12 ME / 0.2 ml, 30 ME / 0.5 ml, 48 ME / 0.5 ml solution for injection / infusion
filgrastim
What Nivestim is and what it is used for
Nivestim 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 through biotechnology for use as medicines. Nivestim works by stimulating the bone marrow to produce more white blood cells.
The number of white blood cells can be low ( neutropenia ) for various reasons and this makes it harder for the body to fight infection. Nivestim stimulates the bone marrow to rapidly produce new white blood cells.
Nivestim can be used for the following:
- To increase the number of white blood cells after treatment with chemotherapy to help prevent infection .
- To increase the number of white blood cells after bone marrow transplantation to help prevent infection .
- Before chemotherapy in high doses you to make so that the bone marrow produces more stem cells that can be collected and given back to you after the treatment. The stem cells can be taken from you or from a donor. They are then returned to the bone marrow where they produce blood cells .
- To increase the number of white blood cells if you suffer from severe chronic neutropenia , to help prevent infection .
- To patients with advanced HIV infection , to help reduce the risk of infection .
What you need to know before using Nivestim
Do not use Nivestim
- 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 Nivestim.
Tell your doctor before starting treatment if you have any
- sickle cell anemia , as Nivestim may cause sickle cell crisis
- osteoporosis (osteoporosis).
Tell your doctor immediately during treatment with Nivestim, if you
- 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, below the ribs on the left side or at the tip of the left shoulder blade (this may be a symptom of an enlarged spleen (so-called splenomegaly ) or possibly a broken spleen ).
- bleeds or bruises unusually easily (there may be symptoms of low platelet count ( thrombocytopenia ), which causes the blood not to coagulate properly).
Inflammation of the aorta (the large blood vessel that transports 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 increased 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, your doctor will check if you have developed antibodies that neutralize the activity of filgrastim.
Your doctor may want to monitor you closely, see section 4 of this leaflet.
If you are a patient and have severe chronic neutropenia, there may be a risk of developing blood cancer ( leukemia, myelodysplastic syndrome (MDS)). Talk to your doctor about the risks of getting cancer in the blood and what tests should be done. If you get cancer or there is a chance that you may get cancer in your blood, do not use Nivestim 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 medicines that stimulate the white blood cells
Nivestim belongs to a group of medicines that stimulate the production of white blood cells. The healthcare staff must always note in the medical record exactly which medicine you are using.
Other medicines and Nivestim
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Nivestim has not been studied in pregnant or lactating women.
Nivestim 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.
Tell your doctor if you become pregnant while you are being treated with Nivestim.
Unless your doctor tells you otherwise, stop breastfeeding if you are using Nivestim.
Driving and using machines
Nivestim 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 Nivestim, before driving or using machines.
Nivestim contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose of 0,6 mg / ml or 0,96 mg / ml, ie essentially ‘sodium-free’.
Nivestim 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 Nivestim
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, nurse, or pharmacist.
How do I get Nivestim and how big is dose one?
Nivestim is usually given as a daily injection into the tissue just under the skin (a so-called subcutaneous injection ). It can also be given as a daily, slow injection into a vein (a so-called intravenous infusion ). How much does you get depends on your illness and your weight. Your doctor will tell you how much Nivestim to take.
Patients undergoing bone marrow transplantation after chemotherapy:
In normal cases, you will receive the first dose of Nivestim at least 24 hours after chemotherapy and at least 24 hours after receiving your bone marrow transplant.
You, or people who take care of you, can teach you how to give your subcutaneous injection so that you can continue your treatment at home. However, you should not try this yourself if you have not received enough instruction first from your healthcare provider.
How long do I need to take Nivestim?
You will need to take Nivestim until your white blood cell count is normal. Blood samples will be taken regularly to check the number of white blood cells in your body. Your doctor will tell you how long you need to take Nivestim.
Use for children
Nivestim is used to treat children who are receiving chemotherapy or who have low white blood cell count ( neutropenia ). Dosage for children receiving chemotherapy is the same as for adults.
If you use more Nivestim than you should
Do not increase the dose as prescribed by your doctor. If you think you have injected more Nivestim than you should, contact your doctor as soon as possible.
If you forget to use Nivestim
If you have missed an injection, or have injected too little, contact your doctor as soon as possible. Do not take a double dose to make up for a forgotten dose.
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 get an allergic reaction with weakness, drop in blood pressure, difficulty breathing, swelling of the face ( anaphylaxis ), skin rash, itchy rash ( hives ), swelling of the face, lips, mouth, tongue, or throat ( angioedema ) and shortness of breath ( dyspnoea ).
– If you get a cough, fever, and difficulty breathing ( dyspnoea ). This may be a sign of acute respiratory distress syndrome (ARDS).
– If you get kidney damage ( glomerulonephritis). Kidney damage has been observed in patients receiving filgrastim. Contact your doctor immediately if you get swollen in the face or around the ankles, get blood in the urine or brown urine, or notice that you do not urinate as often as usual.
