Pelgraz 6 mg solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Pelgraz 6 mg solution for injection in pre-filled syringe
pegfilgrastim
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Pelgraz is and what it is used for
- What you need to know before using Pelgraz
- How to use Pelgraz
- Possible side effects
- How to store Pelgraz
- Contents of the pack and other information
1. What Pelgraz is and what it is used for
Pelgraz contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in the bacterium E. coli. Pegfilgrastim belongs to a group of proteins called cytokines, and is very similar to a naturally occurring protein (granulocyte colony-stimulating factor) produced by our body.
Pelgraz is used to reduce the duration of neutropenia (low white blood cell count) and the incidence of febrile neutropenia (low white blood cell count and fever) that may occur as a result of cytotoxic chemotherapy (medicines that destroy rapidly dividing cells). White blood cells are important cells because they help fight infections. These cells are sensitive to the effects of chemotherapy, which can cause their numbers to decrease. If the number of white blood cells drops too low, there may not be enough to fight bacteria, resulting in a higher risk of developing an infection.
Your doctor has prescribed Pelgraz to stimulate your bone marrow (the part inside the bone where blood cells are produced) to produce more white blood cells to help you fight infections.
2. What you need to know before using Pelgraz
Do not use Pelgraz
- if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Tell your doctor, pharmacist, or nurse before using Pelgraz if:
-
you experience an allergic reaction including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash, and itching in areas of the skin.
-
you are allergic to latex. The needle cap of the pre-filled syringe contains a latex derivative which may cause severe allergic reactions.
-
you experience cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
-
you experience any one or a combination of the following adverse effects:
-
swelling that may be associated with reduced frequency of urination, difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling of fatigue.
These may be symptoms of a condition called "Capillary Leak Syndrome," which can cause blood to leak from small blood vessels into other areas of your body. See section 4.
- you have pain in the upper left side of the abdomen or pain at the tip of the shoulder. This may be a sign of a problem with the spleen (splenomegaly).
- you recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary edema), lung inflammation (pulmonary interstitial disease), or an abnormal chest X-ray result (pulmonary infiltration).
- you are aware of any blood cell count disorders (e.g., increased number of white blood cells or anemia) or a decrease in platelet count, which may reduce the blood's ability to clot (thrombocytopenia). Your doctor may wish to monitor you more closely.
- you have sickle cell anemia. Your doctor may monitor your condition more closely.
- you are a patient with breast cancer or lung cancer, combination treatment with Pelgraz, chemotherapy, and/or radiotherapy may increase the risk of developing a pre-cancerous blood disorder called myelodysplastic syndrome (MDS) or a blood neoplasm called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, easy bruising, or bleeding.
- you experience sudden signs of allergy such as rash, itching, or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing, which may be signs of a severe allergic reaction.
- symptoms of inflammation of the aorta (the large blood vessel carrying blood from the heart to the body), which has rarely been reported in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, general malaise, back pain, and elevated inflammatory markers (e.g., C-reactive protein and white blood cell count). Inform your doctor if you experience these symptoms.
Your doctor will perform regular blood and urine tests because Pelgraz may damage the small filters in the kidneys (glomerulonephritis).
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelgraz. Stop using Pelgraz and seek immediate medical attention if you notice any of the symptoms described in section 4.
You should discuss with your doctor the risk of developing blood cancer. If you have or may develop blood cancer, you should not use Pelgraz unless your doctor advises otherwise.
Loss of response to pegfilgrastim
If you experience a loss of response or are unable to maintain a response to pegfilgrastim treatment, your doctor will investigate possible causes, including whether you have developed antibodies that may neutralize the activity of pegfilgrastim.
Children and adolescents
The safety and efficacy of Pelgraz in children and adolescents have not yet been established. Consult your doctor or pharmacist before taking any medication.
Other medicines and Pelgraz
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine. Pelgraz has not been used in pregnant women. It is important that you inform your doctor if:
- you are pregnant;
- you think you may be pregnant; or
- you plan to become pregnant.
If you become pregnant while being treated with Pelgraz, please inform your doctor.
Unless your doctor advises otherwise, you should stop breastfeeding while using Pelgraz.
Driving and using machines
The influence of Pelgraz on the ability to drive and use machines is none or negligible.
Pelgraz contains sorbitol (E420) and sodium
This medicine contains 30 mg of sorbitol in the pre-filled injector, equivalent to 50 mg/ml.
This medicine contains less than 1 mmol of sodium (23 mg) per 6 mg dose; i.e., essentially "sodium-free".
3. How to use Pelgraz
Pelgraz is indicated for patients over 18 years of age.
Follow exactly the administration instructions for Pelgraz provided by your doctor. Consult your doctor or pharmacist if you have any doubts. The usual dose is one 6 mg subcutaneous injection (under the skin) using a pre-filled syringe, to be administered at the end of each chemotherapy cycle, starting 24 hours after your last dose of chemotherapy.
Do not shake Pelgraz vigorously, as this may affect its activity.
Self-injection of Pelgraz
Your doctor may consider it more convenient for you to self-administer Pelgraz. Your doctor or nurse will teach you how to do this. Do not attempt it unless you have received special training from your doctor or nurse.
Instructions on how to self-inject Pelgraz are provided below; however, proper treatment of your condition requires close and continuous cooperation with your doctor.
If you are unsure about how to administer the injection yourself or have any questions, ask your doctor or nurse for help.
How do I give myself a Pelgraz injection?
You must administer the injection into the tissue beneath the skin. This is called a subcutaneous injection.
Equipment you need
To give yourself a subcutaneous injection, you will need:
- a pre-filled syringe of Pelgraz;
- alcohol swab.
