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Indications

BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:

Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy ... Read More 

Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission

Relapsed or refractory disease

Important Safety Information Prescribing Information Medication Guide Indications Patient Site Connect with a BLINCYTO® rep

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NOW APPROVED
for use in frontline consolidation in patients with CD19-positive
Ph(–) B-cell precursor ALL, regardless of MRD status* or age1

BLINCYTO® is indicated in adult and pediatric patients one month and older.1

LEARN MORE IN THE
BLINCYTO® PRESS RELEASE
Review the BLINCYTO®
Prescribing Information

*In the E1910 study, MRD was assessed centrally using standardized 6-color flow cytometry, with MRD(–) defined as < 0.01% leukemic cells in the bone marrow.2 The MRD tests were performed at laboratory sites using assays that have not been analytically validated by FDA.

ALL, acute lymphoblastic leukemia; CD, cluster of differentiation; FDA, Food and Drug Administration; MRD, measurable or minimal residual disease; Ph(–), Philadelphia chromosome–negative.

Please see Indications in above "Indications" tray and full Important Safety Information,
including BOXED WARNINGS below.

References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Litzow MR, Sun Z, Paietta E, et al. ECOG-ACRIN-E1910 NCTN clinical trial: A phase III randomized trial of blinatumomab for newly diagnosed BCR-ABL-negative B lineage acute lymphoblastic leukemia in adults. Presented at: 64th ASH Annual Meeting and Exposition; December 10–13, 2022; New Orleans, LA.

Preparing BLINCYTO®

BLINCYTO® package contents and vials

BLINCYTO® (blinatumomab) package and vials

Each BLINCYTO® package contains:1

  • One BLINCYTO® vial supplied in a single-dose vial as a sterile, preservative-free, white to off-white lyophilized powder (35 mcg of BLINCYTO®/vial)
  • One Intravenous Solution Stabilizer (IVSS) vial supplied in a 10 mL single-dose glass vial as a sterile, preservative-free, colorless to slightly yellow, clear solution
    • The IVSS is injected into the IV bag prior to the addition of reconstituted BLINCYTO® to prevent adhesion of BLINCYTO® to the IV bags and IV tubing
    • Do not use the IVSS to reconstitute BLINCYTO®

NOTE: The package does not include preservative-free Sterile Water for Injection, USP, which should be used to reconstitute the lyophilized BLINCYTO® powder.

Please see full Prescribing Information for complete reconstitution and preparation instructions.

Storage and handling of BLINCYTO® and IV Solution Stabilizer (IVSS) vials1

Refrigerate vials at 2°C to 8°C in the original packaging

Refrigerate vials of BLINCYTO® and IVSS at 2°C to 8°C (36°F to 46°F) in the original packaging.

Do not freeze BLINCYTO® (blinatumomab)

Do not freeze.

Protect the vials of BLINCYTO® (blinatumomab) and IVSS

Protect the vials of BLINCYTO® and IVSS from light until time of use.


  • Store BLINCYTO® and IV solution stabilizer vials in the original package, refrigerated at 2°C to 8°C (36°F to 46°F), and protect from light until time of use. Do not freeze
  • BLINCYTO® and IV solution stabilizer vials may be stored for a maximum of 8 hours at 23°C to 27°C (73°F to 81°F) in the original carton to protect from light

What you need to know to prepare BLINCYTO®

The information provided here is an abbreviated summary and does not replace the Prescribing Information. Please consult the Prescribing Information when preparing BLINCYTO®. 

Aseptic preparation and admixing area checklist1

Strictly observe aseptic technique when preparing the solution for infusion since BLINCYTO® vials do not contain antimicrobial preservatives. To prevent accidental contamination, prepare BLINCYTO® according to aseptic standards, including but not limited to:

  • Prepare BLINCYTO® in a USP <797> compliant facility
  • Prepare BLINCYTO® in an ISO Class 5 laminar flow hood or better
  • Ensure that the admixing area has appropriate environmental specifications, confirmed by periodic monitoring
  • Ensure that personnel are appropriately trained in aseptic manipulations and admixing of oncology drugs
  • Ensure that personnel wear appropriate protective clothing and gloves
  • Ensure that gloves and surfaces are disinfected

Premedication for consolidation:1

  • For adult patients, premedicate with dexamethasone 20 mg intravenously within 1 hour prior to the first dose of each BLINCYTO® cycle

