Accord Healthcare AB
Solution for injection / infusion in pre-filled syringe 30 MU / 0.5 ml
(Clear, colorless solution.)
What Accofil Filgrastim Injection Uses For
What Accofil 30 is
Accofil contains the active substance Filgrastim. It is a protein produced in a bacterium called Escherichia coli by recombinant DNA technology. It belongs to a group of proteins called cytokines and is very similar to granulocyte colony-stimulating factor ( G-CSF ) which is produced in the human body.
Filgastrim stimulates the bone marrow (the tissue where new blood cells are produced) so that it forms more white blood cells that help the body fight infection.
Filgrastim Injection Uses
Your doctor has prescribed Accofil 30 to help your body produce more white blood cells. Your doctor will tell you the benefits of filgrastim injection. Filgrastim injection uses are several in different conditions, namely:
- Chemotherapy
- Bone marrow transplant
- Severe chronic neutropenia (a small number of white blood cell types )
- Neutropenia (low number of a type of white blood cells ) in patients with HIV – infection.
- Mobilization of peripheral stem cells (to stimulate stem cells to enter the bloodstream where they can be collected and used in bone marrow transplantation).
What You Need To Know Before Using Filgrastim Injection
Do Not Use
- If you are allergic (hypersensitive) to filgrastim or any of the other ingredients of this medicine.
Warnings And Cautions Of Filgrastim Injection Uses
Talk to your doctor, pharmacist, or nurse before taking a filgrastim:
Before treatment, tell your doctor if you:
- If you have sickle cell anemia, filgrastim may cause a sickle cell crisis.
- If you have osteoporosis (osteoporosis).
Tell your doctor immediately if you are taking Filgastrim during treatment:
- Gets pain in the upper left part of the abdomen (abdomen), pain under the ribs on the left side or at the tip of the shoulder blade (this may be a symptom of an enlarged spleen ( splenomegaly ) or possibly a broken spleen ).
- Detects unusual bleeding or bruising (this may be a symptom of decreased platelet count ( thrombocytopenia ), which reduces the blood’s ability to clot).
- Suffer from sudden signs of allergy, such as rash, itching or hives, swelling of the face, lips, tongue, or other body parts, shortness of breath, wheezing, or difficulty breathing, as these may be signs of a severe allergy.
- Get swelling of the face or ankles, blood in the urine or brown urine, or if you notice that you urinate less than usual ( glomerulonephritis ).
The needle cover of the pre-filled syringe contains dry natural rubber (latex), which may cause an allergic reaction.
Inflammation of the aorta (the large carotid artery that carries blood from the heart to the body) has been reported as a rare side effect in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers.
Tell your doctor if you experience these symptoms.
Unsatisfactory treatment response to Filgrastim
If you respond less or stop responding to filgrastim treatment, your doctor will investigate what is causing this. Among other things, he or she will check if you have developed antibodies that neutralize the activity of filgrastim.
Your doctor may want you to have frequent check-ups; see section 4 of the Package Leaflet.
If you have severe chronic neutropenia, you may be at risk of developing blood cancer ( leukemia, myelodysplastic syndrome [MDS]). Talk to your doctor about the risk of developing blood cancer and what tests should be done. If you develop or are at high risk of developing blood cancer, do not use it unless your doctor tells you to.
If you are a stem cell donor, you must be between 16 and 60 years old.
Take Special Care With Other Products That Stimulate White Blood Cells
Filgrastim belongs to a group of medicines that stimulate the production of white blood cells. Healthcare professionals should always note the exact product they are using.
Other Medicines And Filgrastim Injection
You should not receive it 24 hours before and 24 hours after chemotherapy.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Filgrastim Injection With Pregnancy And Breastfeeding
Inj Filgrastim has not been tested in pregnant women.
You must tell your doctor if you:
- Is pregnant or breastfeeding
- Think you may be pregnant or
- Planning to have children.
It is unknown if filgrastim passes into breast milk. Therefore, your doctor may decide not to use this medicine if you are Breast Feeding.
Driving And Using Machines With
Filgrastim Injection
Filgrastim may have less effect on your ability to drive and use machines. This medicine may cause dizziness. You should wait and see how you feel after taking Accofil 30 before driving or using machines.
Filgrastim Injection Contains Sorbitol And Sodium
This medicine contains sorbitol.
If your doctor has told you that you are intolerant to some sugars (fructose), contact your doctor before taking this medicine.
This medicine also contains sodium.
Contains less than 1 mmol sodium (0.035 mg) per filgrastim dose, ie essentially ‘sodium-free’.
