Package leaflet: Information for the patient

Lonquex 6 mg solution for injection in pre-filled syringe

lipegfilgrastim
Please 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 questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Lonquex is and what it is used for
What you need to know before using Lonquex
How to use Lonquex
Possible side effects
How to store Lonquex
Contents of the pack and other information

1. What Lonquex is and what it is used for

What Lonquex is
Lonquex contains the active substance lipegfilgrastim. Lipegfilgrastim is a long-acting modified protein,
produced by biotechnology in bacteria called Escherichia coli. It belongs to a group of proteins known as
cytokines and is similar to a natural protein (granulocyte colony-stimulating factor [G-CSF]) produced by the
human body.

What Lonquex is used for
Lonquex is used in adults and children aged 2 years and above.
Your doctor has prescribed Lonquex for you or your child to reduce the duration of a condition called
neutropenia (low white blood cell count in the blood) and the occurrence of febrile neutropenia (low white
blood cell count with fever). These conditions may be caused by cytotoxic chemotherapy (medicines that
destroy rapidly growing cells).

How Lonquex works
Lipegfilgrastim stimulates the bone marrow (the tissue where new blood cells are produced) to produce a
greater number of white blood cells. White blood cells are important because they help the body fight
infections. These cells are highly sensitive to the effects of chemotherapy, which can reduce the number of
these cells in the body. If white blood cells drop to a low level, there may not be enough cells to fight bacteria,
and you may become more susceptible to infections.

2. What you need to know before using Lonquex

Do not use Lonquex

if you or your child are allergic to lipegfilgrastim or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Lonquex:

if you or your child experience pain in the upper left side of the abdomen or at the tip of the shoulder. This could be due to a disorder affecting the spleen (see section 4 “Possible side effects”).
if you or your child have cough, fever and difficulty breathing. This could be due to a disorder affecting the lungs (see section 4 “Possible side effects”).
if you or your child have sickle cell disease, an inherited disorder characterized by sickle-shaped red blood cells.
if you or your child have previously had allergic reactions to other medicines similar to this one (e.g. filgrastim, lenograstim or pegfilgrastim in the G-CSF group). There may be a risk that you also react to Lonquex.

Your doctor will regularly perform certain blood tests to monitor the different components of the blood and their levels. Your doctor will also regularly check your urine or your child’s urine, as other medicines similar to this one (e.g. other granulocyte colony-stimulating factors such as filgrastim, lenograstim or pegfilgrastim) may damage the tiny filters inside the kidneys (glomerulonephritis; see section 4 “Possible side effects”).
Inform your doctor if you or your child are being treated for breast cancer or lung cancer in association with chemotherapy and/or radiotherapy and experience symptoms such as fatigue, fever, and easy bruising or bleeding. These symptoms may be due to a pre-cancerous blood condition called myelodysplastic syndrome (MDS) or a blood tumour called acute myeloid leukaemia (AML), which have been associated with another medicine similar to this one (pegfilgrastim in the G-CSF group).
Rare cases of inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body) have been reported with other medicines similar to this one (e.g. filgrastim, lenograstim or pegfilgrastim in the G-CSF group). Symptoms may include fever, abdominal pain, malaise, back pain and increased markers of inflammation. Inform your doctor if such symptoms occur.
Children and adolescents
Lonquex is not recommended for children under 2 years of age.
Other medicines and Lonquex
Inform your doctor or pharmacist if you or your child are using, have recently used or might use any other medicines.
Pregnancy and breastfeeding
Lonquex has not been studied in pregnant women. It is important to inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, as your doctor may decide that you should not use this medicine.
It is not known whether the active substance of this medicine passes into breast milk. You must therefore interrupt breastfeeding during treatment.
Driving and using machines
Lonquex does not affect or has negligible influence on the ability to drive and use machines.
Lonquex contains sorbitol
This medicine contains 30 mg of sorbitol per pre-filled syringe.
Lonquex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, i.e. essentially “sodium-free”.

