What Nivestim is and what it is used for

2.What you need to know before you use Nivestim

3.How to use Nivestim

4.Possible side effects

5.How to store Nivestim

6.Contents of the pack and other information

1.What Nivestim is and what it is used for

What Nivestim is

Nivestim 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. Nivestim works by encouraging 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. Nivestim stimulates the bone marrow to produce new white cells quickly.

Nivestim 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 Nivestim

Do not use Nivestim

-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 Nivestim.

Please tell your doctor before starting treatment if you have:

-sickle cell anaemia, as Nivestim may cause sickle cell crisis.

-osteoporosis (bone disease).

Please tell your doctor immediately during treatment with Nivestim, 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 Nivestim, unless instructed by your doctor.

If you are a stem cell donor, you must be aged between 16 and 60 years.

Take special care with other products that stimulate white blood cells

Nivestim 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 Nivestim

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

Pregnancy and breast-feeding

Nivestim 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 Nivestim treatment, please inform your doctor.

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

Driving and using machines

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

Nivestim contains sodium and sorbitol

Nivestim contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially sodium-free.

Nivestim 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 Nivestim

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

How is Nivestim given and how much should I take?

Nivestim is usually given as a daily injection into the tissue 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 Nivestim you should take.

Patients having a bone marrow transplant after chemotherapy:

You will normally receive your first dose of Nivestim at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.

How long will I have to take Nivestim?

You will need to take Nivestim 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 Nivestim.

Use in children

Nivestim 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 Nivestim 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 Nivestim

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

If you have any further questions on the use of this medicine, ask your doctor 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 (enlargement of the spleen (splenomegaly) or rupture of the 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 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.

- 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 filgrastim 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 (may affect more than 1 in 10 people): 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)

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

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 (may affect up to 1 in 10 people) 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

rupture of the spleen

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

damage to the tiny filters inside your kidneys (glomerulonephritis)

in HIV patients

enlargement of the spleen (splenomegaly)

Uncommon side effects (may affect up to 1 in 100 people): 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 a fever

(Sweets syndrome)

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

worsening of rheumatoid arthritis

unusual change in the 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)

severe allergic 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 (frequency 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.

5.How to store Nivestim

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 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nivestim contains

The active substance is filgrastim. Each ml contains 60 million units [MU] (600 micrograms) or 96 million units [MU] (960 micrograms) of filgrastim.

Nivestim 12 MU/ 0.2 ml solution for injection/ infusion: each pre-filled syringe contains 12 million units (MU), 120 micrograms of filgrastim in 0.2 ml (corresponding to 0.6 mg/ml).

Nivestim 30 MU/ 0.5 ml solution for injection/ infusion: each pre-filled syringe contains 30 million units (MU), 300 micrograms of filgrastim in 0.5 ml (corresponding to 0.6 mg/ml).

Nivestim 48 MU/ 0.5 ml solution for injection/ infusion: each pre-filled syringe contains 48 million units (MU), 480 micrograms of filgrastim in 0.5 ml (corresponding to 0.96 mg/ml).

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

What Nivestim looks like and contents of the pack

Nivestim is a clear colourless solution for injection/ infusion in a glass pre-filled syringe with an injection needle (stainless steel) with a needle guard. There are 1, 5, 8 or 10 syringes in each pack. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Hospira UK Limited

Horizon

Honey Lane

Hurley

Maidenhead

SL6 6RJ

UK

Tel: + 44 (0) 1628 515500

Fax: + 44 (0) 1628 829827

Manufacturer

Hospira Enterprises B.V.

Randstad 22-11

1316 BN Almere

The Netherlands

Hospira Zagreb d.o.o.

Prudnička cesta 60

10291 Prigorje Brdovečko

Croatia

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

België/Belgique/Belgien

Lietuva

Pfizer S.A. / N.V.

Pfizer Luxembourg SARL filialas Lietuvoje

Tél/Tel: +32 2 554 62 11

Tel. + 370 52 51 4000

България

Luxembourg/Luxemburg

Alvogen Pharma Bulgaria Ltd

Pfizer S.A. / N.V.

Teл.: + 359 2 441 7136

Tél/Tel: +32 2 554 62 11

Česká republika

Magyarország

Pfizer, spol. s r.o.

Pfizer Kft.

Tel: +420-283-004-111

Tel.: + 36 1 488 37 00

Danmark

Malta

Pfizer ApS

Hospira UK Limited

Tlf: + 45 44 20 11 00

Tel: + 44 (0) 1628 515500

Deutschland

Nederland

Pfizer Pharma PFE GmbH

Pfizer S.A. / N.V.

Tel: + 49 (0)800 8535555

Tél/Tel: +32 2 554 62 11

Eesti

Norge

Pfizer Luxembourg SARL Eesti filiaal

Pfizer AS

Tel: +372 666 7500

Tlf: +47 67 52 61 00

Ελλάδα

Österreich

Aenorasis S.A.

Pfizer Corporation Austria Ges.m.b.H

Τηλ: + 30 210 6136332

España

Polska

Pfizer GEP, S.L.

Alvogen Poland Sp. z.o.o.

Tel: +34 91 490 99 00

Tel.: + 482 24609200

France

Portugal

Pfizer PFE France

Hospira Portugal Lda

Tél: + 33 (0)1 58 07 34 40

Tel: +351 21 423 55 00

Hrvatska

România

Alvogen d.o.o.

