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Indications

BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:

Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy ... Read More 

Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission

Relapsed or refractory disease

Important Safety Information Prescribing Information Medication Guide Indications Patient Site Connect with a BLINCYTO® rep

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External Page

NOW AVAILABLEBLINCYTO® offers 72- and 96-hour* infusion durations—offering more flexibility for you and your patients

The choice between these infusion duration options should be made by the treating healthcare professional, considering the frequency of the infusion bag changes and the weight of the patient.†

*Prepared with Bacteriostatic 0.9% Sodium Chloride Injection (containing 0.9% benzyl alcohol).

†Use the preservative-free preparations of BLINCYTO® where possible in neonates. When prescribing BLINCYTO® (with preservative) for neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative), other products containing benzyl alcohol or other excipients (eg, ethanol, propylene glycol) which compete with benzyl alcohol for the same metabolic pathway. Serious adverse reactions, including fatal reactions and the “gasping syndrome,” have been reported in very low birth weight neonates born weighing less than 1500 g, and early preterm neonates who received intravenous drugs containing benzyl alcohol as a preservative.

Please see Indications in above "Indications" tray and full Important Safety Information, including BOXED WARNINGS, below.

Reference: BLINCYTO® (blinatumomab) prescribing information, Amgen.

BLINCYTO® (blinatumomab) logo

R/R: The TOWER landmark study

Study design: A large (N=405), international, randomized, controlled, phase 3 study of single-agent BLINCYTO® vs SOC chemotherapy in patients ≥ 18 years of age: refractory to primary induction therapy or to last therapy, in first relapse (first remission duration < 12 months), in second or later relapse, or in any relapse after HSCT. Primary endpoint was mOS: 7.7 months for BLINCYTO® (n=271) vs 4.0 months for SOC chemotherapy (n=134); P = 0.012; HR: 0.71 (95% Cl: 0.55–0.93).1 Selected secondary endpoints: CR within 12 weeks after initiation of treatment, CR/CRh*/CRi within 12 weeks after initiation of treatment, MRD remission rate, duration of remission, adverse event rates.1,2

BLINCYTO® is an established approach that significantly improved survival vs SOC chemotherapy1

BLINCYTO® nearly doubled median overall survival vs SOC chemotherapy1

Primary endpoint: Overall survival (intent-to-treat population)1

Download
efficacy-survival-chart-desktop

CI, confidence interval; HR, hazard ratio; HSCT, allogeneic hematopoietic stem cell transplantation; OS, overall survival; R/R, relapsed or refractory; SOC, standard-of-care.

Intervening early with BLINCYTO® in first salvage more than doubled median OS vs SOC chemotherapy3,*

OS in patients treated in first salvage3,*

Download
efficacy-survival-chart-2-desktop

*OS in patients treated in first salvage was a prespecified subgroup analysis in TOWER; however, the OS efficacy in this subgroup was not a study objective and the study was not powered to assess OS efficacy in this subgroup.4

NR, not reached.

BLINCYTO® demonstrated improved overall survival for patients not proceeding to HSCT2,*

Patients not proceeding to HSCT still achieved an OS benefit when treated with BLINCYTO®2

median_os_adult
median_os_adult-mb

*OS in patients censored for allogeneic transplant was a prespecified sensitivity subgroup analysis in TOWER; however, the OS efficacy in this subgroup was not a study objective, and the study was not powered to assess OS efficacy in this subgroup.4

Patients receiving BLINCYTO® achieved higher rates and longer duration of remission vs SOC chemotherapy2,†

CR/CRh*/
CRi rates of

44%

(n=119/271)

(95% CI: 37.9–50.0)

for patients treated with BLINCYTO® vs 25% (n=33/134) (95% CI: 17.6–32.8) for patients treated with SOC chemotherapy2 (P < 0.001)

Median duration of remission for patients who achieved CR/CRh*/CRi2

duration-of-response
  • CR/CRh*/CRi rates achieved within 12 weeks after treatment initiation2
  • 53% (n=60/114) of patients in first salvage treated with BLINCYTO® achieved CR/CRh*/CRi2
    • CR/CRh*/CRi in patients treated in first salvage was a prespecified subgroup analysis in TOWER; however, the CR/CRh*/CRi in this subgroup was not a study objective and the study was not powered to assess efficacy in this subgroup

†CR was defined as ≤ 5% blasts in the BM, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/μL and ANC > 1,000/μL). CRh* was defined as ≤ 5% blasts in the BM, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/μL and ANC > 500/μL). CRi was defined as ≤ 5% blasts in the BM, no evidence of disease, and incomplete recovery of peripheral blood counts (platelets > 100,000/μL or ANC > 1,000/μL).2

ANC, absolute neutrophil count; BM, bone marrow; CR, complete remission; CRh*, complete remission with partial hematologic remission; CRi, complete remission with incomplete hematologic recovery.