  • For pediatric patients, premedicate with 5 mg/m2 of dexamethasone intravenously or orally, to a maximum dose of 20 mg, prior to the first dose of BLINCYTO® in the first cycle and when restarting an infusion after an interruption of 4 or more hours in the first cycle

Premedication for MRD(+):1

  • For adult patients, premedicate with prednisone 100 mg intravenously or equivalent (eg, dexamethasone 16 mg) 1 hour prior to the first dose of each BLINCYTO® cycle

  • For pediatric patients, premedicate with 5 mg/m2 of dexamethasone, to a maximum dose of 20 mg prior to the first dose of BLINCYTO® in the first cycle, and when restarting an infusion after an interruption of 4 or more hours in the first cycle

Premedication for R/R:1

  • For adult patients, premedicate with 20 mg dexamethasone 1 hour prior to the first dose of BLINCYTO® of each cycle, prior to a step dose (such as cycle 1 day 8), and when restarting an infusion after an interruption of 4 or more hours

  • For pediatric patients, premedicate with 5 mg/m2 of dexamethasone, to a maximum dose of 20 mg prior to the first dose of BLINCYTO® in the first cycle, prior to a step dose (such as cycle 1 day 8), and when restarting an infusion after an interruption of 4 or more hours in the first cycle

Reconstitution of BLINCYTO®1

Vials needed for a dose and infusion
1.

Determine the number of BLINCYTO® vials needed for a dose and infusion duration.

  • Reconstitute each BLINCYTO® vial with 3 mL of preservative-free Sterile Water for Injection, USP by directing the water along the walls of the BLINCYTO® vial and not directly on the lyophilized powder (resulting in a final BLINCYTO® concentration of 12.5 mcg/mL)
  • Do not reconstitute BLINCYTO® with IVSS
Gently swirl the contents to avoid excess foaming
2.

Gently swirl the contents to avoid excess foaming. Do not shake.

Visually inspect the reconstituted solution for particulate matter and discoloration
3.

Visually inspect the reconstituted solution for particulate matter and discoloration during reconstitution and prior to infusion. The resulting solution should be clear to slightly opalescent, colorless to slightly yellow. Do not use if solution is cloudy or has precipitated.

Preparation of BLINCYTO® solution for 24- or 48-hour infusion

In order to prepare BLINCYTO® solution for 24- or 48-hour infusion, you will need to know:1

  • The prescribed dose
  • The infusion duration
  • The patient’s body surface area (BSA) for patients weighing less than 45 kg

It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).1

Before preparation, ensure that you have the following supplies ready:1

  • Patients weighing 45 kg or more:
    • 1 vial of BLINCYTO® is needed for preparation of 28 mcg/day dose infused over 24 hours at a rate of 10 mL/hour
    • 2 vials of BLINCYTO® are needed for preparation of 28 mcg/day dose infused over 48 hours at a rate of 5 mL/hour
  • Patients weighing less than 45 kg:
    • 1 vial of BLINCYTO® is needed for preparation of 15 mcg/m2/day dose infused over 24 hours at a rate of 10 mL/hour
    • 1–2 vials of BLINCYTO® are needed for preparation of 15 mcg/m2/day dose infused over 48 hours at a rate of 5 mL/hour for patients with a BSA greater than 1.09 m2

The following supplies are also required, but not included in the package:1

  • Supplies to make a 270 mL 0.9% Sodium Chloride IV bag
    • An empty IV bag (use only di-ethylhexylphthalate-free [DEHP-free], polyvinyl chloride [PVC], polyolefin, or ethyl vinyl acetate [EVA] infusion bags/pump cassettes)
    • 0.9% Sodium Chloride Injection, USP (eg, 1,000 mL)
  • Preservative-free Sterile Water for Injection, USP
  • DEHP-free PVC, polyolefin, or EVA IV tubing with a sterile, nonpyrogenic, low protein-binding 0.2-micron in-line filter
    • Ensure that the IV tubing is compatible with the infusion pump

