Accofil: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Accofil 30 MU/0.5 mL (0.6 mg/mL) solution for injection/infusion in pre-filled syringe

filgrastim
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

What Accofil is and what it is used for
What you need to know before using Accofil
How to use Accofil
Possible side effects
How to store Accofil
Contents of the pack and other information

1. What Accofil is and what it is used for

What Accofil is
Accofil is a white blood cell growth factor (granulocyte colony-stimulating factor) and belongs to a group of medicines called cytokines. Growth factors are proteins naturally produced in the body, but they can also be produced using biotechnology for use as medicines. Accofil stimulates the bone marrow to produce a greater number of white blood cells.

A reduction in the number of white blood cells (neutropenia) can occur for various reasons, reducing the body's ability to defend itself against infections. Accofil stimulates the bone marrow to rapidly produce new white blood cells.

Accofil may be used:

to increase the number of white blood cells after chemotherapy treatment, thereby helping to prevent infections;
to increase the number of white blood cells after a bone marrow transplant, thereby helping to prevent infections;
prior to high-dose chemotherapy to stimulate the bone marrow to produce more stem cells, which can be collected and reinfused after treatment. These cells may be taken from you or from a donor. The stem cells will then return to the bone marrow and produce blood cells;
to increase the number of white blood cells if you suffer from severe chronic neutropenia, thereby helping to prevent infections;
in patients with advanced HIV infection, to help reduce the risk of infections.

2. What you need to know before using Accofil

Do not use Accofil

If you are allergic to filgrastim or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Accofil:
Before starting treatment, inform your doctor if you have:

Sickle cell disease, as Accofil may trigger a sickle cell crisis.
Osteoporosis (a bone disease).

Immediately inform your doctor if, during treatment with Accofil, you:

Experience pain in the upper left part of the abdomen or at the tip of the left shoulder (these may be symptoms of an enlarged spleen (splenomegalia) or possibly of spleen rupture).
Notice unusual bleeding or bruising (these may be symptoms of a reduced platelet count in the blood (thrombocytopenia), resulting in decreased blood clotting ability).
Develop sudden symptoms of an allergic reaction, such as rash, itching, or hives, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing, as these may indicate a severe allergic reaction (hypersensitivity).
Have swelling of the face or ankles, blood in the urine, or notice brown-colored urine, or if you urinate less than usual (glomerulonephritis).
Experience symptoms of inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), which has been rarely reported in cancer patients and healthy individuals. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Inform your doctor if any of these symptoms occur.

Loss of response to filgrastim
If during treatment with filgrastim you notice a loss of effectiveness or inability to maintain efficacy,
your doctor will investigate the reasons, including the possibility that you have developed antibodies that
neutralize the activity of filgrastim.
Your doctor may wish to monitor you particularly closely (see section 4).
If you have severe chronic neutropenia, you may be at risk of developing a blood cancer (leukemia, myelodysplastic syndrome). Discuss with your doctor the risks of developing blood cancers and the necessary tests. You must not use Accofil if you have developed or are likely to develop blood cancers, unless otherwise directed by your doctor.
If you are a stem cell donor, you must be between 16 and 60 years of age.
Pay special attention to 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 record the exact name of the medicine you are using.
Other medicines and Accofil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Accofil has not been studied in pregnant or breastfeeding women.
Accofil is not recommended during pregnancy.
It is important that you inform your doctor if:

You are pregnant or breastfeeding;
You suspect you might be pregnant, or
You are planning to become pregnant.

If you become pregnant while being treated with Accofil, inform your doctor.
Unless otherwise instructed by your doctor, you must stop breastfeeding while using Accofil.
Driving and using machines
Accofil has minor effects on the ability to drive or operate machinery. This medicine may cause dizziness; therefore, before driving or operating machinery, you should wait and observe how you feel after receiving Accofil.
Accofil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, i.e., it is essentially "sodium-free."
Accofil contains sorbitol
This medicine contains 50 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with hereditary fructose intolerance, a rare genetic disorder, you (or your child) must not take this medicine. Patients with hereditary fructose intolerance cannot properly metabolize fructose, and its accumulation may lead to serious side effects.
Before taking this medicine, inform your doctor if you (or your child) have hereditary fructose intolerance or if your child becomes unwell, vomits, or experiences unpleasant reactions such as bloating, stomach cramps, or diarrhea after consuming sweet foods or drinks.
Allergy to natural rubber (latex): The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause severe allergic reactions.