BLINCYTO® helped patients achieve and maintain a durable remission through up to 9 cycles5

27 patients in the landmark phase 3 TOWER study proceeded to continued therapy with BLINCYTO® after induction and consolidation5

74%

(n=20/27)

of patients achieved a best response of complete remission during continued therapy

  • Patients who received BLINCYTO® and had bone marrow blasts ≤ 5% after induction (up to 2 cycles) and consolidation (up to 3 cycles) with BLINCYTO® were eligible to receive continued therapy for an additional 12 months (4 weeks on treatment, 8 weeks off)5
  • At the time of data collection for patients receiving continued therapy, 11 patients were continuing therapy with BLINCYTO®, while 16 had discontinued therapy due to: completion of maintenance therapy (n=3); intention to receive HSCT (n=4); intention to receive treatment other than HSCT (n=2); relapse (n=6); or an AE (n=1)5
  • During continued therapy of cycles 6–9, no new safety concerns were identified; treatment-emergent AEs included:5
    • 4 patients had a neurological event
    • 1 patient had cytokine release syndrome (CRS)
  • Overall, safety event rates were lower in the continued therapy cycles vs the induction or consolidation cycles5

AE, adverse event.

Patients treated with BLINCYTO® had higher MRD negativity rates† than patients treated with SOC chemotherapy2

MRD negativity rates for patients who achieved CR/CRh*/CRi with BLINCYTO® vs SOC chemotherapy2

BLINCYTO®

76%

(n=90/119)

vs SOC chemotherapy (n=16/33): 48%

†Molecular remission was assessed in patients achieving CR/CRh*/CRi, and was defined as MRD by PCR or flow cytometry with a minimum assay sensitivity of2 < 1 x 10–4.

MRD, measurable or minimal residual disease; PCR, polymerase chain reaction.

BLINCYTO® differences in HRQoL measures from baseline vs SOC chemotherapy6

Mean changes in HRQoL functional domains and symptoms at the end of cycle 1 (day 29)6

leave-behind-chart-desk
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  • These data come from an analysis of a secondary descriptive endpoint from a phase 3 study. The endpoint measured the change from baseline of scores from a validated PRO instrument* during the first cycle of treatment7
  • The study was not powered to assess statistical differences in QoL measures between BLINCYTO® and SOC chemotherapy treatment groups7
  • Select AE rates for patients treated with BLINCYTO® were fatigue (12.7%), back pain (13.1%), nausea (19.1%), vomiting (12.4%), insomnia (10.5%), constipation (12.7%), and diarrhea (21.7%)8

Click here for the EORTC QoL Questionnaire from the TOWER Study9

*The PRO instrument—The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)—is a validated self-rating questionnaire used to assess patients’ perceptions of treatment effectiveness in oncology.7

HRQoL, health-related quality of life; PRO, patient-reported outcome; QoL, quality of life.

TOWER study design and baseline characteristics of patients

  • TOWER landmark phase 3 study: BLINCYTO® single-agent immunotherapy was compared with SOC chemotherapy in a large, international, prospective, randomized, controlled, phase 3 trial of 405 patients with Ph(–) R/R B-cell precursor ALL1
2
 
2:1
Randomization2
 
1
 
BLINCYTO® single-agent immunotherapy (n=271)1
  • Continuous IV infusion for 1 to 2 induction cycles (4 weeks on, 2 weeks off)2
  • 9 mcg/day on days 1–7 of cycle 1 and 28 mcg/day on subsequent days2
 
SOC chemotherapy (investigator's choice of one of the regimens below) (n=134)1
  • FLAG ± anthracycline-based regimen
  • HiDAC-based regimen
  • High-dose methotrexate-based regimen
  • Clofarabine-based regimen
 
 
Consolidation, maintenance,† and follow-up, depending on response to induction2
 
 
2
 
2:1
Randomization14
 
1
 
BLINCYTO® single-agent immunotherapy (n=271)1
  • Continuous IV infusion for 1 to 2 induction cycles (4 weeks on, 2 weeks off)2
  • 9 mcg/day on days 1–7 of cycle 1 and 28 mcg/day on subsequent days2
 
