Prescription medicine
Blinatumomab Brand names: Blincyto
Blinatumomab (Blincyto) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the blinatumomab FDA label on DailyMed (effective April 14, 2026, Amgen, Inc); the BLA 125557 record on Drugs@FDA; every blinatumomab label on DailyMed.
Highlights of the record
FDA label of April 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 [see Dosage and Administration (2.4), Warnings and Precautions (5.1) ]. 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 [see Dosage and Administration (2.4), Warnings and Precautions (5.2) ]. WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. 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. ( 2.4 , 5.1 ) 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.
Used for
From the label: indications and usageBLINCYTO 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%.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- December 3, 2014 Blincyto, Amgen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 10,373 through July 30, 2026
What is blinatumomab used for?
From the label: indications and usageBLINCYTO 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). ( 1.2 ) CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. […]
Conditions named in the indications of blinatumomab's FDA labels, with every medicine labeled for each:
From other blinatumomab labelsLeukemia, lymphoma and myeloma: MRD-positive B-cell Precursor ALL BLINCYTO is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal …
Source: FDA drug label (BLINCYTO), Amgen, Inc, effective April 14, 2026 (SPL set 38b482a8-960b-4591-9857-5031ecb830aa), via openFDA; the full label on DailyMed
What does the patient leaflet for blinatumomab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about BLINCYTO?Call your healthcare provider or get emergency medical help right away if you get any of the symptoms listed below. BLINCYTO may cause serious side effects that can be severe, life-threatening, or lead to death, including: Cytokine Release Syndrome (CRS) and Infusion Reactions. Symptoms of CRS and infusion reactions may include: fever tiredness or weakness dizziness headache low blood pressure nausea vomiting chills face swelling wheezing or trouble breathing skin rash Neurologic problems. Symptoms of neurologic problems may include: seizures difficulty in speaking or slurred speech loss of consciousness trouble sleeping confusion and disorientation loss of balance headache difficulty with facial movements, hearing, vision, or swallowing tremors People with Down Syndrome may have a higher risk of seizures with BLINCYTO treatment and may be given anti-seizure medicine before starting BLINCYTO treatment. Your healthcare provider will check for these problems during treatment with BLINCYTO. Your healthcare provider may temporarily stop or completely stop your treatment with BLINCYTO, if you have severe side effects. See “ What are the possible side effects of BLINCYTO? ” below for other side effects of BLINCYTO.
From the patient leaflet: What should I avoid while receiving BLINCYTO?Do not drive, operate heavy machinery, or do other dangerous activities while you are receiving BLINCYTO because BLINCYTO can cause neurological symptoms, such as dizziness, seizures, and confusion.
From the patient leaflet: How should I store BLINCYTO?Intravenous (IV) bags containing BLINCYTO for infusion will arrive in a special package. Do not open the package. Do not freeze the package. The package containing BLINCYTO will be opened by your healthcare provider and stored in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not throw away (dispose of) any BLINCYTO in your household trash. Talk with your healthcare provider about disposal of BLINCYTO and used supplies. Keep BLINCYTO and all medicines out of reach of children.
Source: FDA drug label (BLINCYTO), Amgen, Inc, effective April 14, 2026 (SPL set 38b482a8-960b-4591-9857-5031ecb830aa), via openFDA; the full label on DailyMed
Is there a generic for blinatumomab (Blincyto)?
No generic blinatumomab is approved (Drugs@FDA, October 8, 2026).
- 2014 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the blinatumomab label say about other medicines?
The blinatumomab label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | In these patients, monitor for toxicity (e.g., warfarin) or drug concentrations (e.g., cyclosporine). |
| Cytarabine | warnings and precautions | Cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO, especially in patients with prior treatment with cranial irradiation and antileukemic chemotherapy (including systemic high-dose methotrexate or intrathecal cytarabine). |
| Dexamethasone | warnings and precautions | Management of pancreatitis may require either temporary interruption or discontinuation of BLINCYTO and dexamethasone [see Dosage and Administration (2.4) ]. |
| Methotrexate | warnings and precautions | Cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO, especially in patients with prior treatment with cranial irradiation and antileukemic chemotherapy (including systemic high-dose methotrexate or intrathecal cytarabine). |
| Warfarin | drug interactions | In these patients, monitor for toxicity (e.g., warfarin) or drug concentrations (e.g., cyclosporine). |
Source: FDA drug label (BLINCYTO), Amgen, Inc, effective April 14, 2026 (SPL set 38b482a8-960b-4591-9857-5031ecb830aa), via openFDA; the full label on DailyMed
What do FAERS reports show for blinatumomab?
The FDA Adverse Event Reporting System holds 10,373 reports that list blinatumomab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,893 are coded as a death and 2,787 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Blinatumomab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other