6 mg solution for injection in a pre-filled syringe
pegfilgrastim
What Lonquex is and what it is used for
What Lonquex is
Lonquex contains the active substance pegfilgrastim. Lipegfilgrastim is a long-acting modified protein produced by biotechnology in the bacterium Escherichia coli. It belongs to a group of proteins called cytokines and is similar to a natural protein (granulocyte colony-stimulating factor [G- CSF ] that is formed in your own body.
What Lonquex is used for
Your doctor has prescribed Lonquex to shorten the duration of neutropenia (low white blood cell count ) and the occurrence of febrile neutropenia (low white blood cell count and fever). These conditions can be caused by the use of cytotoxic chemotherapy (drugs that destroy fast-growing cells).
How Lonquex works
Lipegfilgrastim stimulates bone marrow (where new blood cells are formed) to form more white blood cells. The white blood cells are important because they help the body fight infection. These blood cells are very sensitive to chemotherapy, and such treatment can lead to a decrease in the number of white blood cells. If the number of white blood cells drops to a low level, there may not be enough left to fight bacteria, and then you may be more susceptible to infection.
What you need to know before using Lonquex
Do not use Lonquex:
- if you are allergic to lipegfilgrastim or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse BEFORE you use Lonquex
- if you get pain in the upper left side of the abdomen or up against the left shoulder. This may indicate a problem with the spleen (see section 4, “Possible side effects”).
- if you have a cough, fever and difficulty breathing. It may indicate lung problems (see section 4, “Possible side effects”).
- if you have sickle cell anemia , a hereditary disease characterized by the fact that the shape of the red blood cells can change so that they resemble a sickle (English ‘sickle’).
- if you have previously had allergic reactions to other similar medicines (eg filgrastim, lenograstim or pegfilgrastim in the G-CSF group of medicines). There may be a risk that you will also react to Lonquex.
Your doctor will take regular blood tests to check different blood components and their levels. Your doctor will also regularly check your urine, like other drugs like this (eg other granulocyte colony-stimulating factors such as filgrastim, lenograstim, or pegfilgrastim) may damage the very small filters in the kidneys (glomerulonephritis; see section 4, “Possible side effects” “).
Inflammation of the aorta (the large blood vessel that carries blood from the heart to the body) has in rare cases been reported with other drugs similar to this (eg filgrastim, lenograstim, or pegfilgrastim in the group G‑ CSF ‑drugs). Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Tell your doctor if you experience these symptoms.
Children and young people
This medicine should not be given to children or adolescents under 18 years of age as there is only limited experience in children to demonstrate that the medicine is safe and effective in this age group.
Other medicines and Lonquex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You usually inject your dose of Lonquex approximately 24 hours after your last chemotherapy dose at the end of each chemotherapy cycle (cycle of treatment).
Pregnancy and breastfeeding
Lonquex has not been studied 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 your doctor may decide not to use this medicine.
It is unknown whether the active substance in this medicine passes into breast milk. You should therefore stop breastfeeding during treatment.
Driving and using machines
Lonquex has no or negligible effect on the ability to drive and use machines.
Lonquex contains sorbitol and sodium
This medicine contains 30 mg of sorbitol per pre-filled syringe.
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, ie essentially ‘sodium-free’.
How to use Lonquex
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
The recommended dose is one pre-filled syringe (6 mg pegfilgrastim) once per cycle of chemotherapy.
When to use Lonquex
This medicine should be given approximately 24 hours after the last dose of chemotherapy at the end of each chemotherapy cycle.
How are the injections given?
This medicine is given as an injection using a pre-filled syringe. An injection is given into the tissue located just under the skin ( subcutaneous injection ).
Your doctor may suggest that you learn how to inject yourself with this medicine. Your doctor or nurse will show you how to do this. Do not try to inject Lonquex yourself until you have received these instructions. Information required to use the pre-filled syringe can be found under the heading “Instructions on how to inject yourself”. Appropriate treatment of your disease requires close and constant cooperation with your doctor.
Information on how to inject yourself
This section contains information on how to give yourself an injection of Lonquex under the skin. You mustn’t try to give yourself an injection unless you have received special training from a doctor or nurse. If you are not sure how to inject one or if you have any questions, ask your doctor or nurse for help.
How to use Lonquex
You must give yourself an injection into the tissue under the skin. It is called a subcutaneous injection.
Equipment you need
To give yourself a subcutaneous injection you need:
- a pre-filled syringe with Lonquex.