Special considerations for 24- or 48-hour BLINCYTO® infusion bags:1

  • IVSS is provided with the BLINCYTO® package and is used to coat the IV bag prior to addition of reconstituted BLINCYTO® to prevent adhesion of BLINCYTO® to IV bags and IV tubing. Therefore, add IVSS to the IV bag containing 0.9% Sodium Chloride Injection, USP. Do not use IVSS for reconstitution of BLINCYTO®
  • The entire volume of the admixed BLINCYTO® will be more than the volume administered to the patient (240 mL) to account for the priming of the IV line and to ensure that the patient will receive the full dose of BLINCYTO®
  • When preparing an IV bag, remove air from IV bag. This is particularly important for use with an ambulatory infusion pump
  • Use the specific volumes described in the admixing instructions in the full Prescribing Information to minimize errors in calculation

Preparation of the BLINCYTO® infusion bag:1

Verify the prescribed dose and infusion duration for each BLINCYTO® infusion bag. To minimize errors, use the specific volumes described in the tables below to prepare the BLINCYTO® infusion bag.

Empty IV bag
1.

Aseptically add 270 mL of 0.9% Sodium Chloride Injection, USP to the empty IV bag.

Aseptically transfer IVSS to the IV bag containing Sodium Chloride Injection, USP
2.

Aseptically transfer 5.5 mL of IVSS to the IV bag containing 0.9% Sodium Chloride Injection, USP.

Gently mix the contents of the bag to avoid foaming
  • Gently mix the contents of the bag to avoid foaming. Discard the vial containing the unused IVSS
Aseptically transfer the required volume of reconstituted BLINCYTO® (blinatumomab) into the IV bag
3.

Aseptically transfer the required volume of reconstituted BLINCYTO® into the IV bag containing 0.9% Sodium Chloride Injection, USP and IVSS.

  • Use the tables below to determine the specific volume of reconstituted BLINCYTO® required for the prescribed dose and duration
  • Gently mix the contents of the bag to avoid foaming
  • Discard the vial containing unused BLINCYTO®

For patients receiving a 24- or 48-hour infusion: volume to add to IV bag

0.9% Sodium Chloride injection, USP (starting volume) 270 mL
IV Solution Stabilizer (fixed volume for 24-hour and 48-hour infusion durations) 5.5 mL
For patients weighing ≥ 45 kg (fixed dose)
Infusion duration Dose Infusion rate Reconstituted BLINCYTO®
Volume Vials
24 hours
9 mcg/day 10 mL/hour 0.83 mL 1
28 mcg/day 10 mL/hour 2.6 mL 1
48 hours
9 mcg/day 5 mL/hour 1.7 mL 1
28 mcg/day 5 mL/hour 5.2 mL 2
For patients weighing < 45 kg (BSA-based dose)
Infusion duration Dose Infusion rate BSA (m2) Reconstituted BLINCYTO®
Volume Vials
24 hours 5 mcg/m2
/
day		 10 mL/
hour
1.5–1.59 0.7 mL 1
1.4–1.49 0.66 mL 1
1.3–1.39 0.61 mL 1
1.2–1.29 0.56 mL 1
1.1–1.19 0.52 mL 1
1–1.09 0.47 mL 1
0.9–0.99 0.43 mL 1
0.8–0.89 0.38 mL 1
0.7–0.79 0.33 mL 1
0.6–0.69 0.29 mL 1
0.5–0.59 0.24 mL 1
0.4–0.49 0.2 mL 1
24 hours 15 mcg/m2
/
day		 10 mL/
hour
1.5–1.59 2.1 mL 1
1.4–1.49 2 mL 1
1.3–1.39 1.8 mL 1
1.2–1.29 1.7 mL 1
1.1–1.19 1.6 mL 1
1–1.09 1.4 mL 1
0.9–0.99 1.3 mL 1
0.8–0.89 1.1 mL 1
0.7–0.79 1 mL 1
0.6–0.69 0.86 mL 1
0.5–0.59 0.72 mL 1
0.4–0.49 0.59 mL 1
48 hours 5 mcg/m2
/
day		 5 mL/
hour
1.5–1.59 1.4 mL 1
1.4–1.49 1.3 mL 1
1.3–1.39 1.2 mL 1
1.2–1.29 1.1 mL 1
1.1–1.19 1 mL 1
1–1.09 0.94 mL 1
0.9–0.99 0.85 mL 1
0.8–0.89 0.76 mL 1
0.7–0.79 0.67 mL 1
0.6–0.69 0.57 mL 1
0.5–0.59 0.48 mL 1
0.4–0.49 0.39 mL 1
48 hours 15 mcg/m2
/
day		 5 mL/
hour
1.5–1.59 4.2 mL 2
1.4–1.49 3.9 mL 2
1.3–1.39 3.7 mL 2
1.2–1.29 3.4 mL 2
1.1–1.19 3.1 mL 2
1–1.09 2.8 mL 1
0.9–0.99 2.6 mL 1
0.8–0.89 2.3 mL 1
0.7–0.79 2 mL 1
0.6–0.69 1.7 mL 1
0.5–0.59 1.4 mL 1
0.4–0.49 1.2 mL 1
Under aseptic conditions, attach the IV tubing to the IV bag
4.

