0.3 mg / ml solution for injection
filgrastim
What Neupogen is and what it is used for
Neupogen is a white blood cell growth factor (granulocyte colony-stimulating factor) and belongs to a group of medicines called cytokines. Growth factors are proteins that are produced naturally in the body, but they can also be produced using biotechnology for use as medicines. The Neupogen works by getting the bone marrow to produce more white blood cells.
A reduced number of white blood cells ( neutropenia ) can occur for several reasons and it makes the body worse at fighting infection. Neupogen stimulates the bone marrow to rapidly produce new white blood cells.
Neupogen can be used:
- to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;
- to increase the number of white blood cells after a bone marrow transplant to help prevent infections;
- before chemotherapy in high doses to get bone marrow one to produce more stem cells , which can be collected and given back to the body after treatment. These stem cells can be taken from you or from a donor. Then the stem cells go back into the bone marrow and produce blood cells;
- to increase white blood cell count if you suffer from severe chronic neutropenia to help prevent infections;
- to patients with advanced HIV infection to help reduce the risk of infection .
What you need to know before using Neupogen
Do not use Neupogen
- if you are allergic 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 Neupogen.
Before treatment, you must tell your doctor if you:
- have sickle cell anemia , as Neupogen can cause sickle cell crisis.
- have osteoporosis (osteoporosis).
Tell your doctor immediately if you are taking Neupogen during treatment:
- 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 allergic reaction (hypersensitivity).
- suffer from swelling of the face or ankles, blood in the urine or brown urine or if you find that you urinate less than usual ( glomerulonephritis ).
- 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).
- Inflammation of the aorta (the large blood vessel that carries blood from the heart to the body) has been reported with the frequency “rare” in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, malaise, back pain and elevated inflammatory markers. Tell your doctor if you experience these symptoms.
Unsatisfactory treatment response
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 this 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 Neupogen 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
Neupogen belongs to a group of drugs 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 Neupogen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Neupogen has not been tested in pregnant or lactating women.
Neupogen is not recommended during pregnancy.
You must tell your doctor if you:
- is pregnant or breastfeeding;
- think you may be pregnant; or
- plans to have children.
If you become pregnant during treatment with Neupogen, tell your doctor.
Unless your doctor tells you otherwise, you must stop breastfeeding if you are using Neupogen.
Driving and using machines
Neupogen may have less effect on the ability to drive and use machines. This medicine may cause dizziness. You should wait and see how you feel after taking Neupogen before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Neupogen contains sodium and sorbitol
Neupogen contains sodium
Neupogen contains less than 1 mmol (23 mg) sodium per dose of 0.3 mg / ml, ie essentially ‘sodium-free’. is next to “sodium-free”.
Neupogen contains sorbitol
This medicine contains 50 mg of sorbitol per ml.
Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance, a rare, inherited disease, you (or your child) should not use this medicine. Patients with hereditary fructose intolerance can not break down fructose, which can cause serious side effects.
Talk to your doctor before using this medicine if you (or your child) have hereditary fructose intolerance, or if your child can no longer eat sweet food or drink without feeling sick, vomiting, or feeling uncomfortable such as bloating stomach cramps, or diarrhea.
How to use Neupogen
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, nurse, or pharmacist.
How is Neupogen given and how much should I take?
Neupogen is usually given as a daily injection into the tissue just under the skin (called a subcutaneous injection ). It can also be given as a daily slow injection into a vein (called an intravenous infusion ). The usual dose varies depending on your illness and weight. Your doctor will tell you how much Neupogen to take.
Patients undergoing a bone marrow transplant after chemotherapy:
You will normally receive the first dose of Neupogen at least 24 hours after the end of chemotherapy and at least 24 hours after the bone marrow transplant.
How long do I have to take Neupogen?
You must take Neupogen until your white blood cell count is normal. Regular blood tests are done to check the number of white blood cells in your body. Your doctor will tell you how long to take Neupogen.
Use for children
Neupogen is used to treat children who are receiving chemotherapy or who have a severely reduced number of white blood cells ( neutropenia ). Dosage one for children receiving chemotherapy is the same as for adults.
If you use more Neupogen than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Neupogen
If you have missed an injection, contact your doctor as soon as possible.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately during treatment:
- if you suffer from an allergic reaction with weakness, drop in blood pressure, difficulty breathing, swelling of the face ( anaphylaxis ), rash, itchy rash ( urticaria ), swelling of the face, lips, mouth, tongue or throat ( angioedema ) and shortness of breath ( dyspnoea ).
- if you have a cough, fever and difficulty breathing ( dyspnoea ) as this may be a sign of ARDS ( acute severe respiratory failure ).
