LONQUEX 6 mg/0.6 mL Injectable Solution

2. What you need to know before you receive Lonquex

Do not use Lonquex:

• if you or your child is 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 starting Lonquex.

• if you or your child notices pain in the upper left side of the abdomen or in the tip 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 anaemia or other conditions where the red blood cells are abnormal.
• if you or your child has previously experienced allergic reactions to other medicines similar to this one (e.g. filgrastim, lenograstim or pegfilgrastim from the G-CSF group). You may also be at risk of a reaction to Lonquex.

Your doctor will perform regular blood tests to monitor various components of your blood and their concentrations. Your doctor will also periodically 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 small filters in 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 medicines like this one (e.g. filgrastim, lenograstim or pegfilgrastim from the G-CSF group). Symptoms may include fever, abdominal pain, general malaise, back pain, and increased inflammatory markers. Tell your doctor if you experience these symptoms.

Children and adolescents

4. Possible side effects

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

More serious side effects

• Rarely (may affect up to 1 in 100 people), allergic reactions such as skin rash, raised and itchy patches on the skin, and severe allergic reactions with weakness, low blood pressure, difficulty breathing, and swelling of the face have been reported. If you think you are experiencing this type of reaction, you must stop the injection of Lonquex and seek medical help immediately.
• Rarely, cases of enlarged spleen and spleen rupture have been reported with other medicines similar to Lonquex. Some cases of spleen rupture were fatal. It is important that you contact your doctor immediately if you notice pain in the upper left side of the abdomen or in the left shoulder, as these symptoms may be related to a problem with the spleen.
• Cough, fever, and difficulty or pain when breathing may be signs of serious lung 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 important that you contact your doctor immediately.
• Contact your doctor immediately if you experience any of the following symptoms: swelling that may be associated with urinating less often, difficulty breathing, swelling, and feeling of fullness in the abdomen, and a general feeling of tiredness. These symptoms usually develop very quickly.

These may be symptoms of a condition called “capillary leak syndrome”, which causes blood to leak 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, joint pain, muscle pain, limb pain, chest pain, neck pain, or back pain. Tell your doctor if you experience severe 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 can cause muscle weakness, twitching, or heart rhythm disturbances.
• Chest pain.
• Bloody cough.

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known (cannot be estimated from the available data)

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

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

• Sickle cell crisis in patients with sickle cell anaemia.
• Painful red-purple skin lesions on the limbs, and sometimes on the face and neck, accompanied by fever (Sweet's syndrome).
• Inflammation of the blood vessels in the skin.
• Damage to the small filters in the kidneys (glomerulonephritis; see section 2 under the heading “Warnings and precautions”).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are 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. Storage of 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 packaging and on the label of the vial after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

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