38.5 micrograms concentrate for concentrate and solution for infusion , blinatumomab solution

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • 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 also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
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 packaging and other information 

1. What BLINCYTO is and what it is used for

The active substance in BLINCYTO is blinatumomab. It belongs to a group of drugs called cytostatic / cytotoxic drugs that target cancer cells.

BLINCYTO is used to treat adults with acute lymphocytic leukemia . Acutelymphocytic leukemia is a cancer of the blood in which a special type of white blood cell called “B lymphocytes” multiplies uncontrollably. This drug works by enabling the immune system to attack and destroy these blood cancer cells. BLINCYTO is used when acute lymphocytic leukemia has recurred or has not responded to previous treatment (called recurrent or refractory acute lymphocytic leukemia ).

It is also used for patients with acute lymphocytic leukemia who still have a small number of cancer cells left after previous treatment (called MRD (minimal residual disease), minimal residual disease).

BLINCYTO is used to treat children (≥ 1 year), adolescents and young adults with acute lymphocytic leukemia (ALL) when previous treatments have not worked or have stopped working.

2. What you need to know before using BLINCYTO

Do not use BLINCYTO

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

Warnings and cautions

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

  • if you have ever had neurological problems, such as tremors , sensory disturbances, seizures, memory loss, confusion, disorientation, balance difficulties or speech difficulties. If you still have active neurological problems or conditions, tell your doctor. If the leukemia has spread to the brain and / or spinal cord, your doctor may need to treat this before you can start treatment with BLINCYTO. Your doctor will examine your nervous system and perform tests before deciding whether or not to get BLINCYTO. Your doctor may need to give you special care during treatment with BLINCYTO.
  • if you have an active infection .
  • if you have previously had an infusion reaction after receiving BLINCYTO. Symptoms may include wheezing, shortness of breath, swelling of the face, difficulty breathing, low or high blood pressure .
  • if you think you may soon need some vaccination, even those you may need when traveling abroad. Some vaccines must not be given within two weeks before, at the same time as or during the months following treatment with BLINCYTO. Your doctor will decide if you should be vaccinated.

Tell a doctor, pharmacist, or nurse immediately about you

  • suffer from any of the following reactions while you are receiving BLINCYTO, as they may need to be treated and the dose adjusted:
  • if you have seizures, speech difficulties or slurred speech, confusion and disorientation or balance difficulties.
  • If you experience chills or chills, or feel hot, take the temperature and check if you have a fever, as these symptoms may mean that you have an infection .
  • if you experience any type of reaction during infusion , which may include dizziness, fainting, nausea, swelling of the face, difficulty breathing, wheezing or rash.
  • if you suffer from severe and persistent stomach pain, with or without nausea and vomiting, as this may be a symptom of a serious and potentially fatal condition called 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 become pregnant while receiving BLINCYTO. The doctor will talk to you about precautions in connection with vaccinations of the child.

Before each infusion of BLINCYTO, you will be given medicines that help to minimize a possible life-threatening complication called tumor lysis syndrome. The syndrome is due to chemical disorders in the blood, which are caused by the breakdown of dying cancer cells. You may also be given medicines to lower your fever.

During treatment and especially during the very first days after starting treatment, you may experience a severe decrease in white blood cell count ( neutropenia ), severe decrease in white blood cell count and fever (febrile neutropenia ), elevated liver levels or elevated levels of uric acid . Your doctor will regularly take blood samples to check the number of blood cells during treatment with BLINCYTO.

Children and young people

BLINCYTO should not be used by children under 1 year of age.

Other medicines and BLINCYTO

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant, 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.

Contraceptive

Women who may become pregnant should use an effective contraceptive during treatment and for at least 48 hours after the last treatment. Talk to your doctor or nurse about appropriate contraceptive methods.

Pregnancy

It is not known what effects BLINCYTO has on pregnant women, but given BLINCYTO’s mechanism of action, it could harm the unborn baby. Do not use BLINCYTO during pregnancy unless your doctor thinks it is the best medicine for you.

If you become pregnant during treatment with BLINCYTO, tell your doctor or nurse. The doctor will talk to you about precautions in connection with vaccinations of the child.

Breast-feeding

You should not breast-feed during and for at least 48 hours after your last treatment. It is not known whether BLINCYTO is excreted in human milk, but a risk to the breast-fed baby cannot be ruled out.

Driving and using machines

You should not drive, use heavy machinery or engage in risky activities while receiving BLINCYTO. BLINCYTO can cause neurological problems, such as dizziness, seizures, confusion, coordination and balance disorders.

BLINCYTO contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose , ie essentially ‘sodium-free’. is next to “sodium-free”.

