4 million IU / ml powder and solvent for solution for injection or infusion.
1. What Granocyte is and what it is used for
The name of your medicine is Granocyte powder and solvent for solution for injection or infusion (only called Granocyte in this leaflet). The active substance in Granocyte is lenograstim, which belongs to a group of medicines called cytokines.
Granocyte helps your body produce more blood cells, which are needed to fight infection.
- These blood cells are produced in your bone marrow .
- Granocyte stimulates your bone marrow to produce more of the cells known as blood stem cells .
- Granocyte then facilitates the conversion of these immature cells into well-functioning blood cells .
- Granocyte especially helps to form more white blood cells called neutrophils . Neutrophils are important in the body’s defense against infection .
Granocyte is used:
- After cancer treatment, when your level of white blood cells is too low (so-called neutropenia )Some cancer treatments (also called chemotherapy ) affect your bone marrow , which can lead to a decrease in the number of white blood cells . It is mainly the neutrophils that are affected and this is called “neutropenia”. Neutropenia lasts until your body is prone to produce more white blood cells . When you have only a few neutrophils , you are more susceptible to infections , which can sometimes be very serious. Granocyte reduces the period of time when you have low levels of these by stimulating your body to produce new white blood cells .
- When you need more of your own blood stem cells (so-called mobilization)Granocyte can be used to stimulate your bone marrow production of blood stem cells, so-called “mobilization”. This can occur on its own or possibly after chemotherapy . These blood stem cells are taken from your body and collected using a special machine. The blood stem cells can then be stored and can then be returned to you by transfusion .
- After a bone marrow or blood stem cell transplantTo kill diseased cells before undergoing a bone marrow or blood stem cell transplant, you will either receive high-dose chemotherapy or undergo whole-body radiation therapy. A bone marrow or blood cell transplant is then given to you by blood transfusion . It may take some time for your new bone marrow to start producing new blood cells (including white blood cells ). Granocyte helps your body speed up the recovery of your new white blood cells .
- When you want to donate your blood stem cellsGranocyte can also be used on healthy donors. In these cases, the bone marrow is stimulated to produce extra blood stem cells, so-called mobilization – see above. These healthy donors can then donate blood stem cells to anyone who needs them.
Granocyte can be given to adults, adolescents, and children older than 2 years.
2. What you need to know before you use Granocyte
Do not use Granocyte
- if you are allergic to lenograstim or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: skin rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
- if you have a certain type of cancer called myeloid cancer. However, in some cases of newly diagnosed acute myeloid leukemia or if you are older than 55 years, you can still use Granocyte.
- if you have received chemotherapy for your cancer the same day.
Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Granocyte.
Warnings and cautions
Talk to your doctor or pharmacist before using Granocyte:
- if you have ever had an illness, especially allergies , infections , kidney or liver problems
- if you have sickle cell anemia or are a carrier of sickle cell anemia as Granocyte may cause sickle cell crisis.
Contact a doctor immediately during treatment with Granocyte if you:
- Experiencing swelling of the face or ankles, blood in the urine or brown urine or discovering that you urinate less than usual
If you are not sure if this applies to you, talk to your doctor or pharmacist before using Granocyte.
During treatment with lenograstim, your doctor may recommend further checks because some patients have developed blood clots in the veins and arteries are (see also section 4 “Possible Side Effects”).
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 increased inflammatory markers. Tell your doctor if you experience these symptoms.
Children and young people
Talk to your doctor before using this medicine:
- if you or your child have a type of cancer called acute lymphocytic leukemia and if you or your child are younger than 18 years.
Other drugs and Granocyte
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal remedies.
If you want to donate your blood stem cells and you are receiving anticoagulation therapy (such as warfarin or heparin ) then make sure that your doctor is aware of this before starting treatment with Granocyte. Also, tell your doctor if you know you have any other blood clot problems.
You should not use Granocyte for the next 24 hours before starting anti-cancer chemotherapy or within 24 hours after stopping anti-cancer chemotherapy.
Pregnancy and breastfeeding
Do not use this medicine if you are pregnant, may become pregnant, or are breastfeeding unless your doctor considers it necessary.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Granocyte has not been tested in pregnant or lactating women.