How To Give Filgrastim Injection: Instructions
Always use Accofil injection exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The dose inj filgrastim of your requirement depends on your body’s condition and weight.
Filgrastim Dose
Filgrastim and neutropenia (a small number of white blood cell types ) associated with chemotherapy
The usual dose of filgrastim injection is 0.5 million units (5 micrograms) per kg of body weight daily. For example, if you weigh 60 kilograms, your daily filgrastim injection dose is 30 million units (300 micrograms). Treatment with filgrastim usually lasts for about 14 da
ys. In some types of disease, however, longer treatment of up to about a month may be required.
Filgrastim Injection And Bone Marrow Transplant
The usual starting dose is 1 million units (10 micrograms) per kg body weight each day is given as an infusion. For example, if you weigh 60 kg, your daily Filgastrim injection dose will be 60 million units (600 micrograms).
You will usually receive your first dose of Accofil 30 at least 24 hours after chemotherapy and at least 24 hours after receiving your bone marrow transplant. The doctor can then test the blood to see how well the treatment works and how long it should last.
Accophilic And Severe Chronic Neutropenia (A Small Number Of White Blood Cell Types )
The usual starting dose is between 0.5 million units (5 micrograms) and 1.2 million units (12 micrograms) per kg body weight daily as a single dose or divided into several doses. The doctor can then test your blood to see how well the treatment works and find the best dose for you. To reduce neutropenia, long-term treatment with filgrastim is required.
Filgrastim Injection And Neutropenia (Low Number Of A Type Of White Blood Cells ) In Patients With HIV – Infection
The usual starting dose is between 0.1 million units (1 microgram) and 0.4 million units (4 micrograms) per kg of body weight daily. Your doctor may test your blood regularly to see how well the treatment works. When the number of white blood cells in the blood has returned to normal, it may be possible to reduce the dosing frequency to less than once a day. To maintain a normal white blood cell count, long-term treatment with filgrastim may be needed.
Accumulation And Transplantation Of Peripheral Stem Cells ( Stem Cells Collected From The Blood For Use In A Bone Marrow Transplant)
If you donate stem cells to yourself, the usual dose is 0.5 million (5 micrograms) to 1.0 million units (10 micrograms) per kg body weight each day. Treatment with filgrastim lasts for up to 2 weeks. Your doctor will check your blood to determine the best time for stem cell collection. If you are a stem cell donor to another person, the usual filgrastim dose is 1 million units (10 micrograms) per kg body weight each day. Treatment with filgrastin lasts for 4 to 5 days. Your doctor will take regular blood tests to determine the best time for stem cell collection.
How To Give Filgrastim Injection
This medicine is given as an injection, either by intravenous (iv) infusion (drip) or as a subcutaneous (SC) injection into the tissue just under the skin.
If you are given this medicine as a subcutaneous injection, your doctor may suggest you learn to give yourself the injections. Your doctor or nurse will give instructions on how to do this (see information below for instructions for injection with filgrastim). Do not try to self-administer without this training. Some of the information you need is given at the end of this leaflet, but proper treatment of your illness requires close and constant cooperation with your doctor.
Information On How To Give Yourself And Filgrastim Injection
This section contains information on how to give yourself an injection of filgrastim. You mustn’t try to give yourself an injection without first receiving special training from your doctor or nurse.
If you are not sure how to give yourself an injection, or if you have any questions, contact your doctor or nurse for help.
How Do I Give Myself A Filgrastim Injection?
You should inject one into the tissue just below the skin. This is called a subcutaneous injection. You should take the injections at about the same time each day.
Equipment you need
To give yourself a subcutaneous injection, you need the following:
- A pre-filled syringe with Accofil injection solution
- Injection dryer or similar
What Should I Do Before Giving Myself A Subcutaneous Filgrastim Injection?
Leave the needle cover on the syringe until you are ready to inject one
- Take your pre-filled syringe of filgrastin out of the refrigerator.
- Check the expiration date on the pre-filled syringe label (Exp. Date). Do not use it if the last day of the month indicated has passed, if it has been stored outside the refrigerator for more than 15 days, or is unusable for any other reason.
- Check the appearance of Filgrastim. It must be a clear and colorless liquid. If it contains particles, do not use it.
- Injection one feels more comfortable if you leave the pre-filled syringe for 30 minutes to reach room temperature or hold it gently in your hand for a few minutes. Do not heat Filgastrim in any other way (eg do not heat the syringe in the microwave or hot water).
