BLINCYTO blinatumomab Kit — NDC 55513-160-01 (Billing 55513-0160-01)
This is a package of BLINCYTO blinatumomab Kit from Amgen, Inc, marketed since Dec 2014 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 55513-160-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 55513 labeler · 160 product · 01 package
- Package marketed since
- Dec 18, 2014
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5551316001 8
- Medicaid fills, this package
- 6,278 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 073187
- GCN: 37552
- GPI-14 (Medi-Span): 21352020002120
- HICL (First Databank): 041612
- AHFS class code: 10:00.00.00
- RxCUI (RxNorm): 1597262
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Bispecific CD19-directed CD3-directed T Cell Engager class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $5,920.10 | — |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9039 | $172.900 / J9039 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Oct 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 55513-0160-01 You're viewing this Main listing | 1 KIT in 1 PACKAGE * 3.088 mL in 1 VIAL * 10.6 mL in 1 VIAL | 2014-12-18 | — | Active |
| 55513-0160-21 55513-160-21 | 1 KIT in 1 PACKAGE * 3.088 mL in 1 VIAL * 10.6 mL in 1 VIAL | 2026-04-30 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of BLINCYTO blinatumomab Kit?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Blincytothis 55513-0160-01 | Amgen, | 1 kit | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Dec 3, 2026 |
Is there a biosimilar for BLINCYTO 35MCG VL W-STABILIZER?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
More NDCs from Amgen, Inc labeler code 55513
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- Neulasta pegfilgrastim 6 mg/.6mL Injection NDC 55513-190-01
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 [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.
( 2.4 , 5.2 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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). ( 1.2 ) CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.
( 1.3 )
1.1MRD-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 to 0.1% in adult and pediatric patients one month and older.
1.2Relapsed or Refractory B-cell Precursor ALL BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older.
1.3B-cell Precursor ALL in the Consolidation Phase BLINCYTO is indicated for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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.
2.1Treatment of MRD-positive B-cell Precursor ALL A treatment course consists of 1 cycle of BLINCYTO for induction followed by up to 3 additional cycles for consolidation. A single cycle of treatment of BLINCYTO induction or consolidation consists of 28 days of continuous intravenous infusion followed by a 14-day treatment-free interval (total 42 days). See Table 1 for the recommended dose by patient weight and schedule.
Patients weighing 45 kg or more receive a fixed-dose. For patients weighing less than 45 kg, the dose is calculated using the patient's body surface area (BSA). Table 1.
Recommended BLINCYTO Dose and Schedule for the Treatment of MRD-positive B-cell Precursor ALL Cycle Patients Weighing 45 kg or More (Fixed-dose) Patients Weighing Less Than 45 kg (BSA-based dose) Induction Cycle 1 Days 1-28 28 mcg/day 15 mcg/m 2 /day (not to exceed 28 mcg/day) Days 29-42 14-day treatment-free interval 14-day treatment-free interval Consolidation Cycles 2-4 Days 1-28 28 mcg/day 15 mcg/m 2 /day (not to exceed 28 mcg/day) Days 29-42 14-day treatment-free interval 14-day treatment-free interval Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle.
For all subsequent cycle starts and re-initiations (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended. Intrathecal chemotherapy prophylaxis is recommended before and during BLINCYTO therapy to prevent central nervous system ALL relapse. Premedicate with prednisone or equivalent for MRD-positive B-cell Precursor ALL: For adult patients, premedicate with prednisone 100 mg intravenously or equivalent (e.g., dexamethasone 16 mg) 1 hour prior to the first dose of BLINCYTO in each cycle.
For pediatric patients, premedicate with 5 mg/m 2 of dexamethasone intravenously or orally, to a maximum dose of 20 mg, prior to the first dose of BLINCYTO in the first cycle and when restarting an infusion after an interruption of 4 or more hours in the first cycle. For administration of BLINCYTO: 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).
The administration of BLINCYTO as a 72-hour, 96-hour, and 7-day infusion is not recommended for patients weighing less than 5.4 kg.
