Fulphila 6 mg solucion inyectable en jeringa precargada
Introduction
Package Insert: Information for the User
Fulphila 6 mg injectable solution in pre-filled syringe
Pegfilgrastim
Read this package insert carefully before starting to use this medication because it contains important information for you.
- Keep this package insert, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.
1. What is Fulphila and what is it used for
Fulphila contains the active ingredient pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in the bacteriumE. coli. Pegfilgrastim belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte colony-stimulating factor) produced by our body.
Fulphila 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 be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly dividing cells). White blood cells are important cells that contribute to fighting infections. These cells are sensitive to the effects of chemotherapy, which can cause their number to decrease. If the white blood cell count drops too low, there may not be enough to fight off bacteria, which implies a higher risk of contracting an infection.
Your doctor has prescribed Fulphila to stimulate your bone marrow (the part of the bone where blood cells are produced) to produce more white blood cells that will help you fight off infections.
Fulphila is indicated for patients 18 years of age or older.
2. What you need to know before starting to use Fulphila
No use Fulphila
- If you are allergic to pegfilgrastim, filgrastim, or any of the other components of this medication (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Fulphila:
- If you experience an allergic reaction that includes weakness, decreased blood pressure, difficulty breathing, facial swelling (anaphylaxis), redness and warmth, skin rash, and itching in areas of the skin.
- If you experience cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
- If you experience any or a combination of the following adverse effects:
- Swelling that may be associated with urinating less frequently, difficulty breathing, swelling, and a feeling of fullness in the abdomen and a general feeling of fatigue.
These may be symptoms of a condition called "capillary leak syndrome" and may cause blood to escape from small blood vessels into other parts of your body. See section 4.
- If you have pain in the upper left abdominal area or pain in the shoulder tip. This may be a sign of a problem with the spleen (splenomegaly).
- If you recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), inflammation of the lungs (interstitial lung disease), or an abnormal chest X-ray result (pulmonary infiltration).
- If you are aware of any changes in your blood cell count (e.g., an increase in white blood cells or anemia) or a decrease in platelet count, which may reduce the blood's ability to clot (thrombocytopenia). Your doctor may want to monitor you more closely.
- If you have sickle cell anemia. Your doctor may closely monitor your disease.
- If you are a breast cancer or lung cancer patient, the combined treatment of Fulphila with chemotherapy and/or radiation therapy may increase the risk of developing a pre-cancerous blood disorder called Myelodysplastic Syndrome (MDS) or a blood cancer called Acute Myeloid Leukemia (AML). Symptoms may include fatigue, fever, bruising easily, or bleeding.
- If you experience sudden signs of allergy, such as skin rash, itching, or hives, facial swelling, lips, tongue, or other body parts, shortness of breath, wheezing, or difficulty breathing; these may be signs of a severe allergic reaction.
- If you experience symptoms of aorta inflammation (the large blood vessel that carries blood from the heart to the rest of the body); this has rarely been reported in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, general discomfort, back pain, and increased inflammatory markers. Inform your doctor if you experience these symptoms.
Your doctor will perform regular blood and urine tests, as Fulphila may damage the small filters within the kidneys (glomerulonephritis).
Severe skin reactions (Stevens-Johnson syndrome) have been reported with pegfilgrastim. Stop using Fulphila and seek medical attention immediately if you notice any of the symptoms described in section 4.
You should consult with your doctor about the risk of developing blood cancer. If you have or may have blood cancer, do not use Fulphila, except if your doctor advises you to.
Loss of response to Fulphila
If you experience a loss of response or if you are unable to maintain the response to treatment with pegfilgrastim, your doctor will investigate the causes, including whether you have developed antibodies that may neutralize the activity of pegfilgrastim.
Children and adolescents
The use of Fulphila in children and adolescents is not recommended, as there is insufficient data on its safety and efficacy.
Other medications and Fulphila
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
Fulphila has not been used in pregnant women. Therefore, your doctor may decide that you should not use this medication.
If you become pregnant during treatment with Fulphila, inform your doctor.
Unless your doctor advises you otherwise, you should stop breastfeeding if you use Fulphila.
Driving and operating machinery
The influence of Fulphila on your ability to drive and operate machinery is negligible or insignificant.
Fulphila contains sorbitol and sodium
This medication contains 30 mg of sorbitol in each pre-filled syringe, which is equivalent to 50 mg/mL.
This medication contains less than 1 mmol of sodium (23 mg) per dose of 6 mg, which is essentially "sodium-free".