3. How to use BLINCYTO

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

How BLINCYTO is given

You will receive BLINCYTO via a vein ( intravenously ) for a continuous period of 4 weeks using an infusion pump (this is 1 treatment cycle). This is followed by a period of 2 weeks when you do not receive any infusion . You will have the infusion catheter inserted throughout the treatment cycle.

Normally, 2 treatment cycles are given with BLINCYTO if you have recurrent or refractory acute lymphocytic leukemia , and 1 treatment cycle if you have acute lymphatic leukemia of the MRD type (minimal residual disease). If you respond well to this treatment, your doctor may decide to give you up to 3 additional treatment cycles. The number of treatment cycles and dose one you will receive depends on how well you tolerate and respond to BLINCYTO. The doctor will discuss with you how long treatment you should receive. Treatment may also be discontinued depending on how you tolerate BLINCYTO.

If you have recurrent or refractory acute lymphocytic leukemia , it is recommended that you spend the first 9 days of treatment and the first 2 days of the second treatment cycle in a hospital under the supervision of a physician or nurse experienced in the use of anticancer drugs.

If you have acute lymphatic leukemia of the type MRD (minimal residual disease), it is recommended that you spend the first 3 days of treatment and the first 2 days of subsequent treatment cycles, in a hospital under the supervision of a doctor or nurse experienced in the use of cancer drugs.

If you have or have had neurological problems, it is recommended that you be treated in hospital for the first 14 days. The doctor will discuss with you if you can receive the continued treatment at home after the first hospital stay. The treatment may involve a nurse regularly changing the infusion bag.

Your doctor will decide when to change your BLINCYTO infusion bag, which may vary from day to day every 4 days. The infusion rate may be faster or slower depending on how often the bag is changed.

The first treatment cycle

If you have recurrent or refractory acute lymphocytic leukemia and your body weight is greater than or equal to 45 kg, the recommended starting dose in the first treatment cycle is 9 micrograms per day for 1 week. The doctor may then decide to increase the dose one to 28 micrograms per day during treatment weeks 2, 3 and 4.

If your body weight is less than 45 kg, the recommended starting dose in the first treatment cycle will be based on your weight and height. The doctor may then decide to increase the dose one in treatment weeks 2, 3 and 4.

If you have acute lymphoblastic leukemia of the type MRD (minimal residual disease), your dose of BLINCYTO will be 28 micrograms per day during the first cycle.

Subsequent treatment cycles

If your doctor decides that you should receive additional BLINCYTO cycles and your body weight is 45 kg or more, your pump will be set to infuse a dose of 28 micrograms per day.

If your doctor decides that you should receive additional BLINCYTO cycles and your body weight is less than 45 kg, your pump will be set to infuse a dose based on your weight and height.

Medicines that you receive before each BLINCYTO cycle

Before treatment with BLINCYTO you will be given other medicines (pre-medication) to minimize infusion reactions and other possible side effects . This may include treatment with cortisone (eg dexamethasone).

Infusion catheter

If you have a catheter for infusion , it is very important that the area around the catheter is kept clean, otherwise there is a risk that you may get an infection . Your doctor or nurse will show you how to care for the catheter.

Infusion pump and intravenous tubes

Do not adjust the pump settings , even if problems have occurred or if the pump is alarming. Any change in the pump settings can lead to a dose that is too high or too low.

Contact a doctor or nurse immediately if:

  • there is a problem with the pump or if the pump is alarming
  • the bag has been emptied before it is time for the next scheduled bag change
  • the infusion pump unexpectedly stops. Do not try to start the pump again.


The doctor or nurse will give you advice on how to take care of your daily tasks when you are connected to the pump. Contact your doctor or nurse if you have any questions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects can be serious.

Tell your doctor immediately if you get any of the following or a combination of the following side effects:

  • chills, chills, fever, rapid heartbeat, drop in blood pressure, aching muscles, feeling tired, coughing, difficulty breathing, confusion, redness , swelling or discharge in the affected area or at the infusion site – these may be signs of an infection
  • neurological symptoms: tremors ( tremor ), confusion, disorders of brain function ( encephalopathy ), communication difficulties ( aphasia ), seizures (convulsions)
  • fever, swelling, chills, decreased or elevated blood pressure and fluid in the lungs, which can become severe – these can be signs of a so-called cytokine release syndrome
  • if you suffer from severe and persistent stomach pain, with or without nausea and vomiting, as this may be a symptom of a serious and potentially fatal condition called pancreatitis ( inflammation of the pancreas).

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 elevated levels of potassium, uric acid, and phosphate in the blood as well as decreased calcium levels in the blood (tumor lysis syndrome). Your doctor will regularly take blood samples during treatment with BLINCYTO.

