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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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The product code(s) for this leaflet is: PLGB 13832/0018.
Blincyto
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion
blinatumomab
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What BLINCYTO is and what it is used for
2. What you need to know before you use BLINCYTO
3. How to use BLINCYTO
4. Possible side effects
5. How to store BLINCYTO
6. Contents of the pack and other information
The active ingredient in BLINCYTO is blinatumomab. This belongs to a group of medicines called antineoplastic agents which target cancer cells.
BLINCYTO is used to treat adults with acute lymphoblastic leukaemia. Acute lymphoblastic leukaemia is a cancer of the blood in which a particular kind of white blood cell called “B lymphocyte” is growing out of control. This medicine works by enabling your immune system to attack and destroy these abnormal white blood cancer cells. BLINCYTO is used when acute lymphoblastic leukaemia has come back or has not responded to previous treatment (referred to as relapsed/refractory acute lymphoblastic leukaemia).
It is also used in adult patients with acute lymphoblastic leukaemia who still have a small number of cancer cells remaining after previous treatment (referred to as minimal residual disease).
BLINCYTO is used to treat children (≥ 1 year old), teenagers and young adults with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Talk to your doctor, pharmacist or nurse before using BLINCYTO if any of these apply to you. BLINCYTO may not be suitable for you:
Tell your doctor, pharmacist or nurse immediately if you experience any of the following reactions whilst receiving BLINCYTO as these may need to be treated and your dose adjusted:
Your doctor or nurse will monitor you for signs and symptoms of these reactions.
Tell your doctor, pharmacist or nurse immediately if you became pregnant whilst receiving BLINCYTO. Your doctor will talk to you about precautions in using vaccinations for your baby.
Before each infusion cycle of BLINCYTO, you will be given medicines which help reduce a potentially life-threatening complication known as tumour lysis syndrome, which is caused by chemical disturbances in the blood due to the breakdown of dying cancer cells. You may also be given medicines to reduce fever.
During treatment, especially in the first few days after treatment start, you may experience a severe low white blood cell count (neutropenia), severe low white blood cell count with a fever (febrile neutropenia), elevated liver enzymes, or elevated uric acid. Your doctor will take regular blood tests to monitor your blood counts during treatment with BLINCYTO.
BLINCYTO should not be used in children below 1 year of age.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Contraception
Women who are able to become pregnant have to use effective contraception during treatment and for at least 48 hours after your last treatment. Talk to your doctor or nurse about suitable methods of contraception.
Pregnancy
The effects of BLINCYTO in pregnant women are not known but based on its mechanism of action, BLINCYTO may harm your unborn baby. You should not use BLINCYTO during pregnancy, unless your doctor thinks that it is the best medicine for you.
If you become pregnant during BLINCYTO treatment, please inform your doctor or nurse. Your doctor will talk to you about precautions in using vaccinations for your baby.
Breast-feeding
You must not breast-feed during and for at least 48 hours after your last treatment. It is not known whether BLINCYTO is excreted in breast milk but a risk for suckling baby cannot be excluded.
Do not drive, use heavy machines, or engage in hazardous activities while you are being given BLINCYTO. BLINCYTO can cause neurological problems such as dizziness, seizures, confusion, coordination and balance disorders.
This medicine contains less than 1 mmol sodium (23 mg) over a 24-hour infusion, that is to say essentially ‘sodium-free’.
Always use this medicine exactly as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.
BLINCYTO will be given to you through a vein (intravenous) continuously for 4 weeks using an infusion pump (this is 1 treatment cycle). You will then have a 2-week break where you will not be given the infusion. Your infusion catheter will be attached to you at all times during each cycle of your treatment.
BLINCYTO is usually given for 2 treatment cycles if you have relapsed/refractory acute lymphoblastic leukaemia, or for 1 treatment cycle if you have minimal residual acute lymphoblastic leukaemia. If you respond to this treatment, your doctor may decide to give you up to 3 additional cycles of treatment. The number of treatment cycles and the dose which you will be given will depend on how you tolerate and respond to BLINCYTO. Your doctor will discuss with you how long your treatment will last. In paediatric patients with high risk first relapse of acute lymphoblastic leukaemia, BLINCYTO will be given for 1 treatment cycle. Your treatment may also be interrupted depending on how you tolerate BLINCYTO.
