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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

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NOW APPROVED
for use in frontline consolidation in patients with CD19-positive
Ph(–) B-cell precursor ALL, regardless of MRD status* or age1

BLINCYTO® is indicated in adult and pediatric patients one month and older.1

*In the E1910 study, MRD was assessed centrally using standardized 6-color flow cytometry, with MRD(–) defined as < 0.01% leukemic cells in the bone marrow.2 The MRD tests were performed at laboratory sites using assays that have not been analytically validated by FDA.

ALL, acute lymphoblastic leukemia; CD, cluster of differentiation; FDA, Food and Drug Administration; MRD, measurable or minimal residual disease; Ph(–), Philadelphia chromosome–negative.

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

References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Litzow MR, Sun Z, Paietta E, et al. ECOG-ACRIN-E1910 NCTN clinical trial: A phase III randomized trial of blinatumomab for newly diagnosed BCR-ABL-negative B lineage acute lymphoblastic leukemia in adults. Presented at: 64th ASH Annual Meeting and Exposition; December 10–13, 2022; New Orleans, LA.

Pediatric/AYA safety profile

R/R: Amgen 20120215 study

The safety results in the BLINCYTO® arm were consistent with the known safety profile of BLINCYTO®1

AEs reported with > 5% incidence for patients receiving BLINCYTO® or chemotherapy1

Adverse event BLINCYTO®
(n=54)
n (%)
Chemotherapy
(n=51)
n (%)


Pyrexia 44 (81.5) 10 (19.6)
Nausea 22 (40.7) 9 (17.6)
Headache 19 (35.2) 9 (17.6)
Stomatitis* 19 (35.2) 31 (57.4)
Vomiting 16 (29.6) 11 (21.6)
Anemia 12 (22.2) 23 (45.1)
Erythema/rash 12 (22.2) 5 (9.8)
Thrombocytopenia 11 (20.4) 20 (39.2)
Diarrhea 11 (20.4) 9 (17.6)
Neutropenia§ 10 (18.5) 18 (35.3)
Abdominal pain 7 (13.0) 11 (21.6)
Hypertension 7 (13.0) 4 (7.8)
Hypokalemia 7 (13.0) 5 (9.8)
Hypotension 7 (13.0) 4 (7.8)
Hypogammaglobulinemia 6 (11.1) 2 (3.9)
Pruritus 6 (11.1) 5 (9.8)
Constipation 5 (9.3) 7 (13.7)
Epistaxis 5 (9.3) 7 (13.7)
Tremor 5 (9.3) 0 (0.0)
Elevated liver enzymes** 5 (9.3) 12 (23.5)
Abdominal pain upper 4 (7.4) 3 (5.9)
Agitation 4 (7.4) 1 (2.0)
Cough 4 (7.4) 1 (2.0)
Fluid overload 4 (7.4) 0 (0.0)
Immunodeficiency†† 4 (7.4) 0 (0.0)
Febrile neutropenia 3 (5.6) 13 (25.5)

Incidence of Grade ≥ 3 AEs for BLINCYTO® vs chemotherapy2

Adverse event BLINCYTO®
(n=54)
n (%)
Chemotherapy
(n=51)
n (%)


Thrombocytopenia* 10 (18.5) 18 (35.3)
Stomatitis 10 (18.5) 16 (31.4)
Neutropenia 9 (16.7) 16 (31.4)
Anemia 8 (14.8) 21 (41.2)
Leukopenia§ 4 (7.4) 4 (7.8)
Pyrexia 3 (5.6) 0 (0.0)
Elevated liver enzyme levels** 3 (5.6) 9 (17.6)
Aplasia 2 (3.7) 4 (7.8)
Febrile neutropenia 2 (3.7) 13 (25.5)
Hypotension 2 (3.7) 1 (2.0)
Hypokalemia 1 (1.9) 2 (3.9)
Epistaxis 0 (0.0) 3 (5.9)
Cytopenia†† 0 (0.0) 2 (3.9)
Hepatotoxicity not otherwise specified 0 (0.0) 2 (3.9)
  • Incidence of AEs higher than Grade 3 was 57% in the BLINCYTO® arm vs 82% in the chemotherapy arm1
  • All patients receiving BLINCYTO® experienced an AE vs 96% of patients receiving chemotherapy1
  • 24% of patients receiving BLINCYTO® and 43% of patients receiving chemotherapy experienced serious AEs. No fatal AEs were reported in either treatment arm1
  • Grade 3 neurologic event incidence was 6% for patients receiving BLINCYTO® and 2% for patients receiving chemotherapy1
  • No Grade 3 CRS or serious CRS events were reported in either treatment arm1
  • One patient receiving BLINCYTO® and one patient receiving chemotherapy experienced CD19-negative relapse1