Under aseptic conditions, attach the IV tubing to the IV bag with the sterile 0.2 micron in-line filter.

  • Use only DEHP-free PVC, polyolefin or EVA IV tubing with a sterile, nonpyrogenic, low protein-binding 0.2 micron in-line filter
  • Ensure that the IV tubing is compatible with the infusion pump
Remove air from the IV bag
5.

Remove air from the IV bag. This is particularly important for use with an ambulatory infusion pump.

  • Prime the IV tubing only with the solution in the bag containing the FINAL prepared BLINCYTO® solution for infusion
  • Do not prime with 0.9% Sodium Chloride Injection, USP
Store at 2°C to 8°C if not used immediately
6.

Store at 2°C to 8°C (36°F to 46°F) if not used immediately.*

*Additional storage directions and maximum storage times are listed in the BLINCYTO® Prescribing Information.

IMPORTANT NOTE: Do not flush the BLINCYTO® infusion line or IV catheter, especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof. When administering via a multilumen venous catheter, BLINCYTO® should be infused through a dedicated lumen.

Preparation of BLINCYTO® solution for 7-day infusion1

In order to prepare BLINCYTO® solution for a 7-day infusion, you will need to know:

  • The prescribed dose
  • The infusion duration
  • BSA for patients weighing less than 45 kg

It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).

Before preparation, ensure that you have the following supplies ready:

  • 4 to 6 packages of BLINCYTO® are needed for each dosage
    • Patients weighing 45 kg or more: 6 packages of BLINCYTO® are needed for preparation of 28 mcg/day dose infused over 7 days at a rate of 0.6 mL/hour
    • Patients weighing less than 45 kg: 2 to 5 packages of BLINCYTO® are needed for preparation of 15 mcg/m2/day dose infused over 7 days at a rate of 0.6 mL/hour

The following supplies are also required, but not included in the package:

  • Supplies to make a 110 mL 0.9% Sodium Chloride IV bag
    • An empty IV bag (use only di-ethylhexylphthalate-free [DEHP-free] PVC, polyolefin, or ethyl vinyl acetate [EVA] infusion bags/pump cassettes)
    • Bacteriostatic 0.9% Sodium Chloride Injection, USP
    • 0.9% Sodium Chloride Injection, USP (eg, 1,000 mL)
  • Preservative-free Sterile Water for Injection, USP
  • DEHP-free PVC, polyolefin, or EVA IV tubing†
    • Ensure that the IV tubing is compatible with the infusion pump

†Do not use an in-line filter for a 7-day infusion bag.

Special considerations for a 7-day BLINCYTO® infusion bag1

  • IVSS is provided with the BLINCYTO® package and is used to coat the IV bag prior to addition of reconstituted BLINCYTO® to prevent adhesion of BLINCYTO® to IV bags and IV tubing. Therefore, add IVSS to the IV bag containing bacteriostatic saline. Do not use IVSS for reconstitution of BLINCYTO®
  • The entire volume of the admixed BLINCYTO® will be more than the volume administered to the patient (100 mL) to account for the priming of the IV tubing and to ensure that the patient will receive the full dose of BLINCYTO®
  • When preparing an IV bag, remove air from IV bag. This is particularly important for use with an ambulatory infusion pump
  • Use the specific volumes described in the admixing instructions in the full Prescribing Information to minimize errors

Preparation of the BLINCYTO® infusion bag1

When preparing BLINCYTO® solution for infusion, it is important to remember the volume of reconstituted BLINCYTO® used differs depending on the dose, infusion duration, and patient's weight/BSA.

Verify the prescribed dose and infusion duration for each BLINCYTO® infusion bag. To minimize errors, use the specific volumes described in the table below to prepare the BLINCYTO® infusion bag.

1.

Aseptically add 90 mL Bacteriostatic 0.9% Sodium Chloride Injection, USP to the empty IV bag.