2.2Treatment of Relapsed or R… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For injection: 35 mcg of white to off-white lyophilized powder in a single-dose vial for reconstitution. For injection: 35 mcg of lyophilized powder in a single-dose vial for reconstitution. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 )
5.1Cytokine 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 manifestations of CRS after treatment with BLINCYTO overlap with those of infusion reactions, capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS). Evaluation for HLH/MAS should be considered when CRS is atypical or prolonged, or when features of macrophage activation are present. Using all of these terms to define CRS in clinical trials of BLINCYTO, CRS was reported in 15% of patients with relapsed or refractory ALL, in 7% of patients with MRD-positive ALL, and in 16% of patients receiving BLINCYTO cycles in the consolidation phase of therapy [see Adverse Reactions (6.1) ] .
Monitor patients for signs or symptoms of these events. Advise outpatients on BLINCYTO to contact their healthcare professional for signs and symptoms associated with CRS. 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 [see Dosage and Administration (2.4) ] .
5.2Neurological Toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome BLINCYTO can cause serious or life-threatening neurologic toxicity, including ICANS [see Adverse Reactions 6.1 ] . The incidence of neurologic toxicities in clinical trials was approximately 65% [see Adverse Reactions (6.1) ] . Among patients that experienced a neurologic toxicity, 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; the neurological toxicity profile varied by age group [see Use in Specific Populations (8.4 , 8.5) ] . Grade 3 or higher neurological toxicities following initiation of BLINCYTO administration occurred in approximately 13% of patients and included 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.… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
6.1Clinical 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. 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. MRD-positive B-cell Precursor ALL The safety of BLINCYTO in patients with MRD-positive B-cell precursor ALL was evaluated in two single-arm clinical studies in which 137 adult patients were treated with BLINCYTO. The median age of the study population was 45 years (range: 18 to 77 years).
The most common adverse reactions (≥ 20%) were pyrexia, infusion-related reactions, headache, infections (pathogen unspecified), tremor, and chills. Serious adverse reactions were reported in 61% of patients. The most common serious adverse reactions (≥ 2%) included pyrexia, tremor, encephalopathy, aphasia, lymphopenia, neutropenia, overdose, device related infection, seizure, and staphylococcal infection.
Adverse reactions of Grade 3 or higher were reported in 64% of patients. Discontinuation of therapy due to adverse reactions occurred in 17% of patients; neurologic events were the most frequently reported reasons for discontinuation. There were 2 fatal adverse reactions that occurred within 30 days of the end of BLINCYTO treatment (atypical pneumonia and subdural hemorrhage).
Table 6 summarizes the adverse reactions occurring at a ≥ 10% incidence for any grade or ≥ 5% incidence for Grade 3 or higher. Table 6. Adverse Reactions Occurring at ≥ 10% Incidence for Any Grade or ≥ 5% Incidence for Grade 3 or Higher in BLINCYTO-treated Adult Patients with MRD-Positive B-cell Precursor ALL Adverse Reaction BLINCYTO (N = 137) Any Grade Grading based on NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. n (%) Grade ≥ 3 n (%) Blood and lymphatic system disorders Neutropenia Neutropenia includes febrile neutropenia, neutropenia, and neutrophil count decreased.
21 (15) 21 (15) Leukopenia Leukopenia includes leukopenia and white blood cell count decreased. 19 (14) 13 (9) Thrombocytopenia Thrombocytopenia includes platelet count decreased and thrombocytopenia. 14 (10) 8 (6) Cardiac disorders Arrhythmia Arrhythmia includes bradycardia, sinus arrhythmia, sinus bradycardia, sinus tachycardia, tachycardia and ventricular extrasystoles.
17 (12) 3 (2) General disorders and ad… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No formal drug interaction studies have been conducted with BLINCYTO. Initiation of BLINCYTO treatment causes transient release of cytokines that may suppress CYP450 enzymes. The highest drug-drug interaction risk is during the first 9 days of the first cycle and the first 2 days of the second cycle in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index.
In these patients, monitor for toxicity (e.g., warfarin) or drug concentrations (e.g., cyclosporine). Adjust the dose of the concomitant drug as needed [see Clinical Pharmacology (12.2 , 12.3) ] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
In embryo-fetal developmental toxicity studies, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis. The surrogate molecule crossed the placental barrier and did not cause embryo-fetal toxicity or teratogenicity. The expected depletions of B and T cells were observed in the pregnant mice, but hematological effects were not assessed in fetuses.
