6 mg solution for injection
pegfilgrastim
What Neulasta is and what it is used for
Neulasta contains the active substance pegfilgrastim. Pegfilgrastim is a protein that is produced using biotechnology in a bacterium called E. coli. It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte colony-stimulating factor) produced in the body.
Neulasta is used to reduce the duration of neutropenia (low white blood cell count ) and the occurrence of febrile neutropenia (low white blood cell count with concomitant fever) which may be due to the use of cytotoxic chemotherapy (drugs that destroy fast-growing cells). The white blood cells are important because they help your body fight infection. These blood cells are very sensitive to chemotherapy, and this treatment can lead to a reduction in their number in the body. About the number of white blood cells drops to a low level, there may not be enough left in the body to fight bacteria, and then you may become more susceptible to infection.
Your doctor has given you Neulasta to help your bone marrow (the part of the skeleton where blood cells are formed) form more white blood cells that help your body fight infection.
What you need to know before using Neulasta
Do not use Neulasta
- if you are allergic to pegfilgrastim, filgrastim or any of the other ingredients of this medicine.
Warnings and cautions
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Neulasta:
- if you suffer from an allergic reaction , which can manifest itself as a feeling of weakness, drop in blood pressure, difficulty breathing, swelling of the face ( anaphylaxis ), redness and swelling, rash and itchy skin areas .
- if you are allergic to latex. The gray needle sleeve on the pre-filled syringe contains a latex derivative that can cause severe allergic reactions.
- if you are allergic to acrylate-based adhesive. The self-adhesive injector is attached with an acrylate-based adhesive and can therefore give rise to an allergic reaction .
- if you have a cough, fever and difficulty breathing. This may be a sign of acute respiratory distress syndrome.
- if you experience any of the following side effects:
- swelling or fluid retention, which may occur while urinating less frequently than usual; breathing difficulties; swollen abdomen and a feeling of satiety; as well as a general feeling of tiredness.This can be a symptom of a condition called capillary leakage syndrome, which causes blood to leak from the small blood vessels. See section 4.
- if you experience pain in the upper abdomen on the left side or the tip of the left shoulder blade. This may be a sign of splenomegaly .
- if you have recently had a serious lung infection ( pneumonia ), fluid in the lungs ( pulmonary edema ), inflammation of the lungs (interstitial lung disease) or abnormal results on chest X-ray (lung infiltration).
- if you know you have altered blood cell count (eg increased white blood cell count or anemia ) or decreased platelet count , which reduces the blood’s ability to coagulate ( thrombocytopenia ). Your doctor may want to check this more often than usual.
- if you have sickle cell anemia . Your doctor may want to check this more often than usual.
- If you are a patient with breast or lung cancer, then Neulasta in combination with chemotherapy and / or radiation therapy may increase the risk of a cancerous stage called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever and easy bruising and bleeding.
- if you experience sudden signs of allergy , such as a rash, itching or hives , swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing. These may be signs of a severe allergic reaction .
- if you have symptoms that indicate inflammation of the aorta (the large blood vessel that carries blood from the heart to the body). This has been reported with the frequency “rare” 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.
You will have to submit blood and urine samples regularly as Neulasta can damage the small “filters” in your kidneys ( glomerulonephritis ).
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Neulasta. Stop using Neulasta and seek medical attention immediately if you experience any of the symptoms described in section 4.
Talk to your doctor about the risk of developing blood cancer. If you develop or are at high risk of developing blood cancer, do not use Neulasta unless your doctor tells you to.
Impaired treatment response to pegfilgrastim
If you stop responding to treatment with pegfilgrastim or if the response to treatment decreases, your doctor will investigate the reasons for this. Your doctor will, among other things, check if you have developed antibodies that neutralize the activity of pegfilgrastim.
Other medicines and Neulasta
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Neulasta has not been tested by pregnant women. You must tell your doctor if you:
- is pregnant,
- think you are pregnant or,
- plans to have children.
If you do not receive any other instructions from your doctor, you must stop breastfeeding if you are using Neulasta.
Driving and using machines
Neulasta has no or negligible effect on the ability to drive and use machines.
Neulasta contains sorbitol (E420) and sodium
This medicine contains 30 mg sorbitol in each prefilled syringe equivalent to 50 mg/ml.
