Neupogen

Package Leaflet: Information for the Patient

Neupogen, 300 micrograms/ml (30 million IU/ml), solution for injection
filgrastim

Read all of 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Neupogen is and what it is used for
• 2. Important information before using Neupogen
• 3. How to use Neupogen
• 4. Possible side effects
• 5. How to store Neupogen
• 6. Contents of the pack and other information

1. What Neupogen is and what it is used for

Neupogen is a white blood cell growth factor (granulocyte-colony stimulating factor) that belongs to a group of medicines called cytokines. Growth factors are proteins that are produced naturally in the body and can be made using biotechnology methods for use as medicines. Neupogen stimulates the bone marrow to produce more white blood cells. A decrease in white blood cells (neutropenia) can occur for several reasons. Neutropenia makes the body more susceptible to infection. Neupogen stimulates the bone marrow to produce new white blood cells quickly. Neupogen can be used:

• to increase the number of white blood cells after chemotherapy, to prevent infections;
• to increase the number of white blood cells after bone marrow transplantation, to prevent infections;
• before high-dose chemotherapy to stimulate the bone marrow to produce more stem cells, which can be collected from the patient's blood and given back after the treatment. The stem cells can be collected from the patient or a donor. The transplanted stem cells return to the bone marrow and start producing blood cells;
• to increase the number of white blood cells in people with severe chronic neutropenia, to prevent infections;
• in patients with advanced HIV infection to reduce the risk of infections.

2. Important information before using Neupogen

When not to use Neupogen

• if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Neupogen, discuss this with your doctor, pharmacist, or nurse. Before starting treatment, tell your doctor:

• if you have sickle cell disease; Neupogen may cause a crisis;
• if you have osteoporosis (bone disease).

Tell your doctor immediately if you experience any of the following while using Neupogen:

• sudden signs of an allergic reaction, such as rash, itching, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, difficulty breathing, or swallowing;
• swelling of the face or ankles, blood in the urine, or urine that is darker than usual, or less urine than usual (kidney problems);
• pain in the upper left side of the abdomen, pain on the left side under the ribs, or pain at the top of the left shoulder [these may be signs of an enlarged spleen (splenomegalia) or a ruptured spleen];
• unusual bleeding or bruising [these may be signs of a low platelet count (thrombocytopenia) and reduced blood clotting];
• in patients with cancer and in healthy donors, rare cases of a condition called aortitis (inflammation of the aorta) have been reported. Symptoms may include fever, abdominal pain, feeling unwell, back pain, and increased markers of inflammation. If you experience any of these symptoms, tell your doctor.

Loss of response to filgrastim

If you experience a loss of response or inability to maintain a response to filgrastim, your doctor will investigate the cause, including the possibility of antibodies that neutralize the effect of filgrastim. Your doctor may recommend closer monitoring, as described in section 4 of this leaflet. In patients with severe chronic neutropenia, there is a risk of developing blood cancer (leukemia, myelodysplastic syndrome). Discuss with your doctor the risk of developing blood cancer and what tests should be performed. If you develop blood cancer or are at risk of developing it, do not use Neupogen unless your doctor recommends it. Donors of stem cells must be between 16 and 60 years old.

Special precautions when using other white blood cell stimulating products

Neupogen belongs to a group of medicines that stimulate the production of white blood cells. The doctor should always clearly record the trade name of the medicine given to the patient.

Neupogen and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

No studies have been conducted with Neupogen in pregnant or breastfeeding women. Neupogen should not be used during pregnancy. It is important to tell your doctor:

• if you are pregnant or breastfeeding;
• if you think you may be pregnant; or
• if you plan to have a baby.

If you become pregnant while using Neupogen, tell your doctor. If your doctor does not recommend otherwise, you should stop breastfeeding while using Neupogen.

Driving and using machines

Neupogen may have a minor influence on the ability to drive and use machines. This medicine may cause dizziness. It is recommended that you wait and see how you feel after taking Neupogen before driving or operating machinery.

