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Indication
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BLINCYTO® (blinatumomab) is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
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Indication
BLINCYTO® (blinatumomab) for injection 35 mcg single-use vial
SAFETY PROFILE

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES

  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO® (blinatumomab). Interrupt or discontinue BLINCYTO® as recommended.

  • Neurological toxicities, 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 and Infusion Reactions

  • Neurological Toxicities

  • Infections

  • Tumor Lysis Syndrome

  • Neutropenia and Febrile Neutropenia

  • Effects on the ability to Drive and Use Machines

  • Elevated Liver Enzymes

  • Pancreatitis

  • Leukoencephalopathy

  • Preparation and Administration Errors

  • Immunization

ADVERSE REACTIONS IN PATIENTS WEIGHING ≥ 45 KG

Serious adverse reactions were reported in 61% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, sepsis, pneumonia, device-related infection, neutropenia, tremor, overdose, encephalopathy, infection, confusion, and headache. Adverse reactions of grade 3 or higher were reported in 80% of patients. Discontinuation of therapy due to adverse reactions occurred in 16% of patients treated with BLINCYTO®. The adverse reactions reported most frequently as the reason for discontinuation of treatment included encephalopathy and sepsis. Fatal adverse events occurred in 12% of patients. The majority of the fatal events were infections. No fatal adverse events occurred on treatment among patients in remission.

Adverse Reactions With ≥ 10% Incidence for Any Grade or ≥ 5% Incidence for Grade 3 or Higher

Adverse Reaction Any Grade* (%) Grade 3 or Higher* (%)
Blood and lymphatic system disorders
Febrile neutropenia 25 23
Anemia 21 16
Neutropenia 19 18
Thrombocytopenia 16 12
Leukopenia 14 12
Cardiac Disorders
Arrhythmia 19 2
Gastrointestinal Disorders
Nausea 26 0
Constipation 20 0
Diarrhea 19 1
Abdominal pain 19 2
Vomiting 13 0
General disorders and administration site conditions
Pyrexia 64 7
Edema 30 2
Fatigue 16 1
Chills 15 0
Chest pain 10 1
Immune system disorders
Infusion-related reactions 34 4
Cytokine release syndrome 13 3
Infections and infestations
Infections (pathogen unspecified) 45 27
Bacterial infections 19 12
Fungal infections 14 7
Viral infections 13 4
Investigations
Decreased immunoglobulins 12 2
Increased weight 11 0
Metabolism and nutrition disorders
Hypokalemia 27 8
Hypomagnesemia 12 0
Hyperglycemia 12 7
Decreased appetite 10 3
Hypophosphatemia 6 4
Hypocalcernia 5 2
Musculoskeletal and connective tissue disorders
Back pain 15 2
Pain in extremity 12 1
Bone pain 11 3
Arthralgia 10 2
Nervous system disorders
Headache 36 4
Tremor 19 1
Dizziness 13 <1
Altered state of consciousness 10 1
Psychiatric disorders
Insomnia 14 0
Respiratory, thoracic, and mediastinal disorders
Cough 20 <1
Dyspnea 15 5
Epistaxis 10 <1
Skin and subcutaneous tissue disorders
Rash 21 2
Vascular disorders
Hypotension 13 3
Hypertension 9 5
*Grading based on NCI Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is fatal.
Includes multiple event terms consistent with this adverse reaction. For complete list, please see full Prescribing Information.
ADVERSE REACTIONS IN PATIENTS WEIGHING < 45 kg

Serious adverse reactions were reported in 51% of patients. The most common serious adverse reactions (≥ 2%) included pyrexia, febrile neutropenia, cytokine release syndrome, convulsion, device-related infection, hypoxia, sepsis, and overdose. Adverse reactions of Grade 3 or higher were reported in 88% of patients. Discontinuation of therapy due to adverse reactions occurred in 5% of patients treated with BLINCYTO®. Adverse reactions that led to discontinuation of treatment were CRS and fungal infection. Three patients experienced a fatal adverse event within 30 days of the last dose of BLINCYTO® (2 infection and 1 multi-organ failure after undergoing subsequent HSCT).

Adverse Reactions With ≥ 10% Incidence for Any Grade or ≥ 5% Incidence for Grade 3 or Higher

Adverse Reactions Any Grade* (%) Grade 3 or Higher* (%)
Blood and lymphatic system disorders
Febrile neutropenia 19 18
Anemia 42 35
Neutropenia 32 32
Thrombocytopenia 25 35
Leukopenia 26 21
Cardiac Disorders
Arrhythmia 11 0
Gastrointestinal Disorders
Nausea 30 0
Constipation 9 2
Diarrhea 19 4
Abdominal pain 23 4
Vomiting 26 2
General disorders and administration site conditions
Pyrexia 75 16
Edema 11 0
Fatigue 9 0
Chills 2 0
Chest pain 4 0
Immune system disorders
Infusion-related reactions 44 12
Cytokine release syndrome 11 4
Infections and infestations
Infections (pathogen unspecified) 42 21
Bacterial infections 11 5
Fungal infections 7 5
Viral infections 9 2
Investigations
Decreased immunoglobulins 5 0
Increased weight 18 5
Metabolism and nutrition disorders
Hypokalemia 21 16
Hypomagnesemia 9 0
Hyperglycemia 11 4
Decreased appetite 4 0
Hypophosphatemia 16 5
Hypocalcernia 11 4
Musculoskeletal and connective tissue disorders
Back pain 16 4
Pain in extremity 11 4
Bone pain 9 0
Arthralgia 4 0
Nervous system disorders
Headache 28 2
Tremor 7 0
Dizziness 5 0
Altered state of consciousness 7 4
Psychiatric disorders
Insomnia 5 0
Respiratory, thoracic, and mediastinal disorders
Cough 18 0
Dyspnea 4 4
Epistaxis 9 2
Skin and subcutaneous tissue disorders
Rash 11 0
Vascular disorders
Hypotension 12 2
Hypertension 25 5
*Grading based on NCI Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is fatal.
Includes multiple event terms consistent with this adverse reaction. For complete list, please see full Prescribing Information.
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Reference:
  1. BLINCYTO® (blinatumomab) Prescribing Information, Amgen.