3. How to Use Fulphila
Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is a subcutaneous injection of 6 mg (under the skin) using a pre-filled syringe, and it should be administered at the end of each chemotherapy cycle, starting 24 hours after the last dose of chemotherapy.
Fulphila Self-Administration
Your doctor may consider it more convenient for you to administer Fulphila yourself. Your doctor or nurse will teach you how to do it. Do not attempt it if you have not been taught.
To obtain more instructions on how to administer Fulphila yourself, read the attached instructions.Do not shake Fulphila vigorously as it may affect its activity.
If You Use More Fulphila Than You Should
If you use more Fulphila than you should, contact your doctor, pharmacist, or nurse.
If You Forget to Use Fulphila
If you have forgotten to administer your dose of Fulphila, contact your doctor to decide when you should inject the next dose.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor immediately if you experience any of the following side effects:
- swelling that may be associated with urinating less frequently, difficulty breathing, swelling, and a feeling of fullness in the abdomen, and a general feeling of fatigue. These symptoms usually develop very quickly.
These may be symptoms of a rare disease (which can affect up to 1 in 100 people) called "capillary leak syndrome" and may cause blood to leak from small blood vessels into other parts of your body and require urgent medical attention.
Very common side effects(may affect more than 1 in 10 people)
- bone pain. Your doctor will inform you about what you can take to relieve the pain.
- nausea and headaches.
Common side effects(may affect up to 1 in 10 people)
- pain at the injection site.
- general pain and pain in the joints and muscles.
- some changes in your blood may occur, which will be detected by periodic blood tests. You may experience an increase in white blood cells for a short period of time. You may experience a decrease in platelets, which may cause bruising.
- chest pain.
Uncommon side effects(may affect up to 1 in 100 people)
- allergic reactions, including redness and flushing/heat, appearance of hives, and skin inflammation with itching.
- severe allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
- sickle cell anemia crisis in patients with this anemia.
- enlargement of the spleen.
- spleen rupture. Some cases of spleen rupture were fatal. It is essential to contact your doctor immediately if you notice pain in the upper left abdomen or left shoulder, as this could be related to a spleen problem.
- respiratory problems. If you have a cough, fever, and difficulty breathing, consult your doctor.
- cases of Sweet syndrome (painful, inflamed, violaceous lesions on the extremities and, in some cases, on the face and neck, accompanied by fever) have been reported, but may be related to other factors.
- cutaneous vasculitis (inflammation of skin blood vessels).
- damage to the small filters within the kidneys (glomerulonephritis).
- redness at the injection site.
- coughing up blood (hemoptysis).
- hematological disorders (SMD or LMA).
Rare side effects(may affect up to 1 in 1,000 people)
- aortic inflammation (the large blood vessel that carries blood from the heart to the rest of the body), see section 2.
- pulmonary hemorrhage.
- Stevens-Johnson syndrome, which may appear as concentric or circular red patches often with central blisters on the trunk, exfoliation, ulcers in the mouth, throat, nose, genitals, and eyes; and may be preceded by fever and flu-like symptoms. Stop using Fulphila if you develop these symptoms and contact your doctor or seek immediate medical attention. See section2.
Reporting side effects
If you experience side effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.
5. Fulphila Storage
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box, the blister pack, and the syringe label after CAD. The expiration date is the last day of the month indicated.
Store in the refrigerator (between 2 °C and 8 °C).
Do not freeze. Fulphila may be used in case of accidental freezing for a period of less than 24 hours.
Store the container in the outer packaging to protect it from light.
Fulphila may be stored at room temperature (as long as it does not exceed 30 °C) for a maximum of 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (which does not exceed 30 °C), it must be used within 3 days or discarded.
Do not use this medication if you observe that the solution is not completely transparent or contains particles.
Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Fulphila
- The active ingredient 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), polisorbate 20, and water for injection. See section 2 “Fulphila contains sorbitol and sodium acetate”.
Appearance of the product and contents of the pack
Fulphila is a transparent and colourless injectable solution (injection) contained in a pre-filled syringe of glass with a stainless steel needle and a needle cap. The syringe is provided packaged in a blister.
Each pack contains 1 pre-filled syringe.
Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited
Unit 35/36
Grange Parade,
Baldoyle Industrial Estate,
Dublin 13
DUBLIN
Ireland
D13 R202
Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne
Dublin
D09 C6X8
Ireland
For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country.
