Tevagrastim

Основна информация

  • Търговско наименование:
  • Tevagrastim
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Tevagrastim
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Immunostimulants,
  • Терапевтична област:
  • Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
  • Терапевтични показания:
  • Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/ l, and a history of severe or recurrent infections, long term administration of Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Teva
  • Каталог на резюме:
  • Revision: 12

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/000827
  • Дата Оторизация:
  • 15-09-2008
  • EMEA код:
  • EMEA/H/C/000827
  • Последна актуализация:
  • 05-05-2020

Доклад обществена оценка

European Medicines Agency

7 Westferry Circus, Canary Wharf, London E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged.

EMEA/H/C/827

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)

TEVAGRASTIM

EPAR summary for the public

This document is a summary of the European Public Assessment Report (EPAR). It explains how

the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to

reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package

Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more

information on the basis of the CHMP recommendations, read the Scientific Discussion (also part

of the EPAR).

What is Tevagrastim?

Tevagrastim is a solution for injection or for infusion (drip into a vein). It contains the active

substance filgrastim.

Tevagrastim is a ‘biosimilar’ medicine. This means that Tevagrastim is similar to a biological

medicine that is already authorised in the European Union (EU) and contains the same active

substance (also known as the ‘reference medicine’). The reference medicine for Tevagrastim is

Neupogen. For more information on biosimilar medicines, see the question-and-answer document

here

What is Tevagrastim used for?

Tevagrastim is used to stimulate the production of white blood cells in the following situations:

to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the

occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy

(cancer treatment) that is cytotoxic (cell-killing);

to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow

cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a

risk of long-term, severe neutropenia;

to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who

have a history of severe, repeated infections;

to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV)

infection, to reduce the risk of bacterial infections when other treatments are not appropriate.

Tevagrastim can also be used in patients who are about to donate blood stem cells for transplant, to

help release these cells from the bone marrow.

The medicine can only be obtained with a prescription.

How is Tevagrastim used?

Tevagrastim is given by injection under the skin or infusion into a vein. How it is given, the dose and

the duration of treatment depend on why it is being used, the patient’s body weight and the response to

treatment. Tevagrastim is usually given in a specialised treatment centre, although patients who

receive it by injection under the skin may inject themselves once they have been trained appropriately.

For more information, see the Package Leaflet.

How does Tevagrastim work?

The active substance in Tevagrastim, filgrastim, is very similar to a human protein called granulocyte

colony stimulating factor (G-CSF). Filgrastim is produced by a method known as ‘recombinant DNA

technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to

produce filgrastim. The replacement acts in same way as naturally produced G-CSF by encouraging

the bone marrow to produce more white blood cells.

How has Tevagrastim been studied?

Tevagrastim was studied to show that it is comparable to the reference medicine, Neupogen.

Tevagrastim was compared to Neupogen and to placebo (a dummy treatment) in one main study

involving 348 patients with breast cancer. The study looked at the duration of severe neutropenia

during the patients’ first cycle of cytotoxic chemotherapy.

To study the safety of Tevagrastim, two further studies were carried out in patients with lung cancer

and with non-Hodgkin’s lymphoma.

What benefit has Tevagrastim shown during the studies?

Treatment with Tevagrastim and Neupogen brought about similar reductions in duration of severe

neutropenia. During the first 21-day chemotherapy cycle, patients treated with either Tevagrastim or

Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those

receiving placebo. Therefore, the effectiveness of Tevagrastim was shown to be equivalent to that of

Neupogen.

What is the risk associated with Tevagrastim?

The most common side effect with Tevagrastim (seen in more than 1 patient in 10) is musculoskeletal

pain (pain in the muscles and bones). Other side effects may be seen in more than 1 patient in 10,

depending on the condition that Tevagrastim is being used for. For the full list of all side effects

reported with Tevagrastim, see the Package Leaflet.

Tevagrastim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of

the other ingredients.

Why has Tevagrastim been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU

requirements, Tevagrastim has been shown to have a comparable quality, safety and efficacy profile to

Neupogen. Therefore, the CHMP’s view was that, as for Neupogen, the benefit outweighs the

identified risk. The Committee recommended that Tevagrastim be given marketing authorisation.

Other information about Tevagrastim:

The European Commission granted a marketing authorisation valid throughout the EU for

Tevagrastim to Teva Generics GmbH on 15 September 2008.

The full EPAR for Tevagrastim can be found here

This summary was last updated in 09-2008.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Tevagrastim 30 MIU/0.5 mL solution for injection/infusion

Tevagrastim 48 MIU/0.8 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

What Tevagrastim is and what it is used for

What you need to know before you use Tevagrastim

How to use Tevagrastim

Possible side effects

How to store Tevagrastim

Contents of the pack and other information

Information for injecting yourself

The following information is intended for healthcare professionals only

1.

What Tevagrastim

is and what it is used for

What Tevagrastim is

Tevagrastim 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. Tevagrastim works by

encouraging the bone marrow to produce more white blood cells.

