Blincyto 38.5 mcg powder for concentrate and solution for infusion

Introduction

Package Leaflet: Information for the Patient

BLINCYTO 38.5microgramspowder for concentrate and solution for solution for infusion

blinatumomab

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• Your doctor will also give you the following informational materials:
• Patient and caregiver information leaflet, which contains important safety information that you should know before receiving BLINCYTO and during treatment with BLINCYTO.
• Patient information card with the contact information of your medical team and information on when to call your doctor or nurse. Always carry the patient information card with you.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience side effects, ask your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is BLINCYTO and what is it used for
2. What you need to know before you start using BLINCYTO
3. How BLINCYTO will be administered to you
4. Possible side effects
5. Storage of BLINCYTO
6. Contents of the pack and further information

1. What is BLINCYTO and what is it used for

The active substance of BLINCYTO is blinatumomab. It belongs to a group of medicines called antineoplastic agents that target cancer cells.

BLINCYTO is used to treat adults, children, and adolescents with acute lymphoblastic leukemia. Acute lymphoblastic leukemia is a blood cancer where a particular type of white blood cell called "B cells" grows out of control. This medicine works by allowing your immune system to attack and destroy these abnormal cancerous white blood cells. BLINCYTO is used when acute lymphoblastic leukemia comes back or has not responded to previous treatment (known as refractory or relapsed acute lymphoblastic leukemia).

It is also used in adult patients with acute lymphoblastic leukemia who still have a small number of cancer cells that persist after previous treatment (known as minimal residual disease).

BLINCYTO is also used during consolidation treatment. Consolidation treatment for acute lymphoblastic leukemia is a phase of treatment that takes place after the initial phase. Its goal is to eliminate any remaining leukemia cells that may be left after the first phase of treatment.

2. What you need to know before you start 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 breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you start using BLINCYTOif you have any of the following conditions. BLINCYTO may not be suitable for you:

• if you have ever had neurological problems, such as tremors, abnormal sensations, seizures, memory loss, confusion, disorientation, loss of balance, or difficulty speaking. If you still have neurological diseases or problems, tell your doctor. If your leukemia has spread to the brain and/or spinal cord, your doctor may need to treat this problem before you can start treatment with BLINCYTO. Your doctor will assess your nervous system and perform tests before deciding if you should receive BLINCYTO. Your doctor may need to provide you with special care during your treatment with BLINCYTO.
• if you have an active infection.
• if you have ever had a reaction to an infusion after using BLINCYTO previously. Symptoms may include wheezing, flushing, facial swelling, difficulty breathing, and low or high blood pressure.
• if you think you will need any vaccination in the near future, including those required for travel to other countries. Some vaccines should not be given in the 2 weeks before, at the same time as, or in the months after receiving treatment with BLINCYTO. Your doctor will check if you should receive the vaccine.

Tell your doctor, pharmacist, or nurse immediatelyif you experience new symptoms, including the following (among others), while receiving BLINCYTO, as they may need to be treated and your dose may need to be adjusted:

• effects on the nervous system. Symptoms include confusion, lack of attention, and difficulty speaking or writing. Some of these symptoms can be signs of a serious immune reaction called "immune effector cell-associated neurotoxicity syndrome" (ICANS).
• if you have chills or tremors, or feel hot; your temperature should be taken, as you may have a fever; all of these can be symptoms of infection.
• if you develop a reaction at any time during the infusion, which can include dizziness, feeling faint, nausea, facial swelling, difficulty breathing, wheezing, or skin rash.
• if you have persistent and severe stomach pain, with or without nausea and vomiting, as these can be symptoms of a serious and potentially life-threatening problem called pancreatitis (inflammation of the pancreas).

Your doctor or nurse will monitor you for signs and symptoms of these reactions.

Consult your doctor, pharmacist, or nurse immediatelyif you become pregnant during treatment with BLINCYTO. Your doctor will inform you about precautions for the use of vaccines for your baby.