3. How to use Accofil

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.
How is Accofil administered and how much should I take?
Accofil is generally administered by daily injection into the tissue just beneath the skin (known as a subcutaneous injection). It may also be given as a daily slow-release injection into the vein (known as an intravenous infusion). The usual dose depends on your condition and body weight. Your doctor will tell you how much Accofil you should take.
Patients receiving bone marrow transplantation after chemotherapy:
You will usually receive the first dose of Accofil at least 24 hours after chemotherapy and at least
24 hours after receiving the bone marrow transplant.
You or the people caring for you may be taught how to administer subcutaneous injections so that treatment can continue at home. However, you must not attempt to inject yourself unless you have first received proper instructions from your doctor.
How long should I take Accofil?
You will need to take Accofil until your white blood cell count has returned to normal. Blood tests will be performed to monitor your white blood cell count. Your doctor will tell you how long you should continue taking Accofil.
Use in children
Accofil is used to treat children undergoing chemotherapy or suffering from a severe reduction in white blood cells (neutropenia). The dosage in children undergoing chemotherapy is the same as that used in adults.
Information for self-injection
This section contains the information necessary to perform self-injection of Accofil. It is important that you do not attempt to perform the injection yourself unless you have first received adequate instructions from your doctor or nurse. If you have any doubts about how to perform the injection or wish to obtain further information, please consult your doctor or nurse.
How to perform self-injection of Accofil?
The injection must be administered into the tissue beneath the skin; this method is known as subcutaneous injection. You must administer the injection at the same time each day.
Equipment required
To perform a subcutaneous injection, you will need:

a pre-filled syringe of Accofil;
an alcohol swab or equivalent disinfectant.

What to do before performing a subcutaneous injection of Accofil
Ensure that the needle safety device remains on the syringe until you are ready to administer the injection.
a. Remove the pre-filled syringe of Accofil from the refrigerator.
b. Check the expiration date (Exp.) on the label of the pre-filled syringe. Do not use the syringe if the date has passed the last day of the month indicated, if it has been kept outside the refrigerator for more than 15 days, or if it is otherwise expired.
c. Check the appearance of Accofil. It should appear as a clear, colourless liquid. If you notice particles, do not use it.
d. To make the injection more comfortable, remove the pre-filled syringe from the refrigerator and allow it to reach room temperature for 30 minutes, or hold it gently in your hands for several minutes. Do not heat Accofil in any other way (for example, do not heat Accofil using a microwave or in warm water).
e. Wash your hands thoroughly.
f. Find a comfortable, well-lit place and arrange all necessary items within easy reach (the pre-filled syringe of Accofil and the alcohol swab).
How to prepare the Accofil injection?
Before administering the Accofil injection, proceed as follows:
Do not use the pre-filled syringe if it has been dropped on a hard surface.
Step 1: Check the integrity of the system
Check that the system is intact and undamaged. Do not use the product if you notice any damage (breakage of the syringe or needle safety device) or detached components, or if the needle safety device is in the safety position before use, as shown in Figure 9, since this indicates that the system has already been activated. In general, the product should not be used if it does not conform to Figure 1. In such cases, dispose of the product in a container for biological hazard waste (sharps).
Figure 1

Technical black and white drawing of a syringe-like medical device with plunger, transparent body with graduated scale, and application tip

Step 2: Remove the needle cap
a. Remove the protective cap as shown in Figure 2. Hold the body of the needle safety device in one hand with the needle end pointing away from you, without touching the plunger rod. Remove the needle cap with the other hand. After removing the needle cap, dispose of it in a container for biological hazard waste (sharps).
b. You may notice a small air bubble in the pre-filled syringe. Do not remove the air bubble before injection. Injecting the solution containing the air bubble is harmless.
c. The syringe may contain more liquid than needed. Use the graduated scale on the syringe as described below to measure the correct dose of Accofil prescribed by your doctor. Expel excess liquid by pushing the plunger to the number (mL) on the syringe corresponding to the prescribed dose of Accofil.
d. Check again to ensure the syringe contains the correct dose of Accofil.
e. The pre-filled syringe is now ready for use.
Figure 2

A hand holding a small rectangular object while the

Where to administer the injection?
The most suitable areas for injection are:

the upper thigh; and
the abdomen, except the area around the navel (see Figure 3).