8.2Lactation Risk Summary There is no information regarding the presence of blinatumomab in human milk, the effects on the breastfed infant, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from BLINCYTO, including B-cell lymphocytopenia, advise patients not to breastfeed during treatment with BLINCYTO and for 48 hours after the last dose.
8.3Females and Males of Reproductive Potential BLINCYTO may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating BLINCYTO treatment. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with BLINCYTO and for 48 hours after the last dose.
8.4Pediatric Use The safety and efficacy of BLINCYTO in pediatric patients less than 1 month of age have not been established for any indication [see Indications and Usage (1) ] . Minimal Residual Disease (MRD)-Positive B-cell Precursor ALL The safety and efficacy of BLINCYTO 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 to 0.1% have been established in pediatric patients one month and older.
Use of BLINCYTO is supported by evidence from two randomized, controlled trials (Study AALL1331, NCT02101853 and Study 20120215, NCT02393859) [see Clinical Studies (14.3) ] in pediatric patients with first relapsed B-cell precursor ALL. Both studies included pediatric patients with MRD-positive B-cell precursor ALL. The studies included pediatric patients treated with BLINCYTO in the following age groups: 6 infants (1 month up to less than 2 years), 165 children (2 years up to less than 12 years), and 70 adolescents (12 years to less than 17 years).
In general, the adverse reactions in BLINCYTO-treated pediatric patients were similar in type to those seen in adult patients with MRD-positive ALL [see Adverse Reactions (6.1) ] , and no differences in safety were observed between the… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy 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.
In embryo-fetal developmental toxicity studies, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis. The surrogate molecule crossed the placental barrier and did not cause embryo-fetal toxicity or teratogenicity. The expected depletions of B and T cells were observed in the pregnant mice, but hematological effects were not assessed in fetuses.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of BLINCYTO in pediatric patients less than 1 month of age have not been established for any indication [see Indications and Usage (1) ] . Minimal Residual Disease (MRD)-Positive B-cell Precursor ALL The safety and efficacy of BLINCYTO 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 to 0.1% have been established in pediatric patients one month and older.
Use of BLINCYTO is supported by evidence from two randomized, controlled trials (Study AALL1331, NCT02101853 and Study 20120215, NCT02393859) [see Clinical Studies (14.3) ] in pediatric patients with first relapsed B-cell precursor ALL. Both studies included pediatric patients with MRD-positive B-cell precursor ALL. The studies included pediatric patients treated with BLINCYTO in the following age groups: 6 infants (1 month up to less than 2 years), 165 children (2 years up to less than 12 years), and 70 adolescents (12 years to less than 17 years).
In general, the adverse reactions in BLINCYTO-treated pediatric patients were similar in type to those seen in adult patients with MRD-positive ALL [see Adverse Reactions (6.1) ] , and no differences in safety were observed between the different pediatric age subgroups. Relapsed or Refractory B-cell Precursor ALL The safety and efficacy of BLINCYTO have been established in pediatric patients one month and older with relapsed or refractory B-cell precursor ALL. Use of BLINCYTO is supported by a single-arm trial in pediatric patients with relapsed or refractory B-cell precursor ALL.
This study included pediatric patients in the following age groups: 10 infants (1 month up to less than 2 years), 40 children (2 years up to less than 12 years), and 20 adolescents (12 years to less than 18 years). No differences in efficacy were observed between the different age subgroups [see Clinical Studies (14.2) ] . In general, the adverse reactions in BLINCYTO-treated pediatric patients with relapsed or refractory ALL were similar in type to those seen in adult patients with relapsed or refractory B-cell precursor ALL [see Adverse Reactions (6.1) ] .
Adverse reactions that were observed more frequently (≥ 10% difference) in the pediatric population compared to the adult population were pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs.
24%), infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%), leukopenia (24% vs.
11%), and weight increased (17% vs. 6%). In pediatric patients less than 2 years old (infants) with relapsed or refractory ALL, the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability.
Infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (17%). B-cell Precursor ALL in the Consolidation Phase The safety and efficacy of BLINCYTO for the treatment of Philadelphia-chromosome negative B-cell precursor ALL in the consolidation phase have been established in pediatric patients one month and older. Use of BLINCYTO for this indication is supported by extrapolation from a randomized controlled study in adults (Study E1910, NCT02003222) and evidence from two randomized, controlled studies in pediatric patients (Study 20120215 and Study AALL1331) [see Adverse Reactions (6.1) , Use in Specific Populations (8.4) , Clinical Pharmacology (12.3) , and Clinical Studies (14.3) ] .
Benzyl Alcohol Toxicity in Neonates Serious and fatal adverse reactions, including "gasping syndrome," can occur 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) treated with benzyl alcohol-preserved drugs intravenously. The "gaspi… [Excerpted — this section continues on DailyMed.]
🧓 Geriatric Use ▾
8.5Geriatric Use There were 158 (7%) patients 65 years and older in clinical studies of BLINCYTO for patients with MRD positive, CD19-positive B-cell precursor ALL in first or second complete remission, relapsed or refractory CD19-positive B-cell precursor ALL, and CD19-positive, Philadelphia-chromosome negative B-cell precursor ALL in the consolidation phase. Of the total number of BLINCYTO-treated patients in these studies, 123 (8%) were 65 years of age and older and 21 (1%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
However, elderly patients experienced a higher rate of serious infections and neurological toxicities, including cognitive disorder, encephalopathy, and confusion [see Warnings and Precautions (5.2 , 5.3) ] .
🆘 Overdosage ▾
10 OVERDOSAGE 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) ] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics During the continuous intravenous infusion over 4 weeks, the pharmacodynamic response was characterized by T-cell activation and initial redistribution, reduction in peripheral B-cells, and transient cytokine elevation. Peripheral T-cell redistribution (i.e., T-cell adhesion to blood vessel endothelium and/or transmigration into tissue) occurred after start of BLINCYTO infusion or dose escalation. T-cell counts initially declined within 1 to 2 days and then returned to baseline levels within 7 to 14 days in the majority of patients.
Increase of T-cell counts above baseline (T-cell expansion) was observed in few patients. Peripheral B-cell counts decreased to less than or equal to 10 cells/microliter during the first treatment cycle at doses ≥ 5 mcg/m 2 /day or ≥ 9 mcg/day in the majority of patients. No recovery of peripheral B-cell counts was observed during the 2-week BLINCYTO-free period between treatment cycles.
Incomplete depletion of B-cells occurred at doses of 0.5 mcg/m 2 /day and 1.5 mcg/m 2 /day and in a few patients at higher doses. Cytokines including IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α, and IFN-γ were measured, and IL-6, IL-10, and IFN-γ were elevated. The highest elevation of cytokines was observed in the first 2 days following start of BLINCYTO infusion.
The elevated cytokine levels returned to baseline within 24 to 48 hours during the infusion. In subsequent treatment cycles, cytokine elevation occurred in fewer patients with lesser intensity compared to the initial 48 hours of the first treatment cycle.
12.3Pharmacokinetics 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. The increase in mean C ss values was approximately proportional to the dose in the range tested.
At the clinical doses of 9 mcg/day and 28 mcg/day for the treatment of relapsed or refractory ALL, the mean (SD) C ss was 228 (356) pg/mL and 616 (537) pg/mL, respectively. The pharmacokinetics of blinatumomab in adult patients with MRD-positive B-cell precursor ALL and in adult patients with B-cell precursor ALL in the consolidation phase were similar to adult patients with relapsed or refractory ALL. Distribution The estimated mean (SD) volume of distribution based on terminal phase (V z ) was 5.27 (4.37) L with continuous intravenous infusion of blinatumomab.
Elimination The estimated mean (SD) systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 3.10 (2.94) L/hour. The mean (SD) half-life was 2.20 (1.34) hours. Negligible amounts of blinatumomab were excreted in the urine at the tested clinical doses.
