BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion

• Keep this leaflet. You may need to read it again.
• Your doctor will also give you the following educational materials:
  • Educational Brochure for Patients and Caregivers, which contains important safety information that you need to be aware of before you are given BLINCYTO and during treatment with BLINCYTO.
  • Patient Card with contact details of your medical team and information when to call your doctor or nurse. Keep this Patient Card with you, at all times.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to blinatumomab or any of the other ingredients of this medicine (listed in section 6).
• if you are breast-feeding.

Talk to your doctor, pharmacist or nurse before using BLINCYTO if any of these apply to you. BLINCYTO may not be suitable for you:

• if you have ever had neurological problems, for example, shaking (or tremor), abnormal sensations, seizures, memory loss, confusion, disorientation, loss of balance, or difficulty in speaking. If you are still suffering from active neurological problems or conditions, tell your doctor. If your leukaemia has spread to your brain and/or spinal cord, your doctor may have to treat this first before you can start treatment with BLINCYTO. Your doctor will assess your nervous system and conduct tests before deciding if you should receive BLINCYTO. Your doctor may need to take special care of you during your treatment with BLINCYTO.
• if you have an active infection.
• if you have ever had an infusion reaction after previously using BLINCYTO. Symptoms may include wheezing, flushing, face swelling, difficulty breathing, low or high blood pressure.
• if you think you may need any vaccinations in the near future, including those needed to travel to other countries. Some vaccines must not be given within two weeks before, at the same time as or in the months after you receive treatment with BLINCYTO. Your doctor will check if you should have the vaccination.

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:

• if you experience seizures, difficulty in speaking or slurred speech, confusion and disorientation, or loss of balance.
• if you develop chills or shivering, or you feel warm; you should take your temperature as you may have a fever - these may be symptoms of an infection.
• if you develop a reaction at any time during your infusion, which may include dizziness, feeling faint, nauseated, face swelling, difficulty breathing, wheezing, or rash.
• if you have severe and persistent stomach pain, with or without nausea and vomiting, as these may be symptoms of a serious and potentially fatal condition known as pancreatitis (inflammation of the pancreas).

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’.

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:

• there is a problem with the pump or the pump alarm sounds
• the infusion bag empties before the scheduled bag change
• if the infusion pump stops unexpectedly. Do not try to restart your pump.

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.

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.

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• The active substance is blinatumomab. Each vial of powder contains 38.5 micrograms of blinatumomab. Reconstitution with water for injections results in a final blinatumomab concentration of 12.5 micrograms/mL.
• The other ingredients in the powder are citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80 (E433), and sodium hydroxide.
• The solution (stabiliser) contains citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80 (E433), sodium hydroxide and water for injections.

BLINCYTO is a powder for concentrate and solution for solution for infusion.

Each pack of BLINCYTO contains:

• 1 glass vial containing a white to off-white powder.
• 1 glass vial containing a colourless-to-slightly yellow, clear solution.