Before each cycle of BLINCYTO infusion, you will be given medicines that help reduce a potentially life-threatening complication called tumor lysis syndrome, which is caused by chemical disorders 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 starting treatment, you may experience a significant decrease in white blood cell count (neutropenia), a significant decrease in white blood cell count with fever (febrile neutropenia), elevated liver enzymes, or an increase in uric acid. Your doctor will perform regular blood tests to monitor your blood counts during treatment with BLINCYTO.

Children and adolescents

Experience with the use of BLINCYTO for the treatment of children under 1 year is limited.

Other medicines and BLINCYTO

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medicine.

Contraception

Women of childbearing potential must use effective contraceptive methods during treatment and for at least 48 hours after the end of treatment. Consult your doctor or nurse about suitable contraceptive methods.

Pregnancy

The effects of BLINCYTO on pregnant women are unknown, but based on the mechanism of action of BLINCYTO, it could harm the fetus. You should not use BLINCYTO during pregnancy unless your doctor considers it the best medicine for you.

If you become pregnant during treatment with BLINCYTO, inform your doctor or nurse. Your doctor will inform you about precautions for the use of vaccines for your baby.

Breastfeeding

You should not breastfeed during treatment and for at least 48 hours after your last treatment. It is unknown whether BLINCYTO passes into breast milk, but the risk to the baby cannot be excluded during breastfeeding.

Driving and using machines

Do not drive, do not use heavy machinery, or engage in hazardous activities while being treated with BLINCYTO. BLINCYTO can cause neurological problems such as dizziness, seizures, confusion, and coordination and balance disorders.

BLINCYTO contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 24 hours of infusion; this is essentially "sodium-free".

3. How BLINCYTO will be administered to you

Follow exactly the administration instructions of this medicine given by your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse again.

BLINCYTO will be administered to you by vein (intravenously) continuously for 4 weeks using an infusion pump (this is 1 treatment cycle). After that, you will have a 2-week rest period where you will not receive the infusion. You will have the infusion catheter in place at all times during each cycle of your treatment. Your doctor will decide when the BLINCYTO infusion bag should be changed, which may be every day or every 4 days. The infusion rate may be faster or slower depending on how often the bag is changed.

How long you will receive treatment with BLINCYTO

BLINCYTO is usually administered for 2 treatment cycles if you have refractory or relapsed acute lymphoblastic leukemia, or for 1 treatment cycle if you have minimal residual disease. If you respond to this treatment, your doctor may decide to administer up to 3 additional treatment cycles.

If you have acute lymphoblastic leukemia and receive BLINCYTO as part of consolidation treatment, your doctor will determine the number of BLINCYTO cycles to be administered.

The number of treatment cycles and the dose that will be administered to you will depend on how you tolerate and respond to BLINCYTO. Your doctor will discuss with you how long your treatment will last. Your treatment may also be interrupted, depending on how you tolerate BLINCYTO.

How long you will stay in the hospital

If you have refractory or relapsed acute lymphoblastic leukemia, it is recommended that the first 9 days of treatment and the first 2 days of the second cycle be administered in a hospital or clinic under the supervision of a doctor or nurse with experience in the use of cancer medicines.

If you have minimal residual disease, it is recommended that the first 3 days of treatment and the first 2 days of subsequent cycles be administered in a hospital or clinic under the supervision of a doctor or nurse with experience in the use of cancer medicines.

If you have acute lymphoblastic leukemia and receive BLINCYTO as part of consolidation treatment, it is recommended that the first 3 days of the first treatment cycle and the first 2 days of the second cycle be administered in a hospital or clinic under the supervision of a doctor or nurse with experience in the use of cancer medicines.

If you have or have had neurological problems, it is recommended that you stay in the hospital or clinic for the first 14 days of treatment. Your doctor will discuss with you whether you can continue treatment at home after your initial hospital stay. The treatment may include a bag change performed by a nurse.

How much BLINCYTO will be administered to you

If you have refractory or relapsed acute lymphoblastic leukemia and your body weight is 45 kilograms or more, the recommended initial dose for your first cycle is 9 micrograms per day for 1 week. After that, your doctor may decide to increase your dose to 28 micrograms per day for weeks 2, 3, and 4 of your treatment. If your doctor decides that you should receive more cycles of BLINCYTO, your pump will be programmed to infuse a dose of 28 micrograms per day for all subsequent treatment cycles.

