Blinatumomab

Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T-cells. It activates endogenous T-cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on benign and malignant B-cells.

• BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. ( 1.1 ) Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).ICD-10: C95.90

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

For the treatment of MRD-positive B-cell Precursor ALL - See Full Prescribing Information for recommended dose by patient weight and schedule. ( 2.1 ) - Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle. ( 2.1 ) - Premedicate with prednisone or equivalent dexamethasone. ( 2.1 ) For the treatment of Relapsed or Refractory B-cell Precursor ALL - See Full Prescribing Information for recommended dose by patient weight and schedule. ( 2.2 ) - Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle. ( 2.2 ) - Premedicate with dexamethasone. ( 2.2 ) For the treatment of B-cell Precursor ALL in the Consolidation Phase - See Full Prescribing Information for recommended dose by patient weight and schedule. ( 2.3 ) - Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle. ( 2.3 ) - Premedicate with dexamethasone. ( 2.3 ) Refer to Full Prescribing Information for important preparation and administration information. ( 2.5 ) Administer as a continuous intravenous infusion at a constant flow rate using an infusion pump. - See Instructions for Use for infusion over 24 hours or 48 hours. - See Instructions for Use for infusion over 72 hours, 96 hours, or 7 days using Bacteriostatic 0.9% Sodium Chloride Injection (containing 0.9% benzyl alcohol). This option is not recommended for patients weighing less than 5.4 kg.

Infections: Monitor patients for signs or symptoms; treat appropriately. ( 5.3 ) Effects on Ability to Drive and Use Machines: Advise patients to refrain from driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO is being administered. ( 5.6 ) Pancreatitis: Evaluate patients who develop signs and symptoms of pancreatitis. Management of pancreatitis may require either temporary interruption or discontinuation of BLINCYTO. ( 5.8 ) Preparation and Administration Errors: Strictly follow instructions for preparation (including admixing) and administration. ( 5.10 ) Benzyl Alcohol Toxicity in Neonates: Use BLINCYTO prepared with preservative-free saline for neonates. BLINCYTO solution containing benzyl alcohol is not recommended for patients weighing less than 5.4 kg. ( 5.12 , 8.4 ) Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.13 , 8.1 , 8.3 ) 5.1 Cytokine Release Syndrome Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. The median time to onset of CRS was 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Manifestations of CRS include fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin, and disseminated intravascular coagulation (DIC).

The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurological Toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome [see Warnings and Precautions (5.2) ] Infections [see Warnings and Precautions (5.3) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.4) ] Neutropenia and Febrile Neutropenia [see Warnings and Precautions (5.5) ] Effects on Ability to Drive and Use Machines [see Warnings and Precautions (5.6) ] Elevated Liver Enzymes [see Warnings and Precautions (5.7) ] Pancreatitis [see Warnings and Precautions (5.8) ] Leukoencephalopathy [see Warnings and Precautions (5.9) ] The most common adverse reactions (≥ 20%) are pyrexia, infusion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary Based on its mechanism of action, BLINCYTO may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of BLINCYTO in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, a murine surrogate molecule administered to pregnant mice crossed the placental barrier (see Data ) . Blinatumomab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD19 on B-cells and the finding of B-cell depletion in non-pregnant animals, blinatumomab can cause B-cell lymphocytopenia in infants exposed to blinatumomab in-utero. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Due to the potential for B-cell lymphocytopenia in infants following exposure to BLINCYTO in utero , the infant's B lymphocytes should be monitored before the initiation of live virus vaccination [see Warnings and Precautions (5.11) ] . Data Animal Data Animal reproduction studies have not been conducted with blinatumomab.

Metabolism

The pharmacokinetics of blinatumomab appear linear over a dose range from 5 to 90 mcg/m 2 /day (approximately equivalent to 9 to 162 mcg/day) in adult patients. Following continuous intravenous infusion, the steady-state serum concentration (C ss ) was achieved within a day and remained stable over time.