SOC
chemotherapy (investigator's choice of one of the regimens below) (n=134)1
  • FLAG ± anthracycline-based regimen
  • HiDAC-based regimen
  • High-dose methotrexate-based regimen
  • Clofarabine-based regimen
 
 
 
Consolidation, maintenance,† and follow-up, depending on response to induction2
 
 

Prephase treatment:

  • All patients with > 50% bone marrow blasts received dexamethasone (10 mg/m2/day up to a maximum of 24 mg/day) prior to randomization to reduce the risk of CRS associated with high tumor burden:1
    • 14% (n=38/267) of patients treated with BLINCYTO® experienced CRS of any grade, and 3% (n=9/267) experienced ≥ Grade 310

Premedication:

  • Patients treated with BLINCYTO® were premedicated‡ with 20 mg dexamethasone within
    1 hour before infusion1,10

†Maintenance as defined by the study protocol: Patients achieving ≤ 5% BM blasts could continue with BLINCYTO® as maintenance therapy for an additional 12 months (4 weeks on, 8 weeks off).2

‡Patients were premedicated prior to each cycle, prior to a step dose (such as cycle 1 day 8), and when restarting an infusion after an interruption of 4 or more hours.1

Primary endpoint:2

  • OS

Select secondary endpoints:2

  • CR within 12 weeks after initiation of treatment
  • CR/CRh*/CRi within 12 weeks after initiation of treatment
  • MRD remission rate
  • Duration of remission
  • Adverse event rates
Key inclusion criteria1,2
Patients ≥ 18 years of age
Ph(–) R/R B-cell precursor ALL occurring as refractory to primary induction therapy or to last therapy, or untreated first relapse (first remission duration < 12 months), or in second or later relapse, or in any relapse after HSCT
With > 5% blasts in the BM and ECOG PS ≤ 2
Key exclusion criteria2
Other active cancers
Clinically relevant pathologic condition of the CNS
Isolated extramedullary disease
Autoimmune disease
Acute GvHD of Grade ≥ 2, active chronic GvHD
Allogeneic stem cell transplantation within 12 weeks before randomization
Autologous stem cell transplantation within 6 weeks before randomization
Chemotherapy or radiotherapy within 2 weeks before randomization
Use of immunotherapy within 4 weeks before randomization
Ongoing use of investigational treatment

BLINCYTO® was studied in a wide range of adult patients, including those with a poor prognosis2

Baseline characteristics of the study population1,2

BLINCYTO®
(N=271) 		SOC Chemotherapy (N=134)
Age
Mean ± SD, years 41 ± 17 41 ± 17
Range, years 18–80 18–78
Study entry criteria, n (%)
Refractory to primary or salvage therapy 115 (42) 54 (40)
In early first relapse (CR1 duration < 12 months) 76 (28) 37 (28)
In untreated second or later relapse§ 32 (12) 16 (12)
Relapsed after HSCT§ 46 (17) 27 (20)
Not specified 2 (1) 0
Prior salvage therapy, n (%) 171 (63) 70 (52)
Prior transplant, n (%)
Yes 94 (35) 46 (34)
No 176 (65) 87 (65)
Unknown 1 (0) 1 (1)
Disease burden, n (%)
≥ 50% BM blasts 201 (74) 104 (78)

§Patients who met this study entry criterion met none of the above study entry criteria.2

  • Patients in late first relapse (≥ 12 months after initial remission) were excluded2
BLINCYTO® is the only immunotherapy to deliver superior OS and deep, durable remission vs SOC chemotherapy in adult patients with Ph(–) R/R B-cell precursor ALL1,2,4,8,11

ALL, acute lymphoblastic leukemia; AYA, adolescent and young adult; CNS, central nervous system; CR1, first complete remission; ECOG PS, Eastern Cooperative Oncology Group performance score; FLAG, fludarabine, cytarabine, granulocyte colony-stimulating factor; GvHD, graft versus host disease; HiDAC, high-dose cytarabine; IV, intravenous; NCCN, National Comprehensive Cancer Network; Ph(–), Philadelphia chromosome–negative; SD, standard deviation.