If your body weight is less than 45 kilograms, the recommended initial dose for the first cycle will be calculated based on your weight and height. During the first week of treatment with BLINCYTO, your pump will be programmed to infuse a dose of 5 micrograms/m2/day. The dose should be increased to 15 micrograms/m2/day during weeks 2, 3, and 4, depending on your response to treatment with BLINCYTO. If your doctor decides that you should receive more cycles of BLINCYTO, your pump will be programmed to infuse a dose of 15 micrograms/m2/day for all subsequent treatment cycles. You may not notice the difference between the dose infused during the first week of the first cycle and the increased dose infused during the rest of the first cycle and subsequent cycles.

If you have minimal residual disease and your body weight is 45 kilograms or more, your dose of BLINCYTO will be 28 micrograms per day for all treatment cycles. If your body weight is less than 45 kilograms, the dose programmed in the pump will be 15 micrograms/m2/day and will depend on your weight and height for all treatment cycles.

If you have acute lymphoblastic leukemia and receive BLINCYTO as part of consolidation treatment, and if your body weight is 45 kilograms or more, the dose of BLINCYTO will be 28 micrograms per day for all treatment cycles. If your body weight is less than 45 kilograms, the dose programmed in the pump will be 15 micrograms/m2/day and will depend on your weight and height for all treatment cycles.

Medicines administered before each cycle of BLINCYTO

Before your treatment with BLINCYTO, you will be given other medicines (premedication) to help reduce infusion reactions and other possible side effects. These medicines may include corticosteroids (e.g., dexamethasone).

During treatment with BLINCYTO and before this, you may be given chemotherapy by intrathecal injection (injection into the space surrounding the spinal cord and brain) to prevent the recurrence of acute lymphoblastic leukemia in the central nervous system. If you have questions about the treatment, consult your doctor.

Infusion catheter

If you have an infusion catheter in place, it is very important to keep the area around the catheter clean; otherwise, you may get an infection. Your doctor or nurse will teach you how to care for the catheter area.

Infusion pump and intravenous tube

Do not adjust the pump settings,even if there is a problem or the pump alarm sounds. Any change to the pump settings can make the dose 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 is empty before the scheduled bag change date

• if the infusion pump stops unexpectedly. Do not try to restart your pump.

Your doctor or nurse will advise you on how to perform your daily activities while connected to the infusion pump. If you have any questions, contact your doctor or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Some of these adverse effects can be serious.

Tell your doctor immediatelyif you experience any of the following adverse effects or a combination of them:

• chills, shivering, fever, rapid heart rate, decrease in blood pressure, painful muscles, feeling of tiredness, cough, difficulty breathing, confusion, redness, swelling or secretion from the affected area or the site where the infusion line is located. These may be signs of an infection.
• neurological events: shivering (tremors), confusion, disorders of brain function (encephalopathy), difficulty communicating (aphasia), convulsion.
• fever, swelling, chills, increase or decrease in blood pressure and fluid in the lungs, which can become severe, these may be signs of a condition called cytokine release syndrome.
• if you have persistent and intense stomach pain, with or without nausea and vomiting, as they can be symptoms of a serious and potentially life-threatening problem known as pancreatitis (inflammation of the pancreas).

Treatment with BLINCYTO may cause a decrease in the levels of certain white blood cells, with or without fever (febrile or non-febrile neutropenia), or may cause an increase in blood levels of potassium, uric acid, and phosphate and a decrease in blood levels of calcium (tumor lysis syndrome). Your doctor will perform regular blood tests during treatment with BLINCYTO.