This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, ie essentially ‘sodium-free’
How to use Neulasta
Neulasta is intended for use by adults from 18 years of age.
Always use Neulasta exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The usual dose is a 6 mg subcutaneous injection ( injection under the skin). Dose one should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
How to inject yourself with Neulasta
Your doctor may decide that you should inject Neulasta yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if your doctor or nurse has not shown you what to do.
More information on how to inject yourself with Neulasta can be found at the end of this leaflet.
Do not shake Neulasta vigorously as this may affect its effect.
If you use more Neulasta than you should
If you take more Neulasta then you should contact a doctor, pharmacist, or nurse.
If you forget to take Neulasta
If you are injecting Neulasta yourself and have missed your dose, you should contact your doctor to discuss when you should inject the next dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of these side effects, talk to your doctor straight away:
- swelling or fluid retention, which may occur while urinating less frequently than usual; breathing difficulties; swollen abdomen and a feeling of satiety; as well as a general feeling of tiredness. These symptoms often develop rapidly.
These symptoms may be a sign of a less common condition (may affect up to 1 in 100 people) called “capillary leakage syndrome”, which causes blood to leak from small blood vessels into the body. This condition must be treated immediately.
Very common side effects ( may affect more than 1 user in 10) :
- skeletal pain. Your doctor may recommend what you can take to relieve skeletal pain.
- headache and nausea.
Common side effects ( may affect up to 1 in 10 people) :
- rash, itchy red raised rash (contact dermatitis / local skin reactions) may occur when using the self-adhesive injector.
- injection site pain.
- application site reactions in the form of redness , bleeding, bruising, pain and discomfort may occur with the use of the self-adhesive injector.
- general joint and muscle pain.
- some changes in blood values may occur, but these are detected during routine blood tests. Your white blood cells may increase over a limited period of time. The number of platelets can decrease which can lead to bruising.
Uncommon side effects ( may affect up to 1 in 100 people) :
- allergy-like reactions, including redness and swelling, rash and raised itchy skin areas.
- severe allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
- increased spleen size.
- anthrax. Some cases of anthrax were fatal. It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or up against the left shoulder, as this may indicate problems with the spleen.
- breathing problems. If you have a cough, fever and difficulty breathing, consult a doctor.
- Sweets syndrome (plum-colored, raised, painful skin changes on the arms and legs and sometimes on the face and neck with fever) have occurred, but other factors may be important.
- cutaneous vasculitis ( inflammation of the blood vessels of the skin).
- damage to the small filters in the kidneys ( glomerulonephritis ).
- redness at the injection site.
- bloody cough (hemoptysis).
- blood disorders ( myelodysplastic syndrome [MDS] or acute myeloid leukemia [AML]).
Rare side effects ( may affect up to 1 in 1,000 people) :
- inflammation of the aorta (the large blood vessel that carries blood from the heart to the body), see section 2.
- bleeding from the lungs ( pulmonary hemorrhage).
- Stevens-Johnson syndrome can start as reddish, target-like or round spots on the torso, often with blisters in the middle. Skin peeling and sores in the mouth, throat, nose, genitals and eyes may also occur. These reactions are often preceded by fever and flu-like symptoms . If you develop any of these symptoms, stop using Neulasta and contact your doctor immediately or seek medical attention. See also section 2.
How to store Neulasta
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 carton and syringe label (EXP). The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
You can remove Neulasta from the refrigerator and store it at room temperature (maximum 30 ° C) for a maximum of 3 days. Once a syringe has been removed from the refrigerator and reached room temperature (maximum 30 ° C), it must be used within 3 days or discarded.
Do not freeze. Neulasta can be used if the solution has been inadvertently frozen for less than 24 hours at a time.
Store in the outer carton. Sensitive to light.
Do not use this medicine if it is cloudy or contains particles.
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
Marketing Authorization Holder and Manufacturer
Content declaration
- The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml solution.
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections. See section 2.
What the medicine looks like and the contents of the pack
Neulasta is a clear, colorless solution for injection in a pre-filled syringe (6 mg / 0.6 ml).
Each pack contains 1 pre-filled glass syringe with an attached stainless steel needle with a gray needle sleeve.
The pre-filled syringe (with or without blister pack) can also be delivered with an automatic needle guard.
Marketing Authorization Holder and Manufacturer
Amgen Europe BV
Minervum 7061
4817 ZK Breda
Netherlands