Product Information for the Patient

Lonquex 6 mg/0.6 ml Injectable Solution

Lipegfilgrastim

Read this entire product information carefully before starting to receive this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

What is Lonquex

Lonquex contains the active ingredient lipegfilgrastim. Lipegfilgrastim is a long-acting modified protein produced through biotechnology in a bacterium calledEscherichia coli.

It belongs to a group of proteins called cytokines and is similar to a natural protein (granulocyte colony-stimulating factor [G-CSF]) produced by your own body.

What is Lonquex used for

Lonquex is used in adults and in children 2 years of age 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) and the occurrence of febrile neutropenia (low white blood cell count accompanied by fever). These problems 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 because they help your body fight infections. These cells are very sensitive to the effects of chemotherapy, which can cause a decrease in their number in the body. If white blood cells fall to a low level, there may not be enough in the body to fight bacteria and you may be at a higher risk of developing infections.

You should not use Lonquex:

• if you or your child is allergic to lipegfilgrastim or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse BEFORE starting to use Lonquex.

• if you or your child experiences pain in the upper left side of the abdomen or at the top of the shoulder. This could be due to a spleen disorder (see section 4 “Possible side effects”).
• if you or your child has a cough, fever, and difficulty breathing. This could be due to a lung disorder (see section 4 “Possible side effects”).
• if you or your child has sickle cell anemia or thalassemia, a hereditary disease characterized by crescent-shaped red blood cells.
• if you or your child has previously experienced allergic reactions to other similar medications (e.g., filgrastim, lenograstim, or pegfilgrastim in the G-CSF group). There may also be a risk of reaction to Lonquex.

Your doctor will perform periodic blood tests to monitor various blood components and their concentrations. Your doctor will also periodically analyze your urine or your child's urine, as other similar medications (e.g., other granulocyte colony-stimulating factors such as filgrastim, lenograstim, or pegfilgrastim) may damage the tiny filters found inside the kidneys (glomerulonephritis; see section 4 “Possible side effects”).

Rarely, inflammation of the aorta (the large blood vessel that carries blood from the heart to the rest of the body) has been reported with other medications like this (e.g., filgrastim, lenograstim, or pegfilgrastim in the G-CSF group). Symptoms may include fever, abdominal pain, general discomfort, back pain, and increased inflammatory markers. Inform your doctor if you experience these symptoms.

Children and adolescents

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

Other medications and Lonquex

Inform your doctor or pharmacist if you or your child is using, has used recently, or may need to use any other medication.

Pregnancy and breastfeeding

Lonquex has not been studied in pregnant women. It is essential to inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, as your doctor may decide that you should not use this medication.

The active ingredient in this medication is unknown to pass into breast milk. Therefore, you should stop breastfeeding during treatment.

Driving and operating machines

The influence of Lonquex on your ability to drive and operate machines is negligible or insignificant.

Lonquex contains sorbitol

This medication contains 30 mg of sorbitol in each vial.

Lonquex contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial; essentially “sodium-free”.

Lonquex is usually administered by a doctor or nurse. The injection is administered into the tissue that is located just below the skin (subcutaneous injection).

What is the recommended dose

The recommended dose in adults is 6 mg (one vial of 0.6 ml) once per chemotherapy cycle.

The recommended dose in children and adolescents is based on their body weight:

Lonquex is also available in the form of a pre-filled syringe of 6 mg for adults and for any child weighing 45 kg or more.

When will you administer Lonquex

The dose of Lonquex will usually be injected approximately 24 hours after the last dose of chemotherapy, at the end of each chemotherapy cycle.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

More serious side effects

• Severe allergic reactions, such as skin rash, raised and itchy areas on the skin, and severe allergic reactions with weakness, low blood pressure, difficulty breathing, and facial swelling, have been reported infrequently (may affect up to 1 in 100 people). If you think you are experiencing this type of reaction, stop the Lonquex injection and seek immediate medical assistance.
• Infrequent cases of spleen enlargement and cases of spleen rupture with other similar medications to Lonquex have been reported. Some cases of spleen rupture were fatal. It is essential to contact your doctor immediately if you noticeleft upper abdominal or left shoulder pain, as these symptoms may be related to a spleen problem.
• Cough, fever, and difficulty or pain when breathing may be signs of rare but serious pulmonary side effects, such as pneumonia and acute respiratory distress syndrome, which can be fatal. If you experience fever or any of these symptoms, it is essential to contact your doctor immediately.
• Contact your doctor immediately if you experience any of the following symptoms: swelling that may be associated with decreased urination frequency, difficulty breathing, abdominal swelling and fullness, and a general feeling of fatigue. These symptoms usually develop very quickly.

These may be symptoms of a frequently observed but unknown disease (cannot be estimated from available data) called "capillary leak syndrome," which causes blood to escape from small blood vessels in your body and requires urgent medical attention.

Other side effects

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

• Musculoskeletal pain, such as bone pain and joint pain, muscle pain, limb pain, chest pain, neck pain, or back pain. Inform your doctor if you experience intense musculoskeletal pain.
• Nausea.

Common(may affect up to 1 in 10 people)

• Decreased platelet count, which increases the risk of bleeding or bruising.
• Headache.
• Skin reactions, such as redness or rash.
• Low potassium levels in the blood, which may cause muscle weakness, muscle twitching, or cardiac arrhythmias.
• Chest pain.
• Coughing up blood.

Rare(may affect up to 1 in 100 people)

• Increased white blood cell count.
• Local reactions at the injection site, such as pain or hardness.
• Some changes in the blood may occur, but will be detected in routine blood tests.
• Pulmonary hemorrhage.

Unknown frequency(frequency cannot be estimated from available data)

• Aortic inflammation (the large blood vessel that carries blood from the heart to the rest of the body), see section 2.

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

• Crises of sickle cells in patients with sickle cell anemia.
• Urgent, painful, and purple-colored lesions on the limbs, and sometimes on the face and neck, accompanied by fever (Sweet syndrome).
• Inflammation of the blood vessels in the skin.
• Damage to the small filters found inside the kidneys (glomerulonephritis; see section 2 under the heading "Warnings and precautions").

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the outer packaging and on the vial label after EXP. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C).

Do not freeze.

Store the vial in the outer packaging to protect it from light.

Lonquex can be removed from the refrigerator and stored at a temperature below 25 °C for a maximum period of up to 7 days. Once removed from the refrigerator, the medication must be used within this period or discarded.

This medication should not be used if it is cloudy or contains particles.

Composition of Lonquex

• The active principle is lipegfilgrastim. Each ml of solution contains 10 mg of lipegfilgrastim. Each vial of 0.6 ml contains 6 mg of lipegfilgrastim.
• The other components (excipients) are glacial acetic acid, sodium hydroxide, sorbitol (E420), polisorbate 20 and water for injectable preparations.

Appearance of the product and contents of the package

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

Teva Biotech GmbH

Dornierstraße 10

89079 Ulm

Germany

Merckle GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet: {month YYYY}

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

This information is intended solely for medical or healthcare professionals:

Storage and inspection

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store the vial in the outer packaging to protect it from light.

Allow the solution to reach a comfortable temperature (15°C – 25°C) for injection.

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

The solution should be visually inspected before use. Only solutions that are transparent and colorless without particles should be used.

Avoid vigorous agitation. Excessive agitation can cause the lipegfilgrastim to aggregate, making it biologically inactive.

Administration form

The recommended dose should be injected subcutaneously (SC) using an appropriate syringe with the correct graduation for the prescribed dose.

The injection should be administered in the abdomen, upper arm or thigh.

Lonquex should not be mixed with any other medication.

Proper disposal procedure

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.