Asset 1
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

Connect with a BLINCYTO® (blinatumomab) representative

Do you have questions about BLINCYTO® treatment? Enter your information today and a representative will be in touch with you soon.

First Name

Enter first name

Last Name

Enter last name

Email

Enter email address

Phone Number

Enter Phone Number

Address

Address

City

Enter City

State

State

Zip Code

Enter Zip Code

Select your title

Please check the box to continue.

Privacy Statement By clicking "Submit," you agree to disclose your personal information to Amgen and to be contacted by Amgen and their agents in the future regarding products, services, and/or information related to BLINCYTO®. For more information about Amgen's privacy practices, please visit www.amgen.com/privacy.

Submit

Thank you! A BLINCYTO® (blinatumomab) representative will be in touch with you soon.

Close

You are now leaving BLINCYTOHCP.com

The content of the linked site is the sole responsibility of the site provider. Amgen Inc. does not control or endorse this third-party website.

Go back to Blincytohcp.com
External Page

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

R/R: Amgen 20120215 study

Study design: A randomized, controlled, open-label, phase 3 study of BLINCYTO® vs chemotherapy in 111 patients 28 days to 18 years of age with high-risk,* first-relapsed, Ph(–) B-cell precursor ALL with < 25% blasts in the bone marrow after induction and 2 cycles of consolidation chemotherapy.† Patients were randomized to receive BLINCYTO®‡ or the IntReALL HR 2010 HC3 intensive combination chemotherapy§ as the third cycle of consolidation. Patients were to proceed to HSCT after this cycle of consolidation.1

*High risk was defined as very early or early iBM relapse, very early combined BM + EM relapse, or very early iEM relapse. Very early relapse was defined as < 18 months after primary diagnosis, and early relapse was defined as ≥ 18 months after primary diagnosis and 

< 6 months after completion of primary therapy.2

†Induction therapy and cycles of HC1 and HC2 chemotherapy, administered according to the IntReALL HR 2010, ALL-REZ BFM 2002, ALL R3, COOPRALL, and AIEOP ALL REC 2003 protocols.3

‡Patients in the BLINCYTO® arm received one cycle of BLINCYTO® as a continuous IV infusion at 15 mcg/m2/day over 4 weeks (maximum daily dose was not to exceed 28 mcg/day).1

§Third block of consolidation chemotherapy, HC3, included: dexamethasone IV/vincristine IV/daunorubicin IV/methotrexate IV/ifosfamide IV/PEG-asparaginase IV/IM.2,4

BLINCYTO® efficacy was established based on OS and RFS vs chemotherapy in pediatric and AYA patients with B-cell precursor ALL in high-risk first relapse1

OS for BLINCYTO® vs chemotherapy1

modal
os_for_blincyto_vs_chemotherapy
  • The median follow-up time for OS was 55.2 months for the overall population1

RFS for BLINCYTO® vs chemotherapy1

modal
rfs_for_blincyto_vs_chemotherapy

*Months were calculated as days from randomization date to event/censor date, divided by 30.5.1

†The hazard ratio estimates are obtained from the Cox proportional hazard model.1

ALL, acute lymphoblastic leukemia; AYA, adolescent and young adult; BM, bone marrow; CI, confidence interval; EM, extramedullary; HC1, high-risk consolidation block 1; HC2, high-risk consolidation block 2; HC3, high-risk consolidation block 3; HR, hazard ratio; HSCT, allogeneic hematopoietic stem cell transplantation; iBM, isolated bone marrow; iEM, isolated extramedullary; IM, intramuscular; IV, intravenous; OS, overall survival; Ph(–), Philadelphia chromosome–negative; RFS, relapse-free survival; R/R, relapsed or refractory.

Amgen 20120215 study design and baseline characteristics of patients

Patients 28 days to 18 years of age with
Ph(–) B-cell precursor ALL in high-risk first relapse1,3,*

Pediatric_cycle graph
Pediatric_cycle graph_mobile

Endpoints:1

  • OS
  • RFS
Key inclusion criteria1
Ph(–) B-cell precursor ALL in high-risk first relapse
< 25% blasts in the BM
Key exclusion criteria5
Clinically relevant CNS pathology requiring treatment
Evidence of current CNS (CNS2, CNS3) involvement by ALL§
Abnormal renal or hepatic function prior to start of treatment

Demographics and baseline characteristics1

Characteristic BLINCYTO®
(n=54)
Chemotherapy
(n=57)
Age, n (%)
Median, (range) 6 (1, 17) 5 (1, 17)
< 1 year 0 0
1 to 9 years 39 (72) 41 (72)
≥ 10 to 18 years 15 (28) 16 (28)
Sex, n (%)
Males, n (%) 30 (56) 23 (40)
Race, n (%)
American Indian or Alaska Native 0 0
Asian 1 (2) 3 (5)
Black (or African American) 0 3 (5)
Native Hawaiian or Other Pacific Islander 0 0
Other 3 (6) 5 (9)
White 50 (93) 46 (81)
Cytomorphology at randomization, n (%)
Blasts < 5% 54 (100) 54 (95)
Blasts ≥ 5% and < 25% 0 2 (4)
Blasts ≥ 25% 0 0
Not evaluable 0 1 (2)
MRD PCR value at randomization, n (%)
≥ 10-3 11 (20) 16 (28)
< 10-3 and ≥ 10-4 15 (28) 6 (11)
< 10-4 20 (37) 23 (40)
Unknown 8 (15) 12 (21)
Time from first diagnosis to relapse (month), n (%)
< 18 months 19 (35) 22 (39)
≥ 18 months and ≤ 30 months 32 (59) 31 (54)
> 30 months 3 (6) 4 (7)