What Tevagrastim is used for

A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes

your body less able to fight infection. Tevagrastim stimulates the bone marrow to produce new white

cells quickly.

Tevagrastim 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 Tevagrastim

Do not use Tevagrastim

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 Tevagrastim

Please tell your doctor before starting treatment,

if you have

sickle cell anaemia, as this medicine may cause sickle cell crisis

osteoporosis (bone disease).

Talk to your doctor immediately during treatment with Tevagrastim,

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 as

these could be signs of a severe allergic reaction (hypersensitivity).

experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or

you notice you urinate less than usual (glomerulonephritis).

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

ofthe 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).

Inflammation of aorta (the large blood vessel which transports blood from the heart to the

body) has been reported rarely in cancer patients and healthy donors. The symptoms can

include fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell

your doctor if you experience those symptoms.

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 Tevagrastim, 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

Tevagrastim 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 Tevagrastim

Tell your doctor or pharmacist if you are using have recently used or might use any other medicines.

Pregnancy and breast-feeding

Tevagrastim has not been tested in pregnant or breast-feeding women.

Tevagrastim is not recommended during pregnancy.

It is important to tell your doctor if you:are pregnant or breast-feeding

think you may be pregnant

are planning to have a baby

If you become pregnant during Tevagrastim treatment, please inform your doctor.

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

Driving and using machines

Tevagrastim may have a minor influence on your ability to drive and use machines. This medicine

may cause dizziness. It is advisable to wait and see how you feel after using this medicine and before

driving or operating machinery.

Tevagrastim contains sorbitol

This medicine contains 50 mg sorbitol in each mL.

Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare

genetic disorder, you (or your child) must not receive this medicine. Patients with HFI cannot break

down fructose, which may cause serious side effects. You must tell your doctor before receiving this

medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks

because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.

Tevagrastim contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially

‘sodium-free’.

3.

How to use Tevagrastim

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

How is Tevagrastim given and much should I take?

Tevagrastim 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 Tevagrastim you should take.

Patients having a bone marrow transplant after chemotherapy:

You will normally receive your first dose of Tevagratsim at least 24 hours after your chemotherapy

and at least 24 hours after receiving your bone marrow transplant.

You, or people caring for you, can be taught how to give subcutaneous injections so that you can

continue your treatment at home. However, you should not attempt this unless you have been properly

trained first by your health care provider.

How long will I have to take Tevagrastim?

You will need to take Tevagrastim 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 Tevagrastim.

Use in children

Tevagrastim 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 Tevagrastim than you should

Do not increase the dose your doctor has given you. If you use more Tevagrastim than you should,

contact your doctor or pharmacist as soon as possible.

If you forget to use Tevagrastim

If you have missed an injection, or injected too little, contact your doctor as soon as possible.

Do not

take a double dose to make up for any missed doses.

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

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects

It is important to contact your doctor immediately

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).

if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of

Acute Respiratory Distress Syndrome (ARDS).

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.

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 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 a combination of any of the following symptoms:

fever, or shivering, or feeling very cold, high heart rate, confusion or disorientation,

shortness of breath, extreme pain or discomfort and clammy or sweaty skin.

These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a

severe infection with whole-body inflammatory response which can be life threatening and

needs urgent medical attention.

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).

A common side effect of Tevagrastim use is pain in your muscles or bones (musculoskeletal pain),

which could be relieved 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.

In normal stem cell donors an increase in white blood cells (leukocytosis) and a decrease of platelets

may be seen this reduces the ability of your blood to clot (thrombocytopenia), these will be monitored

by your doctor.

You may experience the following side effects

Very common

(may affect more than 1 in 10 people):

decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)

low red blood cell count (anaemia)

headache

diarrhoea

vomiting

nausea

unusual hair loss or thinning (alopecia)

tiredness (fatigue)

soreness and swelling of the digestive tract lining which runs from the mouth to the anus

(mucosal inflammation)

fever (pyrexia)

Common

(may affect up to 1 in 10 people):

inflammation of the lung (bronchitis)

upper respiratory tract infection

urinary tract infection

decreased appetite

trouble sleeping (insomnia)

dizziness

decreased feeling of sensitivity, especially in the skin (hypoaesthesia)

tingling or numbness of the hands or feet (paraesthesia)

low blood pressure (hypotension)

high blood pressure (hypertension)

cough

coughing up blood (haemoptysis)

pain in your mouth and throat (oropharyngeal pain)

nose bleeds (epistaxis)

constipation

oral pain

enlargement of the liver (hepatomegaly)

rash

redness of the skin (erythema)

muscle spasm

pain when passing urine (dysuria)

chest pain

pain

generalised weakness (asthenia)

generally feeling unwell (malaise)

swelling in the hands and feet (oedema peripheral)

increase of certain enzymes in the blood

changes in blood chemistry

transfusion reaction

Uncommon

(may affect up to 1 in 100 people):

increase in white blood cells (leukocytosis)

allergic reaction (hypersensitivity)

rejection of transplanted bone marrow (graft versus host disease)

high uric acid levels in the blood, which may cause gout (hyperuricaemia) (blood uric acid

increased)

liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)