Other adverse effects include:

Very Common Adverse Effects(may affect more than 1 person in 10):

• blood infection, including bacterial, viral, or other types of infection
• decrease in the levels of certain white blood cells with or without fever (leukopenia, neutropenia [febrile]), decrease in red blood cell levels, decrease in platelet levels
• fever, swelling, chills, increase or decrease in blood pressure and fluid in the lungs, which can become severe (cytokine release syndrome)
• sleeping problems, headache, shivering (tremors). May be symptoms of neurological problems related to a disorder called immune effector cell-associated neurotoxicity syndrome (ICANS).
• rapid heart rate (tachycardia)
• low blood pressure
• high blood pressure (hypertension)
• cough

• nausea, diarrhea, vomiting, constipation, abdominal pain

• skin rash
• back pain, limb pain
• fever (pyrexia), swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing (edema), chills
• low levels of antibodies called "immunoglobulins" that help the immune system fight infections (decreased immunoglobulins)
• high levels of liver enzymes (ALT, AST, GGT)
• infusion-related reactions may include wheezing (whistling sound when breathing), flushing, facial swelling, difficulty breathing, and low or high blood pressure

Common Adverse Effects(may affect up to 1 in 10 people):

• severe infection that can result in organ failure or shock or can be life-threatening (septicemia)
• lung infection (pneumonia)
• fungal infection
• increase in white blood cell count (leukocytosis), decrease in certain white blood cell levels (lymphopenia)
• allergic reaction
• complications that occur after cancer treatment and cause an increase in blood levels of potassium, uric acid, and phosphorus and a decrease in blood levels of calcium (tumor lysis syndrome)

• confusion, disorientation, disorders of brain function (encephalopathy), such as difficulty communicating (aphasia), tingling in the skin (paresthesia), convulsions, difficulty thinking or processing thoughts, difficulty remembering, difficulty controlling movements (ataxia), feeling of sleepiness (somnolence), numbness, dizziness. May be symptoms of neurological problems related to a disorder called immune effector cell-associated neurotoxicity syndrome (ICANS).

• nervous system problems affecting the head and neck, such as visual disturbances, drooping eyelid and/or muscle weakness on one side of the face, difficulty hearing or swallowing problems (cranial nerve disorder)
• wheezing or difficulty breathing (dyspnea), respiratory failure (dyspnea)
• redness
• cough with phlegm
• increase in blood bilirubin levels
• bone pain
• chest pain or other pain
• high blood levels of some enzymes
• weight gain

Uncommon Adverse Effects(may affect up to 1 in 100 people):

• excessive activation of white blood cells associated with inflammation (hemophagocytic histiocytosis)

• inflamed lymph nodes (lymphadenopathy)

• fever, swelling, chills, decrease or high blood pressure and fluid in the lungs, which can be severe and life-threatening (cytokine storm)
• a disorder that causes fluid leakage from small blood vessels into the body (capillary leak syndrome)
• difficulty speaking and/or writing. May be a symptom of neurological problems related to a disorder called immune effector cell-associated neurotoxicity syndrome (ICANS).

In addition, among the adverse effects most frequently observed in adolescents and children are:

• decrease in red blood cell levels (anemia), decrease in platelet levels (thrombocytopenia), decrease in certain white blood cell levels (leukopenia)
• fever (pyrexia)
• infusion-related reactions, such as facial swelling, low blood pressure, high blood pressure (infusion-related reaction)
• weight gain
• • high blood pressure (hypertension)

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of BLINCYTO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the label and carton after EXP or CAD. The expiration date is the last day of the month indicated.

Unopened vials:

• Store and transport refrigerated (between 2°C and 8°C).
• Do not freeze.
• Keep the product in the original packaging to protect it from light.

Reconstituted solution (BLINCYTO solution):

• When refrigerated, the reconstituted solution must be used within 24 hours. Alternatively, the vials can be stored at room temperature (up to 27°C) for up to 4 hours.

Diluted solution (prepared infusion bag):

If your infusion bag is changed at home:

• The infusion bags containing BLINCYTO solution will arrive in special packaging that includes cooling bags.
• • Do not open the packaging.
  • Keep the packaging at room temperature (up to 27°C).
  • Do not refrigerate or freeze the packaging.
• Your nurse will open the packaging, and the infusion bags will be stored in a refrigerator until the time of infusion.
• When refrigerated, the prepared infusion bags must be used within 10 days.
• Once at room temperature (up to 27°C), the solution must be infused within 96 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Composition of BLINCYTO

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

Appearance of BLINCYTO and Container Contents

BLINCYTO is a powder for concentrate and solution for infusion.