Neupogen contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 0.3 mg/ml vial, which is essentially sodium-free.

Neupogen contains sorbitol

This medicine contains 50 mg of sorbitol per ml. Sorbitol is a source of fructose. If you have hereditary fructose intolerance, a rare genetic disorder, you should not take this medicine. In patients with hereditary fructose intolerance, the body does not break down the fructose in this medicine, which can cause serious side effects. Tell your doctor before taking this medicine if you have hereditary fructose intolerance or if you cannot tolerate sweet foods or drinks due to nausea, vomiting, or unpleasant side effects such as bloating, stomach cramps, or diarrhea.

3. How to use Neupogen

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

How Neupogen is given and what dose is used

Neupogen is usually given daily by injection under the skin (subcutaneous injection). It can also be given daily by slow injection into a vein (intravenous infusion). The dose depends on the disease being treated and the patient's body weight. Your doctor will tell you what dose to use. Patients undergoing bone marrow transplantation after chemotherapy: You will usually receive the first dose of Neupogen at least 24 hours after chemotherapy or at least 24 hours after bone marrow transplantation.

How long to use Neupogen

Neupogen should be used until the white blood cell count returns to normal. Regular blood tests will be performed to check the white blood cell count. Your doctor will tell you how long to use Neupogen.

Use in children

Neupogen is used in children receiving chemotherapy or with severe chronic neutropenia. The dosing in children receiving chemotherapy is the same as in adults.

Using more Neupogen than prescribed

If you think you have used more Neupogen than prescribed, contact your doctor as soon as possible.

Missing a dose of Neupogen

If you miss a dose of Neupogen, contact your doctor as soon as possible. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediatelyif you experience any of the following while using Neupogen:

• an allergic reaction, including weakness, sudden drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itching (hives), swelling of the face, lips, mouth, tongue, or throat (angioedema), and shortness of breath (dyspnea).
• cough, fever, and breathing difficulties (dyspnea), which may be signs of acute respiratory distress syndrome.
• kidney damage (kidney problems). Kidney damage has occurred in patients receiving Neupogen. Contact your doctor immediately if you experience swelling of the face or ankles, blood in the urine, or urine that is darker than usual, or less urine than usual.
• any of the following side effects or a combination of them:
• swelling or puffiness, which may be associated with less frequent urination, difficulty breathing, swelling of the abdomen, or a feeling of fullness and general tiredness. These symptoms usually develop rapidly. They may be signs of a condition called capillary leak syndrome, which causes blood to leak from small blood vessels into the body and requires immediate medical attention.
• a combination of any of the following symptoms:
• fever or chills, or a feeling of cold, rapid heart rate, confusion, disorientation, shortness of breath, severe pain or discomfort, and sweaty or clammy skin. These may be signs of a condition called sepsis (blood poisoning), a serious infection that can be life-threatening and requires immediate medical attention.
• pain in the upper left side of the abdomen, pain on the left side under the ribs, or pain at the top of the left shoulder, which may be signs of spleen problems [enlarged spleen (splenomegalia) or ruptured spleen].
• blood in the urine (hematuria) in patients with severe chronic neutropenia. Your doctor may recommend regular urine tests if you experience this side effect or if you have protein in your urine (proteinuria).

