InfoCons Consumer Protection informs you – Lonquex – Package Leaflet

Before anything else

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.

ℹ️ 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 called cytokines and is similar to a n atural protein (granulocyte -colony stimulating factor [G -CSF]) produced by your own body.

What Lonquex is used for

Lonquex is used in adults and in children aged 2 years and older.

Your doctor has prescribed Lonquex for you or for your child in order to reduce the duration of a condition called neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever). These can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly- growing cells).

How Lonquex works

Lipegfilgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells. White blood cells are important as they help your body fight infection. These cells are very sensi tive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level, there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.

⚠️ 2. What you need to know before Lonquex is given

Lonquex must not be used

• if you or your child are allergic to lipegfilgrastim 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 Lonquex:

• if you or your child get left upper abdominal pain or pain at the tip of your shoulder. It could be a consequence of a spleen disorder (see section 4 “Possible side effects”).

43 • if you or your child have a cough, fever and difficulty breathing. It could be a consequence of a pulmonary disorder (see section 4 “Possible side effects”).

• if you or your child have sickle cell anaemia, which is an inherited disease characterised by sickle- shaped r ed blood cells.
• if you or your child have previously experienced allergic reactions to other medicines like this one (e.g. filgrastim, lenograstim or pegfilgrastim of the group of G -CSFs). There could be a risk of reacting to Lonquex too.

Your doctor wi ll carry out regular blood tests in order to monitor various blood components and their levels. Your doctor will also check your or your child`s urine regularly as other medicines similar to this one (e.g. other granulocyte colony stimulating factors such as filgrastim, lenograstim or pegfilgrastim) can possibly harm the tiny filters inside your kidneys (glomerulonephritis; see section 4 “Possible side effects”).

Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely with other medicines like this one (e.g. filgrastim, lenograstim or pegfilgrastim of the group of G -CSFs). The s ymptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor if you experience these symptoms.

Children and adolescents

Lonquex is not recommended for children younger than 2 years of age .

Other medic ines and Lonquex Tell your doctor or pharmacist if you or your child are using , have recently used or might use any other medicines.

Pregnancy and breast -feeding Lonquex has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as the doctor may decide that you should not use this medicine.

It is unknown whether the active substance in this medicine passes into the breast milk. You should therefore interrupt breast -feeding during treatment.

Driving and using machines

Lonquex has no or negligible influence on your ability to drive and use machines.

Lonquex contains sorbitol

This medicine contains 30 mg sorbitol in each vial .

Lonquex contains sodium

This med icine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium -free’.

💊 3. How Lonquex is given

Lonquex is normally given by a doctor or a nurse. The injection is given into the tissue just under the skin (subcutaneous injection).

What the recommended dose is The recommended dose for adults is 6 mg (one 0.6 ml vial) once per chemotherapy cycle.

44 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) ≥ 10 to < 20 1.5 mg (0.15 ml) ≥ 20 to < 30 2.5 mg (0.25 ml) ≥ 30 to < 45 4.0 mg (0.4 0 ml) ≥ 45 6.0 mg (0.6 0 ml) Lonquex is also available as a 6 mg pre -filled syringe for adults and any children weighing 45 kg and more .

When will Lonquex be given The Lonquex dose will normally be injected approximately 24 hours after the last dose of chemotherapy at the end of each chemotherapy cycle.

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.

Most serious side effects

• Allergic reactions such as skin rash, raised itchy areas of skin and serious allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported uncommonly (may affect up to 1 in 100 people). If you think you are having this type of reaction, you must stop your Lonquex injection and get medical help immediately.
• Increased spleen size has been reported uncommonly and cases of splenic ruptures have been reported with other medicines si milar to Lonquex. Some cases of splenic rupture were fatal. It is important to contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
• Cough, fever and difficult or painful breathing can be signs of uncommon serious pulmonary side effects, such as pneumonia and acute respiratory distress syndrome, which may 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 have any of the following symptoms: 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 a condition reported with frequency not known (cannot be estimated from the available data), called “capillary leak syndrome”, whi ch causes blood to leak from the small blood vessels into your body and needs urgent medical attention.

Other side effects

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

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

Common ( may affect up to 1 in 10 people )

• Reduction in blood platelets, which increases risk of blee ding or bruising.
• Headache.
• Skin reactions, such as redness or rash.

