Identification
- Summary
Blinatumomab is an antineoplastic antibody used to treat Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
- Brand Names
- Blincyto
- Generic Name
- Blinatumomab
- DrugBank Accession Number
- DB09052
- Background
Blinatumomab is a BiTE-class (bi-specific T-cell engagers) constructed monoclonal antibody indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blinatumomab is manufactured by Amgen Inc. and marketed under the brand Blincyto™. A full treatment regimen consisting of two cycles of four weeks each, is priced at $178 000 USD. Blinatumomab was approved in December 2014 under the FDA’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Structure
- Protein Chemical Formula
- C2367H3577N649O772S19
- Protein Average Weight
- 54100.0 Da
- Sequences
>single chain variable fragment fusion protein DIQLTQSPASLAVSLGQRATISCKASQSVDYDGDSYLNWYQQIPGQPPKLLIYDASNLVS GIPPRFSGSGSGTDFTLNIHPVEKVDAATYHCQQSTEDPWTFGGGTKLEIKGGGGSGGGG SGGGGSQVQLQQSGAELVRPGSSVKISCKASGYAFSSYWMNWVKQRPGQGLEWIGQIWPG DGDTNYNGKFKGKATLTADESSSTAYMQLSSLASEDSAVYFCARRETTTVGRYYYAMDYW GQGTTVTVSSGGGGSDIKLQQSGAELARPGASVKMSCKTSGYTFTRYTMHWVKQRPGQGL EWIGYINPSRGYTNYNQKFKDKATLTTDKSSSTAYMQLSSLTSEDSAVYYCARYYDDHYC LDYWGQGTTLTVSSVEGGSGGSGGSGGSGGVDDIQLTQSPAIMSASPGEKVTMTCRASSS VSYMNWYQQKSGTSPKRWIYDTSKVASGVPYRFSGSGSGTSYSLTISSMEAEDAATYYCQ QWSSNPLTFGAGTKLELKHHHHHH
Download FASTA Format- Synonyms
- Blinatumomab
- External IDs
- AMG103
- MEDI 538
- MEDI-538
- MEDI538
- MT 103
- MT-103
- MT103
Pharmacology
- Indication
Indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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- Pharmacodynamics
Not Available
- Mechanism of action
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. Blinatumomab mediates the formation of a synapse between the T cell and the tumor cell, upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T cells, which result in redirected lysis of CD19+ cells.
Target Actions Organism AB-lymphocyte antigen CD19 activatorHumans AT-cell surface glycoprotein CD3 delta chain activatorHumans - Absorption
Not Available
- Volume of distribution
4.52 L, standard deviation 2.89.
- Protein binding
Not Available
- Metabolism
The metabolic pathway of blinatumomab has not been characterized. Like other protein therapeutics, blinatumomab is expected to be degraded into small peptides and amino acids via catabolic pathways.
- Route of elimination
Not Available
- Half-life
2.11 hours, standard deviation 1.42.
- Clearance
2.92 L/hour, standard deviation 2.83.
- Adverse Effects
- Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.
- Toxicity
- Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving blinatumomab. Interrupt or discontinue blinatumomab as recommended.
- Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients receiving blinatumomab. Interrupt or discontinue blinatumomab as recommended.
- In patients receiving blinatumomab in clinical trials, serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections were observed in approximately 25% of patients, some of which were life-threatening or fatal.
- Tumor lysis syndrome (TLS), which may be life-threatening or fatal, has been observed in patients.
- Neutropenia and febrile neutropenia, including life-threatening cases, have been observed in patients.
- Treatment with blinatumomab was associated with transient elevations in liver enzymes.
- Cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving blinatumomab, especially in patients with prior treatment with cranial irradiation and antileukemic chemotherapy (including systemic high-dose methotrexate or intrathecal cytarabine).
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbatacept The risk or severity of adverse effects can be increased when Abatacept is combined with Blinatumomab. Abciximab The risk or severity of bleeding can be increased when Abciximab is combined with Blinatumomab. Acenocoumarol The risk or severity of bleeding can be increased when Acenocoumarol is combined with Blinatumomab. Acetylsalicylic acid The risk or severity of bleeding can be increased when Acetylsalicylic acid is combined with Blinatumomab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Blinatumomab. Adenovirus type 7 vaccine live The risk or severity of infection can be increased when Adenovirus type 7 vaccine live is combined with Blinatumomab. Aducanumab The risk or severity of adverse effects can be increased when Blinatumomab is combined with Aducanumab. Aldesleukin The risk or severity of adverse effects can be increased when Aldesleukin is combined with Blinatumomab. Alefacept The risk or severity of adverse effects can be increased when Alefacept is combined with Blinatumomab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Blinatumomab. Identify potential medication risksEasily compare up to 40 drugs with our drug interaction checker.Get severity rating, description, and management advice.Learn more - Food Interactions
- No interactions found.