2.

Aseptically transfer 2.2 mL IVSS to the IV bag containing the Bacteriostatic 0.9% Sodium Chloride Injection, USP.

  • Gently mix the contents of the bag to avoid foaming. Discard the vial containing the unused IVSS
3.

Aseptically transfer the required volume of reconstituted BLINCYTO® into the IV bag containing Bacteriostatic 0.9% Sodium Chloride Injection, USP and IVSS.

  • Use the table below to determine the specific volume of reconstituted BLINCYTO® required for the prescribed dose and duration
  • Gently mix the contents of the bag to avoid foaming
  • Discard the vial containing unused BLINCYTO®

For patients receiving a 7-day infusion:1

Volume to add to IV bag

Bacteriostatic 0.9% Sodium Chloride (starting volume) 90 mL
IVSS (fixed volume for 7-day infusion) 2.2 mL
Dose BSA (m2)‡ Vials Reconstituted BLINCYTO® 0.9% Sodium Chloride, USP to qs to a final volume of 110 mL§
For patients weighing 45 kg or more
28 mcg/day
Infused over 7 days
at a rate of 0.6 mL/hour 		6 16.8 mL 1 mL
For patients weighing less than 45 kg (BSA-based dose )
15 mcg/m2/day
Infused over 7 days
at a rate of 0.6 mL/hour
1.5–1.59 5 14 mL 3.8 mL
1.4–1.49 5 13.1 mL 4.7 mL
1.3–1.39 5 12.2 mL 5.6 mL
1.2–1.29 5 11.3 mL 6.5 mL
1.1–1.19 4 10.4 mL 7.4 mL
1–1.09 4 9.5 mL 8.3 mL
0.9–0.99 4 8.6 mL 9.2 mL
0.8–0.89 3 7.7 mL 10.1 mL
0.7–0.79 3 6.8 mL 11 mL
0.6–0.69 3 5.9 mL 11.9 mL
0.5–0.59 2 5 mL 12.8 mL
0.4–0.49 2 4.1 mL 13.7 mL

‡The safety of the administration of BLINCYTO® at a BSA of less than 0.4 m2 has not been established.

§0.9% Sodium Chloride, USP is added to quantity sufficient (qs) to a final volume of 110 mL.

4.

Aseptically transfer the required volume of 0.9% Sodium Chloride Injection, USP to the IV bag to a final volume of 110 mL.

  • Use the table above to determine the specific volume of 0.9% Sodium Chloride Injection, USP
  • Gently mix the contents of the bag to avoid foaming
5.

Under aseptic conditions, attach the IV tubing to the IV bag.

  • Ensure that the IV tubing is compatible with the infusion pump
  • Do NOT use an in-line filter for a 7-day bag
6.

Remove air from the IV bag. This is particularly important for use with an ambulatory infusion pump.

  • Prime the IV tubing only with the solution in the bag containing the FINAL prepared BLINCYTO® solution for infusion
  • Do not prime with 0.9% Sodium Chloride Injection, USP
7.

Store at 2°C to 8°C (36°F to 46°F) if not used immediately.**

**Additional storage directions and maximum storage times are listed in the BLINCYTO® Prescribing Information.

IMPORTANT NOTE: Do not flush the BLINCYTO® infusion line or IV catheter, especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof. When administering via a multilumen venous catheter, BLINCYTO® should be infused through a dedicated lumen.

IV, intravenous; MRD, measurable or minimal residual disease; R/R, relapsed or refractory; USP, United States Pharmacopeia.

IV, intravenous; MRD, measurable or minimal residual disease; R/R, relapsed or refractory; USP, United States Pharmacopeia.

See more

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended.
  • Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS), which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.
Contraindications

BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.