45 • Low blood levels of potassium, which can cause muscle weakness, twitching or abnormal heart rhythm.

• Chest pain.
• Coughing up blood.

Uncommon ( may affect up to 1 in 100 people )

• Rise in white blood cells.
• Local reactions at the injection site, such as pain or hardening.
• Some changes may occur in your blood, but these will be detected by routine blood tests.
• Bleeding from the lung.

Not known (frequency cannot be estimated from the available data)

• Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.

Side effects that have been seen with similar medicines, but not yet with Lonque x

• Sickle cell crises in patients with sickle cell anaemia.
• Plum -coloured raised painful sores on the limbs and sometimes the face and neck with fever (Sweet’s syndrome).
• Inflammation of the blood vessels in the skin.
• Damage to the tiny filters inside your kidneys (glomerulonephritis; see section 2 under “Warnings and precautions ”).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Lonquex

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 vial label 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 vial in the outer carton, in order to protect from light.

Lonquex may be removed from the refrigerator and stored below 25 °C for a maximum single period of up to 7 days. Once removed from the refrigerator, the medicine must be used within this period or disposed of.

This medicine must not be used if it is cloudy or there are particles in it.

📦 6. Contents of the pack and other information

What Lonquex contains

46 • The active substance is lipegfilgrastim. Each ml of solution contains 10 mg lipegfilgrastim.

Each vial of 0.6 ml contains 6 mg 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.

What Lonquex looks like and co ntents of the pack Lonquex is a solution for injection (injection) supplied in a glass vial as a clear and colourless solution.

Lonquex is availab le 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 Netherlands

Manufacturer

Merckle GmbH, Graf-Arco -Straße 3 89079 Ulm Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: + 32 38207373 Lietuva UAB Teva Baltics Tel: +370 52660203 България Тева Фарма ЕАД Teл: +359 24899585 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tél/Tel: +32 38207373 Česká republika Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.

Tel: +36 12886400 Danmark Teva Denmark A/S Tlf: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: + 44 2075407117 Deutschland TEVA GmbH Tel: +49 73140208 Nederland Teva Nederland B.V.

Tel: +31 8000228400 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 Ελλάδα TEVA HELLAS Α.Ε. Österreich ratiopharm Arzneimittel Vertriebs -GmbH 47 Τηλ: +30 2118805000 Tel: +43 197007 0 España Teva Pharma, S.L.U.

Tel: +34 913873280 Polska Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +48 223459300 France Teva Santé Tél: +33 155917800 Portugal Teva Pharma – Produtos Farmacêuticos, Lda .

Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o.

Tel: + 385 13720000 România Teva Pharmaceuticals S.R.L .

Tel: +40 212306524 Ireland Teva Pharmaceuticals Ireland Tel: + 44 2075407117 Slovenija Pliva Ljubljana d.o.o.

Tel: +386 15890390 Ísland Alvogen ehf. Sími: + 354 5222900 Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911 Italia Teva Italia S.r.l.

Tel: +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 Κύπρος TEVA HELLAS Α.Ε.

Ελλάδα Τηλ: +30 2118805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666 United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 This leaflet was last revised in { month YYYY }.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. ———————————————- —————————————————————————– The following information is intended for medical or healthcare professionals only:

Storage and inspection Store in a refrigerator (2 °C – 8 ° C). Do not freeze. Keep the vial in the outer carton, in order to protect from light.

The solution should be allowed to reach a comfortable temperature (15 °C – 25 °C) before the injection.

Once removed from the refrigerator Lonquex may be stored below 25 °C for a maximum single period of up to 7 days.

48 The solution should be visually inspected before use. Only clear, colourless solutions without particles should be used.

Vigorous shaking should be avoided. Excessive shaking may aggregate lipegfilgrastim, rendering it biologically inact ive.

Method of administration The recommended dose is to be injected subcutaneously (SC) using an appropriate syringe with adequate graduation for the prescribed dose.

The injection should be given into the abdomen, upper arm or thigh.

Lonquex is for s ingle use only. Unused portions of each vial must be discarded properly. Do not save any unused portions for later administration.

Lonquex must not be mixed with other medicinal products.

Procedure for proper disposal Any unused product, any items that come into contact with the product and waste material must be disposed of in accordance with local requirements.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Lonquex (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/13/856).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.