What should I do before giving myself a subcutaneous injection of Pelgraz?
- Remove the pre-filled syringe from the refrigerator.
- Check the expiry date on the label of the pre-filled syringe (EXP). Do not use it if the date has passed, if it has been stored outside the refrigerator for more than 15 days, or if it is expired.
- Check the appearance of Pelgraz. It should be a clear, colourless liquid. Do not use it if particles are present.
- To make the injection more comfortable, allow the pre-filled syringe to stand for 30 minutes to reach room temperature, or gently hold the pre-filled syringe in your hand for a few minutes. Do not heat Pelgraz in any other way (for example, do not heat it in a microwave or in hot water).
- Wash your hands thoroughly.
- Find a comfortable, well-lit place and have everything you need within reach (the pre-filled syringe and the alcohol swab).
How do I prepare my Pelgraz injection?
Before injecting Pelgraz, you must do the following:
- Choose a clean, well-lit area to administer the medication.
- Check the expiry date on the packaging. Do not use if past the expiry date.
- Gather an alcohol swab and a sharps container.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remember
If you have any problems, ask your doctor or nurse for help and advice.
If you use more Pelgraz than you should
If you use more Pelgraz than you should, contact your doctor, pharmacist, or nurse.
If you forget to use Pelgraz
If you are self-injecting and have forgotten to administer your dose of Pelgraz, contact your doctor to determine when you should inject the next dose.
If you stop using Pelgraz
Your doctor will tell you when to stop using Pelgraz. It is quite common to have a series of treatment cycles with Pelgraz.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Contact your doctor immediately if you experience any one or a combination of the following adverse effects:
- swelling that may be associated with reduced frequency of urination, difficulty breathing, abdominal swelling and bloating, and a general feeling of fatigue. These symptoms usually develop very rapidly.
These may be symptoms of a condition that occurs infrequently (which may affect up to 1 in 100 people), called "capillary leak syndrome," which can cause blood to leak from small blood vessels into other areas of the body and requires urgent medical attention.
Very common adverse effects (may affect more than 1 in 10 patients):
-
bone pain. Your doctor will advise you on what you can take to relieve the pain.
-
nausea and headache.
Common adverse effects (may affect up to 1 in 10 patients):
-
pain at the injection site.
-
general pain, and joint and muscle pain.
-
chest pain not caused by heart disease or heart attack.
-
some changes in your blood may occur, which will be detected through periodic blood tests. There may be a temporary increase in white blood cell count. Platelet count may decrease, which could lead to bruising.
Uncommon adverse effects (may affect up to 1 in 100 patients):
-
allergic-type reactions, including redness and flushing, skin rash, and itchy skin inflammation.
-
severe allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
-
enlargement of the spleen.
-
spleen rupture. Some cases of spleen rupture have been fatal. It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder, as these may be related to a spleen problem.
-
respiratory problems. If you develop cough, fever, and difficulty breathing, consult your doctor.
-
cases of Sweet’s syndrome (painful, inflamed, purplish skin lesions on the limbs and sometimes on the face and neck, accompanied by fever) have occurred, although these may be related to other factors.
-
cutaneous vasculitis (inflammation of the skin blood vessels).
-
damage to the small filters within the kidneys (glomerulonephritis).
-
redness at the injection site.
-
abnormal blood test results (lactate dehydrogenase, uric acid, and alkaline phosphatase).
-
abnormal blood test results related to the liver (alanine aminotransferase, aspartate aminotransferase).
-
coughing up blood (haemoptysis).
-
haematological disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]).
Rare adverse effects (may affect 1 in 1,000 people):
-
inflammation of the aorta (the large blood vessel carrying blood from the heart to the body) – see section 2.
-
bleeding from the lung (pulmonary haemorrhage).
-
Stevens-Johnson syndrome, which may appear as red, target-like or circular skin rashes, often with central blisters, on the trunk, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. Stop using Pelgraz if you develop these symptoms and contact your doctor or seek immediate medical attention. See also section 2.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Pelgraz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the pre-filled syringe after EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2°C and 8°C).
Pelgraz may be kept at room temperature (not above 25°C ± 2°C) for a single period of up to 15 days. If Pelgraz is left at room temperature for more than 15 days, it must be discarded. For any questions regarding storage, consult your doctor, nurse, or pharmacist.
Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Pelgraz.
Keep the pre-filled syringe in its carton to protect it from light.
Do not use this medicine if you notice that the solution is not completely clear or contains particles.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
-
The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.
-
The other components are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections. (See section 2).
Nature and contents of the container
Pelgraz is a clear, colourless, injectable solution in a pre-filled syringe with an injection needle. Each pre-filled syringe contains 0.6 ml of solution.
Pelgraz is available in a pack containing 1 pre-filled syringe, an individual carton and an alcohol swab.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6th floor,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IS / LT / LV / LX / MT / NL / NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U. Tel: +34 93 301 00 64
IT
Accord Healthcare Italia
Tel: +39 02 94323700
EL
Win Medica Pharmaceutical S.A.
Tel: +30 210 7488 821
Date of the most recent review of this leaflet: 06/2023
Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.
This information is intended for healthcare professionals only:
Pelgraz contains no preservatives. Due to the potential risk of microbial contamination, Pelgraz pre-filled syringes are for single use only.
Do not freeze. Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Pelgraz. If exposure exceeds 24 hours or if the product has been frozen more than once, Pelgraz must not be used.
To improve traceability of granulocyte colony-stimulating factors, the name of the medicinal product (Pelgraz) and the batch number of the administered pre-filled syringe should be clearly recorded in the patient's medical file.
Disposal
Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.