Overdoses have been observed, including one adult patient who received 133-fold the recommended therapeutic dose of BLINCYTO delivered over a short duration. In the dose evaluation phase of a study in pediatric and adolescent patients with relapsed or refractory B-cell precursor ALL, one patient experienced a fatal cardiac failure event in the setting of life-threatening cytokine release syndrome (CRS) at a 30 mcg/m 2 /day (higher than the maximum tolerated/recommended) dose [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] . Overdoses resulted in adverse reactions, which were consistent with the reactions observed at the recommended dosage and included fever, tremors, and headache. In the event of overdose, interrupt the infusion, monitor the patient for signs of adverse reactions, and provide supportive care [see Warnings and Precautions (5.10) ] . Consider re-initiation of BLINCYTO at the recommended dosage when all adverse reactions have resolved and no earlier than 12 hours after interruption of the infusion [see Dosage and Administration (2.1 , 2.2 and 2.3) ] .

• Dec 3, 2014BLABLA125557Amgen

1. 1Pyrexia1,135—
2. 2Acute Lymphocytic Leukaemia Recurrent1,079—
3. 3Cytokine Release Syndrome1,066—
4. 4Off Label Use711—
5. 5Death644—
6. 6Neurotoxicity574—
7. 7Drug Ineffective416—
8. 8Headache362—
9. 9Neutropenia311—
10. 10Febrile Neutropenia304—
11. 11Therapy Non-responder278—
12. 12Tremor271—
13. 13Seizure258—
14. 14Infection257—
15. 15Acute Lymphocytic Leukaemia241—

The 10 most recently updated of 175 ClinicalTrials.gov registrations naming Blinatumomab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
  Recruiting · Phase 2 · Interventional · 461 enrolled · National Cancer Institute (NCI)
  NCT04546399updated 2026-06-12
• Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
  Recruiting · Phase 2 · Interventional · 153 enrolled · National Cancer Institute (NCI)
  NCT06317662updated 2026-06-11
• Immuno-Targeted Therapy Plus Low-Dose Chemotherapy for Newly Diagnosed Adult Ph-Negative B-ALL: A Prospective Umbrella Trial
  Not yet recruiting · Phase 2 · Interventional · 32 enrolled · Institute of Hematology & Blood Diseases Hospital, China
  NCT07643103updated 2026-06-11
• Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment
  Not yet recruiting · Phase 2 · Interventional · 90 enrolled · SWOG Cancer Research Network
  NCT07636564updated 2026-06-09
• Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia
  Completed · Phase 2 · Interventional · 19 enrolled · University of California, Davis
  NCT02997761updated 2026-06-09
• Phase 1/2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 30 enrolled · M.D. Anderson Cancer Center
  NCT07604233updated 2026-06-08
• Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
  Recruiting · Phase 1 · Phase 2 · Interventional · 40 enrolled · M.D. Anderson Cancer Center
  NCT06308588updated 2026-06-08
• A Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive Acute Lymphoblastic Leukemia (ALL)
  Not yet recruiting · Phase 1 · Interventional · 26 enrolled · Wake Forest University Health Sciences
  NCT07614022updated 2026-06-05
• A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
  Recruiting · Phase 2 · Phase 3 · Interventional · 340 enrolled · Merck Sharp & Dohme LLC
  NCT07570173updated 2026-06-05
• Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
  Recruiting · Phase 2 · Interventional · 84 enrolled · National Cancer Institute (NCI)
  NCT03739814updated 2026-06-03

Frequently asked questions

How does Blinatumomab work?

Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T-cells. It activates endogenous T-cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on benign and malignant B-cells.

What is Blinatumomab used for?

According to FDA labeling, Blinatumomab carries indications including: BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. ( 1.1 ) Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Blinatumomab?

Blinatumomab is classified as Other monoclonal antibodies and antibody drug conjugates, Bispecific CD19-directed CD3-directed T Cell Engager, CD19-directed Antibody Interactions, CD3-directed Antibody Interactions, CD3 Receptor Agonists.

What are the brand names for Blinatumomab?

Blinatumomab is marketed under brand names including Blincyto.

What are the contraindications for Blinatumomab?

Blinatumomab labeling lists contraindications including: BLINCYTO is contraindicated in patients with known hypersensitivity to blinatumomab or to any component of the product formulation. Known hypersensitivity to blinatumomab or to any component of the product formulation.. Always consult the full prescribing information and a clinician.