6 mg solution for injection
pegfilgrastim
What Nyvepria is and what it is used for
Nyvepria contains the active substance pegfilgrastim. It is used in patients treated with cytotoxic chemotherapy (drugs that destroy fast-growing cells) to reduce the duration of neutropenia (low neutrophil count, a type of white blood cell ) and to prevent febrile neutropenia (low white blood cell count with concomitant fever). Nyvepria is intended for adults from the age of 18.
The white blood cells are important in fighting infection. If the number of white blood cells drops too low, e.g. Due to cytotoxic chemotherapy, the body may not be able to fight microorganisms and this increases the risk of infection. Pegfilgrastim is similar to a natural protein in the body, called granulocyte colony-stimulating factor, which stimulates the bone marrow to form more white blood cells and thus helps the body fight infection.
What you need to know before using Nyvepria
Do not use Nyvepria
- if you are allergic to pegfilgrastim, filgrastim or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Nyvepria:
- If you are a patient with breast or lung cancer, then pegfilgrastim in combination with chemotherapy and / or radiation therapy may increase the risk of a cancerous stage called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever and easy bruising and bleeding.
- if you have recently had a serious lung infection ( pneumonia ), fluid in the lungs ( pulmonary edema ), inflammation of the lungs (interstitial lung disease) or abnormal results on chest X-ray (lung infiltration).
- if you know you have altered blood cell count (eg increased white blood cell count or anemia ) or decreased platelet count ( thrombocytopenia ), which reduces the blood’s ability to coagulate. Your doctor may want to check this more often than usual.
- if you have sickle cell anemia . Your doctor may want to check this more often than usual.
Talk to your doctor, pharmacist, or nurse while using Nyvepria:
- if you have an allergic reaction , which may manifest as a feeling of weakness, drop in blood pressure, difficulty breathing, swelling of the face, lips, tongue or other parts of the body ( anaphylaxis ), redness and swelling, rash or hives on the skin and itchy skin areas .
- if you have a cough or fever and have difficulty breathing. This may be a sign of acute respiratory distress syndrome (ADRDS).
- if you experience any of the following side effects:
- swelling or fluid retention, urination less frequently than usual, difficulty breathing; swollen abdomen (stomach) and a feeling of satiety, as well as a general feeling of tiredness.This can be a symptom of a condition called capillary leakage syndrome, which causes blood to leak from the small blood vessels. See section 4.
- if you experience pain in the upper abdomen on the left side or the tip of the left shoulder blade. This may be a sign of splenomegaly .
- if you get fever, abdominal pain, malaise and back pain then this may be a symptom of inflammation of the aorta (the large blood vessel that carries blood from the heart and out into the body). This condition can in rare cases occur in cancer patients and healthy donors.
You will have to submit blood and urine samples regularly as Nyvepria can damage your kidneys ( glomerulonephritis ).
Severe skin reactions ( Stevens-Johnson syndrome, a skin condition that causes painful blisters and sores on the skin and mucous membranes, especially in the mouth) have been reported with the use of pegfilgrastim. Stop using Nyvepria and seek medical attention immediately if you experience any of the following symptoms: reddish target-like or round spots on the torso (often with central blisters), skin peeling, blisters in the mouth, throat, nose, genitals, or eyes, possibly with fever and flu-like symptoms. See section 4.
Talk to your doctor about the risk of developing blood cancer. If you have blood cancer or if your doctor has told you that you are at risk of developing blood cancer, do not use Nyvepria unless your doctor tells you to.
Impaired treatment response to pegfilgrastim
If pegfilgrastim treatment does not work or stops working, your doctor will investigate why this has happened. Your doctor will, among other things, check if you have developed antibodies that neutralize the activity of pegfilgrastim.
Children and young people
Nyvepria is not recommended for children and adolescents as there is insufficient information on its safety and efficacy.
Other medicines and Nyvepria
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nyvepria has not been studied in pregnant women. Therefore, your doctor may decide that you should not use this medicine.
Talk to a doctor if you become pregnant while you are being treated with Nyvepria.
Unless your doctor tells you otherwise, you must stop breastfeeding if you are using Nyvepria.
Driving and using machines
Nyvepria has no or negligible effect on the ability to drive or use machines.
Nyvepria contains sorbitol (E420) and sodium
This medicine contains 30 mg sorbitol per pre-filled syringe equivalent to 50 mg/ml. The additive effect of concomitantly administered drugs containing sorbitol (or fructose) and food intake of sorbitol (or fructose) should be considered.