- a booze
- a piece of gauze or sterile compress .
What to do before injecting yourself
- Take the medicine out of the refrigerator.
- Open the blister and remove the pre-filled syringe (see picture 1). Do not take the pre-filled syringe in the plunger or needle cover. This can damage the safety mechanism.
- Check the expiration date on the pre-filled syringe label (Exp. Date). Do not use it if the date has passed the last day of the specified month.
- Check the appearance of Lonquex. It must be a clear and colorless liquid. If the liquid is discolored, cloudy or contains particles, do not use it.
- Do not shake Lonquex vigorously as this may affect its effect.
- To make injection more comfortable, leave the pre-filled syringe for 30 minutes at room temperature (not above 25 ° C) or hold the pre-filled syringe gently in your hand for a few minutes. Heat not Lonquex in any other way (for example, do not be heated in a microwave or in hot water).
- Do not remove the needle cover from the syringe until you are ready to inject.
- Find a comfortable, well-lit place. Put everything you need within reach (the pre-filled syringe with Lonquex, an alcohol swab and a piece of gauze or sterile compress ).
- Wash your hands thoroughly.
How to prepare an injection
Before giving yourself an injection of Lonquex, you must do the following:
- Hold the syringe and carefully remove the cover from the needle without twisting it. Pull straight out as shown in Figures 2 and 3. Do not touch the needle or push the plunger.
- You may see small air bubbles in the pre-filled syringe. If there are air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the tip of the syringe. Hold the syringe so that the needle points upwards and push all the air out of the syringe by pushing the plunger slowly upwards.
- You can now use the pre-filled syringe.
Where to give your injection
The most suitable place to inject yourself is:
- at the top of the thigh
- abdomen (gray areas in Figure 4), except the area around the navel.
If someone else is injecting, he or she can also use the back of your arms (see gray areas in pictures 5 and 6).
How to inject yourself
- Disinfect the injection site on the skin with an alcohol swab and pinch the skin between the thumb and forefinger without squeezing (see picture 7).
- Insert the needle completely into the skin as instructed by your doctor or nurse. The angle between the syringe and the skin should not be too small (at least 45 °, see figure 8).
- Gently pull on the plunger to make sure you have not punctured a blood vessel. If you see blood in the syringe, pull out the needle and insert it in another place.
- Inject the liquid slowly and evenly without releasing the grip on the skin (see picture 9).
- Push the plunger down as far as it will go and inject all the liquid. While holding the plunger fully depressed, pull the needle out of the skin (see Figure 10). Then release the plunger. The safety mechanism is activated immediately. The entire needle and syringe are automatically retracted and covered so that you cannot sting (see Fig. 11).
- Press a gauze pad or a sterile compress against the injection site for several seconds.
- Each pre-filled syringe is for single use only.
Remember
If you have problems, do not hesitate to ask your doctor or nurse for help and advice.
If you use more Lonquex than you should
If you have used too much Lonquex, consult a doctor.
If you forget to use Lonquex
If you have missed an injection, contact your doctor to discuss when to inject the next dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
- Allergic reactions such as skin rash, raised itchy skin areas and severe reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported with less frequent frequency (may affect up to 1 in 100 people). If you think you have a reaction of this type, you must stop Lonquex injection and seek medical attention immediately.
- Enlarged spleen has been reported as a less common side effect and cases of splenectomy have been reported with other drugs similar to Lonquex. Some cases where the spleen broke had a fatal outcome. It is important that you contact a doctor immediately if you experience pain in the upper left side of the abdomen or pain in the left shoulder as this may be related to problems with the spleen.
- Cough, fever, difficulty breathing or pain when breathing can be signs of less common cases of severe lung effects, e.g. pneumonia and acute respiratory distress syndrome, which can be fatal. If you have a fever or any of these symptoms, it is important that you contact your doctor immediately.
- It is important that you contact a doctor immediately if you experience any of the following symptoms: swelling or fluid retention, which may be associated with urinating less frequently than usual, difficulty breathing, swollen abdomen and a feeling of satiety, and a general feeling of tiredness. These symptoms often develop at a rapid rate.These can be symptoms of a condition that is reported with no known frequency (can not be calculated from the available data) and is called “capillary leakage syndrome” and which causes blood to leak from small blood vessels into the body. This condition must be treated immediately.
Other side effects are
Very common (may affect more than 1 in 10 people)
- Musculoskeletal pain such as skeletal pain and pain in joints, muscles, arms or legs, chest, neck or back. 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 e.g. redness or rash.