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. Specific Populations There were no clinically meaningful differences in the pharmacokinetics of blinatumomab based on age (0.6 to 80 years of age), sex, race (72% White, 17% Asian, 3% Black), ethnicity, Philadelphia chromosome status or mild (total bilirubin ≤ upper limit… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each BLINCYTO package (NDC 55513-160-01, NDC 55513-160-21) contains: One BLINCYTO (blinatumomab) for injection 35 mcg single-dose vial containing a sterile, preservative-free, white to off-white lyophilized powder and One IV Solution Stabilizer 10 mL single-dose glass vial containing a sterile, preservative-free, colorless to slightly yellow, clear solution. Store BLINCYTO and IV Solution Stabilizer vials in the original package refrigerated at 2°C to 8°C (36°F to 46°F) and protect from light until time of use.
Do not freeze. BLINCYTO and IV Solution Stabilizer vials may be stored for a maximum of 8 hours at room temperature [23°C to 27°C (73°F to 81°F)] in the original carton to protect from light.
📦 Storage and Handling ▾
Store BLINCYTO and IV Solution Stabilizer vials in the original package refrigerated at 2°C to 8°C (36°F to 46°F) and protect from light until time of use. Do not freeze. BLINCYTO and IV Solution Stabilizer vials may be stored for a maximum of 8 hours at room temperature [23°C to 27°C (73°F to 81°F)] in the original carton to protect from light.
📋 Description ▾
11 DESCRIPTION Blinatumomab is a bispecific CD19-directed CD3 T-cell engager. Blinatumomab is produced in Chinese hamster ovary cells. It consists of 504 amino acids and has a molecular weight of approximately 54 kilodaltons.
Each BLINCYTO package contains one vial BLINCYTO and one vial IV Solution Stabilizer. BLINCYTO (blinatumomab) for injection is supplied in a single-dose vial as a sterile, preservative-free, white to off-white lyophilized powder for intravenous use. Each single-dose vial of BLINCYTO contains 35 mcg blinatumomab, citric acid monohydrate (3.35 mg), lysine hydrochloride (23.23 mg), polysorbate 80 (0.64 mg), trehalose dihydrate (95.5 mg), and sodium hydroxide to adjust pH to 7.0.
After reconstitution with 3 mL of preservative-free Sterile Water for Injection, USP, the resulting concentration is 12.5 mcg/mL blinatumomab. IV Solution Stabilizer is supplied in a single-dose vial as a sterile, preservative-free, colorless to slightly yellow, clear solution. Each single-dose vial of IV Solution Stabilizer contains citric acid monohydrate (52.5 mg), lysine hydrochloride (2283.8 mg), polysorbate 80 (10 mg), sodium hydroxide to adjust pH to 7.0, and water for injection.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Cytokine Release Syndrome (CRS) Advise patients of the risk of CRS and infusion reactions, and to contact their healthcare professional for signs and symptoms associated with CRS or infusion reactions (pyrexia, fatigue, nausea, vomiting, chills, hypotension, rash, and wheezing) [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Neurological Toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome Advise patients of the risk of neurological toxicities, including ICANS, and to contact their healthcare professional for signs and symptoms associated with this event (including convulsions, speech disorders, and confusion) [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] .
Infections Advise patients of the risk of infections, and to contact their healthcare professional for signs or symptoms of infection [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] . Inform patients of the importance of keeping the skin clean around the intravenous catheter to reduce the risk of infection. Pancreatitis Advise patients of the risk of pancreatitis and to contact their healthcare provider for signs or symptoms of pancreatitis, which include severe and persistent stomach pain, with or without nausea and vomiting [see Warnings and Precautions (5.8) and Adverse Reactions (6.2) ] .
Driving and Engaging in Hazardous Occupations 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. Patients should be advised that they may experience neurological events, including seizures and ICANS [see Warnings and Precautions (5.6) ] . Infusion Pump Errors Inform patients they should not adjust the setting on the infusion pump.
Any changes to pump function may result in dosing errors. If there is a problem with the infusion pump or the pump alarms, patients should contact their doctor or nurse immediately. Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus.
Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant [see Warnings and Precautions (5.13) and Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with BLINCYTO and for 48 hours after the last dose [see Warnings and Precautions (5.13) and Use in Specific Populations (8.3) ] . Lactation Advise women not to breastfeed during treatment with BLINCYTO and for 48 hours after the last dose [see Use in Specific Populations (8.2) ] .