R/R: COG AALL1331 study

The safety results in the BLINCYTO® arm were consistent with the known safety profile of BLINCYTO®1

Incidence of AEs for patients receiving BLINCYTO® vs chemotherapy2

BLINCYTO®
Cycle 1 (n=102)
Chemotherapy Block 2 (n=97) BLINCYTO®
Cycle 2 (n=88)
Chemotherapy Block 3 (n=62)
Adverse event Any Grade n (%) Grades ≥ 3* n (%) Any Grade n (%) Grades ≥ 3* n (%) Any Grade n (%) Grades ≥ 3* n (%) Any Grade n (%) Grades ≥ 3* n (%)
Patients with any adverse event 99 (97) 77 (76) 89 (92) 88 (91) 81 (92) 49 (56) 55 (89) 52 (84)
Anemia 77 (76) 15 (15) 63 (65) 51 (53) 39 (44) 4 (5) 36 (58) 35 (57)
White blood cell decreased 67 (66) 25 (25) 59 (61) 55 (57) 50 (57) 13 (15) 30 (48) 30 (48)
Alanine aminotransferase increased 65 (64) 12 (12) 62 (64) 38 (39) 37 (42) 6 (7) 27 (44) 8 (13)
Fever 54 (53) 6 (6) 24 (25) 5 (5) 20 (23) 2 (2) 20 (32) 6 (10)
Neutrophil count decreased 51 (50) 34 (33) 58 (60) 57 (59) 43 (49) 25 (28) 32 (52) 31 (50)
Aspartate aminotransferase increased 49 (48) 9 (9) 51 (53) 14 (14) 26 (30) 1 (1) 24 (39) 3 (5)
Hypoalbuminemia 47 (46) 0 43 (44) 6 (6) 18 (21) 0 23 (37) 1 (2)
Lymphocyte count decreased 43 (42) 37 (36) 32 (33) 30 (31) 33 (38) 18 (21) 16 (26) 15 (24)
Platelet count decreased 43 (42) 8 (8) 63 (65) 56 (58) 18 (21) 3 (3) 37 (60) 34 (55)
Hyperglycemia 32 (31) 2 (2) 24 (25) 6 (6) 31 (35) 2 (2) 19 (31) 8 (13)
Hypocalcemia 31 (30) 2 (2) 36 (37) 6 (6) 12 (14) 0 18 (29) 0
Hypokalemia 28 (28) 7 (7) 36 (37) 19 (20) 21 (24) 2 (2) 28 (45) 14 (23)
Hypophosphatemia 18 (18) 0 18 (19) 5 (5) 8 (9) 0 7 (11) 2 (3)
Hypotension 16 (16) 1 (1) 11 (11) 7 (7) 12 (14) 3 (3) 7 (11) 4 (7)
Blood bilirubin increased 15 (15) 2 (2) 31 (32) 7 (7) 4 (5) 0 16 (26) 2 (3)
Infection 15 (15) 10 (10) 48 (49) 39 (40) 20 (23) 9 (10) 42 (68) 38 (61)
Vomiting 14 (14) 0 20 (21) 2 (2) 15 (17) 1 (1) 13 (21) 4 (7)
GGT increased 12 (12) 4 (4) 9 (9) 5 (5) 5 (6) 1 (1) 3 (5) 1 (2)
Anorexia 11 (11) 4 (5) 15 (16) 12 (12) 6 (7) 2 (2) 8 (13) 4 (7)
Febrile neutropenia 6 (6) 5 (5) 43 (44) 43 (44) 0 0 28 (45) 28 (45)
Mucositis oral 4 (4) 0 44 (45) 25 (26) 2 (2) 1 (1) 16 (26) 5 (8)
Sepsis 1 (1) 1 (1) 13 (13) 13 (13) 2 (2) 2 (2) 14 (23) 14 (23)
Typhlitis 0 0 1 (1) 1 (1) 0 0 4 (7) 4 (7)
BLINCYTO® Cycle 1 (n=102) Chemotherapy Block 2 (n=97)
Adverse event Any Grade n (%) Grades ≥ 3* n (%) Any Grade n (%) Grades ≥ 3* n (%)