- Low levels of potassium in the blood, which can cause muscle weakness, muscle twitching or disturbed heart rhythm.
- Chest pain.
- Bloody vomiting.
Uncommon (may affect up to 1 in 100 people)
- Increased white blood cell count .
- Local reactions at the injection site, e.g. pain or hardening.
- Some changes may occur in the blood but these are detected during routine blood tests.
- Bleeding from the lungs.
No known frequency (can not be calculated from the available data)
- Inflammation of the aorta (the large blood vessel that carries blood from the heart to the body), see section 2.
Side effects have been seen with similar drugs but not yet with Lonquex
- Sickle cell crisis in patients with sickle cell anemia .
- Plum-colored raised painful changes on arms and legs, sometimes face and neck, along with fever (Sweet’s syndrome).
- Inflammation of the blood vessels of the skin.
- Damage to the very small filters in the kidneys (glomerulonephritis; see “Warnings and Precautions” in section 2).
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 the pre-filled syringe label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C-8 ° C).
Do not freeze.
Store the pre-filled syringe in the outer carton. Sensitive to light.
Lonquex can be taken out of the refrigerator and stored at room temperature (maximum 25 ° C) for a maximum of 3 days. Once the medicine has been taken out of the refrigerator, it must be used within this period or discarded.
Do not use this medicine if it is cloudy or contains particles.
Medicines should not be disposed of via wastewater or household waste. Discard this medicine according to the instructions of a doctor, pharmacist, or nurse.
Contents of the pack and other information
Content declaration
- The active substance is lipegfilgrastim. Each pre-filled syringe contains 6 mg of lipegfilgrastim. 1 ml corresponds to 10 mg lipegfilgrastim.
- The other ingredients (excipients) are acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.
What the medicine looks like and contents of the pack
Lonquex is a solution for injection in a pre-filled syringe with a needle attached to a blister. Lonquex is a clear and colorless solution. Each pre-filled syringe contains 0.6 ml of solution.
Each pack contains 1 pre-filled syringe, with or without a safety mechanism.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva BV
Swensweg 5
2031 GA Haarlem
Netherlands
Manufacturer
Teva Biotech GmbH
Dornierstraße 10
89079 Ulm
Germany
Teva Pharmaceuticals Europe BV
Swensweg 5
2031 GA Haarlem
Netherlands
Merckle GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 3 820 73 73 | LithuaniaUAB “Sicor Biotech”Tel: +370 5 266 0203 |
| BulgariaOctavis FADTel: +359 2 489 95 85 | Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AG, Belgium / BelgiumTel: +32 3 820 73 73 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 | HungaryTeva Gyógyszergyár Zrt.Tel .: +36 1 288 64 00 |
| DenmarkTeva Denmark A / STel: +45 44 98 55 11 | MaltaTeva Pharmaceuticals Ireland, L-IrelandTel: +353 51 321740 |
| GermanyTEVA GmbHTel: +49 731 402 08 | The NetherlandsTeva Nederland BVTel: +31 800 0228 400 |
| EestiUAB “Sicor Biotech” Eesti subsidiaryTel: +372 661 0801 | NorwayTeva Norway ASTel: +47 66 77 55 90 |
| GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 211 880 5000 | Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1 97 007 |
| SpainTeva Pharma, SLUTel: +34 91 387 32 80 | PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 22 345 93 00 |
| FranceTeva HealthTel: +33 1 55 91 78 00 | PortugalTeva Pharma – Pharmaceutical Products, LdaTel: +351 21 476 75 50 |
| CroatiaPliva Hrvatska dooTel: +385 1 37 20 000 | RomaniaTeva Pharmaceuticals SRLTel: +40 21 230 65 24 |
| IrelandTeva Pharmaceuticals IrelandTel: +353 51 321740 | SloveniaPliva Ljubljana dooTel: +386 1 58 90 390 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 2 57 26 79 11 |
| ItalyTeva Italia SrlTel: +39 02 89 17 98 1 | Finland / FinlandTeva FinlandPuh / Tel: +358 20 180 5900 |
| .ΠροςTeva Αλλάς Α.Ε., .λλάδα:Ηλ: +30 211 880 5000 | SwedenTeva Sweden ABTel: +46 42 12 11 00 |
| LatviaUAB Sicor Biotech subsidiary LatvijāTel: +371 673 23 666 | United KingdomTeva UK LimitedTel: +44 1977 628500 |