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2025 Medication Guide BLINCYTO ® (blin sye toe) (blinatumomab) for injection 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. What is BLINCYTO? BLINCYTO is a prescription medicine used to treat adults and children 1 month and older with: B-cell precursor acute lymphoblastic leukemia (ALL) in remission when only a small number of cancer cells remain in the body (minimal residual disease) B-cell precursor ALL that has come back or did not respond to previous treatments Philadelphia-chromosome negative B-cell precursor ALL in the consolidation phase of chemotherapy treatment with multiple phases ALL is a cancer of the blood in which a particular kind of white blood cell is growing out of control .
It is not known if BLINCYTO is safe and effective in children less than 1 month of age. Who should not receive BLINCYTO? Do not receive BLINCYTO if you are allergic to blinatumomab or to any of the ingredients of BLINCYTO.
See the end of this Medication Guide for a complete list of ingredients in BLINCYTO. Before receiving BLINCYTO, tell your healthcare provider about all of your medical conditions, including if you or your child: have a history of neurological problems, such as seizures, confusion, trouble speaking or loss of balance have Down Syndrome have an infection have ever had an infusion reaction after receiving BLINCYTO or other medications have a history of radiation treatment to the brain, or chemotherapy treatment are scheduled to receive a vaccine.
You should not receive a “live vaccine” for at least 2 weeks before you start treatment with BLINCYTO, during treatment, and until your immune system recovers after you receive your last cycle of BLINCYTO. If you are not sure about the type of vaccine, ask your healthcare provider. are pregnant or plan to become pregnant. BLINCYTO may harm your unborn baby.
Tell your healthcare provider if you become pregnant during treatment with BLINCYTO. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with BLINCYTO. Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with BLINCYTO, and for 48 hours after your last dose of BLINCYTO. are breastfeeding or plan to breastfeed.
It is not known if BLINCYTO passes into your breast milk. You should not breastfeed during treatment with BLINCYTO and for 48 hours after your last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive BLINCYTO? BLINCYTO will be given to you by intravenous… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics 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. The increase in mean C ss values was approximately proportional to the dose in the range tested.
At the clinical doses of 9 mcg/day and 28 mcg/day for the treatment of relapsed or refractory ALL, the mean (SD) C ss was 228 (356) pg/mL and 616 (537) pg/mL, respectively. The pharmacokinetics of blinatumomab in adult patients with MRD-positive B-cell precursor ALL and in adult patients with B-cell precursor ALL in the consolidation phase were similar to adult patients with relapsed or refractory ALL. Distribution The estimated mean (SD) volume of distribution based on terminal phase (V z ) was 5.27 (4.37) L with continuous intravenous infusion of blinatumomab.
Elimination The estimated mean (SD) systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 3.10 (2.94) L/hour. The mean (SD) half-life was 2.20 (1.34) hours. Negligible amounts of blinatumomab were excreted in the urine at the tested clinical doses.
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. Specific Populations There were no clinically meaningful differences in the pharmacokinetics of blinatumomab based on age (0.6 to 80 years of age), sex, race (72% White, 17% Asian, 3% Black), ethnicity, Philadelphia chromosome status or mild (total bilirubin ≤ upper limit of normal [ULN] and AST > ULN or total bilirubin > 1 to 1.5 × ULN and any AST) or moderate hepatic impairment (total bilirubin > 1.5 to 3 × ULN and any AST).
The effect of other races or severe hepatic impairment (total bilirubin > 3 × ULN, any AST) on the pharmacokinetics of blinatumomab is unknown. Body surface area (0.4 to 2.9 m 2 ) influences the pharmacokinetics of blinatumomab, supporting BSA-based dosing in patients < 45 kg. Pediatric Patients The pharmacokinetics of blinatumomab appear linear over a dose range from 5 to 30 mcg/m 2 /day in pediatric patients.
At the recommended doses of 5 and 15 mcg/m 2 /day for the treatment of relapsed or refractory B-cell precursor ALL, the mean (SD) steady-state concentration (C ss ) values were 162 (179) and 533 (392) pg/mL, respectively. The pharmacokinetics of blinatumomab in pediatric patients with MRD-positive B-cell precursor ALL and in pediatric patients with B-cell precursor ALL in the consolidation phase were similar to pediatric patients with relapsed or refractory ALL. In all pediatric patients with ALL, the estimated mean (SD) volume of distribution (V z ), clearance (CL), and terminal half-life (t 1/2,z ) in Cycle 1 were 4.14 (3.32) L/m 2 , 1.65 (1.62) L/hour/m 2 , and 2.14 (1.44) hours, respectively.