Patients with any adverse event 99 (97) 77 (76) 89 (92) 88 (91)
Anemia 77 (76) 15 (15) 63 (65) 51 (53)
White blood cell decreased 67 (66) 25 (25) 59 (61) 55 (57)
Alanine aminotransferase increased 65 (64) 12 (12) 62 (64) 38 (39)
Fever 54 (53) 6 (6) 24 (25) 5 (5)
Neutrophil count decreased 51 (50) 34 (33) 58 (60) 57 (59)
Aspartate aminotransferase increased 49 (48) 9 (9) 51 (53) 14 (14)
Hypoalbuminemia 47 (46) 0 43 (44) 6 (6)
Lymphocyte count decreased 43 (42) 37 (36) 32 (33) 30 (31)
Platelet count decreased 43 (42) 8 (8) 63 (65) 56 (58)
Hyperglycemia 32 (31) 2 (2) 24 (25) 6 (6)
Hypocalcemia 31 (30) 2 (2) 36 (37) 6 (6)
Hypokalemia 28 (28) 7 (7) 36 (37) 19 (20)
Hypophosphatemia 18 (18) 0 18 (19) 5 (5)
Hypotension 16 (16) 1 (1) 11 (11) 7 (7)
Blood bilirubin increased 15 (15) 2 (2) 31 (32) 7 (7)
Infection 15 (15) 10 (10) 48 (49) 39 (40)
Vomiting 14 (14) 0 20 (21) 2 (2)
GGT increased 12 (12) 4 (4) 9 (9) 5 (5)
Anorexia 11 (11) 4 (5) 15 (16) 12 (12)
Febrile neutropenia 6 (6) 5 (5) 43 (44) 43 (44)
Mucositis oral 4 (4) 0 44 (45) 25 (26)
Sepsis 1 (1) 1 (1) 13 (13) 13 (13)
Typhlitis 0 0 1 (1) 1 (1)
BLINCYTO® Cycle 2 (n=88) Chemotherapy Block 3 (n=62)
Adverse event Any Grade n (%) Grades ≥ 3* n (%) Any Grade n (%) Grades ≥ 3* n (%)
Patients with any adverse event 81 (92) 49 (56) 55 (89) 52 (84)
Anemia 39 (44) 4 (5) 36 (58) 35 (57)
White blood cell decreased 50 (57) 13 (15) 30 (48) 30 (48)
Alanine aminotransferase increased 37 (42) 6 (7) 27 (44) 8 (13)
Fever 20 (23) 2 (2) 20 (32) 6 (10)
Neutrophil count decreased 43 (49) 25 (28) 32 (52) 31 (50)
Aspartate aminotransferase increased 26 (30) 1 (1) 24 (39) 3 (5)
Hypoalbuminemia 18 (21) 0 23 (37) 1 (2)
Lymphocyte count decreased 33 (38) 18 (21) 16 (26) 15 (24)
Platelet count decreased 18 (21) 3 (3) 37 (60) 34 (55)
Hyperglycemia 31 (35) 2 (2) 19 (31) 8 (13)
Hypocalcemia 12 (14) 0 18 (29) 0
Hypokalemia 21 (24) 2 (2) 28 (45) 14 (23)
Hypophosphatemia 8 (9) 0 7 (11) 2 (3)
Hypotension 12 (14) 3 (3) 7 (11) 4 (7)
Blood bilirubin increased 4 (5) 0 16 (26) 2 (3)
Infection 20 (23) 9 (10) 42 (68) 38 (61)
Vomiting 15 (17) 1 (1) 13 (21) 4 (7)
GGT increased 5 (6) 1 (1) 3 (5) 1 (2)
Anorexia 6 (7) 2 (2) 8 (13) 4 (7)
Febrile neutropenia 0 0 28 (45) 28 (45)
Mucositis oral 2 (2) 1 (1) 16 (26) 5 (8)
Sepsis 2 (2) 2 (2) 14 (23) 14 (23)
Typhlitis 0 0 4 (7) 4 (7)