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Blincyto Powder, for solution 38.5 mcg / vial Intravenous Amgen 2016-03-17 Not applicable Canada Blincyto Kit 12.5 ug/1mL Intravenous AMGEN INC 2014-12-18 Not applicable US Blincyto Solution 38.5 mcg Intravenous Amgen Europe B.V. 2020-12-22 Not applicable EU
Categories
- ATC Codes
- L01XC19 — Blinatumomab
- Drug Categories
- Amides
- Amino Acids, Peptides, and Proteins
- Antibodies
- Antibodies, Monoclonal
- Antineoplastic Agents
- Antineoplastic and Immunomodulating Agents
- Bicyclic Monoterpenes
- Bispecific CD19-directed CD3-directed T Cell Engager
- Blood Proteins
- Bridged-Ring Compounds
- Cancer immunotherapy
- CD19-directed Antibody Interactions
- CD3 Receptor Agonists
- CD3-directed Antibody Interactions
- Globulins
- Immunoglobulins
- Immunoproteins
- Immunosuppressive Agents
- Immunotherapy
- Monoterpenes
- Myelosuppressive Agents
- Narrow Therapeutic Index Drugs
- Norbornanes
- Proteins
- Serum Globulins
- Sulfones
- Sulfur Compounds
- Terpenes
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- 4FR53SIF3A
- CAS number
- 853426-35-4
References
- General References
- Zugmaier G, Klinger M, Schmidt M, Subklewe M: Clinical overview of anti-CD19 BiTE((R)) and ex vivo data from anti-CD33 BiTE((R)) as examples for retargeting T cells in hematologic malignancies. Mol Immunol. 2015 Oct;67(2 Pt A):58-66. doi: 10.1016/j.molimm.2015.02.033. Epub 2015 Apr 13. [Article]
- Garber K: Bispecific antibodies rise again. Nat Rev Drug Discov. 2014 Nov;13(11):799-801. doi: 10.1038/nrd4478. [Article]
- External Links
- KEGG Drug
- D09325
- PubChem Substance
- 347910400
- 1597258
- ChEMBL
- CHEMBL1742992
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Blinatumomab
- FDA label
- Download (242 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Recruiting Treatment Precursor-B Acute Lymphoblastic Leukemia 1 3 Active Not Recruiting Treatment Acute Lymphoblastic Leukemia (ALL) 1 3 Active Not Recruiting Treatment Acute Lymphoblastic Leukemia (ALL) / B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative 1 3 Active Not Recruiting Treatment Recurrent B Acute Lymphoblastic Leukemia 1 3 Completed Treatment Acute Lymphoblastic Leukemia (ALL) 1 3 Not Yet Recruiting Treatment Acute Lymphoblastic Leukemia (ALL) / Mixed Phenotype Acute Leukemia (MPAL) 1 3 Recruiting Treatment Acute Lymphoblastic Leukemia (ALL) 1 3 Recruiting Treatment Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive) / ALL, Adult / Philadelphia-Positive ALL 1 3 Recruiting Treatment B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 1 3 Recruiting Treatment B Acute Lymphoblastic Leukemia / B Lymphoblastic Lymphoma / Down Syndrome (DS) 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, lyophilized, for solution Intravenous 38.5 mcg/1vial Kit Intravenous 12.5 ug/1mL Powder Intravenous; Parenteral 38.5 MICROGRAMMI Powder, for solution Intravenous 38.5 mcg / vial Solution Intravenous 38.5 mcg Injection Intravenous Injection Parenteral Injection, powder, lyophilized, for solution Intravenous 55 mcg/ml Injection, powder, lyophilized, for solution Intravenous 38.5 mcg - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US7235641 No 2007-06-26 2023-12-22 US US7575923 No 2009-08-18 2018-04-21 US US7635472 No 2009-12-22 2023-05-31 US US8247194 No 2012-08-21 2024-05-05 US US20120328618 No 2009-10-27 2029-10-27 US US20130323247 No 2008-11-07 2028-11-07 US
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets

- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Activator
- General Function
- Receptor signaling protein activity
- Specific Function
- Assembles with the antigen receptor of B-lymphocytes in order to decrease the threshold for antigen receptor-dependent stimulation.
- Gene Name
- CD19
- Uniprot ID
- P15391
- Uniprot Name
- B-lymphocyte antigen CD19
- Molecular Weight
- 61127.985 Da
References
- Zugmaier G, Klinger M, Schmidt M, Subklewe M: Clinical overview of anti-CD19 BiTE((R)) and ex vivo data from anti-CD33 BiTE((R)) as examples for retargeting T cells in hematologic malignancies. Mol Immunol. 2015 Oct;67(2 Pt A):58-66. doi: 10.1016/j.molimm.2015.02.033. Epub 2015 Apr 13. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Activator
- General Function
- Transmembrane signaling receptor activity
- Specific Function
- The CD3 complex mediates signal transduction.
- Gene Name
- CD3D
- Uniprot ID
- P04234
- Uniprot Name
- T-cell surface glycoprotein CD3 delta chain
- Molecular Weight
- 18929.38 Da
References
- Zugmaier G, Klinger M, Schmidt M, Subklewe M: Clinical overview of anti-CD19 BiTE((R)) and ex vivo data from anti-CD33 BiTE((R)) as examples for retargeting T cells in hematologic malignancies. Mol Immunol. 2015 Oct;67(2 Pt A):58-66. doi: 10.1016/j.molimm.2015.02.033. Epub 2015 Apr 13. [Article]
Drug created at May 06, 2015 22:29 / Updated at June 03, 2022 07:24