Blinatumomab is an NCCN Category 1 recommended therapy option for both AYA and adult patients with R/R Ph(–) B-cell precursor ALL12

NCCN Recommended

Safety profile in R/R disease has been established1

Adverse events occurring at ≥ 10% incidence for any Grade or ≥ 5% incidence for Grade 3 or higher in BLINCYTO®-treated patients in first cycle of therapy1

Adverse event BLINCYTO® (N=267) SOC Chemotherapy (N=109)

Any Grade* n (%) ≥ Grade 3* n (%) Any Grade* n (%) ≥ Grade 3* n (%)
Blood and lymphatic system disorders
Neutropenia† 84 (31) 76 (28) 67 (61) 61 (56)
Anemia‡ 68 (25) 52 (19) 45 (41) 37 (34)
Thrombocytopenia§ 57 (21) 47 (18) 42 (39) 40 (37)
Leukopenia** 21 (8) 18 (7) 9 (8) 9 (8)
Cardiac disorder
Arrhythmia†† 37 (14) 5 (2) 18 (17) 0 (0)
General disorders and administration site conditions
Pyrexia 147 (55) 15 (6) 43 (39) 4 (4)
Edema‡‡ 48 (18) 3 (1) 20 (18) 1 (1)
Immune system disorders
Cytokine release syndrome§§ 37 (14) 8 (3) 0 (0) 0 (0)
Infections and infestations
Infections — pathogen unspecified 74 (28) 40 (15) 50 (46) 35 (32)
Bacterial infectious disorders 38 (14) 19 (7) 35 (32) 21 (19)
Viral infectious disorders 30 (11) 4 (1) 14 (13) 0 (0)
Fungal infectious disorders 27 (10) 13 (5) 15 (14) 9 (8)
Injury, poisoning, and procedural complications
Infusion-related reaction*** 79 (30) 9 (3) 9 (8) 1 (1)
Investigations
Hypertransaminasemia††† 40 (15) 22 (8) 13 (12) 7 (6)
Nervous system disorders
Headache‡‡‡ 61 (23) 1 (<1) 30 (28) 3 (3)
Skin and subcutaneous tissue disorders
Rash§§§ 31 (12) 2 (1) 21 (19) 0 (0)
  • The most common adverse reactions (≥ 20%) in the BLINCYTO® arm were infections (bacterial and pathogen unspecified), pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia. Serious adverse reactions were reported in 62% of patients1
  • Adverse reactions of Grade 3 or higher were reported in 87% of patients1
  • Fatal adverse events occurred in 16% of patients. The majority of the fatal events were infections1

*Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.1

†Neutropenia includes agranulocytosis, febrile neutropenia, neutropenia, and neutrophil count decreased.1

‡Anemia includes anemia and hemoglobin decreased.1

§Thrombocytopenia includes platelet count decreased and thrombocytopenia.1

**Leukopenia includes leukopenia and white blood cell count decreased.1

††Arrhythmia includes arrhythmia, atrial fibrillation, atrial flutter, bradycardia, sinus bradycardia, sinus tachycardia, supraventricular tachycardia, and tachycardia.1

‡‡Edema includes face edema, fluid retention, edema, edema peripheral, peripheral swelling, and swelling face.1

§§Cytokine release syndrome includes cytokine release syndrome and cytokine storm.1

***Infusion-related reaction is a composite term that includes the term infusion-related reaction and the following events occurring with the first 48 hours of infusion and the event lasted ≤ 2 days: pyrexia, cytokine release syndrome, hypotension, myalgia, acute kidney injury, hypertension, and rash erythematous.1

†††Hypertransaminasemia includes alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, and transaminases increased.1

‡‡‡May represent ICANS.1

§§§Rash includes erythema, rash, rash erythematous, rash generalized, rash macular, rash maculopapular, rash pruritic, skin exfoliation, and toxic skin eruption.1

ICANS, immune effector cell-associated neurotoxicity syndrome.

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IMPORTANT SAFETY INFORMATION

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.
  • 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.
Contraindications

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

Warnings and Precautions
  • Cytokine Release Syndrome (CRS): CRS, which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. The median time to onset of CRS is 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Closely monitor and advise patients to contact their healthcare professional for signs and symptoms of serious adverse events such as 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 histiocytosis/macrophage activation syndrome (MAS). Using all of these terms to define CRS in clinical trials of BLINCYTO®, CRS was reported in 15% of patients with R/R ALL, in 7% of patients with MRD-positive ALL, and in 16% of patients receiving BLINCYTO® cycles in the consolidation phase of therapy. 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.
  • Neurological Toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome:
    BLINCYTO® can cause serious or life-threatening neurologic toxicity, including ICANS. The incidence of neurologic toxicities in clinical trials was approximately 65%. 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. Grade 3 or higher neurological toxicities occurred in approximately 13% of patients, including 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. There is limited experience with BLINCYTO® in patients with active ALL in the central nervous system (CNS) or a history of neurologic events. Patients with a history or presence of clinically relevant CNS pathology were excluded from clinical studies. Patients with Down Syndrome may have a higher risk of seizures with BLINCYTO® therapy; consider seizure prophylaxis prior to initiation of BLINCYTO® for these patients.