- Wash your hands thoroughly.
- Find a comfortable and well-lit place and put everything you need within reach (the pre-filled syringe with filgastrim and injection dryer).
How do I Prepare My Injection With Filgrastim?
Before injecting filgrastim, you must do the following:
- Hold the syringe and gently take the protection of the needle without twisting. Pull straight out as shown in Figure 1 and Figure 2. Do not touch the needle or push the syringe plunger.
- You may notice a small air bubble in the pre-filled syringe. You do not need to remove the air bubble before injecting. It is safe to inject the solution with the air bubble left.
- The syringe may contain more liquid than you need. Use the scale on the cylinder container as follows to set the correct dose of filgastrim prescribed by your doctor. Squeeze out unnecessary liquid by pushing the plunger to the number (ml) on the syringe that corresponds to the prescribed dose.
- Check again to ensure that the syringe contains the correct dose of filgastrim.
- You can now use the pre-filled syringe.
Filgrastim Injection Site
The most suitable places to give yourself an injection are the following:
- At the top of the thighs
- Abdomen, except the area around the navel (see picture 3)
If someone else gives you an injection, he or she can also use the back of your arms (see picture 4).
It is better to change the injection site every day to avoid the risk of soreness in one place.
How Do I Give Myself An Accofil Filgrastim Injection?
- Disinfect the injection site with an injection dryer and pinch the skin between the thumb and forefinger without squeezing (see picture 5).
Pre-filled syringe without needle cover - Insert the needle completely through the skin, as shown by the nurse or doctor (see picture 6).
- Pull the plunger up slightly to ensure you have not punctured a blood vessel. If you see blood in the syringe, pull the needle and insert it in another place.
- Always hold the grip on the skin and simultaneously push the plunger down with a slow, constant pressure until the entire dose has been injected and the plunger can no longer be pushed down. Do not release the pressure on the piston!
- Inject only the dose prescribed by your doctor.
- After injecting the liquid, remove the needle while maintaining the pressure on the plunger and then release the skin.
- Place the used syringe in the waste container. Each syringe should only be used for one injection.
Pre-filled syringe with the needle guard - Insert the needle completely through the skin as instructed by the nurse or doctor (see Figure 7).
- Pull the plunger up slightly 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.
- Only inject the dose prescribed by your doctor by following the instructions below.
- Always hold the grip on the skin and push the plunger down with a slow, constant pressure while holding the flange, until the entire dose has been injected and the plunger can no longer be pushed down. Do not release the pressure on the piston!
- After injecting the liquid, remove the needle while holding the syringe at the same angle and maintaining the pressure on the plunger, then release the skin. The protective cuff automatically covers the needle and an audible “click” confirms that the protection has been activated (see figure 8). The needle guard is not activated unless the full dose has been given.
Remember
If you have problems, do not hesitate to ask your doctor or nurse for help and advice.
Disposal of used syringes
The needle guard prevents stab injuries after use and therefore no special precautions are required for waste disposal. Dispose of the syringe according to the instructions of a doctor, nurse, or pharmacist.
Overdose Of Filgrastim Injection
If you use more Accofil than you should, contact your doctor or pharmacist as soon as possible.
Missed Dose Of Filgrastim Injection
Do not take a double dose to make up for a forgotten injection. Contact your doctor to discuss when you should inject the next dose.
If You Stop Using Filgrastim Injection
Your doctor will tell you when to stop using filgrastim. It is perfectly normal to receive several treatments with filgastrim.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Accofil Filgrastim Side Effects
Like all medicines, side effects of Inj Filgrastim can occur, although not everybody gets them.
Talk to your doctor immediately during treatment
- After getting Filgrastin injection if you have an allergic reaction with weakness, drop in blood pressure, difficulty breathing, swelling of the face ( anaphylaxis ), skin rash, itchy rash ( urticaria ), swelling of the face, lips, mouth, tongue, or throat ( angioedema ) and shortness of breath ( dyspnoea ). Hypersensitivity is common in patients with cancer.
- A cough, fever, and difficulty breathing ( dyspnoea ) may be a sign of acute respiratory distress syndrome (ARDS). ARDS is less common in patients with cancer.
- If you experience pain in the left upper abdomen (abdomen), pain under the left rib arch or at the tip of the shoulder blade, this may be due to problems with the spleen (enlargement of the spleen [splenomegaly] or ruptured spleen ).
- If you are being treated for severe chronic neutropenia and have blood in your urine ( haematuria ). Your doctor may test your urine regularly if you experience this side effect or if the protein is detected in your urine ( proteinuria ).
