Lonquex (Lipegfilgrastim) Injection

When you must not use it

Do not have Lonquex if you have allergies to:

• Lipegfilgrastim or any other medicines like this one (i.e. filgrastim, lenograstim or pegfilgrastim of the group of G-CSFs).
• certain sugars
• This medicine contains sorbitol.
• This medicine contains less than 1 mmol (23 mg) sodium per prefilled syringe, i.e. essentially 'sodium-free'

Before you start to use it

Tell your doctor if

• 1. you have sickle cell anaemia, which is an inherited disease characterized by sickle-shaped red blood cells.
• 2. you have a cough, fever and difficulty breathing.

It could be a consequence of a pulmonary disorder.

• 3. you have upper abdominal pain or pain at the tip of your shoulder.

It could be a consequence of a spleen disorder.

• 4. you are pregnant or intend to become pregnant.

Lonquex has not been tested in pregnant women. It is important that you 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.

• 5. you are breast-feeding.

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

• 6. If you have not told your doctor about any of these things, tell him/her before you use Lonquex.

How to use it

• Lonquex is given by injection using a prefilled syringe, usually into the tissues just below the skin. This is called a subcutaneous injection and it is a simple procedure.
• 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.
• The recommended dose is one prefilled syringe (6 mg lipegfilgrastim) ONCE PER CHEMOTHERAPY CYCLE. This medicine should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.

While you are using it: Things you must do

• Be alert for any signs or symptoms of infection.
• There are many ways an infection may show itself.

You should watch for:

• fever (a temperature of 38.2°C or greater, or as your doctor suggests)
• chills
• rash
• sore throat
• diarrhea
• ear ache
• difficult or painful breathing, coughing or wheezing.
• Go straight to your hospital if you develop any of these symptoms.

Tell your doctor, nurse and pharmacist that you are using Lonquex if you are about to be started on any new medicine.
Tell any other doctors who treat you that you are taking this medicine.
Tell your doctor immediately if you become pregnant while taking this medicine.
Keep all of your doctor's appointments so that your health can be monitored.

Side Effects

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 and cases of spleen ruptures have been reported with other medicines similar to Lonquex. 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 (may affect up to 1 in 100 people) 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 other medicines similar to Lonquex called "capillary leak syndrome", which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.

Other side effects

Very common:

• Musculoskeletal pains such as bone pain and pain in the joints, muscles, limbs, chest, neck or back. Your doctor will tell you what you can take to ease the bone pain.
• Reduction in blood platelets, which increases risk of bleeding or bruising
• Headache
• Skin reactions, such as redness or rash
• Low blood levels of potassium, which can cause muscle weakness, twitching or abnormal heart rhythm
• Chest pain

If you get any side effects, talk to your doctor, pharmacist or nurse. This also includes any possible side effects not mentioned earlier. Tell your doctor if you notice anything that worries you or that is making you feel unwell.

Storage

• Keep Lonquex in a refrigerator at a temperature of 2°C to 8°C.
• Do not freeze.
• Lonquex may be removed from the refrigerator and stored below 25°C for a maximum single period of up to 3 days. Once removed from the refrigerator, the medicine must be used within this period or disposed of.
• Keep the pre-filled syringe in the outer carton, in order to protect from light.
• Keep Lonquex out of the sight and reach of children.
• Dispose this medicine as instructed by your doctor or pharmacist

Referemces:

https://www.news-medical.net/drugs/Lonquex.aspx

https://www.scottishmedicines.org.uk/medicines-advice/lipegfilgrastim-6mg-solution-for-injection-lonquex-fullsubmission-90813/

https://www.medicines.org.uk/emc/product/5422/smpc

https://www.ema.europa.eu/en/documents/product-information/lonquex-epar-product-information_en.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4730998/

https://www.medicines.org.uk/emc/product/5422/smpc