    Monitor patients for signs and symptoms of neurological toxicities, including ICANS, and interrupt or discontinue BLINCYTO® and/or treat with corticosteroids as outlined in the PI. Advise outpatients to contact their healthcare professional if they develop signs or symptoms of neurological toxicities.

  • Infections: Approximately 25% of patients receiving BLINCYTO® in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO® as needed.
  • Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO® as needed to manage these events.
  • Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO® infusion and interrupt BLINCYTO® if prolonged neutropenia occurs.
  • Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures and ICANS, patients receiving BLINCYTO® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO® is being administered.
  • Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO® treatment with a median time to onset of 3 days. In patients receiving BLINCYTO®, although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days. Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase, and total blood bilirubin prior to the start of and during BLINCYTO® treatment. BLINCYTO® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if total bilirubin rises to > 3 times ULN.
  • Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO® in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO® and dexamethasone as needed.
  • Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO®, especially in patients previously treated with cranial irradiation and antileukemic chemotherapy.
  • Preparation and administration errors have occurred with BLINCYTO® treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
  • Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO® treatment, during treatment, and until immune recovery following last cycle of BLINCYTO®.
  • Benzyl Alcohol Toxicity in Neonates: Serious adverse reactions, including fatal reactions and the “gasping syndrome,” have been reported 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) who received intravenous drugs containing benzyl alcohol as a preservative. Early preterm VLBW neonates may be more likely to develop these reactions, because they may be less able to metabolize benzyl alcohol.

    Use the preservative-free preparations of BLINCYTO® where possible in neonates. When prescribing BLINCYTO® (with preservative) for neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative), other products containing benzyl alcohol or other excipients (e.g., ethanol, propylene glycol) which compete with benzyl alcohol for the same metabolic pathway.

    Monitor neonatal patients receiving BLINCYTO® (with preservative) for new or worsening metabolic acidosis. The minimum amount of benzyl alcohol at which serious adverse reactions may occur in neonates is not known. The BLINCYTO® 72-Hour bag (with preservative) and 96-Hour bag (with preservative) contain 2.5 mg of benzyl alcohol per mL, and the 7-Day bag (with preservative) contains 7.4 mg of benzyl alcohol per mL.

  • Embryo-Fetal Toxicity: Based on its mechanism of action, BLINCYTO® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with BLINCYTO® and for 48 hours after the last dose.
Adverse Reactions
  • 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.
Dosage and Administration Guidelines
  • BLINCYTO® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
  • It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).
INDICATIONS

BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:

  • Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy
  • Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission
  • Relapsed or refractory disease

Please see BLINCYTO® full Prescribing Information, including BOXED WARNINGS.

BLINCYTO® is a registered trademark of Amgen Inc.

See more

IMPORTANT SAFETY INFORMATION

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.
  • 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.
Contraindications

References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376:836-847. 3. Dombret H, Topp MS, Schuh A, et al. Blinatumomab versus chemotherapy in first salvage or in later salvage for B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2019;60:2214-2222. 4. Data on file, Amgen; 2014. 5. Rambaldi A, Huguet F, Zak P, et al. Maintenance therapy with blinatumomab in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia: overall survival in adults enrolled in a phase 3 open-label trial. Presented at: 59th ASH Annual Meeting and Exposition; December 9–12, 2017; Atlanta, GA. Abstract 2552. 6. Topp MS, Zimmerman Z, Cannell P, et al. Health-related quality of life (HRQoL) of blinatumomab versus standard of care (SOC) chemotherapy in patients with relapsed or refractory Philadelphia negative B-cell precursor acute lymphoblastic leukemia in a randomized, open-label phase 3 study (TOWER). Blood. 2016;128:222. 7. Data on file, Amgen; 2017. 8. Data on file, Amgen; 2016. 9. European Organisation for Research and Treatment of Cancer. EORTC QLQ-C30 (version 3). https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-QLQ-C30-English.pdf. Accessed April 2, 2025. 10. Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376(suppl):836-847. 11. Kantarjian H, DeAngelo D, Stelljes M, et al. Inotuzumab ozogamicin versus standard therapy for acute lymphoblastic leukemia. N Engl J Med. 2016;375:740-753. 12. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.1.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 15, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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