Alvogen Romania SRL

Tél/Tel: + 385 1 6641 830

Tel: +(40) 21 351 0286

Ireland

Slovenija

Hospira Ireland Sales Limited

Pfizer Luxembourg SARL

Tel: 1800 633 363 (toll free)

Pfizer, podružnica za svetovanje s področja

+44 (0) 1304 616161

farmacevtske dejavnosti, Ljubljana

 

Tel: +386 (0)1 52 11 400

Ísland

Slovenská republika

Icepharma hf.

Pfizer Luxembourg SARL, organizačná zložka

Sími: +354 540 8000

Tel: +421–2–3355 5500

Italia

Suomi/Finland

Pfizer Italia Srl

Pfizer PFE Finland Oy

Tel: +39 06 33 18 21

Puh/Tel: +358 (0)9 430 040

Κύπρος

Sverige

Hospira UK Limited

Pfizer AB

Τηλ: + 44 (0) 1628 515500

Tel: +46 (0)8 550 520 00

Latvija

United Kingdom

Pfizer Luxembourg SARL filiāle Latvijā

Hospira UK Limited

Tel.: + 371 670 35 775

Tel: + 44 (0) 1628 515500

This leaflet was last revised in

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

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Information on self administration by the patient

This section contains information on how to give yourself an injection of Nivestim. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. It is also important that you dispose of the syringe in a puncture-proof container. If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.

How do I administer my Nivestim?

Nivestim is usually given once a day by injection, usually into the tissue just under the skin. This is known as a subcutaneous injection.

Learning to give your own injections will mean that you will not have to wait at home for a nurse to call, nor will you have to go to the hospital or clinic every day to receive your injections.

You will need to have your injections at about the same time every day. The most suitable places for injection are:

the front of the thighs,

the abdomen, except for the area around the navel.

It is better to change the injection site every day to avoid the risk of soreness at any one site.

Equipment required for administration

To give yourself a subcutaneous injection you will need the following items:

A new pre-filled syringe of Nivestim.

A sharps container (puncture proof container) for disposing of used syringes safely.

Antiseptic wipes (if recommended by your doctor or nurse).

How do I give my subcutaneous Nivestim injection?

1.Try to self-inject at approximately the same time every day.

2.Remove the Nivestim syringe from the fridge and allow it to reach room temperature (approximately 25 C). This will take 15–30 minutes. Check the date on the pack to make sure that the medicine has not passed the expiry date. Make sure you have your sharps container nearby.

3.Find a comfortable well lit working place to give your injection and check the dose that you have been prescribed.

4.Wash your hands thoroughly with soap and water.

5.Remove the syringe from the blister pack and check that the solution is clear, colourless and practically free from visible particles. Do not use the Nivestim syringe if the liquid has particles floating in it or any of the liquid has leaked out of the syringe.

6.Hold the syringe with the needle pointing upwards. Remove the protective cap from the injection needle. The syringe is now ready for use. You may notice a small air bubble in the syringe. You do not have to remove the air bubble before injecting. Injecting the solution with an air bubble present is harmless.

7.Decide where to inject Nivestim - find a place on the front of your abdomen or the front of your thigh. Choose a different injection site each time. Do not choose an area which is tender, red, bruised or scarred. If your nurse or doctor recommends it, clean the area of skin with an antiseptic wipe.

8.Pinch a large area of skin, taking care not to touch the area you have cleaned.

9.With your other hand, insert the needle at an approximate 45˚ angle.

10.Pull the plunger back slightly to check if any blood appears in the syringe. If you do see blood inside the syringe, remove the needle and re-insert it in a different site. Slowly push down the plunger until all the contents of the syringe have been emptied.

11.After injecting the solution remove the needle from the skin.

12.Ensure the needle guard covers the needle according to the instructions for active needle guard or passive needle guard below.

13.Place the syringe into the sharps container. Do not try to replace the protective cap.

Keep used syringes out of the reach and sight of children

NEVER put used syringes into your normal household waste bin.

Remember

Most people can learn to give themselves a subcutaneous injection, but if you are experiencing a lot of difficulty, please do not be afraid to ask for help and advice from your doctor or nurse.

Use of Active Ultrasafe Needle Guard for Nivestim 12 MU/ 0.2 ml solution for injection/ infusion

The pre-filled syringe has an UltraSafe Needle Guard attached in order to protect from needle stick injury. When handling the pre-filled syringe, keep hands behind the needle.

1.Perform the injection using the technique described above.

2.When you have completed the injection, slide the needle guard forward until the needle is completely covered (device ‘clicks’ into place).

Use of Ultrasafe Passive Needle Guard for Nivestim 30 MU/ 0.5 ml solution for injection/ infusion and Nivestim 48 MU/ 0.5 ml solution for injection/ infusion

The pre-filled syringe has an UltraSafe Needle Guard attached in order to protect from needle stick injury. When handling the pre-filled syringe, keep hands behind the needle.

1.Perform the injection using the technique described above.

2.Depress the plunger while grasping the finger flange until the entire dose has been given. The passive needle guard will NOT activate unless the ENTIRE dose has been given.

3.Remove the needle from your skin, then let go of the plunger and allow the syringe to move up until the entire needle is guarded and locks into place.

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THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:

Nivestim does not contain any preservative. In view of the possible risk of microbial contamination, Nivestim syringes are for single use only.

Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Nivestim. The frozen pre-filled syringes can be thawed and then refrigerated for future use. If exposure has been greater than 24 hours or frozen more than once, then Nivestim should NOT be used.

Nivestim must 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, Nivestim may be diluted in glucose 50 mg/ml (5%) solution for infusion. Dilution to a final concentration less than 0.2 MU (2 micrograms) 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 micrograms) 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 micrograms) 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, Nivestim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.

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.

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