- If you have any of the following or a combination of the following accofil side effects: swelling or bags, which may be associated with less frequent passing water, difficulty breathing, swollen abdomen and feeling of fullness, and a general feeling of tiredness. These symptoms usually appear quickly. These can be the symptoms of an unusual disease (which may occur in 1 in 100 people) called capillary leakage syndrome, which causes the blood to leak from the small blood vessels in the body and needs urgent medical attention.
- If you have a combination of any of the following symptoms:
Fever or chills or if you feel very cold, high heart rate, confusion or disorientation, shortness of breath, extreme pain or discomfort, and sticky or sweaty skin. These can be symptoms of a condition called “sepsis” (also called sepsis), a serious infection that involves the whole body responding to inflammation. This can be life-threatening and requires immediate emergency medical attention. - if you get kidney damage ( glomerulonephritis ). Kidney damage has been seen in patients receiving filgrastim. Contact a doctor immediately if you experience swelling of the face or ankles, blood in the urine or brown urine, or if you notice that you urinate less than usual.
Common side effects of Accofil injection is muscle or skeletal pain (musculoskeletal pain), which can be relieved with common painkillers ( analgesics ). In patients undergoing stem cell or bone marrow transplantation, graft-versus-host disease (GvHD) may occur – this is a reaction of the donor cells to the patient receiving the graft; Signs and symptoms are rashes on the palms and soles of the feet and sores in the
- Mouth
- Intestines
- Liver
- Skin or eyes
- Lungs
- Vagina
- Joints
A side effect that is very common in healthy stem cell donors is increased white blood cell count ( leukocytosis ) and decreased number of platelets, which impairs the blood’s ability to coagulate ( thrombocytopenia ), your doctor will check this.
Very common Side Effects of Filgrastim Injection Are (seen in more than 1 in 10 people taking Accofil):
- Vomiting
- Nausea
- Abnormal hair loss or thinning ( Alopecia )
- Fatigue (Exhaustion)
- Soreness and swelling of the mucous membrane in the digestive tract that goes from the mouth to the anus (Mucositis)
- The decrease in platelets which impairs the blood’s ability to coagulate ( Thrombocytopenia )
- A small number of red blood cells ( Anemia )
- Fever ( Pyrexia )
- Headache
- Diarrhea
Common Filgrastim Injection Side Effects are (seen in more than 1 in 100 people taking Accofil):
- Inflammation of the lungs ( Bronchitis )
- Upper respiratory tract infection
- Urinary tract infection
- Reduced appetite
- Sleep disorders ( insomnia )
- Dizziness
- Decreased sensitivity, especially on the skin ( Hypesthesia )
- Tingling or numbness in the hands or feet ( Paresthesia )
- Low blood pressure ( Hypotension )
- High blood pressure ( Hypertension )
- Cough
- Bloody cough (Hemoptysis)
- Pain in the mouth and throat ( Oropharyngeal pain)
- Epistaxis
- Constipation
- Pain in the mouth
- Enlargement of the liver ( Hepatomegaly )
- Rash
- Redness ( Erythema )
- Muscle spasm
- Pain when urinating ( Dysuria )
- Chest pain
- Pain
- A general feeling of weakness ( Asthenia )
- General malaise
- Swelling of hands and feet (Peripheral edema )
- Increase in certain enzymes in the blood
- Changes in the chemical composition of the blood
- Transfusion reaction
Less common Accofil Injection Side Effects Are (seen in more than 1 in 1000 People taking Accofil):
- Increase in white blood cells
- Allergic reaction (Hypersensitivity)
- Rejection of transplanted bone marrow ( Graft ‑ against ‑ host disease)
- Elevated levels of uric acid in the blood, which can cause gout (Hyperuricemia)
- Liver damage due to blockage of the small veins in the liver (Venous occlusive disease)
- Lungs not functioning properly leading to shortness of breath (Respiratory failure)
- Swelling and/or fluid in the lungs ( Pulmonary edema )
- Inflammation of the lungs (Interstitial lung disease)
- Abnormalities on lung X-ray (Lung infiltration)
- Hemorrhage from the lungs ( Pulmonary hemorrhage)
- Decreased oxygen uptake in the lungs ( Hypoxia )
- Elevated skin rash (Maculopapular rash)
- Osteoporosis (A disease that makes the skeleton less dense, so that it becomes weaker, more fragile, and more easily broken; osteoporosis )
- The reaction at the injection site
Rare Accofil Filgrastim Injection Side Effects Are (seen in more than 1 in 10,000 people taking Accofil):
- Inflammation of the aorta (The large carotid artery that carries blood from the heart to the body), see section 2
- Severe pain in the skeleton, chest, intestines, or joints ( Sickle cell anemia with crisis)
- Sudden life-threatening allergic reaction ( Anaphylactic reaction )
- Pain and swelling in the joints similar to gout (Pseudoarthrosis)
- A change in how the body regulates fluid in the body which can lead to swelling (Fluid volume disturbances)
- Inflammation of the blood vessels in the skin ( Cutaneous vasculitis )
- Plum-colored, raised, painful sores on the arms and legs and sometimes on the face and neck with fever (Sweets syndrome)
- Aggravated rheumatoid arthritis
- Unusual change in urine
- Reduced bone density
Talk to your doctor, pharmacist, or nurse if you get any side effects. This also applies to Accofil Side Effects that are not mentioned in this information.