The steady-state concentrations of blinatumomab were comparable in adult and pediatric patients at the equivalent dose levels based on BSA-based regimens. Patients with Renal Impairment Pharmacokinetic analyses showed an approximately 2-fold difference in mean blinatumomab clearance values between patients with moderate renal impairment (CrCL ranging from 30 to 59 mL/min, N = 49) and normal renal function (CrCL more than 90 mL/min, N = 674). However, high interpatient variability was discerned (CV% up to 98.4%), and clearance values in renal impaired patients were essentially within the range observed in patients with normal renal function.
There is no information available in patients with severe renal impairment (CrCL 15-29 mL/min) or patients on hemodialysis. Drug Interaction Studies Transient elevation of cytokines may suppress CYP450 enzyme activities [see Drug Interactions (7) and Clinical Pharmacology (12.2) ] .
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics During the continuous intravenous infusion over 4 weeks, the pharmacodynamic response was characterized by T-cell activation and initial redistribution, reduction in peripheral B-cells, and transient cytokine elevation. Peripheral T-cell redistribution (i.e., T-cell adhesion to blood vessel endothelium and/or transmigration into tissue) occurred after start of BLINCYTO infusion or dose escalation. T-cell counts initially declined within 1 to 2 days and then returned to baseline levels within 7 to 14 days in the majority of patients.
Increase of T-cell counts above baseline (T-cell expansion) was observed in few patients. Peripheral B-cell counts decreased to less than or equal to 10 cells/microliter during the first treatment cycle at doses ≥ 5 mcg/m 2 /day or ≥ 9 mcg/day in the majority of patients. No recovery of peripheral B-cell counts was observed during the 2-week BLINCYTO-free period between treatment cycles.
Incomplete depletion of B-cells occurred at doses of 0.5 mcg/m 2 /day and 1.5 mcg/m 2 /day and in a few patients at higher doses. Cytokines including IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α, and IFN-γ were measured, and IL-6, IL-10, and IFN-γ were elevated. The highest elevation of cytokines was observed in the first 2 days following start of BLINCYTO infusion.
The elevated cytokine levels returned to baseline within 24 to 48 hours during the infusion. In subsequent treatment cycles, cytokine elevation occurred in fewer patients with lesser intensity compared to the initial 48 hours of the first treatment cycle.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1MRD-positive B-cell Precursor ALL BLAST Study The efficacy of BLINCYTO was evaluated in an open-label, multicenter, single-arm study (BLAST Study) [NCT01207388] that included patients who were ≥ 18 years of age, had received at least 3 chemotherapy blocks of standard ALL therapy, were in hematologic complete remission (defined as < 5% blasts in bone marrow, absolute neutrophil count > 1 Gi/L, platelets > 100 Gi/L) and had MRD at a level of ≥ 0.1% using an assay with a minimum sensitivity of 0.01%. BLINCYTO was administered at a constant dose of 15 mcg/m 2 /day (equivalent to the recommended dosage of 28 mcg/day) intravenously for all treatment cycles.
Patients received up to 4 cycles of treatment. Dose adjustment was possible in case of adverse events. The treated population included 86 patients in first or second hematologic complete remission (CR1 or CR2).
The demographics and baseline characteristics are shown in Table 11. The median number of treatment cycles was 2 (range: 1 to 4). Following treatment with BLINCYTO, 45 out of 61 (73.8%) patients in CR1 and 14 out of 25 (56.0%) patients in CR2 underwent allogeneic hematopoietic stem cell transplantation in continuous hematologic complete remission.