Figure 3

Schematic drawing of a human body showing gray areas on the lower part of the

If the injection is administered by another person, the medicine may also be injected into the back of the arm (see Figure 4).
Figure 4

Linear diagram of a man's torso and arms viewed from the back, with two gray areas indicating injection sites on the arms

It is advisable to change the injection site daily to reduce the risk of hardening at the injection site.
Step 3: Inserting the needle

Gently pinch the skin at the injection site with one hand;
With the other hand, insert the needle into the injection site without touching the end of the plunger rod (at an angle of 45–90 degrees) (see Figures 6 and 7).

How to administer the injection?
Disinfect the injection site using the alcohol swab and pinch the skin between your thumb and index finger, without compressing it (see Figure 5).
Figure 5

Line drawing of a hand pressing with the thumb on the skin of the

Pre-filled syringe
without needle
safety device
or Insert the needle
fully into the skin,
as shown to you by
the nurse or doctor
(see Figure 6).
or Gently pull back on
the plunger to check
that a blood vessel
has not been
punctured. If you see
blood in the syringe,
withdraw the needle and insert it at another site.
o While maintaining the skin fold, slowly and steadily push the plunger until the full dose has been administered and the plunger can no longer be pushed. Do not release pressure on the plunger!
o Inject only the dose prescribed by your doctor.
o After injecting the liquid, withdraw the needle while maintaining pressure on the plunger, then release the skin.
o Place the used syringe into a disposal container. Use each syringe only once.
Figure 6

A hand holding a syringe angled at 45 degrees for inserting the

Pre-filled syringe with needle safety device

Insert the needle fully into the skin, as shown to you by the nurse or doctor.
Gently pull back on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, withdraw the needle and insert it at another site.
Inject only the dose prescribed by your doctor, following the instructions below.

Figure 7

A hand holding a syringe with needle pointed toward a leg, indicated by a dashed arrow suggesting the direction of the

Step 4: Injection
Place your thumb on the end of the plunger rod. Push the plunger and press firmly at the end of the injection to ensure the syringe is completely emptied (see Figure 8). Keep the skin steady until the injection is complete.
Figure 8

Step 5: Needle protection
The safety mechanism will activate once the plunger rod is fully depressed:

Keep the syringe steady and slowly lift your thumb from the end of the plunger rod;
The plunger rod will rise with your thumb, and the spring will retract the needle from the injection site into the needle safety device (see Figure 9).

Figure 9

A hand holding an injection pen oriented toward the

Reminder
If you have any questions or problems, contact your doctor or nurse for help or advice.
Disposal of used syringes
The needle safety device prevents accidental needle sticks after use, so no special precautions are required. To dispose of the used syringe, follow the instructions provided by your doctor, nurse, or pharmacist.
If you use more Accofil than you should
Do not increase the dose prescribed by your doctor. If you think you have administered an extra injection, contact your doctor as soon as possible.
If you forget to use Accofil
If you miss an injection or the injected amount is too low, contact your doctor as soon as possible. Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important to inform your doctor immediately during treatment

if you develop an allergic reaction including weakness, low blood pressure, difficulty breathing (dyspnea), swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face, lips, mouth, tongue or throat (angioedema), and shortness of breath (dyspnea).
if you develop cough, fever and difficulty breathing (dyspnea), as these may be signs of acute respiratory distress syndrome (ARDS).
if you experience kidney damage (glomerulonephritis). Kidney damage has been observed in patients receiving filgrastim. Contact your doctor immediately if you have swelling of the face or ankles, blood in the urine, brown-colored urine, or if you notice that you are urinating less than usual.
if you develop pain in the upper left part of the abdomen, pain under the left side of the ribs, or pain at the tip of the shoulder, as this may indicate a problem with the spleen (enlargement of the spleen (splenomegaly) or rupture of the spleen);
if you are being treated for severe chronic neutropenia and have blood in your urine (hematuria). If you experience this side effect or have protein in your urine (proteinuria), your doctor may perform urine tests at regular intervals;
if you develop one or a combination of the following side effects: swelling or bloating, which may be associated with fluid retention, difficulty breathing, abdominal swelling and a feeling of fullness, or general feeling of tiredness. These symptoms usually develop rapidly.