Each container of BLINCYTO contains:

• 1 glass vial containing a lyophilized powder that is white to off-white.
• 1 glass vial containing a clear to slightly yellowish solution.

Marketing Authorization Holder and Manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Marketing Authorization Holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

Further information on this medicinal product is available on the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

The BLINCYTO infusion solution is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump for a period of up to 96 hours.

B-Cell Precursor ALL with Refractory or Relapsed Disease

The recommended daily dose depends on body weight. Patients with a weight of 45 kg or more receive a fixed dose, while for patients with a weight below 45 kg, the dose is calculated using the patient's body surface area (BSA). See the following table for the recommended daily dose for B-Cell Precursor ALL with refractory or relapsed disease.

Pediatric patients with B-Cell Precursor ALL in first relapse at high risk may receive 1 cycle of treatment with BLINCYTO after induction and 2 cycles of consolidation chemotherapy. See the following table for the recommended daily dose based on body weight for pediatric patients with B-Cell Precursor ALL in first relapse at high risk after induction chemotherapy.

B-Cell Precursor ALL with Positive MRD

The recommended daily dose depends on body weight. The recommended dose of BLINCYTO for patients weighing 45 kg or more throughout each 4-week treatment cycle is 28 μg/day. For patients weighing less than 45 kg, the dose is calculated based on BSA. The recommended dose of BLINCYTO throughout each 4-week treatment cycle is 15 μg/m2/day.

Adults with B-Cell Precursor ALL in the Consolidation Phase

The recommended daily dose depends on body weight. The recommended dose of BLINCYTO for patients weighing 45 kg or more throughout each 4-week treatment cycle is 28 μg/day. For patients weighing less than 45 kg, the dose is calculated based on BSA. The recommended dose of BLINCYTO throughout each 4-week treatment cycle is 15 μg/m2/day.

The initial volume (270 ml) is greater than the volume administered to the patient (240 ml) to compensate for the priming of the intravenous tubing and to ensure that the patient receives the full dose of BLINCYTO.

The infusion of the final BLINCYTO infusion solution prepared should be performed according to the instructions on the label of the prepared bag at one of the following constant infusion rates:

• Infusion rate of 10 ml/h for 24 hours
• Infusion rate of 5 ml/h for 48 hours
• Infusion rate of 3.3 ml/h for 72 hours
• Infusion rate of 2.5 ml/h for 96 hours

The choice of infusion duration should be made by the specialist physician, taking into account the frequency of bag changes and the patient's weight. The target therapeutic dose of BLINCYTO administered does not vary.

Aseptic Preparation

It should be ensured that the preparation is handled aseptically. The preparation of BLINCYTO should:

• be carried out under aseptic conditions by qualified personnel following good practice guidelines, especially with regard to the aseptic preparation of parenteral products.
• be prepared in a laminar flow cabinet or a biological safety cabinet, establishing standard precautions for the safe handling of intravenous agents.

It is very important that the preparation and administration instructions provided in this section are followed strictly to minimize medication errors (including underdosing and overdosing).

Other Instructions

• BLINCYTO is compatible with polyolefin, PVC without diethylhexyl phthalate (DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
• At the end of the infusion, the disposal of unused medicinal product or all materials that have come into contact with it will be carried out in accordance with local regulations.

Preparation of Infusion Solution

The following supplies are also required, which are not included in the container:

• Sterile, single-use disposable syringes
• Needle(s) with a gauge of 21-23 (recommended)
• Water for injectable preparations
• Infusion bag with 250 ml of sodium chloride 9 mg/ml (0.9%) injectable solution;

• To minimize the number of aseptic transfers, use a prepared 250 ml infusion bag. The dose calculations of BLINCYTO are based on a normal overfill volume of 265 to 275 ml of sodium chloride 9 mg/ml (0.9%) injectable solution.
• Only polyolefin, PVC without diethylhexyl phthalate (DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes should be used.