Table 11. Demographics and Baseline Characteristics in BLAST Study Characteristics BLINCYTO (N = 86) Age Median, years (min, max) 43 (18, 76) ≥ 65 years, n (%) 10 (12) Males, n (%) 50 (58) Race, n (%) Asian 1 (1) Other (mixed) 0 (0) White 76 (88) Unknown 9 (11) Philadelphia chromosome disease status, n (%) Positive 1 (1) Negative 85 (99) Relapse history, n (%) Patients in 1 st CR 61 (71) Patients in 2 nd CR 25 (29) MRD level at baseline Assessed centrally using an assay with minimum sensitivity of 0.01%. , n (%) ≥ 10% 7 (8) ≥ 1% and < 10% 34 (40) ≥ 0.1% and < 1% 45 (52) Efficacy was based on achievement of undetectable MRD within one cycle of BLINCYTO treatment and hematological relapse-free survival (RFS).
The assay used to assess MRD response had a sensitivity of 0.01% for 6 patients and ≤ 0.005% for 80 patients. Overall, undetectable MRD was achieved by 70 patients (81.4%: 95% CI: 71.6%, 89.0%). The median hematological RFS was 22.3 months.
Table 12 shows the MRD response and hematological RFS by remission number. Table 12. Efficacy Results in Patients ≥ 18 Years of Age with MRD-positive B-cell Precursor ALL (BLAST Study) Patients in CR1 (n = 61) Patients in CR2 (n = 25) Complete MRD response Complete MRD response was defined as the absence of detectable MRD confirmed in an assay with minimum sensitivity of 0.01%. , n (%), [95% CI] 52 (85.2) [73.8, 93.0] 18 (72.0) [50.6, 87.9] Median hematological relapse-free survival Relapse was defined as either hematological or extramedullary relapse, secondary leukemia, or death due to any cause; Includes time after transplantation; Kaplan-Meier estimate. in months (range) 35.2 (0.4, 53.5) 12.3 (0.7, 42.3) Undetectable MRD was achieved by 65 of 80 patients (81.3%: 95% CI: 71.0%, 89.1%) with an assay sensitivity of at least 0.005%.
The estimated median hematological RFS among the 80 patients using the higher sensitivity assay was 24.2 months (95% CI: 17.9, NE).
14.2Relapsed/Refractory B-cell Precursor ALL TOWER Study The efficacy of BLINCYTO was compared to standard of care (SOC) chemotherapy in a randomized, open-label, multicenter study (TOWER Study) [NCT02013167]. Eligible patients were ≥ 18 years of age with relapsed or refractory B-cell precursor ALL [> 5% blasts in the bone marrow and refractory to primary induction therapy or refractory to last therapy, untreated first relapse with first remission duration < 12 months, untreated second or later relapse, or relapse at any time after allogeneic hematopoietic stem cell transplantation (alloHSCT)].
BLINCYTO was administered at 9 mcg/day on Days 1-7 and 28 mcg/day on Days 8-28 for Cycle 1, and 28 mcg/day on Days 1-28 for Cycles 2-5 in 42-day cycles and for Cycles 6-9 in 84-day cycles. Dose adjustment was possibl… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with blinatumomab. No studies have been conducted to evaluate the effects of blinatumomab on fertility. A murine surrogate molecule had no adverse effects on male and female reproductive organs in a 13-week repeat-dose toxicity study in mice.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with blinatumomab. No studies have been conducted to evaluate the effects of blinatumomab on fertility. A murine surrogate molecule had no adverse effects on male and female reproductive organs in a 13-week repeat-dose toxicity study in mice.
📄 Recent Major Changes ▾
Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 12/2024 Dosage and Administration ( 2.4 , 2.5 , 2.6 ) 12/2024 Warnings and Precautions, Cytokine Release Syndrome ( 5.1 ) 10/2025 Warnings and Precautions, Neurological Toxicities including Immune Effector Cell-Associated Neurotoxicity ( 5.2 ) 4/2025 Warnings and Precautions, Benzyl Alcohol Toxicity in Neonates ( 5.12 ) 12/2024
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - Kit Package AMGEN ® 35 mcg/vial 1 BLINCYTO ® Single-Dose Vial 1 IV Solution Stabilizer Vial NDC 55513-160-01 BLINCYTO ® (blinatumomab) for Injection 35 mcg/vial For Intravenous Infusion Only Store refrigerated at 2°C to 8°C (36°F to 46°F). Store in carton to protect from light. DO NOT SHAKE reconstituted solution.
Dispense the enclosed Medication Guide to each patient. No Preservative Single-Dose Vial – Discard unused portion. Rx Only Principal Display Panel - Kit Package
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