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)

bleeding from the lung (pulmonary haemorrhage)

lack of absorption of oxygen in the lung (hypoxia)

bumpy skin rash (rash macuo-papular)

disease which causes bones to become less dense, making them weaker, more brittle and

likely to break (osteoporosis)

injection site reaction

Rare

(may affect up to 1 in 1,000 people):

severe pain in the bones, chest, gut or joints (sickle cell anaemia with crisis)

sudden life-threatening allergic reaction (anaphylactic reaction)

pain and swelling of the joints, similar to gout (pseudogout)

a change in how your body regulates fluids within your body and may result in puffiness (fluid

volume disturbances)

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

plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a

fever (Sweets syndrome)

worsening of rheumatoid arthritis

unusual change in the urine

bone density decreased

Inflammation of aorta (the large blood vessel which transports blood from the heart to the

body), see section

Reporting of side effects

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.

5.

How to store Tevagrastim

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

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.

6.

Contents of the pack and other information

What Tevagrastim contains

The active substance is filgrastim. Each mL of solution for injection/infusion contains

60 million international units [MIU] (600 microgram) of filgrastim.

Tevagrastim 30 MIU/0.5 mL: Each pre-filled syringe contains 30 million international units

[MIU] (300 microgram) of filgrastim in 0.5 mL solution.

Tevagrastim 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.

What Tevagrastim looks like and contents of the pack

Tevagrastim is a solution for injection/infusion in a pre-filled syringe. Tevagrastim is a clear and

colourless solution. Each pre-filled syringe contains either 0.5 mL or 0.8 mL of solution.

Tevagrastim is supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5)

pre-filled syringes with injection needle and with or without a needle safety guard. Not all pack sizes

may be marketed.

Marketing Authorisation Holder

TEVA GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturer

Teva Pharma B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

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

Authorisation Holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tél/Tel: +32 3 820 73 73

Lietuva

UAB Teva Baltics

Tel: +370 5 266 0203

България

Актавис ЕАД

Тел: +359 24899585

Luxembourg/Luxemburg

Teva Pharma Belgium N.V./S.A./AG,

Belgique/Belgien

Tél/Tel: +32 3 820 73 73

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Magyarország

Teva Gyógyszergyár Zrt.

Tel.: +36 1 288 64 00

Danmark

Teva Denmark A/S

Tlf: +45 44 98 55 11

Malta

Teva Pharmaceuticals Ireland

L-Irlanda

Tel: +353 19 630330

Deutschland

TEVA GmbH

Tel: +49 731 402 08

Nederland

Teva Nederland B.V.

Tel: +31 800 0228 400

Eesti

UAB Teva Baltics Eesti filiaal

Tel: +372 661 0801

Norge

Teva Norway AS

Tlf: +47 66 77 55 90

Ελλάδα

Teva Ελλάς Α.Ε.

Τηλ: +30 211 880 5000

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel: +43 1 97 007

España

Teva Pharma, S.L.U.

Tél: +34 91 387 32 80

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel.: +48 22 345 93 00

France

Teva Santé

Tél: +33 1 55 91 78 00

Portugal

Teva Pharma - Produtos Farmacêuticos, Lda

Tel: +351 21 476 75 50

Hrvatska

Pliva Hrvatska d.o.o.

Tel: +385 1 37 20 000

România

Teva Pharmaceuticals S.R.L

Tel: +40 21 230 65 24

Ireland

Teva Pharmaceuticals Ireland

Tel: +353 19 630330

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 57 26 79 11

Italia

Teva Italia S.r.l.

Tel: +39 02 89 17 98 1

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 20 180 5900

Κύπρος

Teva Ελλάς Α.Ε., Ελλάδα

Τηλ: +30 211 880 5000

Sverige

Teva Sweden AB

Tel: +46 42 12 11 00

Latvija

UAB Teva Baltics filiāle Latvijā

Tel: +371 673 23 666

United Kingdom

Teva UK Limited

Tel: +44 1977 628500

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.

7.

Information for injecting yourself

This section contains information on how to give yourself an injection of Tevagrastim. 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.

How do I inject Tevagrastim myself?

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.

Equipment that you need

To give yourself a subcutaneous injection you will need:

a pre-filled syringe of Tevagrastim;

alcohol wipes or similar;

a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can

dispose of used syringes safely.

What should I do before I give myself a subcutaneous injection of Tevagrastim?

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

Take your Tevagrastim 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.

Check the appearance of Tevagrastim. 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

Tevagrastim in any other way (for example, do

not

warm it in a microwave or in hot water).

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

Tevagrastim pre-filled syringe, alcohol wipes and the puncture-proof container).

How do I prepare my Tevagrastim injection?

Before you inject Tevagrastim 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.

1

2

You 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 Tevagrastim that your doctor prescribed.

Check again to make sure the correct dose of Tevagrastim is in the syringe.

You can now use the pre-filled syringe.

Where should I give my injection?

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).