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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 AVAILABLEBLINCYTO® offers 72- and 96-hour* infusion durations—offering more flexibility for you and your patients

The choice between these infusion duration options should be made by the treating healthcare professional, considering the frequency of the infusion bag changes and the weight of the patient.†

*Prepared with Bacteriostatic 0.9% Sodium Chloride Injection (containing 0.9% 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 (eg, ethanol, propylene glycol) which compete with benzyl alcohol for the same metabolic pathway. Serious adverse reactions, including fatal reactions and the “gasping syndrome,” have been reported in very low birth weight neonates born weighing less than 1500 g, and early preterm neonates who received intravenous drugs containing benzyl alcohol as a preservative.

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

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

BLINCYTO® (blinatumomab) logo

In CD19-positive Ph(–) B-cell precursor ALL

BLINCYTO® IS REDEFINING SURVIVAL EXPECTATIONS

Integrate BLINCYTO® into frontline consolidation with your chemotherapy of choice to help your patients who are MRD(–) stay in remission1,2

  • Median RFS in E1910 was not reached in the BLINCYTO® arm (n=112) vs 22.4 months in the chemotherapy only arm (n=112); HR: 0.46 (95% CI: 0.27–0.78); P = 0.004. Median follow-up was 3.6 years in both arms2,3

Proven efficacy and established safety across age groups1,4,5

E1910 study: Frontline consolidation in adults and young adults

Outpatient clinic, Infusion center, Home Outpatient clinic, Infusion center, Home
  • The rate of Grade 3 or 4 CRS events was 4% when BLINCYTO® was used in frontline consolidation1

*Based on KM estimates. Median follow-up was 4.5 years.6

†Study met its primary endpoint.1

‡The hazard ratio estimates are obtained from a stratified Cox regression model at the third interim analysis. Median follow-up was 3.6 years in both arms.1

§Stratified log-rank test.1

**Age < or ≥ 55 years old was a prespecified stratification factor in the E1910 study, while the analysis of patients 30–39 years old was post-hoc. Efficacy in the 30–39 year old subgroup was not a study objective and the study was not powered to assess for an OS benefit in this subgroup.2

COG AALL1731: Frontline consolidation in pediatric patients

3-year DFS (primary endpoint) 3-year DFS (primary endpoint)
  • At a median follow-up of 2.5 years, 81 events*** had occurred5
  • The safety data in COG AALL1731 are consistent with the known safety profile of BLINCYTO® and chemotherapy in the consolidation phase in adult and pediatric patients with B-cell precursor ALL1,5
  • Grade ≥ 3 sepsis or catheter-related infections occurred more frequently among patients in the SR-Average cohort who received BLINCYTO®, but no difference between arms was observed in the SR-High cohort5

††SR-Favorable was defined as having all of the following: Favorable genetics (ETV6::RUNX1 fusion or double trisomies of chromosomes 4 and 10), CNS1/2, peripheral blood MRD < 1% at induction day 8, and bone marrow MRD < 0.01% at end of induction. SR-High was defined as having one or more of the following: Unfavorable genetics (iAMP21, KMT2A rearrangement, hypodiploidy (< 44 chromosomes and/or DNA index < 0.81), or t(17;19)(q21-q22;p13.3) or resultant E2A::HLF fusion transcript), end of induction MRD ≥ 0.1% and double trisomies of chromosomes 4 and 10, end of induction bone marrow MRD ≥ 0.01% and not double trisomies of chromosomes 4 and 10, and/or neutral genetics and CNS2. SR-Average was defined as not being SR-Favorable or SR-High.5,8

‡‡DFS was defined as the time from randomization to a first event (relapse, a second malignant neoplasm, or death), with data censoring at the date of last contact.5

§§The hazard ratio is > 1 for approximately 2 months post randomization, after which it crosses to < 1 for the duration of the follow-up period, with evidence of increasing effect over time.8

***Relapse, second malignant neoplasm, or death.5

Blinatumomab is recommended by the National Comprehensive Cancer Network® (NCCN®) as a preferred therapy as part of frontline consolidation for AYA and adult patients with MRD(+) or MRD(–) Ph(–) B-cell precursor ALL9

Blinatumomab is also recommended by NCCN as part of the frontline consolidation phase for pediatric patients with MRD(+) or MRD(–) Ph(–) B-cell precursor ALL10,†††

NCCN Recommended

†††For patients with an expected very favorable outcome, the benefit of blinatumomab should be weighed with potential toxicities, including increased infection risk.10

ALL, acute lymphoblastic leukemia; AYA, adolescent and young adult; CD, cluster of differentiation; CI, confidence interval; COG, Children’s Oncology Group; CNS, central nervous system; CRS, cytokine release syndrome; DFS, disease-free survival; HR, hazard ratio; KM, Kaplan-Meier; MRD, measurable or minimal residual disease; NCCN, National Comprehensive Cancer Network; OS, overall survival; Ph(–), Philadelphia chromosome–negative; RFS, relapse-free survival; SR, standard risk.

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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

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 may have a higher risk of seizures with BLINCYTO® therapy; consider seizure prophylaxis prior to initiation of BLINCYTO® for these patients.

    Monitor patients for signs and symptoms of neurological toxicities, including ICANS, and interrupt or discontinue BLINCYTO® and/or treat with corticosteroids 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® 72-Hour bag (with preservative) and 96-Hour bag (with preservative) contain 2.5 mg of benzyl alcohol per mL, and the 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.

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

References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Litzow MR, Sun Z, Mattison RJ, et al. Blinatumomab for MRD-negative acute lymphoblastic leukemia in adults. N Engl J Med. 2024;391:320-333. 3. 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. 4. Dinner SN, Sun Z, Paietta EM, et al. Addition of blinatumomab to consolidation therapy for younger adults (< 55 years) with newly diagnosed BCR:ABL1-negative B-acute lymphoblastic leukemia (ALL) on the ECOG-ACRIN E1910 phase III trial. Presented at: 30th European Haematology Association Congress; June 12–15, 2025; Milan, Italy. 5. Gupta S, Rau RE, Kairalla JA, et al. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. N Engl J Med. 2025;392:875-891. 6. Data on file, Amgen; 2024. 7. Rau R, Gupta S, Kairalla J, et al. Blinatumomab added to chemotherapy improves disease-free survival in newly diagnosed NCI standard risk pediatric B-acute lymphoblastic leukemia: Results from Children’s Oncology Group Study AALL1731. Presented at: 66th ASH Annual Meeting and Exposition; December 7–10, 2024; San Diego, CA. 8. Gupta S, Rau RE, Kairalla JA, et al. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. N Engl J Med. 2025;392(suppl):875-891. 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.2.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 11, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Acute Lymphoblastic Leukemia V.1.2026. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 13, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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