3. How to use Lonquex

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose
The recommended dose is one pre-filled syringe (6 mg of lipegfilgrastim) once per chemotherapy cycle.
The pre-filled syringe is suitable only for adults or children weighing 45 kg or more.
Lonquex is also available in a vial formulation for children weighing less than 45 kg.
The recommended dose will be based on their body weight, and the appropriate dose will be administered by a
doctor or nurse.
When to use Lonquex
The dose of Lonquex is generally injected approximately 24 hours after the last dose of chemotherapy at
the end of each chemotherapy cycle.
How are the injections given?
This medicine is administered by injection using a pre-filled syringe. The injection
is given into the tissue directly beneath the skin (subcutaneous injection).
Your doctor may suggest that you learn to inject the medicine yourself or to inject it into your
child. Your doctor or nurse will show you how to do this. Do not attempt to inject Lonquex yourself
or into your child without proper training. The necessary information for using the
pre-filled syringe is provided in the section “Information for self-injection or injection into the
child”. Close and continuous cooperation with your doctor is essential for the proper treatment of
your condition or your child’s condition.
Information for self-injection or injection into the child
This section contains information on how to self-inject Lonquex under the skin or inject it into your
child. It is important that you do not attempt to inject the medicine yourself or into your
child before being specifically trained by your doctor or nurse. If you have any doubts or
questions about self-injection or injection into the child, consult your doctor or nurse.
How to use Lonquex
You must administer the injection into the tissue directly beneath the skin. This technique is called
subcutaneous injection.
Materials needed
To administer an injection into the tissue beneath the skin, you will need:

one pre-filled syringe of Lonquex,
an alcohol swab,
a piece of gauze dressing or sterile gauze pad,
a non-puncture-resistant container (plastic container provided by the hospital or pharmacy) for safe disposal of syringes.

What to do before administering the injection

Remove the medicine from the refrigerator.
Open the blister pack and remove the pre-filled syringe (see Figure 1). Do not handle the pre-filled syringe at the plunger or needle cap.
Check the expiry date printed on the label of the pre-filled syringe (Exp.). Do not use after the last day of the month indicated.
Check the appearance of Lonquex. It should be a clear, colourless liquid. Do not use if it is cloudy or contains particles.
Do not shake Lonquex vigorously, as this may impair its activity.
For greater comfort:
- leave the pre-filled syringe out of the refrigerator for 30 minutes to reach room temperature (not exceeding 25 °C), or
- hold it gently in your hand for a few minutes. Do not heat Lonquex in any other way (for example, do not heat it in a microwave or in hot water).
Do not remove the needle cap from the syringe until you are ready to inject.
Choose a comfortable, well-lit place. Prepare all necessary items within easy reach (the pre-filled syringe of Lonquex, an alcohol swab, a piece of gauze dressing or sterile gauze pad, and the non-puncture-resistant container).
Wash your hands thoroughly.

A hand holding a syringe with liquid inside

1
Injection sites
The most suitable injection sites are:

the upper thigh,
the abdomen (see grey areas in Figure 2), except the area around the navel.

Schematic drawing of a human body showing gray areas on

2
If another person is administering the injection, or if you are injecting your child, the following sites may also be used:

the upper and outer part of the arm (see grey areas in Figures 3 and 4).

Schematic drawing of a person's back with gray areas highlighted on the upper part of both arms

3 4
How to prepare for the injection
Before injecting Lonquex into yourself or your child, perform the following steps:

Disinfect the skin at the injection site with an alcohol swab.
Pick up the syringe and gently remove the needle cap without twisting it. Pull horizontally as shown in Figures 5 and 6. Do not touch the needle and do not push the plunger.

Two hands holding a syringe horizontally with black arrows indicating a sliding motion to the right and left

Two hands preparing a syringe with a vial and a close-up of the syringe showing graduated scale markings

5 6

You may notice small air bubbles in the pre-filled syringe. If so, hold the syringe with the needle pointing upwards (see Figure 7), and gently tap the syringe with your finger to allow the air bubbles to rise to the top. With the syringe pointing upwards, slowly push the plunger upwards to expel all air from the syringe.

The pre-filled syringe is now ready for use.

How to perform self-injection or injection into the child

Pinch a fold of disinfected skin between your thumb and index finger, without squeezing tightly (see Figure 8).
Insert the needle fully into the skin, as shown by your doctor or nurse. The angle between the syringe and the skin should not be too narrow (at least 45°, see Figure 9).
While keeping the skin fold pinched, inject the liquid slowly and steadily.
After injecting the liquid, withdraw the needle and release the skin.
Press the injection site with a piece of gauze dressing or sterile gauze pad for several seconds.
Each syringe is intended for single use only. Do not use any remaining Lonquex left in the syringe.