Select AEs for patients receiving BLINCYTO®2

BLINCYTO®
Cycle 1 (n=102)
BLINCYTO®
Cycle 2 (n=88)
Adverse event Any Grade
n (%)
Grades 3
n (%)
Any Grade
n (%)
Grades 3
n (%)
CRS 22 (22) 1 (1) 1 (1) 0
Encephalopathy 11 (11) 2 (2) 7 (8) 2 (2)
Seizure 4 (4) 1 (1) 1 (1) 0
  • Incidence of most AEs decreased from cycle 1 to cycle 2 of BLINCYTO®2
  • The majority of AEs were mild to moderate in severity2,
  • All AEs related to BLINCYTO® were fully reversible, and there were no deaths related to AEs2
  • There were 5 toxic deaths during blocks 2 and 3 of the chemotherapy arm (all infections) and none in the BLINCYTO® arm. Four of the five toxic deaths were AYA patients2

R/R: MT103-205 study

Adverse events occurring in patients who received the recommended dosage (N=70)3,*

Adverse event n (%)
Patients with AEs 70 (100)
AEs of worst Grade ≥ 3 occurring in ≥ 5% of patients 61 (87)
Anemia 25 (36)
Thrombocytopenia 15 (21)
Febrile neutropenia 12 (17)
Hypokalemia 12 (17)
Neutropenia 12 (17)
Alanine aminotransferase increased 11 (16)
Platelet count decreased 10 (14)
Pyrexia 10 (14)
Neutrophil count decreased 9 (13)
Aspartate aminotransferase increased 8 (11)
Leukopenia 7 (10)
WBC decreased 7 (10)
CRS 4 (6)
Hypertension 4 (6)
  • The most common AEs, regardless of causality, were pyrexia (80%), anemia (41%), nausea (33%), and headache (30%)3
  • Most AEs occurred in the first few days of cycle 13
  • Neurologic events were rare; three patients (4%) experienced Grade 3 events, and no Grade 4 or 5 neurological events were reported3

MRD(+): Retrospective study

Adverse events occuring in pediatric patients who received BLINCYTO® therapy prior to transplant (N=14)4

Adverse event n (%)
Grade 2 or 3 GvHD 2 (14)
Extensive chronic GvHD 3 (21)
  • One patient experienced a Grade 3 seizure4,*
  • Causes of death were disease progression in 1 patient who did not proceed to HSCT and complications due to chronic GvHD in another patient4
  • No other Grade 3 or 4 toxicities or CRS events were reported4
  • No toxicities were reported as having delayed or prevented patients from receiving HSCT4

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 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 over the age of 10 years may have a higher risk of seizures with BLINCYTO® therapy.

    Monitor patients for signs and symptoms of neurological toxicities, including ICANS, and interrupt or discontinue BLINCYTO® 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® 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.

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. Locatelli F, Zugmaier G, Rizzari C, et al. Effect of blinatumomab vs chemotherapy on event-free survival among children with high-risk first-relapse B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325:843-854. 2. Brown PA, Ji L, Xu X, et al. Effect of postreinduction therapy consolidation with blinatumomab vs chemotherapy on disease-free survival in children, adolescents, and young adults with first relapse of B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325:833-842. 3. von Stackelberg A, Locatelli F, Zugmaier G, et al. Phase I/phase II study of blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia. J Clin Oncol. 2016;34:4381-4389. 4. Keating AK, Gossai N, Phillips CL, et al. Reducing minimal residual disease with blinatumomab prior to HCT for pediatric patients with acute lymphoblastic leukemia. Blood Adv. 2019;3:1926-1929.

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