This may be a condition called "Capillary Leak Syndrome," which causes fluid and blood to leak from small blood vessels into your body and requires urgent medical treatment.

If you experience a combination of any of the following symptoms:
fever, chills, feeling generally cold, rapid heartbeat, confusion, disorientation, breathlessness, severe pain or discomfort, and moist or sweaty skin.

These may be symptoms of a condition called "sepsis" (also known as "blood poisoning"), a serious infection that triggers a body-wide inflammatory response, which can be life-threatening and requires urgent medical treatment.
A common side effect of Accofil is muscle or bone pain (musculoskeletal pain), which can be relieved with standard painkillers (analgesics). In patients undergoing stem cell or bone marrow transplantation, graft-versus-host disease may occur, i.e. rejection of donor cells by the transplant recipient; signs and symptoms include skin rash on the palms of the hands or soles of the feet, and ulcers and lesions in the mouth, intestines, liver, skin, eyes, lungs, vagina, and joints.
In healthy stem cell donors, an increase in white blood cells (leukocytosis) and a reduction in platelet count leading to reduced blood clotting ability (thrombocytopenia) may be observed; your doctor will monitor this reaction.

Very common side effects (may affect more than 1 in 10 people)

vomiting
nausea
unusual hair loss or thinning (alopecia)
tiredness (fatigue)
sores and swelling of the lining of the digestive tract from mouth to anus (mucositis)
reduced platelet count leading to reduced blood clotting ability (thrombocytopenia)
low red blood cell count (anemia)
fever (pyrexia)
headache
diarrhea

Common side effects (may affect up to 1 in 10 people)

lung inflammation (bronchitis)
upper respiratory tract infection
urinary tract infection
decreased appetite
difficulty sleeping (insomnia)
dizziness
loss of sensation, particularly of the skin (hypoesthesia)
tingling or numbness of hands or feet (paresthesia)
low blood pressure (hypotension)
high blood pressure (hypertension)
cough
coughing up blood (hemoptysis)
mouth and throat pain (oropharyngeal pain)
nosebleed (epistaxis)
constipation
oral pain
enlarged liver (hepatomegaly)
skin rash
redness of the skin (erythema)
muscle spasm
pain during urination (dysuria)
chest pain
pain
generalized weakness (asthenia)
general malaise (malaise)
swelling of hands and feet (peripheral edema)
increased levels of certain enzymes in the blood
changes in blood chemistry
transfusion reaction

Uncommon side effects (may affect up to 1 in 1,000 people)

increased white blood cell count (leukocytosis)
allergic reaction (hypersensitivity)
rejection of bone marrow transplant (graft-versus-host disease)
high levels of uric acid in the blood, which may cause gout (hyperuricemia) (increased uric acid in the blood)
liver damage caused by blockage of small liver veins (veno-occlusive disease)
impaired lung function causing breathlessness (respiratory failure)
swelling and/or fluid accumulation in the lungs (pulmonary edema)
lung inflammation (interstitial pneumonitis)
abnormal lung X-ray (pulmonary infiltration)
bleeding from the lung (pulmonary hemorrhage)
impaired oxygen uptake in the lungs (hypoxia)
skin rash with lesions (maculopapular rash)
condition causing loss of bone density, making bones weaker, more fragile and prone to fractures (osteoporosis)
reaction at the injection site

