Accord Healthcare AB

Solution for injection / infusion in pre-filled syringe 30 ME / 0.5 ml 
(Clear, colorless solution.)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, nurse, or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Accofil is and what it is used for 
2. What you need to know before using Accofil 
3. How to use Accofil 
4. Possible side effects 
5. How to store Accofil 
6. Contents of the packaging and other information

1. What Accofil is and what it is used for

What Accofil is

Accofil contains the active substance filgrastim. Filgrastim 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. Filgrastim 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.

What Accofil is used for

Your doctor has prescribed Accofil to help your body produce more white blood cells. Your doctor will tell you why you are being treated with Accofil. Accofil can be used for several 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).

2. What you need to know before using Accofil

Do not use Accofil

  • If you are allergic (hypersensitive) to 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 Accofil:

Before treatment, tell your doctor if you:

  • if you have sickle cell anemia, as filgrastim may cause sickle cell crisis.
  • if you have osteoporosis (osteoporosis).

Tell your doctor immediately if you are taking filgrastim 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 Accofil 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 
Accofil belongs to a group of medicines that stimulate the production of white blood cells. Healthcare professionals should always make a note of the exact product you are using.

Other medicines and Accofil

You should not receive Accofil 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.

Pregnancy and breastfeeding

Accofil has not been tested in pregnant women.


It is important that you 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

Accofil 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 before driving or using machines.

Accofil contains sorbitol and sodium

This medicine contains sorbitol.

If you have been told by your doctor that you have an intolerance 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 dose, ie essentially ‘sodium-free’.

3. How to use Accofil

Always use Accofil exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The amount of Accofil you need depends on the condition of your Acofil condition and your body weight.

Dosage

Accofil and neutropenia (a small number of white blood cell types ) associated with chemotherapy

The usual dose is 0.5 million units (5 micrograms) per kg of body weight daily. For example, if you weigh 60 kilograms, your daily dose is 30 million units (300 micrograms). Treatment with Accofil usually lasts for about 14 days. In some types of disease, however, longer treatment for up to about a month may be required.

Accofil 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 dose will be 60 million units (600 micrograms). You will usually receive your first dose of Accofil 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 each day as a single dose or divided into several doses. The doctor can then test your blood to see how well the treatment works and to find the dose that is best for you. To reduce neutropenia, long-term treatment with Accofil is required.

Accofil 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 each day. Your doctor may test your blood at regular intervals 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. Long-term treatment with Accofil may be needed to maintain a normal white blood cell count.

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 Accofil 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 dose is 1 million units (10 micrograms) per kg body weight each day. Treatment with Accofil lasts for 4 to 5 days. Your doctor will take regular blood tests to determine the best time for stem cell collection.

How Accofil is given

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 that you learn to give yourself the injections. Your doctor or nurse will give you instructions on how to do this (see information below for instructions for injection with Accofil). 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 an injection

This section contains information on how to give yourself an injection of Accofil. It is important that you do not 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 an injection of Accofil?

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 dryer or similar

What should I do before giving myself a subcutaneous injection of Accofil?

Leave the needle cover on the syringe until you are ready to inject one

  1. Take your pre-filled syringe of Accofil out of the refrigerator.
  2. 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.
  3. Check the appearance of Accofil. It must be a clear and colorless liquid. If it contains particles, do not use it.
  4. 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 Accofil in any other way (eg do not heat the syringe in the microwave or in hot water).
  5. Wash your hands thoroughly.
  6. Find a comfortable and well-lit place and put everything you need within reach (the pre-filled syringe with Accofil and injection dryer).

How do I prepare my injection with Accofil?

Before injecting Accofil, you must do the following:

  1. 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.

    1

    2
  2. 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.
  3. The syringe may contain more liquid than you need. Use the scale on the cylinder container as follows to set the correct dose of Accofil 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.
  4. Check again to make sure that the syringe contains the correct dose of Accofil.
  5. You can now use the pre-filled syringe.

Where should I inject one?

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)
Picture describes where on the body the injection can be given.

3

If someone else gives you an injection, he or she can also use the back of your arms (see picture 4).

Picture describes how injection with help can be given on the back of the arm.

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 injection?

  1. Disinfect the injection site with an injection dryer and pinch the skin between the thumb and forefinger, without squeezing (see picture 5).
    5
    Pre-filled syringe without needle cover
  2. Insert the needle completely through the skin as shown by the nurse or doctor (see picture 6).
  3. 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.
  4. Always hold the grip on the skin and at the same time 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!
  5. Inject only the dose prescribed by your doctor.
  6. After injecting the liquid, remove the needle while maintaining the pressure on the plunger and then release the skin.
  7. Place the used syringe in the waste container. Each syringe should only be used for one injection.
    6
    Pre-filled syringe with the needle guard
  8. Insert the needle completely through the skin as instructed by the nurse or doctor (see Figure 7).
  9. 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.
  10. Only inject the dose prescribed by your doctor by following the instructions below.
  11. 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!
  12. 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.
    7
    8

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.

If you use more Accofil than you should  

If you use more Accofil than you should, contact your doctor or pharmacist as soon as possible.

If you forget to use Accofil

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 Accofil

Your doctor will tell you when to stop using Accofil. It is perfectly normal to receive several treatments with Accofil.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Talk to your doctor immediately during treatment

  • 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.
  • if you get a cough, fever, and difficulty breathing ( dyspnoea ) as it 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, as 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 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 (may occur in 1 in 100 people) called capillary leakage syndrome that 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 Accofil. 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.

A very common side effect with Accofil 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, and 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 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 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 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 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

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Accofil

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 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.

6. Contents of the packaging and other information

Content declaration

  • 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 looks like and the contents of the pack

Accofil 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.

Accofil 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

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 is intended for healthcare professionals only:

Accofil 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 of Accofil. If the exposure has lasted for more than 24 hours or if the solution has been frozen more than once, Accofil should NOT be used.

To improve the traceability of Granulocyte Colony Stimulating Factors, the product name (Accofil) and batch number of the administered product should be clearly recorded in the patient’s medical record.

Accofil 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 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 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

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.

Muhammad Nadeem

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