Filgrastim Injection Storage Instructions
Keep out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and on the pre-filled syringe after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
The syringe can be taken out of the refrigerator and left at room temperature (but not above 25 ° C) for a single period of no more than 15 days, before the expiry date stated on the package. At the end of this period, the product should not be put back in the refrigerator but should be discarded.
Store the prefilled syringe in the carton. Sensitive to light.
Do not use Accofil 30 if you notice that it is cloudy, discolored or if there are particles in it.
Do not replace the protection on used needles, as you may sting yourself. 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 Packaging And Other Information
Contents of Filgrastim Injection
- The active substance is filgrastim. One pre-filled syringe contains 30 ME (300 micrograms) filgrastim in 0.5 ml, equivalent to 0.6 mg / ml.
- The other ingredients are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injections.
What the medicine Accofil filgrastim injection looks like and the contents of the pack
Filgrastin injection is a clear, colorless solution for injection/infusion in a pre-filled syringe marked with 1/40 printed markings from 0.1 ml to 1 ml on the shaft with an injection needle. One pre-filled syringe contains 0.5 ml of solution.
Filgrastim injection is available in packs containing 1, 3, 5, 7, or 10 pre-filled syringes, with or without attached needle guard and alcohol swab.
Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer of Filgrastim injection
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n
Edifici Est 6ª planta
08039 Barcelona
Spain
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow,
Middlesex HA1 4HF
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
This leaflet was last modified 06/2020
The following Information About Filgrastim Injection uses is intended for healthcare professionals only:
filgrastim injection uses contains no preservatives. Given the potential for micro bacterial contamination, Accofil syringes are for single use only.
Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability. If the exposure has lasted for more than 24 hours or if the solution has been frozen more than once, should NOT be used.
To improve the traceability of Granulocyte Colony Stimulating Factors, the product name and batch number of the administered product should be clearly recorded in the patient’s medical record.
Injection should not be diluted with sodium chloride solution. This medicinal product must not be mixed with other medicinal products except those listed below. Diluted filgrastim can be adsorbed by glass and plastic materials unless diluted as mentioned below.
If necessary, Accofil 30 can be diluted in 5% glucose. Dilution to a final concentration lower than 0.2 ME (2 micrograms) per ml is never recommended.
The solution should be inspected visually before use. Only clear solutions without particles should be used.
For patients treated with filgrastim injection uses diluted to concentrations below 1.5 ME (15 micrograms) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ml. Example: At a final injection volume of 20 ml, total doses of filgrastim below 30 ME (300 micrograms) should be given with the addition of 0.2 ml of 200 mg/ml (20%) human serum albumin solution.
Diluted in 5% glucose, Accofil is compatible with glass and several different plastics, including PVC, polyolefin (polypropylene and polyethylene copolymer), and polypropylene.
After Dilution Of Filgrastim Injection
The diluted solution has shown chemical and physical stability for 24 hours at 2 ° C to 8 ° C. From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ° C to 8 ° C, unless dilution has taken place under controlled and validated aseptic conditions.
Use Of Pre-Filled Syringe With A Needle Guard
The safety guard of the needle covers the needle after injection to prevent needle stick damage. This does not affect the normal handling of the syringe. Push the plunger in slowly and evenly until the entire dose has been injected and the plunger can not be pushed in further. While maintaining the pressure on the plunger, the syringe is removed from the patient. The safety guard of the needle covers the needle when the piston is released.
Use of Pre-Filled Syringe Without A Needle Guard
Administer dose one as usual.
Destruction
Any unused product or waste material should be disposed of in accordance with local requirements.