Rare side effects (may affect up to 1 in 1,000 people)

inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), see section 2.
severe bone, chest, intestinal or joint pain (sickle cell crisis)
sudden, potentially fatal allergic reaction (anaphylactic reaction)
joint pain and swelling resembling gout (pseudogout)
unusual fluid regulation in the body, which may cause swelling (fluid volume disorders)
inflammation of blood vessels in the skin (cutaneous vasculitis)
painful, purplish skin lesions on limbs, sometimes also on face and neck, accompanied by fever (Sweet’s syndrome)
worsening of rheumatoid arthritis
unusual changes in urine
decreased bone density
formation of blood cells outside the bone marrow (extramedullary hematopoiesis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or nurse. You may also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Accofil

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 outer carton and on the prefilled syringe after the abbreviation “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
The syringe may be kept outside the refrigerator and stored at room temperature (not above 25°C) for a single period, ending before the expiry date indicated on the label, of up to 15 days. After this period, the product must not be returned to the refrigerator and must be discarded.
Keep the syringe in the outer packaging to protect the medicine from light.
Do not use Accofil if you notice that the solution is cloudy, has changed colour, or contains particles.
Do not recap used needles, as you may accidentally prick yourself. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Accofil contains

The active substance is filgrastim. Each pre-filled syringe contains 30 MU (300 micrograms) of filgrastim in 0.5 mL, corresponding to 0.6 mg/mL.
The other components are acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80, and water for injections.

Description of the appearance of Accofil and contents of the pack
Accofil is a clear, colourless solution for injection or infusion in a pre-filled syringe marked with a graduated scale with 40 notches from 0.1 mL to 1 mL, with an injection needle. Each pre-filled syringe contains 0.5 mL of solution.
Accofil is available in packs of 1, 3, 5, 7 and 10 pre-filled syringes, with or without a safety needle device and alcohol swabs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare Single Member S.A.,
64th Km National Road Athens Lamia, Schimatari,
32009, Greece

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL /
NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A.E.
Tel: +30 210 7488 821

More detailed information on this medicinal product is available on the following website: European Medicines Agency https://www.ema.europa.eu

The following information is intended exclusively for physicians or healthcare professionals:
Accofil does not contain preservatives. To avoid potential risks of microbial contamination, Accofil syringes are for single use only.
Accidental exposure to freezing temperatures for up to 48 hours does not affect the stability of Accofil. If exposure exceeds 48 hours or if the product has been frozen more than once, Accofil MUST NOT be used.
To improve traceability of granulocyte colony-stimulating factors, the product name (Accofil) and the batch number of the administered product should be clearly recorded in the patient's medical record.
Accofil must not be diluted with sodium chloride solution. This medicinal product must not be mixed with other medicinal products except as indicated below. Diluted filgrastim may be adsorbed onto glass and plastic materials unless diluted as specified below.
If necessary, Accofil may be diluted in 5% glucose. Dilution to a final concentration below 0.2 MU (2 µg) per mL is not recommended at any time.
The solution should be inspected visually before use. Only clear, particle-free solutions should be used.
For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per mL, human serum albumin should be added to a final concentration of 2 mg/mL.
Example: in a final injection volume of 20 mL, total doses of filgrastim below 30 MU (300 µg) should be administered with 0.2 mL of 200 mg/mL (20%) human albumin solution.
When diluted in 5% glucose, Accofil is compatible with glass and plastic materials including PVC, polyolefin (a copolymer of polypropylene and polyethylene), and polypropylene.

After dilution
Chemical and physical in-use stability of the diluted infusion solution has been demonstrated for 30 hours at a temperature of 25 °C ± 2 °C. From a microbiological standpoint, the medicinal product should be used immediately. Otherwise, storage times and conditions prior to use are the responsibility of the user and must not exceed 30 hours at 25 °C ± 2 °C, unless the solution was prepared under aseptic, controlled, and validated conditions.

Use of the pre-filled syringe with needle safety device
The needle safety device covers the needle after injection and prevents needle-stick injury to the operator. The device does not interfere with normal syringe use. Push the plunger rod and push firmly at the end of the injection to ensure complete emptying of the syringe. Hold the skin firmly until the injection is complete. Keep the syringe steady and slowly lift the thumb from the plunger head. The plunger rod will move upward with the thumb, and the spring will retract the needle from the injection site into the needle shield.

Use of the pre-filled syringe without needle safety device
Administer the dose according to standard procedure.
Do not use the pre-filled syringe if it has been dropped on a hard surface.