A hand holding a syringe to inject medication into the body at an angle of inclination greater than or equal to 45 degrees

8 9
Remember
For any problems, seek help and advice from your doctor or nurse.
Disposal of used syringes

Do not recap the used needle.
Place used syringes into the non-puncture-resistant container and keep the container out of sight and reach of children.
When the container is full, dispose of the non-puncture-resistant container according to instructions from your doctor, pharmacist, or nurse.
Never throw used syringes into the regular household waste.

Information for self-injection or injection into the child
This section contains information on how to self-inject Lonquex under the skin or inject it into your
child. It is important that you do not attempt to inject the medicine yourself or into your
child before being specifically trained by your doctor or nurse. If you have any doubts or
questions about self-injection, consult your doctor or nurse.
How to use Lonquex
You must administer the injection into the tissue directly beneath the skin. This technique is called
subcutaneous injection.
Materials needed
To administer an injection into the tissue beneath the skin, you will need:

one pre-filled syringe of Lonquex,
an alcohol swab,
a piece of gauze dressing or sterile gauze pad.

What to do before administering the injection

Remove the medicine from the refrigerator.
Open the blister pack and remove the pre-filled syringe (see Figure 1). Do not handle the pre-filled syringe at the plunger or needle cap. Otherwise, you may damage the safety device.
Check the expiry date printed on the label of the pre-filled syringe (Exp.). Do not use after the last day of the month indicated.
Check the appearance of Lonquex. It should be a clear, colourless liquid. Do not use if it is cloudy or contains particles.
Do not shake Lonquex vigorously, as this may impair its activity.
For greater comfort:
- leave the pre-filled syringe out of the refrigerator for 30 minutes to reach room temperature (not exceeding 25 °C), or
- hold it gently in your hand for a few minutes. Do not heat Lonquex in any other way (for example, do not heat it in a microwave or in hot water).
Do not remove the needle cap from the syringe until you are ready to inject.
Choose a comfortable, well-lit place. Prepare all necessary items within easy reach (the pre-filled syringe of Lonquex, an alcohol swab, and a piece of gauze dressing or sterile gauze pad).
Wash your hands thoroughly.

Technical drawing of a hand inserting a syringe into a plastic container with two black arrows indicating the insertion movement

1
Injection sites
The most suitable injection sites are:

the upper thigh,
the abdomen (see grey areas in Figure 2), except the area around the navel.

Schematic drawing of a human body with gray areas highlighted on

2
If another person is administering the injection, or if you are injecting your child, the following sites may also be used:

the upper and outer part of the arm (see grey areas in Figures 3 and 4).

Schematic drawing of a man's back with gray areas highlighted on the upper part of both arms

3 4
How to prepare for the injection
Before injecting Lonquex into yourself or your child, perform the following steps:

Disinfect the skin at the injection site with an alcohol swab.
Pick up the syringe and gently remove the needle cap without twisting it. Pull horizontally as shown in Figures 5 and 6. Do not touch the needle and do not push the plunger.

Two hands gripping a syringe and separating it laterally to the left as indicated by a horizontal black arrow

Two hands attaching a needle to a loaded syringe and one hand holding the syringe vertically with the

5 6

You may notice small air bubbles in the pre-filled syringe. If so, hold the syringe with the needle pointing upwards (see Figure 7), and gently tap the syringe with your finger to allow the air bubbles to rise to the top. With the syringe pointing upwards, slowly push the plunger upwards to expel all air from the syringe.

The pre-filled syringe is now ready for use.

How to perform self-injection or injection into the child

Pinch a fold of disinfected skin between your thumb and index finger, without squeezing tightly (see Figure 8).
Insert the needle fully into the skin, as shown by your doctor or nurse. The angle between the syringe and the skin should not be too narrow (at least 45°, see Figure 9).
While keeping the skin fold pinched, inject the liquid slowly and steadily (see Figure 10).
Push the plunger all the way to inject the entire liquid. While keeping the plunger pressed, withdraw the needle from the skin (see Figure 11). Then release the plunger. The safety device will activate immediately. The entire needle and syringe will automatically retract and be covered, thus preventing accidental needlestick injury (see Figure 12).
Press the injection site with a piece of gauze dressing or sterile gauze pad for several seconds.
Each pre-filled syringe is for single use only.