Warnings and Precautions
  • Cytokine Release Syndrome (CRS): CRS, which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. The median time to onset of CRS is 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Closely monitor and advise patients to contact their healthcare professional for signs and symptoms of serious adverse events such as fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin, and disseminated intravascular coagulation (DIC). The manifestations of CRS after treatment with BLINCYTO® overlap with those of infusion reactions, capillary leak syndrome (CLS), and hemophagocytic histiocytosis/macrophage activation syndrome (MAS). Using all of these terms to define CRS in clinical trials of BLINCYTO®, CRS was reported in 15% of patients with R/R ALL, in 7% of patients with MRD-positive ALL, and in 16% of patients receiving BLINCYTO® cycles in the consolidation phase of therapy. If severe CRS occurs, interrupt BLINCYTO® until CRS resolves. Discontinue BLINCYTO® permanently if life-threatening CRS occurs. Administer corticosteroids for severe or life-threatening CRS.
  • Neurological Toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome: BLINCYTO® can cause serious or life-threatening neurologic toxicity, including ICANS. The incidence of neurologic toxicities in clinical trials was approximately 65%. The median time to the first event was within the first 2 weeks of BLINCYTO® treatment. The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Grade 3 or higher neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. Manifestations of neurological toxicity included cranial nerve disorders. The majority of neurologic toxicities resolved following interruption of BLINCYTO®, but some resulted in treatment discontinuation.

    The incidence of signs and symptoms consistent with ICANS in clinical trials was 7.5%. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. There is limited experience with BLINCYTO® in patients with active ALL in the central nervous system (CNS) or a history of neurologic events. Patients with a history or presence of clinically relevant CNS pathology were excluded from clinical studies. Patients with Down Syndrome over the age of 10 years may have a higher risk of seizures with BLINCYTO® therapy.

    Monitor patients for signs and symptoms of neurological toxicities, including ICANS, and interrupt or discontinue BLINCYTO® as outlined in the PI. Advise outpatients to contact their healthcare professional if they develop signs or symptoms of neurological toxicities.

  • Infections: Approximately 25% of patients receiving BLINCYTO® in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO® as needed.
  • Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO® as needed to manage these events.
  • Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO® infusion and interrupt BLINCYTO® if prolonged neutropenia occurs.
  • Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures and ICANS, patients receiving BLINCYTO® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO® is being administered.
  • Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO® treatment with a median time to onset of 3 days. In patients receiving BLINCYTO®, although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days. Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase, and total blood bilirubin prior to the start of and during BLINCYTO® treatment. BLINCYTO® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if total bilirubin rises to > 3 times ULN.
  • Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO® in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO® and dexamethasone as needed.
  • Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO®, especially in patients previously treated with cranial irradiation and antileukemic chemotherapy.
  • Preparation and administration errors have occurred with BLINCYTO® treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
  • Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO® treatment, during treatment, and until immune recovery following last cycle of BLINCYTO®.
  • Benzyl Alcohol Toxicity in Neonates: Serious adverse reactions, including fatal reactions and the “gasping syndrome,” have been reported in very low birth weight (VLBW) neonates born weighing less than 1500 g, and early preterm neonates (infants born less than 34 weeks gestational age) who received intravenous drugs containing benzyl alcohol as a preservative. Early preterm VLBW neonates may be more likely to develop these reactions, because they may be less able to metabolize benzyl alcohol.

    Use the preservative-free preparations of BLINCYTO® where possible in neonates. When prescribing BLINCYTO® (with preservative) for neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative), other products containing benzyl alcohol or other excipients (e.g., ethanol, propylene glycol) which compete with benzyl alcohol for the same metabolic pathway.

    Monitor neonatal patients receiving BLINCYTO® (with preservative) for new or worsening metabolic acidosis. The minimum amount of benzyl alcohol at which serious adverse reactions may occur in neonates is not known. The BLINCYTO® 7-Day bag (with preservative) contains 7.4 mg of benzyl alcohol per mL.

  • Embryo-Fetal Toxicity: Based on its mechanism of action, BLINCYTO® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with BLINCYTO® and for 48 hours after the last dose.
Adverse Reactions
  • The safety of BLINCYTO® in adult and pediatric patients one month and older with MRD-positive B-cell precursor ALL (n=137), relapsed or refractory B-cell precursor ALL (n=267), and Philadelphia chromosome-negative B-cell precursor ALL in consolidation (n=165) was evaluated in clinical studies. The most common adverse reactions (≥ 20%) to BLINCYTO® in this pooled population were pyrexia, infusion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea.
Dosage and Administration Guidelines
  • BLINCYTO® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
  • It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).
INDICATIONS

BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:

  • Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy
  • Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission
  • Relapsed or refractory disease

Please see BLINCYTO® full Prescribing Information, including BOXED WARNINGS.

BLINCYTO® is a registered trademark of Amgen Inc.

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IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended.
  • Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS), which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.
Contraindications

Reference: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen.

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