*High risk was defined as very early or early iBM relapse, very early combined BM + EM relapse, or very early iEM relapse. Very early relapse was defined as < 18 months after primary diagnosis, and early relapse was defined as ≥ 18 months after primary diagnosis and
< 6 months after completion of primary therapy.2

†Induction therapy and cycles of HC1 and HC2 chemotherapy, administered according to the IntReALL HR 2010, ALL-REZ BFM 2002, ALL R3, COOPRALL, and AIEOP ALL REC 2003 protocols.3

‡Third block of consolidation chemotherapy, HC3, included: dexamethasone IV/vincristine IV/daunorubicin IV/methotrexate IV/ifosfamide IV/PEG-asparaginase IV/IM.2,4

§CNS2, patients with WBC count in CSF < 5 per microliter and having blasts in the CSF; CNS3, patients with WBC count in CSF ≥ 5 per microliter and having blasts in the CSF, or clinical/radiographic signs of central nervous leukemia.6

CNS, central nervous system; CSF, cerebrospinal fluid; MRD, measurable or minimal residual disease; PCR, polymerase chain reaction; WBC, white blood cell.

The National Comprehensive Cancer Network® (NCCN®) for Pediatric ALL recommends blinatumomab as a treatment option in pediatric patients with relapsed or refractory B-cell precursor ALL7

NCCN Recommended

Safety in high-risk first relapse consistent with established safety profile1

Adverse reactions with a difference between arms of ≥ 10% for any Grade or ≥ 5% for Grade 3 or 4 during consolidation cycle 31

Adverse reaction BLINCYTO®
(n=54) 		Chemotherapy
(n=52)
All Grades
(%)		 Grade 3 or 4
(%)		 All Grades
(%)		 Grade 3 or 4
(%)
Blood and lymphatic system disorders
Anemia* 24 15 46 42
Neutropenia* 19 17 35 31
Thrombocytopenia* 15 15 39 35
Febrile neutropenia 2 2 25 25
Gastrointestinal disorders
Nausea† 43 2 31 2
Abdominal pain* 13 0 23 2
Stomatitis‡ 11 4 60 29
General disorders and administration site conditions
Pyrexia 76 6 19 0
Hepatobiliary disorders
Liver function test abnormal§ 9 6 27 17
Immune system disorders
Hypogammaglobulinemia* 24 2 12 2
Infections and infestations
Infection – pathogen unspecified 13 6 29 10
Musculoskeletal and connective tissue disorders
Musculoskeletal pain** 9 0 29 2
Nervous system disorders
Headache‡‡ 37 0 15 0
Skin and subcutaneous disorders
Rash* 22 2 12 0
Vascular disorders
Hemorrhage†† 11 2 23 6
  • Serious adverse reactions occurred in 28% of patients who received BLINCYTO®1
  • Permanent discontinuation of BLINCYTO® due to an adverse reaction occurred in 4% of patients. Adverse reactions that led to discontinuation included nervous system disorder and seizure1
  • Dosage interruptions of BLINCYTO® due to an adverse reaction occurred in 11% of patients. Adverse reactions which required dosage interruption in > 2% of patients included nervous system disorder1
  • The most common (≥ 20%) adverse reactions in the BLINCYTO® arm were pyrexia, nausea, headache, rash, hypogammaglobulinemia, and anemia1

*Other related adverse reactions included:1

†Nausea: vomiting.1

‡Stomatitis: mouth ulceration, mucosal inflammation.1

§Liver function test abnormal: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hypertransaminasemia.1

**Musculoskeletal pain: back pain, pain in extremity, bone pain.1

††Hemorrhage: Epistaxis, petechiae, hemarthrosis, hematoma, hematuria.1

‡‡May represent ICANS.1

ICANS, immune effector cell-associated neurotoxicity syndrome.

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 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
BACK TO TOP

References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Data on file, Amgen; 2020. 3. Locatelli F, Zugmaier G, Rizzari C, et al. Effect of blinatumomab vs chemotherapy on event-free survival among children with high-risk first-relapse B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325:843-854. 4. Locatelli F, Zugmaier G, Rizzari C, et al. Effect of blinatumomab vs chemotherapy on event-free survival among children with high-risk first-relapse B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325(suppl 3):843-854. 5. Locatelli F, Zugmaier G, Rizzari C, et al. Effect of blinatumomab vs chemotherapy on event-free survival among children with high-risk first-relapse B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325(suppl):843-854. 6. Brown PA, Ji L, Xu X, et al. Effect of postreinduction therapy consolidation with blinatumomab vs chemotherapy on disease-free survival in children, adolescents, and young adults with first relapse of B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325(suppl 2):833-842. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Acute Lymphoblastic Leukemia V.3.2025. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed April 21, 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.