- if you get kidney damage ( glomerulonephritis ). Kidney damage has been observed in patients receiving Neupogen. Contact a doctor immediately if you experience swelling of the face or ankles, blood in the urine or brown urine or if you find that you urinate less than usual.
- if you get any of the following side effects:- swelling or accumulation of fluid, which may be associated with urination less frequently than usual, difficulty breathing, swollen abdomen and a feeling of satiety, and a general feeling of tiredness. These symptoms often develop at a rapid rate.These symptoms can be a sign of a side effect called “capillary leakage syndrome”, which causes fluid to leak from small blood vessels into the body. This condition must be treated immediately.
- if you experience two or more of the following symptoms at the same time:fever, or frostbite, or freezing sharply, rapid heartbeat, confusion or disorientation, shortness of breath, severe pain or discomfort, and cold sweaty or sweaty skin.These can be symptoms of a condition called sepsis (or blood poisoning), a serious infection with inflammation throughout the body, which can be life-threatening and requires immediate medical attention.
- if you get 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, as it may indicate problems with the spleen (enlarged spleen ( splenomegaly ) or ruptured spleen ).
- if you are being treated for severe chronic neutropenia and have blood in your urine ( haematuria ). Your doctor may need to check your urine regularly if you experience this side effect or if you have protein in your urine ( proteinuria ).
A common side effect of using Neupogen 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 towards the patient being transplanted. Signs and symptoms include skin rashes on the palms or soles of the feet and sores in the mouth, intestines, liver, skin or eyes, lungs, vagina, and joints.
In healthy stem cell donors, there may be an increase in the number of white blood cells ( leukocytosis ) and a decrease in the number of platelets, which impairs the blood’s ability to coagulate ( thrombocytopenia ). The doctor will check this.
Very common side effects ( may affect more than 1 in 10 people):
- decreased platelet count , which reduces the blood’s ability to coagulate ( thrombocytopenia )
- low red blood cell count ( anemia )
- headache
- diarrhea
- vomiting
- nausea
- abnormal hair loss or thinning ( alopecia )
- fatigue (exhaustion)
- soreness and swelling of the mucous membrane on the inside of the digestive tract that runs from the mouth to the anus ( mucositis )
- fever ( pyrexia )
Common side effects ( may affect up to 1 in 10 people):
- inflammation of the lungs ( bronchitis )
- upper respiratory tract infection
- urinary tract infection
- decreased appetite
- difficulty sleeping (insomnia)
- dizziness
- decreased sensitivity to touch, in particular skin stimulation ( 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)
- nosebleeds ( epistaxis )
- constipation
- pain in the mouth
- enlarged liver ( hepatomegaly )
- rash
- redness ( erythema )
- muscle spasms
- pain associated with urination ( dysuria )
- chest pain
- pain
- general feeling of weakness ( asthenia )
- general malaise
- swelling of the hands and feet (peripheral edema )
- elevated levels of certain enzymes in the blood
- changes in blood chemistry
- transfusion reactions
Uncommon side effects ( may affect up to 1 in 100 people):
- increased white blood cell count ( leukocytosis )
- allergic reaction (hypersensitivity)
- rejection of transplanted bone marrow (graft versus host disease)
- high levels of uric acid in the blood, which can cause gout (hyperuricemia) (elevated level of uric acid in the blood)
- liver damage caused by blockage of the thin veins inside the liver (venous occlusive disease)
- impaired lung function, causing shortness of breath (respiratory failure)
- swelling and / or fluid in the lungs ( pulmonary edema )
- pneumonia (interstitial lung disease)
- abnormal X-rays of the lungs (lung infiltration)
- bleeding from the lungs ( pulmonary haemorrhage)
- decreased oxygen uptake in the lungs ( hypoxia )
- elevated skin rash (maculopapular rash)
- disease that makes the skeleton more fragile, which makes the skeleton weaker and easier to break ( osteoporosis )
- reaction at the injection site
Rare side effects ( may affect up to 1 in 1,000 people):
- severe pain in the skeleton, chest, intestines or joints (sickle cell anemia with crisis)
- sudden life-threatening allergic reaction ( anaphylactic reaction )
- gout-like pain and swelling in joints (pseudoarthritis)
- changes in fluid regulation in the body, which can lead to swelling (fluid volume disturbances)
- inflammation of the blood vessels of 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 changes in the urine
- reduced bone density
- inflammation of the aorta (the large blood vessel that carries blood from the heart to the body), see section 2
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 container in the outer carton. Sensitive to light.
Temporary freezing does not harm Neupogen.
Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you notice discoloration, turbidity, or particles. The liquid 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 to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is filgrastim 0.3 mg in a 1 ml vial (0.3 mg / ml).
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 80, water for injections.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Amgen Europe BV
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
This medicine is authorized in the European Economic Area under the name Neupogen, except in Cyprus, Greece, and Italy where it is called Granulokine.