• Polyolefin, PVC without DEHP, or EVA intravenous tubing with an in-line filter of 0.2 μm with low protein binding, apyrogenic, and sterile
• • Ensure that the tubing is compatible with the infusion pump.

Reconstitute BLINCYTO with water for injectable preparations.Do not reconstitute BLINCYTO vials with the solution (stabilizer).

To prime the intravenous tubing, use only the solution from the bag containing the final prepared BLINCYTO infusion solution.Do not prime with sodium chloride 9 mg/ml (0.9%) injectable solution.

Reconstitution of BLINCYTO

1. Determine the number of BLINCYTO vials needed for a dose and the infusion duration.
2. Using a syringe, reconstitute each BLINCYTO powder vial using 3 ml of water for injectable preparations. Direct the water towards the walls of the BLINCYTO vial and not directly onto the lyophilized powder.
   • Do not reconstitute BLINCYTO powder with the solution (stabilizer).
   • When adding water for injectable preparations to the powder, a total volume of 3.08 ml is achieved for a final concentration of BLINCYTO of 12.5 μg/ml.
3. Gently rotate the contents to avoid excessive foam formation.

• Do not shake.

1. Visually inspect the reconstituted solution for particles and color changes during reconstitution and before infusion. The resulting solution should be clear to slightly opalescent and colorless to slightly yellowish.

• Do not use the solution if it is turbid or has precipitated.

Preparation of the BLINCYTO Infusion Bag

Verify the prescribed dose and infusion duration for each BLINCYTO infusion bag. To minimize errors, use the specific volumes described in Tables 1 and 2 to prepare the BLINCYTO infusion bag.

• Table 1 for patients with a weight of 45 kg or more
• Table 2 for patients with a weight below 45 kg

1. Use a prepared infusion bag with 250 ml of sodium chloride 9 mg/ml (0.9%) injectable solution, which normally contains a total volume of 265 to 275 ml.
2. To prime the bag, using a syringe, transfer 5.5 ml of solution (stabilizer) aseptically to the infusion bag. Gently mix the contents of the bag to avoid foam formation. Discard the vial with the remaining solution (stabilizer).
3. Using a syringe, transfer the required volume of reconstituted BLINCYTO solution aseptically to the infusion bag with sodium chloride 9 mg/ml (0.9%) injectable solution and the solution (stabilizer). Gently mix the contents of the bag to avoid foam formation.
   • Consult Table 1 for the specific volume of reconstituted BLINCYTO for patients with a weight of 45 kg or more.
   • Consult Table 2 for the specific volume of reconstituted BLINCYTO for patients with a weight below 45 kg (dose based on BSA).
   • Discard the vial with any unused reconstituted BLINCYTO solution.
4. In aseptic conditions, connect the intravenous tubing to the infusion bag with the in-line filter of 0.2 microns, sterile. Ensure that the tubing is compatible with the infusion pump.

1. Remove the air from the infusion bag. This is particularly important when using an ambulatory infusion pump.
2. Prime the intravenous line only with the infusion solution in the bag with the final prepared BLINCYTO infusion solution.
3. Store in the refrigerator between 2 °C and 8 °C if not used immediately.

Table 1. For patients with a weight of 45 kg or more: volumes of sodium chloride 9 mg/ml (0.9%) injectable solution, solution (stabilizer), and reconstituted BLINCYTO to add to the infusion bag

Table 2. For patients with a weight below 45 kg: volumes of sodium chloride 9 mg/ml (0.9%) injectable solution, solution (stabilizer), and reconstituted BLINCYTO to add to the infusion bag

• Country of registration
  Spain
• Active substance
  blinatumomab
• Prescription required
  Yes
• Manufacturer
  Amgen Europe B.V.
• Composition
  POLISORBATO 80 (10 mg mg), HIDROXIDO DE SODIO (E 524) (N/A C.S mg), HIDROXIDO DE SODIO (E 524) (N/A C.S mg), POLISORBATO 80 (0,70 mg mg)
• This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
• Alternatives to Blincyto 38.5 mcg powder for concentrate and solution for infusion
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