This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, ie it is essentially ‘sodium-free’.
How to use Nyvepria
Nyvepria is intended for use by adults from the age of 18.
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is a 6 mg subcutaneous injection ( injection under the skin) using a pre-filled syringe. Dose one should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
How to inject yourself with Nyvepria
Your doctor may decide that you can inject Nyvepria yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject it yourself if your doctor or nurse has not shown you how to do it.
Information on how to inject Nyvepria can be found at the end of this leaflet.
Do not shake Nyvepria vigorously as this may affect its effect.
If you use more Nyvepria than you should
If you have used more Nyvepria then you should contact a doctor, pharmacist, or nurse for advice.
If you forget to use Nyvepria
If you miss a dose of Nyvepria, you should contact your doctor to discuss when you should 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.
If you get any of the following side effects, talk to your doctor straight away:
- swelling or fluid retention, urination less frequently than usual, difficulty breathing, swollen abdomen (stomach) and a feeling of satiety, and a general feeling of tiredness. These symptoms often develop rapidly.
They can be symptoms of a less common condition (may affect up to 1 in 100 people) called capillary leakage syndrome, which causes blood to leak from small blood vessels into the body. This condition must be treated immediately.
Very common: may affect more than 1 user in 10
- skeletal pain. Your doctor may recommend what you can take to relieve skeletal pain.
- headache and nausea.
Common: may affect up to 1 in 10 users
- injection site pain.
- general joint and muscle pain.
- some changes in blood values may occur, but these are detected during routine blood tests. Your white blood cells may increase for a limited time. The number of platelets ( platelets ) can decrease, which can lead to bruising.
- chest pain that is not related to heart disease.
Uncommon: may affect up to 1 in 100 people
- allergy-like reactions, including redness and swelling, rash and raised itchy skin areas.
- severe allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
- increased spleen size (the spleen is an organ in the abdomen to the left of the stomach, which participates in the production and purification of blood cells and is part of the immune system). Talk to a doctor if you feel an increased volume in the upper left part of the abdomen.
- anthrax, which can be fatal. It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or up against the left shoulder, as this may indicate problems with the spleen.
- breathing problems. If you have a cough, fever and difficulty breathing, consult a doctor.
- Sweets syndrome (plum-colored, raised, painful injuries to the arms and legs and sometimes to the face and neck with fever).
- cutaneous vasculitis ( inflammation of the blood vessels of the skin).
- damage to the kidneys (so-called glomerulonephritis ).
- redness at the injection site.
- bloody cough (hemoptysis).
- Blood disorders ( myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
Rare: may affect up to 1 in 1,000 users
- inflammation of the aorta (the large blood vessel that carries blood from the heart to the body). See section 2.
- bleeding from the lungs ( pulmonary hemorrhage).
- Stevens-Johnson syndrome can start as reddish, target-like or round spots on the torso, often with blisters in the middle. Skin peeling and sores in the mouth, throat, nose, genitals and eyes may also occur. These reactions may be preceded by fever and flu-like symptoms . If you develop any of these symptoms, stop using Nyvepria and contact your doctor immediately or seek medical attention. See also section 2.
How to store Nyvepria
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 carton and syringe label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C-8 ° C).
You can take Nyvepria out of the refrigerator and store it at room temperature (maximum 25 ° C) for a maximum of 15 days. Once a syringe has been removed from the refrigerator and reached room temperature (maximum 25 ° C), it must be used within 15 days or discarded.
Do not freeze. Nyvepria can be used if the solution has been inadvertently frozen for less than 24 hours at a time.
Store the container in the outer carton. Sensitive to light.
Do not use this medicine if it is cloudy or contains particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml solution.
- The other ingredients are sodium acetate trihydrate, concentrated acetic acid, sorbitol (E420), polysorbate 20 and water for injections (see section 2 “Nyvepria contains sorbitol (E420) and sodium acetate”).
What the medicine looks like and contents of the pack
Nyvepria is a clear, colorless injection solution, free from visible particles, provided in a pre-filled syringe (6 mg / 0.6 ml).
Each pack contains 1 pre-filled glass syringe with a stainless steel needle, a needle sleeve, and an automatic needle guard.
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Hospira Zagreb doo
Prudnička Cesta 60
10291 Prigorje Brdovečko
Croatia
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienLuxembourg / LuxemburgPfizer NV / SATel: +32 (0) 2 554 62 11 | ΎπροςPFIZER EΛΛAΣ AE (CYPRUS BRANCH)Tηλ: +357 22 817690 |
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