Line drawing showing a hand pressing with the thumb on the top of the

A hand holding a tilted syringe and inserting the

9 10
11 12
Remember
For any problems, seek help and advice from your doctor or nurse.
If you use more Lonquex than you should
If you use more Lonquex than recommended, contact your doctor.
If you forget to use Lonquex
If you have missed an injection, consult your doctor to determine when you should administer the next dose.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

More serious side effects

Allergic reactions such as skin rash, skin swelling with itching, and severe allergic reactions with weakness, low blood pressure, breathing difficulties, and facial swelling have been observed uncommonly (may affect up to 1 in 100 people). If you think you are having such a reaction, you must stop the Lonquex injection and contact your doctor immediately.
An increase in spleen size has been observed uncommonly, and cases of spleen rupture have been reported with medicines similar to Lonquex. Some cases of spleen rupture have been fatal. It is important to contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder, as this may be a sign of spleen problems.
Cough, fever, and difficulty breathing or pain when breathing may be signs of uncommon but serious lung-related side effects such as pneumonia and acute respiratory distress syndrome, which can be fatal. If you have a fever or any of these symptoms, it is important to contact your doctor immediately.
It is important to contact your doctor immediately if you experience any of the following symptoms: swelling or puffiness, which may be associated with reduced frequency of urination, difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling of fatigue. These symptoms usually develop rapidly. They may be signs of a condition reported with unknown frequency (frequency cannot be determined from available data), called "capillary leak syndrome", which causes fluid leakage from small blood vessels into body tissues and requires urgent medical treatment.

Other side effects

Very common (may affect more than 1 in 10 people)

Musculoskeletal pain such as bone pain, and pain in joints, muscles, limbs, chest, neck, or back. Inform your doctor if you develop severe musculoskeletal pain.
Nausea.

Common (may affect up to 1 in 10 people)

Decrease in the number of platelets in the blood, increasing the risk of bleeding or bruising.
Headache.
Skin reactions such as redness or rash.
Low levels of potassium in the blood, which may cause muscle weakness, muscle cramps, or irregular heart rhythms.
Chest pain.
Coughing up blood.

Uncommon (may affect up to 1 in 100 people)

Increase in white blood cells in the blood.
Local reactions at the injection site, such as pain or hardening.
Some blood changes may occur, detectable through routine blood tests.
Bleeding from the lungs.

Not known (frequency cannot be determined from available data)

Inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body); see section 2.

Side effects observed with similar medicines, but not yet with Lonquex

Sickle cell crises in patients with sickle cell anaemia.
Painful, raised, purplish lesions on the limbs and sometimes on the face and neck, accompanied by fever (Sweet's syndrome).
Inflammation of blood vessels in the skin.
Damage to the tiny filters within the kidneys (glomerulonephritis; see section 2 under "Warnings and precautions").

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lonquex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of 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 freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Lonquex may be removed from the refrigerator and stored at a temperature below 25 °C for a single period not exceeding 7 days. Once removed from the refrigerator, the medicine must be used within this time period, otherwise it must be discarded.
Do not use this medicine if it appears cloudy or contains particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lonquex contains

The active substance is lipegfilgrastim. Each pre-filled syringe contains 6 mg of lipegfilgrastim. Each mL of solution contains 10 mg of lipegfilgrastim.
The other ingredients (excipients) are glacial acetic acid, sodium hydroxide (see section 2 “Lonquex contains sodium”), sorbitol (E420) (see section 2 “Lonquex contains sorbitol”), polysorbate 20 and water for injections.

Description of the appearance of Lonquex and contents of the pack
Lonquex is an injectable solution (injection preparation) in a pre-filled syringe with a fixed injection needle in a blister. Lonquex is a clear, colourless solution. Do not use if it is cloudy or contains particles.
Each pre-filled syringe contains 0.6 mL of solution.
Lonquex is available in packs containing 1 or 4 pre-filled syringes with safety device, or 1 pre-filled syringe without safety device.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
Merckle GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany

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

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Alvogen ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5222900 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu.

