Blincyto (blinatumomab)
Amgen · CD3×CD19 BiTE (Bispecific T-cell Engager)
What is Blincyto? Blincyto (blinatumomab) is a CD3×CD19 BiTE (bispecific T-cell engager) antibody by Amgen. It simultaneously binds CD19 on B-cell leukemia/lymphoma cells and CD3 on T cells, bringing them into contact and redirecting T cells to kill cancer cells. Approved for B-cell ALL and MRD+ B-cell ALL.
About Blincyto
| Brand Name | Blincyto |
| Generic / INN | blinatumomab |
| Drug Class | CD3×CD19 BiTE (Bispecific T-cell Engager) |
| Manufacturer | Amgen |
| Administration | Continuous IV infusion (via infusion pump) |
| FDA Approval | 2014 |
FDA-Approved Uses
- Relapsed or refractory B-cell precursor ALL — adults and children
- MRD-positive B-cell precursor ALL — adults and children in first or second complete remission with MRD ≥0.1%
- Philadelphia chromosome-positive B-cell precursor ALL — after tyrosine kinase inhibitor therapy
How Does Blincyto Work?
Blinatumomab is a bispecific antibody simultaneously binding CD19 (on malignant B cells) and CD3 (on cytotoxic T cells). This brings T cells into close proximity with leukemia cells, activating T cells to release perforin and granzymes that kill the target cell. As little as one T cell can kill many leukemia cells sequentially.
Dosage & Administration
Adults MRD+ ALL: 28 mcg/day continuous IV infusion for 4 weeks, rest 2 weeks (6-week cycle), up to 3 cycles. R/R ALL: Cycle 1: 9 mcg/day week 1, then 28 mcg/day weeks 2–4; subsequent cycles 28 mcg/day. Administered via dedicated IV line with pump. Hospitalization for first 3 days and start of cycle 2 recommended.
Dosing is individualized by the treating oncologist. Do not adjust without medical guidance. This page is educational only.
Warnings & Side Effects
- CRS — BOXED WARNING, can be life-threatening
- Neurological toxicity — BOXED WARNING, encephalopathy, seizures
- Serious infections
- Preparation errors — overdose risk; dedicated pharmacist preparation required
- Embryo-fetal toxicity
Common Side Effects
- CRS (fever, chills, hypotension)
- Neurological toxicity (confusion, tremor)
- Infections
- Fatigue
- Headache
- Edema
- Thrombocytopenia
- Nausea
Storage & Handling
Refrigerate at 2°C to 8°C (36°F to 46°F). IV stabilizer solution at room temperature. Prepared bags stable 96 hours at room temperature or 14 days refrigerated.
💰 Medication Cost & Insurance Coverage
Approximate Wholesale Acquisition Cost (WAC / List Price)
~$45,000–$55,000/cycle
continuous infusion 4 weeks
Insurance & Prior Authorization
Blincyto requires prior authorization from all major insurance plans. BiologicHealthPlus handles the full PA process — clinical documentation, peer-to-peer reviews, and appeals — at no cost to patients or providers.
Prior Authorization Guide Patient Assistance Insurance & Savings
Frequently Asked Questions — Blincyto
Blincyto is a BiTE antibody that simultaneously grabs CD19 on B-cell leukemia cells and CD3 on the patient's own T cells, forcing T cells to kill the cancer cells. It is approved for relapsed ALL and MRD-positive ALL.
Minimal residual disease (MRD) is the small number of leukemia cells that remain after treatment — too few to detect on standard tests. MRD positivity (≥0.1%) after achieving remission predicts relapse. Blinatumomab is uniquely approved to treat MRD+ ALL, potentially preventing relapse.
CRS (cytokine release syndrome) and neurological toxicities including encephalopathy and seizures are the most serious — both boxed warnings. Patients require hospitalization for the first 3 days of each cycle.
Yes — blinatumomab is given as a continuous IV infusion over 4 weeks via an ambulatory pump. This requires a dedicated IV line and careful pump management.
Blincyto is covered by Medicare Part B and commercial insurance for approved ALL indications with prior authorization. Amgen patient support is available.
Related Medications & Conditions
Related Medications
Besponsa (inotuzumab ozogamicin) · Kymriah (tisagenlecleucel — CD19 CAR-T) · Asparaginase · Dasatinib (Ph+ ALL with TKI)
Related Conditions
Acute lymphoblastic leukemia (ALL) · MRD-positive B-cell ALL · Ph+ B-cell ALL