If you have relapsed/refractory acute lymphoblastic leukaemia it is recommended that the first 9 days of treatment and the first 2 days of the second cycle will be given to you in a hospital or clinic under the supervision of a doctor or nurse experienced in the use of anti-cancer medicines.
If you have minimal residual acute lymphoblastic leukaemia, it is recommended that the first 3 days of treatment and the first 2 days of subsequent cycles will be given to you in a hospital or clinic under the supervision of a doctor or nurse experienced in the use of anti-cancer medicines.
For paediatric patients with high risk first relapse of acute lymphoblastic leukaemia it is recommended that the first 3 days of the treatment cycle with BLINCYTO be given to you in a hospital or clinic under the supervision of a doctor or nurse experienced in the use of anti-cancer medicines.
If you have or had neurological problems, it is recommended that the first 14 days of treatment will be given to you in a hospital or clinic. Your doctor will discuss with you if you can continue treatment at home after your initial hospital stay. Treatment may include a bag change by a nurse.
Your doctor will determine when your BLINCYTO infusion bag will be changed, which may range from every day to every 4 days. The infusion rate may be faster or slower depending on how often the bag is changed.
If you have relapsed/refractory acute lymphoblastic leukaemia and your body weight is greater than or equal to 45 kilograms the recommended initial dose in your first cycle is 9 micrograms per day for 1 week. Your doctor may decide to then increase your dose to 28 micrograms per day for weeks 2, 3, and 4 of your treatment.
If your body weight is less than 45 kilograms, the recommended initial dose in your first cycle will be based on your weight and height. Your doctor may decide to then increase your dose for weeks 2, 3, and 4 of your treatment.
If you have minimal residual acute lymphoblastic leukaemia, your dose of BLINCYTO will be 28 micrograms per day throughout the first cycle.
If you are a paediatric patient with high risk first relapse of acute lymphoblastic leukaemia and your body weight is less than 45 kilograms, the recommended dose for 1 treatment cycle will be based on your weight and height. If your body weight is greater than or equal to 45 kilograms, your dose of BLINCYTO will be 28 micrograms per day throughout 1 treatment cycle.
If your doctor determines that you should be given more cycles of BLINCYTO and if your body weight is greater than or equal to 45 kilograms, your pump will be set to infuse a dose of 28 micrograms per day.
If your doctor determines that you should be given more cycles of BLINCYTO and if your body weight is less than 45 kilograms, your pump will be set to infuse a dose based on your weight and height.
Before your treatment with BLINCYTO, you will be given other medicines (premedication) to help reduce infusion reactions and other possible side effects. These may include corticosteroids (e.g. dexamethasone).
If you have a catheter for infusion, it is very important to keep the area around the catheter clean; otherwise you could get an infection. Your doctor or nurse will show you how to care for your catheter site.
Do not adjust the settings on the pump, even if there is a problem or the pump alarm sounds. Any changes to the pump settings may result in a dose that is too high or too low.
Contact your doctor or nurse immediately if:
Your doctor or nurse will advise you on how to manage your daily activities around your infusion pump. Contact your doctor or nurse if you have questions.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects may be serious.
Tell your doctor immediately if you get any of the following or combination of the following side effects:
Treatment with BLINCYTO can cause a decrease in the levels of certain white blood cells with or without fever (febrile neutropenia or neutropenia) or can lead to increased blood levels of potassium, uric acid, and phosphate and decreased blood levels of calcium (tumour lysis syndrome). Your doctor will take regular blood tests during treatment with BLINCYTO.
Other side effects include:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Additionally, the side effects that happened more often in adolescents and children include:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
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 label and carton after EXP. The expiry date refers to the last day of that month.
Unopened vials:
Reconstituted solution (BLINCYTO solution):
Diluted solution (prepared infusion bag):
If your infusion bag is changed at home:
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
BLINCYTO is a powder for concentrate and solution for solution for infusion.
Each pack of BLINCYTO contains:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in April 2023.