Muscle or bone pain (musculoskeletal pain) is a common side effect of Neupogen, which can be relieved with painkillers. In patients undergoing stem cell or bone marrow transplantation, a condition called graft-versus-host disease may occur, which is a reaction of the donor cells against the recipient's body; symptoms and signs of this condition include rash on the palms of the hands or soles of the feet, and mouth ulcers, and pain in the mouth, gut, liver, skin, or eyes, lungs, vagina, and joints. In healthy donors of stem cells, increased white blood cell count (leukocytosis) and decreased platelet count (thrombocytopenia) have been observed, which will be monitored by your doctor. Very common side effects(may affect more than 1 in 10 people):

• decreased platelet count, which reduces the ability of blood to clot (thrombocytopenia)
• decreased red blood cell count (anemia)
• headache
• diarrhea
• vomiting
• nausea
• unusual hair loss or weakness (alopecia)
• fatigue
• pain and swelling of the mucous membranes of the digestive tract from the mouth to the anus (mucositis)
• fever

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

• inflammation of the lungs (bronchitis)
• infection of the upper respiratory tract
• infection of the urinary tract
• decreased appetite
• sleep disorders (insomnia)
• dizziness
• numbness or tingling, especially in the skin (paresthesia)
• low blood pressure (hypotension)
• high blood pressure (hypertension)
• cough
• coughing up blood (hemoptysis)
• pain in the mouth and throat (oropharyngeal pain)
• nosebleeds
• pain in the mouth
• enlargement of the liver (hepatomegaly)
• rash
• redness of the skin (erythema)
• muscle spasms
• pain when urinating (dysuria)
• chest pain
• discomfort
• general weakness (asthenia)
• general feeling of being unwell
• swelling of the hands and feet (peripheral edema)
• increased activity of some enzymes in the blood
• changes in blood biochemical test results
• transfusion reaction

Uncommon side effects(may affect up to 1 in 100 people):

• increased white blood cell count (leukocytosis)
• allergic reaction (hypersensitivity)
• rejection of the bone marrow transplant (graft-versus-host disease)
• high levels of uric acid in the blood, which can cause gout (hyperuricemia)
• damage to the liver caused by blockage of small veins in the liver (hepatic veno-occlusive disease)
• abnormal lung function leading to shortness of breath (respiratory failure)
• swelling and (or) fluid in the lungs (pulmonary edema)
• inflammation of the lung tissue (interstitial lung disease)
• abnormal lung image on X-ray (pulmonary infiltrates)
• bleeding in the lungs (pulmonary hemorrhage)
• abnormal oxygen absorption in the lungs (hypoxemia)
• raised skin rash (erythematous rash)
• a disease that causes bones to become weak and brittle (osteoporosis)
• inflammation of the aorta (aortitis), see section 2
• production of blood cells outside the bone marrow (extramedullary hematopoiesis)

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. Side effects can be reported to the national reporting system listed below. You can also report side effects directly via:

Department of Drug Safety and Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Neupogen

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2°C – 8°C).

Store the vials in the outer carton to protect from light.

Accidental freezing does not affect the quality of the medicine.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any discoloration, cloudiness, or particles. The solution should be clear and colorless.

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 protect the environment.

6. Contents of the pack and other information

What Neupogen contains

• The active substance is filgrastim at a strength of 300 micrograms/ml (30 million IU/ml).
• The other ingredients are acetic acid, sodium hydroxide 1N, sorbitol (E420), polysorbate 80, and water for injections.

What Neupogen looks like and contents of the pack

Neupogen is a clear, colorless solution for injection/injection concentrate for solution for infusion (sterile concentrate) in a vial. Neupogen is available in packs containing five vials of 1 ml each.

Marketing authorization holder and manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Marketing authorization holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Manufacturer

Amgen Technology (Ireland) Unlimited Company

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

For further information on this medicine, contact the local representative of the marketing authorization holder:

Poland

Amgen Biotechnology Sp. z o.o.

ul. Puławska 145

02-715 Warsaw

Tel.: +48 22 581 3000

medinfo-pol@amgen.com

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the name

Neupogen, except in Cyprus, Greece, and Italy, where it is authorized under the name Granulokine.

Date of last revision of the leaflet: March 2024.

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (www.urpl.gov.pl/).

Information intended for healthcare professionals only:

When used as a concentrate for solution for infusion, Neupogen should be diluted in 20 ml of 5% glucose solution. Further information is available in the Summary of Product Characteristics.