Patient Information Leaflet

Lonquex 6 mg/0.6 mL solution for injection

lipegfilgrastim
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Lonquex is and what it is used for
What you need to know before being given Lonquex
How Lonquex is administered
Possible side effects
How to store Lonquex
Contents of the pack and other information

1. What is Lonquex and what is it used for

What is Lonquex
Lonquex contains the active substance lipegfilgrastim. Lipegfilgrastim is a long-acting modified protein,
produced using biotechnology in bacteria called Escherichia coli. It belongs to a group of proteins known
as cytokines and is similar to a natural protein (granulocyte colony-stimulating factor [G-CSF]) produced by
the human body.
What Lonquex is used for
Lonquex is used in adults and children aged 2 years and older.
Your doctor has prescribed Lonquex for you or your child to reduce the duration of a condition called
neutropenia (low white blood cell count in the blood) and to prevent the occurrence of febrile neutropenia
(low white blood cell count with fever). These conditions may occur as a result of cytotoxic chemotherapy
(medicines that destroy rapidly growing cells).
How Lonquex works
Lipegfilgrastim stimulates the bone marrow (the tissue where new blood cells are produced) to produce a
greater number of white blood cells. White blood cells are important because they help the body fight
infections. These cells are highly sensitive to the effects of chemotherapy, which can reduce the number
of these cells in the body. If white blood cells drop to a low level, there may not be enough cells to fight
bacteria, and you may become more susceptible to infections.

2. What you need to know before Lonquex is administered to you

Do not use Lonquex

if you or your child are allergic to lipegfilgrastim or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Lonquex:

if you or your child experience pain in the upper left part of the abdomen or at the tip of the shoulder. This could be due to a problem affecting the spleen (see section 4, “Possible side effects”).
if you or your child have cough, fever, and difficulty breathing. This could be due to a problem affecting the lungs (see section 4, “Possible side effects”).
if you or your child have sickle cell disease, an inherited condition characterized by sickle-shaped red blood cells.
if you or your child have previously had allergic reactions to other medicines similar to this one (e.g. filgrastim, lenograstim or pegfilgrastim from the G-CSF group). There may be a risk that you also react to Lonquex.

Your doctor will regularly perform certain blood tests to monitor the different blood components and their levels. Your doctor will also regularly check your urine or your child’s urine, as other medicines similar to this one (e.g. other granulocyte colony-stimulating factors such as filgrastim, lenograstim or pegfilgrastim) may damage the tiny filters inside the kidneys (glomerulonephritis; see section 4, “Possible side effects”).
Inform your doctor if you or your child are being treated for breast cancer or lung cancer in association with chemotherapy and/or radiotherapy and experience symptoms such as fatigue, fever, and easy bruising or bleeding. These symptoms may be due to a pre-cancerous blood condition called myelodysplastic syndrome (MDS) or a blood tumor called acute myeloid leukemia (AML), which have been reported with another medicine similar to this (pegfilgrastim from the G-CSF group).
Rare cases of inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body) have been reported with other medicines similar to this one (e.g. filgrastim, lenograstim or pegfilgrastim from the G-CSF group). Symptoms may include fever, abdominal pain, malaise, back pain, and increased markers of inflammation. Inform your doctor if such symptoms occur.

Children and adolescents
Lonquex is not recommended for children under 2 years of age.

Other medicines and Lonquex
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Lonquex has not been studied in pregnant women. It is important to inform your doctor if you are pregnant, suspect you may be pregnant, or are planning to become pregnant, as your doctor may decide that you should not use this medicine.
It is not known whether the active substance of this medicine passes into breast milk. You should therefore interrupt breastfeeding during treatment.

Driving and using machines
Lonquex does not affect or has a negligible effect on the ability to drive vehicles and use machinery.

Lonquex contains sorbitol
This medicine contains 30 mg of sorbitol per vial.

Lonquex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. is essentially “sodium-free”.