Disposal
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Accofil 48 MU/0.5 mL (0.96 mg/mL) injectable solution/infusion in pre-filled syringe

filgrastim
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

What Accofil is and what it is used for
What you need to know before using Accofil
How to use Accofil
Possible side effects
How to store Accofil
Contents of the pack and other information

1. What Accofil is and what it is used for

A reduction in the number of white blood cells (neutropenia) can occur for various reasons and makes the body less able to fight infections. Accofil stimulates the bone marrow to produce more white blood cells, which help fight infections.

Accofil may be used:

to increase the number of white blood cells after chemotherapy treatment, thereby helping to prevent infections;
to increase the number of white blood cells after a bone marrow transplant, thereby helping to prevent infections;
prior to high-dose chemotherapy to stimulate the bone marrow to produce more stem cells, which can then be collected and reinfused after treatment. These stem cells may be collected from you or from a donor. The stem cells will then return to the bone marrow and produce blood cells;
in patients with advanced-stage HIV infection, to help reduce the risk of infections.

2. What you need to know before using Accofil

Do not use Accofil

If you are allergic to filgrastim or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Accofil:
Before starting treatment, inform your doctor if you have:

Sickle cell anaemia, as Accofil may trigger a sickle cell crisis.
Osteoporosis (a bone disease).

Immediately inform your doctor if, during treatment with Accofil, you:

Experience pain in the upper left side of your abdomen or at the tip of your left shoulder (these may be symptoms of an enlarged spleen (splenomegalia) or possibly of a ruptured spleen).
Notice unusual bleeding or bruising (these may be symptoms of a reduced platelet count in the blood (thrombocytopenia), leading to decreased blood clotting ability).
Develop sudden symptoms of an allergic reaction, such as rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing, or difficulty breathing, as these may indicate a severe allergic reaction (hypersensitivity).
Have swelling of the face or ankles, blood in your urine, brown-coloured urine, or notice you are urinating less than usual (possible signs of glomerulonephritis).
Experience symptoms of inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), which has been rarely reported in cancer patients and healthy individuals. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Inform your doctor if you experience any of these symptoms.

Loss of response to filgrastim
If you notice a loss of effectiveness or inability to maintain efficacy during treatment with filgrastim, your doctor will investigate possible reasons, including whether you have developed antibodies that neutralize the activity of filgrastim.
Your doctor may wish to monitor you particularly closely; see section 4.
If you have severe chronic neutropenia, you may be at risk of developing blood cancer (leukaemia, myelodysplastic syndrome). Discuss with your doctor the risks of developing blood cancers and the necessary tests. Do not use Accofil if you have or are likely to develop blood cancers, unless otherwise directed by your doctor.
If you are a stem cell donor, you must be between 16 and 60 years of age.
Pay special attention to other products that stimulate white blood cells.
Accofil belongs to a group of medicines that stimulate the production of white blood cells.
Healthcare professionals must always record the exact name of the medicine you are using.

Other medicines and Accofil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Accofil has not been studied in pregnant or breastfeeding women.
Accofil is not recommended during pregnancy.
It is important that you inform your doctor if:

You are pregnant or breastfeeding;
You suspect you may be pregnant, or
You are planning to become pregnant.

If you become pregnant while being treated with Accofil, inform your doctor.
Unless otherwise instructed by your doctor, you must stop breastfeeding while using Accofil.

Driving and using machines
Accofil has minor effects on the ability to drive or use machines. This medicine may cause dizziness; therefore, before driving or operating machinery, wait and observe how you feel after receiving Accofil.

Accofil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, i.e. it is essentially "sodium-free".

Accofil contains sorbitol
This medicine contains 50 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with hereditary fructose intolerance, a rare genetic disorder, you (or your child) must not take this medicine. Patients with hereditary fructose intolerance are unable to metabolize fructose, and its accumulation can cause serious side effects.
Before taking this medicine, inform your doctor if you (or your child) have hereditary fructose intolerance or if your child feels unwell, vomits, or experiences unpleasant reactions such as bloating, stomach cramps, or diarrhoea after consuming sweet foods or drinks.

Allergy to natural rubber (latex)
The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause severe allergic reactions.