Other side effects are:

Very common side effect is (can occur in more than 1 in 10):

  • infection is in the blood caused by bacteria, fungi or viruses , or other types of infection er
  • decreased levels of certain white blood cells with or without fever ((febrile) neutropenia, leukopenia ), decreased levels of red blood cells , decreased levels of platelets
  • fever, swelling, chills, decreased or elevated blood pressure and fluid in the lungs, which can be severe (cytokine release syndrome)
  • difficulty sleeping
  • headache, tremors ( tremor )
  • rapid heartbeat ( tachycardia )
  • low blood pressure
  • cough
  • nausea, diarrhea, vomiting, constipation, stomach pain
  • rash
  • back pain, pain in arms and / or legs
  • fever ( pyrexia ), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing ( edema ), chills
  • low levels of antibodies, called immunoglobulins, which help the immune system fight infections (reduced immunoglobulins)
  • elevated liver values ​​( ALT, AST, GT)
  • reactions associated with infusion one, which may include wheezing when breathing, swelling, facial swelling, difficulty breathing, low blood pressure , high blood pressure .

Common side effects are (may affect up to 1 in 10):

  • serious infection, which can lead to organ failure, shock, or death ( sepsis )
  • pneumonia ( CAP )
  • elevated levels of white blood cells ( leukocytosis ), decreased levels of certain white blood cells (lymphopenia)
  • allergic reaction
  • complications after cancer treatment, which lead to elevated levels of potassium , uric acid and phosphate in the blood as well as to decreased levels of calcium in the blood (tumor lysis syndrome)
  • confusion, disorientation
  • disorders of brain function ( encephalopathy ), such as communication difficulties ( aphasia ), tingling in the skin ( paresthesia ), seizures, difficulty thinking clearly and reasoning, memory problems, difficulty coordinating body movement ( ataxia)
  • drowsiness ( somnolence ), numbness, dizziness
  • nerve problems affecting the head and neck, such as visual disturbances, drooping eyelids and/or drooping muscles on one side of the face, hearing problems, or difficulty swallowing (cranial nerve disorder)
  • wheezing or breathing difficulties ( dyspnoea ), shortness of breath (respiratory failure)
  • high blood pressure ( hypertension )
  • hot flashes
  • slemhosta
  • elevated bilirubin in the blood
  • skeletal pain
  • chest pain or other pain
  • high levels of certain enzymes, including blood enzymes
  • weight gain.

Less common side effects are (may affect up to 1 in 100):

  • excessive activation of white blood cells associated with inflammation(haemophagocytic histiocytosis)
  • swollen lymph nodes ( lymphadenopathy )
  • fever, swelling, chills, decreased or elevated blood pressure and fluid in the lungs, which can be severe and lead to death (cytokine storm)
  • a condition that causes fluid from small blood vessels to leak into the body (capillary leakage syndrome).
  • speech difficulties
  • nerve problems affecting the head and neck, such as visual disturbances, drooping eyelids and / or drooping muscles on one side of the face, hearing problems or difficulty swallowing (cranial nerve disorder).

Side effects that occurred more often in adolescents and children are:

  • decreased number of red blood cells ( anemia ), decreased number of platelets ( thrombocytopenia ), decreased number of certain white blood cells ( leukopenia )
  • fever ( pyrexia )
  • reactions associated with infusion one, which may include facial swelling, low blood pressure, high blood pressure (infusion-related reaction)
  • weight gain
  • high blood pressure ( hypertension )

Reporting of side effects

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store BLINCYTO

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 expiration date is the last day of the specified month.

Unopened vials:

  • Store and transport cold (2 ° C – 8 ° C).
  • Do not freeze.
  • Store in the original package. Sensitive to light.

Ready-made solution (BLINCYTO solution):

  • Reconstituted solution stored cold must be used within 24 hours. The vials can alternatively be stored at room temperature (up to 27 ° C) for up to 4 hours.

Diluted solution (reconstituted infusion bag ):

If your infusion bag is changed at home:

  • Infusion bags with BLINCYTO solution for infusion come in special packages that contain “cooling lamps”.
    • Do not open the package.
    • Store the package at room temperature (up to 27 ° C).
    • The packaging must not be stored in the refrigerator or freezer.
  • The nurse opens the package and the infusion bag is then stored in the refrigerator until infusion one.
  • Once stored in the refrigerator, the infusion bags must be used within 10 days of preparation.
  • Once the solution has reached room temperature (up to 27 ° C), it should be infused within 96 hours.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is blinatumomab. One vial of powder contains 38.5 micrograms of blinatumomab. Reconstitution with water for injections gives 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 and sodium hydroxide.
  • The solution (stabilizer) contains citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.

What the medicine looks like and the contents of the pack

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

Each package BLINCYTO contains:

  • 1 glass bottle containing white to off-white powder.
  • 1 glass bottle containing a colorless to the slightly yellowish clear solution.

Marketing Authorization Holder and Manufacturer

Amgen Europe BV

Minervum 7061

4817 ZK Breda

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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