– If you get any of the following side effects:
- Swelling or fluid retention, which may be associated with urination more infrequently 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 get two or more of any 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.
This can be a symptom 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 (egg white) in your urine ( proteinuria ).
A common side effect of filgrastim is a pain in muscles and bones (musculoskeletal pain), which can be relieved with common painkillers ( analgesics ). Patients undergoing a stem cell or bone marrow transplant may suffer from a so-called graft-versus-host disease (GvHD). This is a reaction of the donated cells directed at the patient receiving the transplant. Signs and symptoms of this condition are rashes on the palms or soles of the feet, sores in the oral cavity, intestines, liver, skin, or the eyes, lungs, vagina, and joints.
In healthy stem cell donors, an increase in the number of white blood cells ( leukocytosis ) and a decrease in the number of platelets may occur. This impairs the blood’s ability to coagulate ( thrombocytopenia ). The doctor will check this.
Very common side effects ( may affect more than 1 user in 10):
in cancer patients
- 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, which 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
- difficult to sleep (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)
- transplant bone marrow rejection ( 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 (veno-occlusive disease)
- Impaired lung function leading to shortness of breath (respiratory failure)
- swelling and / or fluid accumulation in the lungs ( pulmonary edema )
- inflammation of the lungs (interstitial lung disease)
- abnormal X-ray of the lungs (lung infiltrate)
- haemorrhage 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 Nivestim
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the outer carton and the pre-filled syringe after EXP. The expiration date is the last day of the specified month.
Store and transport cold (2 o C-8 o C). Do not freeze. Store the pre-filled syringe in the outer carton. Sensitive to light.
The syringe can be taken out of the refrigerator and left at room temperature for a single period of a maximum of 15 days (but not above 25ºC).
Do not use this medicine if you notice that it is cloudy or if there are particles in it.
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 pack and other information
What Nivestim contains
- The active substance is filgrastim. Each ml contains 60 million units [ME] (600 micrograms) or 96 million units [ME] (960 micrograms) filgrastim.
- Nivestim 12 ME / 0.2 ml solution for injection or infusion; each pre-filled syringe contains 12 million units (ME), 120 micrograms filgrastim in 0.2 ml (equivalent to 0.6 mg / ml).
- Nivestim 30 ME / 0.5 ml solution for injection / infusion; each pre-filled syringe contains 30 million units (ME), 300 micrograms filgrastim in 0.5 ml (equivalent to 0.6 mg / ml).
- Nivestim 48 ME / 0.5 ml solution for injection or infusion; each pre-filled syringe contains 48 million units (ME), 480 micrograms filgrastim in 0.5 ml (equivalent to 0.96 mg / ml).
- The other ingredients are acetic acid (concentrated), sodium hydroxide, sorbitol E420, polysorbate 80 and water for injections.
What the medicine looks like and contents of the pack
Nivestim is a clear, colorless solution for injection/infusion into pre-filled syringes of glass with an injection needle (stainless steel) fitted with a needle guard. The needle cover contains “epoxyprene”, a derivative of natural rubber latex that can come into contact with the needle.
There are 1, 5, 8, or 10 syringes in each pack. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Hospira Zagreb doo
Prudnička Cesta 60
10291 Prigorje Brdovečko
Croatia
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienLuxembourg / LuxemburgPfizer NV / SATel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000 |
| BulgariaPfizer Luxembourg SARE, Clone of BulgariaTel: +359 2 970 4333 | HungaryPfizer Kft.Tel .: + 36 1 488 37 00 |
| Czech RepublicPfizer, spol. s roTel: + 420-283-004-111 | MaltaDrugsales LtdTel .: +356 21 419 070/1/2 |
| DenmarkPfizer ApSTel: + 45 44 20 11 00 | The NetherlandsPfizer bvTel: +31 (0) 10 406 43 01 |
| GermanyPFIZER PHARMA GmbHTel: + 49 (0) 30 550055-51000 | NorwayPfizer ASTel: +47 67 52 61 00 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| GreeceAenorasis SA:Ηλ: + 30 210 6136332 | PolandPfizer Polska Sp. z ooTel .: +48 22 335 61 00 |
| SpainPfizer, SLTel: +34 91 490 99 00 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 55 00 |
| FrancePfizerTel: + 33 (0) 1 58 07 34 40 | RomaniaPfizer România SRLTel: +40 (0) 21 207 28 00 |
| CroatiaPfizer Croatia dooTel: +385 1 3908 777 | SloveniaPfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel: +386 (0) 1 52 11 400 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | Slovak RepublicPfizer Luxembourg SARL, organizerTel: + 421–2–3355 5500 |
| IcelandIcepharma hf.Phone: +354 540 8000 | Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 430 040 |
| ItalyPfizer SrlTel: +39 06 33 18 21 | SwedenPfizer ABTel: +46 (0) 8 550 520 00 |
| .ΠροςPfizer ΕΛΛΑΣ Α.Ε. (Cyprus Branch):Ηλ: +357 22 817690 | United Kingdom (Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161 |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel .: + 371 670 35 775 |