Driving and using machines
The effect of granocyte on the ability to drive or operate machinery or tools is unknown. Wait to drive or handle machines or tools before you know how you are affected by Granocyte.
Granocyte contains phenylalanine
This medicine contains 10 mg phenylalanine (10 mg/ml after reconstitution ) per vial.
Phenylalanine can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
Granocyte contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free.
3. How to use Granocyte
Granocyte should always be given under the supervision of an experienced oncologist and/or hematologist.
It is usually administered by a doctor, nurse, or pharmacist as an injection or infusion.
However, some patients may be taught how to inject themselves. Talk to your doctor, nurse, or pharmacist if you have any questions regarding the administration of this drug.
How much Granocyte is administered
If you are not sure why you are taking Granocyte or if you have any questions about how much Granocyte you are taking, talk to your doctor, nurse, or pharmacist.
After bone marrow transplantation, chemotherapy or mobilization of blood stem cells after chemotherapy
- Depending on your body surface area, your doctor will decide how much Granocyte to administer to you. The body surface area is calculated using your weight and your length and is measured in square meters (m 2 ).
- The usual dose of Granocyte is 19.2 million IU (150 micrograms) per square meter of body surface area per day. Dose one for children older than 2 years and adolescents is the same as for adults.
- The duration of treatment with Granocyte is determined by your doctor. You can be administered Granocyte for up to 28 days.
- When Granocyte is given after chemotherapy to mobilize blood stem cells, your doctor will tell you when it’s time to collect your blood stem cells.
For blood stem cell mobilization with Granocyte alone
- Depending on your body weight, your doctor will decide how much Granocyte to administer to you.
- The usual dose of Granocyte is 1.28 million IU (10 micrograms) per kilogram body weight per day. Dose one for children older than 2 years and adolescents is the same as for adults.
- Granocyte is administered to you as an injection under the skin for 4-6 days.
- Collection of your blood stem cells takes place between 5 and 7 days later.
GRANOCYTE 34 million IU / ml can be used in patients with a body surface area up to 1.8 m 2.
If you use more Granocyte than you should
If you are given this medicine by a doctor, nurse, or pharmacist, it is unlikely that you will receive an overdose. They will monitor your progress and control dose one. If you are unsure why you are receiving a dose of medicine, always ask.
If you give yourself too much Granocyte, you must contact a doctor immediately or go to a hospital. Take the medicine pack with you. This is so that the doctor knows what it is you have taken. You can get particularly severe side effects if you administer too high a dose of Granocyte. The most likely side effect that you may get is a muscle and skeletal pain.
If you forget to use Granocyte
Do not take a double dose to make up for a forgotten injection. Always contact your doctor who will tell you what to do.
During your treatment with Granocyte, you should be monitored by a doctor who can take regular blood tests on you. With these blood tests, your levels of different blood cells ( neutrophils, other white blood cells, red blood cells, platelets ) can be checked.
Other blood tests performed by other doctors may show changes during the time you are being treated with Granocyte. If you are going to have a blood test, it is therefore important that you tell your doctor that you are being treated with Granocyte as the number of white blood cells may increase, the number of platelets may decrease and the enzyme levels may increase. These changes usually improve when treatment with Granocyte is stopped. If you are having a blood test, it is therefore important that you tell your doctor that you are being treated with Granocyte.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
For cancer patients and healthy donors:
Stop using Granocyte and talk to your doctor immediately about:
- You get pain in your upper left abdomen or in your left shoulder. This may be a sign of an enlarged spleen . This is a common side effect called splenomegaly while a very rare side effect is that the spleen ruptures.
- You get a severe allergic reaction called anaphylactic shock . This is a sudden life-threatening reaction. Symptoms include lethargy, weakness, difficulty breathing or swelling of the face. This is a very rare side effect.
- You have difficulty breathing. Symptoms include cough, fever or shortness of breath. This can be a sign of respiratory failure syndrome (ARDS) which is a very rare side effect .