België/Belgique/Belgien Biocon Biologics Belgium BV Tél/Tel: 0080008250910 | Lietuva Biosimilar Collaborations Ireland Limited Tel: 0080008250910 |
Luxembourg/Luxemburg Biocon Biologics France S.A.S Tél/Tel: 0080008250910 | |
Ceská republika Biocon Biologics Germany GmbH Tel: 0080008250910 | Magyarország Biosimilar Collaborations Ireland Limited Tel: 0080008250910 |
Danmark Biocon Biologics Finland OY Tlf: 0080008250910 | Malta Biosimilar Collaborations Ireland Limited Tel: 0080008250910 |
Deutschland Biocon Biologics Germany GmbH Tel: 0080008250910 | Nederland Biocon Biologics France S.A.S. Tel: 0080008250910 |
Eesti Biosimilar Collaborations Ireland Limited Tel: 0080008250910 | Norge Biocon Biologics Finland OY Tlf: +47 800 62 671 |
Ελλ?δα Biocon Biologics GreeceΜΟΝΟΠΡΟΣΩΠΗΙ.Κ.Ε Τηλ: 0080008250910 | Österreich Biocon Biologics Germany GmbH Tel: 0080008250910 |
España Biocon Biologics Spain S.L. Tel: 0080008250910 | Polska Biosimilar Collaborations Ireland Limited Tel:.: 0080008250910 |
France Biocon Biologics France S.A.S Tél: +Teél: 0080008250910 | Portugal Biocon Biologics Spain S.L.. Tel: 0080008250910 |
Hrvatska Biocon Biologics Germany GmbH Tel: 0080008250910 | România Biosimilar Collaborations Ireland Limited Tel: 0080008250910 |
Ireland Biosimilar Collaborations Ireland Limited Tel: 1800 777 794 | Slovenija Biosimilar Collaborations Ireland Limited Tel: 0080008250910 |
Ísland Biocon Biologics Finland OY Sími:+345 8004316 | Slovenská republika Biocon Biologics Germany GmbH Tel: 0080008250910 |
Italia Biocon Biologics Spain S.L. Tel: 0080008250910 | Suomi/Finland Biocon Biologics Finland OY Puh/Tel: 99980008250910 |
Κ?προς Biosimilar Collaborations Ireland Limited Τηλ: 0080008250910 | Sverige Biocon Biologics Finland OY Tel: 0080008250910 |
Latvija Biosimilar Collaborations Ireland Limited Tel: 0080008250910 |
Date of the last update of the summary of product characteristics: {MM/AAAA}.
Other sources of information
The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
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Instructions for use: |
Guide to the components |
Before use |
After use |
Important | ||
|
Step 1: Preparation | |
A. | Remove the syringe from the blister pack and take the materials you need for the injection: alcohol wipes, cotton balls or swabs, band-aids, and a sharps container (not included). |
To make the injection less painful, leave the pre-filled syringe at room temperature for approximately 30 minutes before the injection. Wash your hands thoroughly with soap and water. Place the new pre-filled syringe and other materials on a clean and well-lit surface.
|
B. | Open the pack, removing the cover. Take the pre-filled syringe by the safety guard to remove it from the blister. |
For safety reasons:
|
C. | Examine the medicine and the pre-filled syringe. |
In any of these cases, contact your doctor or healthcare professional. |
Step 2: Prepare | |
A. | Wash your hands thoroughly. Prepare and clean the injection site. |
You can inject the medicine into:
Clean the injection site with an alcohol wipe. Allow the skin to dry.
Do not inject into areas where the skin is sensitive, bruised, red, or hardened. Avoid injecting into areas with scars or stretch marks. |
B | Pull the grey needle cap straight off in line with the syringe, keeping the syringe separate from your body. |
C | Pinch the injection site to create a firm surface. |
It is essential to keep the skin pinched when injecting. |
Step 3: Inject | |
A | Keep the skin pinched. INSERT the needle into the skin. |
|
B | PUSH the plunger with a light and constant pressure until you feel or hear a “click”. Push all the way down until you hear the “click”. |
It is essential to push down until you hear the “click” to receive your full dose. |
C | STOP pushing the plunger. Then, SEPARATE the syringe from the skin. |
After releasing the plunger, the safety guard on the syringe will cover the needle safely.
|
Only for healthcare professionals The commercial name of the administered product must be correctly registered in the patient's medical history. |
Step 4: Final | |
A | Dispose of the used syringe and other materials in a sharps container. |
Medicines must be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment. Keep the syringe and sharps container out of sight and reach of children.
|
B | Examine the injection site. |
If you see blood, press with a cotton ball or swab on the injection site. Do not rub the injection site. Apply a band-aid if necessary. |
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