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 Tevagrastim is and what it is used for

• 2. What you need to know before you use Tevagrastim

• 3. How to use Tevagrastim

• 4. Possible side effects

• 5. How to store Tevagrastim

• 6. Contents of the pack and other information

• 7. Information for injecting yourself

• 8. The following information is intended for healthcare professionals only

1. what tevagrastim is and what it is used fortevagrastim 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 Yellow Card Scheme Website:or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 °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.

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 UK Limited,

Ridings Point,

Whistler Drive,

Castleford, WF10 5HX,

United Kingdom

Manufacturer

Teva Pharma B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

This leaflet was last revised in 09/2021.

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?

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

• 2. Take your Tevagrastim pre-filled syringe out of the refrigerator.

• 3. 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.

• 4. Check the appearance of Tevagrastim. It must be a clear and colourless liquid. If there are particles in it, you must not use it.

• 5. 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).

• 6. Do not remove the cover from the syringe until you are ready to inject.

• 7. Wash your hands thoroughly.

• 8. 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:

• 1. 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.

• 3. 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.

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

• 5. 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). If 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.

How do I give my injection?

• 1. Disinfect the injection site by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).

• 2. Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).

• 3. 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.

• 4. Inject the liquid slowly and evenly, always keeping your skin pinched.

• 5. Inject only the dose your doctor has told you.

• 6. After injecting the liquid, remove the needle and let go of your skin.

• 7. Only use each syringe for one injection. Do not use any Tevagrastim that is left in the syringe.

  
  
  
  

Remember

If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used syringes

• – 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.

8. The following information is intended for healthcare professionals only

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 Tevagrastim is and what it is used for

• 2. What you need to know before you use Tevagrastim

• 3. How to use Tevagrastim

• 4. Possible side effects

• 5. How to store Tevagrastim

• 6. Contents of the pack and other information

• 7. Information for injecting yourself

• 8. The following information is intended for healthcare professionals only

1. what tevagrastim is and what it is used fortevagrastim 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 or
• 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 Tevagrastim 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 Ratiograstim.

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

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 2

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 Yellow Card Scheme Website:or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 °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.

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 UK Limited,

Ridings Point,

Whistler Drive,

Castleford, WF10 5HX,

United Kingdom

Manufacturer

Teva Pharma B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

This leaflet was last revised in 09/2021.

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.

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.

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

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

• 2. Take your Tevagrastim pre-filled syringe out of the refrigerator.

• 3. 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.

• 4. Check the appearance of Tevagrastim. It must be a clear and colourless liquid. If there are particles in it, you must not use it.

• 5. 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).

• 6. Do not remove the cover from the syringe until you are ready to inject.

• 7. Wash your hands thoroughly.

• 8. Find a comfortable, well-lit place and put everything you need where you can reach them (the Tevagrastim pre-filled syringe and alcohol wipes).

How do I prepare my Tevagrastim injection?

Before you inject Tevagrastim you must do the following:

• 1. 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.

• 3. 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.

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

• 5. 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).

  
  
  
  

If 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.

How do I give my injection?

• 1. Disinfect the injection site by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).

• 2. Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).

• 3. 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.

• 4. Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger!

• 5. Inject only the dose your doctor has told you.

• 6. After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin.

• 7. Let go of the plunger. The needle safety guard will rapidly move to cover the needle (see

picture 7).

5

Remember

If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used syringes

• – 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.

• 8. The following information is intended for healthcare professionals only

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

Accidental exposure to freezing temperatures does not adversely affect the stability of Tevagrastim.

Tevagrastim 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, Tevagrastim may be diluted in glucose 50 mg/mL (5 %) solution for infusion. Dilution to a final concentration less than 0.2 MIU (2 ^g) 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 ^g) 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 ^g) 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, Tevagrastim 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.

Using the pre-filled syringe without a needle safety guard

Administer the dose as per standard protocol.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

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

• 1. What Tevagrastim is and what it is used for

• 2. What you need to know before you use Tevagrastim

• 3. How to use Tevagrastim

• 4. Possible side effects

• 5. How to store Tevagrastim

• 6. Contents of the pack and other information

• 7. Information for injecting yourself

• 8. The following information is intended for healthcare professionals only

1. what tevagrastim is and what it is used fortevagrastim 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 or
• 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 Tevagrastim 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 Ratiograstim.

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

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 2

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 Yellow Card Scheme Website:or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 °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.

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 UK Limited,

Ridings Point,

Whistler Drive,

Castleford, WF10 5HX,

United Kingdom

Manufacturer

Teva Pharma B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

This leaflet was last revised in 09/2021.

• 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.

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.

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

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

• 2. Take your Tevagrastim pre-filled syringe out of the refrigerator.

• 3. 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.

• 4. Check the appearance of Tevagrastim. It must be a clear and colourless liquid. If there are particles in it, you must not use it.

• 5. 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).

• 6. Do not remove the cover from the syringe until you are ready to inject.

• 7. Wash your hands thoroughly.

• 8. Find a comfortable, well-lit place and put everything you need where you can reach them (the Tevagrastim pre-filled syringe and alcohol wipes).

How do I prepare my Tevagrastim injection?

Before you inject Tevagrastim you must do the following:

• 1. 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.

  
  

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• 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.

• 3. 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.

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

• 5. 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).

  
  
  
  

If 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.

How do I give my injection?

• 1. Disinfect the injection site by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).

• 2. Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).

• 3. 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.

• 4. Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger!

• 5. Inject only the dose your doctor has told you.

• 6. After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin.

• 7. Let go of the plunger. The needle safety guard will rapidly move to cover the needle (see

picture 7).

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Remember

If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used syringes

• – The needle safety guard prevents needle stick injuries after use, so no special precautions for

disposal are required. Dispose of the syringe as instructed by your doctor, nurse or pharmacist.

• 8. The following information is intended for healthcare professionals only