- You have any of the following or a combination of the following side effects: swelling or bloating, which may be associated with urinating less often, difficulty breathing, swollen abdomen and satiety and a general feeling of tiredness. These symptoms generally develop rapidly. They can be symptoms of a less common condition, (occurs in up to 1 in 100 users) called “capillary leakage syndrome” which is caused by blood leaking from the small blood vessels in the body and which requires urgent medical attention.
- You have kidney damage ( glomerulonephritis ). Kidney damage has been seen in patients receiving Granocyte. Contact a doctor immediately if you experience swelling of the face or ankles, blood in the urine or brown urine or find that you urinate less than usual.
Contact your doctor or pharmacist as soon as possible if you experience the following side effects:
A very common side effect is (can occur in more than 1 in 10)
- Pain in the skeleton, muscles, joints, back and legs and arms, headache, fever and / or nausea. If these side effects occur, the pain can be controlled with the help of common painkillers.
- Temporary fluctuations in blood test results, including those related to your liver function. This usually does not involve any additional precautions and is normalized after completion of treatment.
- After donating blood stem cells, you may feel tired. This is due to a decrease in the number of red blood cells . The number of white blood cells can become high for a short period of time. You may also experience a decrease in platelet counts ( blood platelets ), which causes you to bleed and bruise more easily than usual.
Common side effects are (may affect up to 1 in 10)
- A reaction at the injection site.
- General tenderness and pain including abdominal pain.
Less common side effects are (may affect up to 1 in 100)
- Bloody cough (hemoptysis).
Rare side effects are (may affect up to 1 in 1000)
- Bleeding from the lungs ( pulmonary haemorrhage).
- Inflammation of the aorta (the large blood vessel that carries blood from the heart to the body), see section 2.
Very rare side effects are (may affect up to 1 in 10 000 users)
- Skin problems such as plum-colored skin, bulging areas on your arms or legs and sometimes on your face or neck. This in connection with fever may be a sign of Sweet’s syndrome. Red nodules in combination with fever and headache may be signs of Lyell’s syndrome . Other skin problems such as red bulging bruises on the legs or sores on your body in combination with fever and joint pain can also occur.
- An allergic reaction . Symptoms may include rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
Has been reported (occurs in an unknown number of users)
- Blood test results indicating inflammation (eg elevated C-reactive protein ).
- Blood clots in veins and arteries .
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Granocyte
Keep this medicine out of the sight and reach of children.
Do not use any part of the contents of the Granocyte Powder and Liquid for Injection or Infusion solution, expiration date (EXP). The expiry date for Granocyte powder is indicated on the outer carton, on the blister paper, and the label of each Granocyte bottle. The expiry date of the diluent (water for injection ) is indicated either on the label of each ampoule filled with water for injection or on the label of the syringe pre-filled with water.
The expiration date is the last day of the specified month.
Do not store above 30 ° C. Do not freeze.
Immediate use of Granocyte after reconstitution or dilution is recommended. If necessary, the reconstituted or diluted solution can be stored for up to 24 hours at 2-8 ºC (in a refrigerator).
The medicine 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.
6. Contents of the packaging and other information
- Granocyte 34 contains after processing 33,6 million international units (equivalent to 263 micrograms) per ml of the active substance lenograstim.
- The other ingredients of Granocyte powder are arginine , phenylalanine, methionine, mannitol (E 421), polysorbate 20 and dilute hydrochloric acid . Excipients with known effect and effect: phenylalanine.
- The diluent used to prepare the solution is water for injections.
What the medicine looks like and contents of the pack
Granocyte powder and solvent for solution for injection or infusion are supplied in a set of:
- Powder in a vial + 1 ml of diluent in a glass ampoule without needles,
- Powder in vial + 1 ml of solvent in a prefilled syringe with two injektionssnålar (larger beige used for preparation (19G) and the smaller brown used for administration (26G))
Granocyte is available in pack sizes of 1 and 5 sets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
In nnehavare Authorization Holder
Sanofi AB, Box 30052, 104 25 Stockholm
Sanofi Winthrop Industrie
180 rue Jean-Jaurés, BP40
94702 Maisons-Alfort Cedex-France