3. How Lonquex is administered

Lonquex is generally administered by a doctor or nurse. The injection is given
into the tissue directly beneath the skin (subcutaneous injection).
Recommended dose
The recommended dose for adults is 6 mg (one vial of 0.6 mL) once per chemotherapy cycle.
The recommended dose for children and adolescents is based on their body weight:

Body weight (kg)	Dose (once per chemotherapy cycle)
<10	0.6 mg (0.06 mL)
from ≥10 to >20	1.5 mg (0.15 mL)
from ≥20 to <30	2.5 mg (0.25 mL)
from ≥30 to <45	4.0 mg (0.40 mL)
≥45	6.0 mg (0.60 mL)

Lonquex is also available as a 6 mg pre-filled syringe for adults and children weighing 45 kg and above.
When Lonquex is administered
The dose of Lonquex is generally injected approximately 24 hours after the last dose of chemotherapy, at the end of each chemotherapy cycle.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

More serious side effects

Allergic reactions such as skin rash, skin swelling with itching, and severe allergic reactions with weakness, low blood pressure, breathing difficulties, and facial swelling have been observed uncommonly (may affect up to 1 in 100 people). If you think you are experiencing such a reaction, you must stop the Lonquex injection and contact your doctor immediately.
An increase in spleen size has been observed uncommonly, and cases of spleen rupture have been reported with medicines similar to Lonquex. Some cases of spleen rupture have been fatal. It is important to contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder, as this may be a sign of spleen problems.
Cough, fever, and difficulty breathing or pain when breathing may be signs of uncommon but serious lung-related side effects, such as pneumonia and acute respiratory distress syndrome, which can be fatal. If you have a fever or any of these symptoms, it is important to contact your doctor immediately.
It is important to contact your doctor immediately if you experience any of the following symptoms: swelling or puffiness, which may be associated with less frequent urination, difficulty breathing, abdominal swelling, a feeling of fullness, and a general feeling of fatigue. These symptoms usually develop rapidly. They may be signs of a condition reported with unknown frequency (frequency cannot be determined from available data), called "capillary leak syndrome", which causes blood to leak from small blood vessels into the body and requires urgent medical treatment.

Other side effects

Very common (may affect more than 1 in 10 people)

Musculoskeletal pain such as bone pain, and pain in the joints, muscles, limbs, chest, neck, or back. Inform your doctor if you develop severe musculoskeletal pain.
Nausea.

Common (may affect up to 1 in 10 people)

Decrease in the number of platelets in the blood, increasing the risk of bleeding or bruising.
Headache.
Skin reactions such as redness or rash.
Low levels of potassium in the blood, which may cause muscle weakness, muscle cramps, or irregular heart rhythm.
Chest pain.
Coughing up blood.

Uncommon (may affect up to 1 in 100 people)

Increase in white blood cells in the blood.
Local reactions at the injection site, such as pain or hardening.
Some blood changes may occur, which can be detected by routine blood tests.
Bleeding from the lungs.

Not known (frequency cannot be determined from available data)

Inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), see section 2.

Side effects observed with similar medicines, but not yet with Lonquex

Sickle cell crises in patients with sickle cell anaemia.
Painful, raised, purple-coloured skin lesions on the limbs and sometimes on the face and neck, accompanied by fever (Sweet's syndrome).
Inflammation of blood vessels in the skin.
Damage to the tiny filters in the kidneys (glomerulonephritis; see section 2 under "Warnings and precautions").

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lonquex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
vial after Exp. The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C – 8 °C).
Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Lonquex may be removed from the refrigerator and stored at a temperature below 25 °C for a
single period not exceeding 7 days. Once removed from the refrigerator, the medicine must be
used within this time period or discarded.
This medicine must not be used if it is cloudy or contains particles.

6. Package contents and other information

What Lonquex contains

The active substance is lipegfilgrastim. Each mL of solution contains 10 mg of lipegfilgrastim. Each 0.6 mL vial contains 6 mg of lipegfilgrastim.
The other components (excipients) are glacial acetic acid, sodium hydroxide (see section 2 “Lonquex contains sodium”), sorbitol (E420) (see section 2 “Lonquex contains sorbitol”), polysorbate 20, and water for injections.

Description of the appearance of Lonquex and contents of the pack
Lonquex is an injectable solution (injectable preparation) supplied in a glass vial as a clear, colourless solution.
Lonquex is available in packs containing 1 or 6 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
Merckle GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: