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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

  • Leukoencephalopathy

  • Preparation and Administration Errors

SERIOUS ADVERSE REACTIONS

Serious adverse reactions were reported in 65% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, pneumonia, sepsis, neutropenia, device-related infection, tremor, encephalopathy, infection, overdose, confusion, Staphylococcal bacteremia, and headache.1

Adverse Reactions ≥ 5% Incidence for Grade 3 or Higher1
  • Blood and lymphatic system disorders
  • Febrile neutropenia (23%)
  • Anemia (13%)
  • Neutropenia (15%)
  • Thrombocytopenia (8%)
  • Leukopenia (8%)
  • General disorders and administration site conditions
  • Pyrexia (7%)
  • Infections and infestations
  • Other pathogen infections (25%)
  • Bacterial infections (12%)
  • Fungal infections (7%)
  • Pneumonia (8%)
  • Sepsis (6%)
  • Investigations
  • Increased alanine aminotransferase (6%)
  • Metabolism and nutrition disorders
  • Hypokalemia (6%)
  • Hyperglycemia (7%)
  • Hypophosphatemia (5%)
  • Respiratory, thoracic, and mediastinal disorders
  • Dyspnea (5%)
  • Vascular disorders
  • Hypertension (5%)
ADVERSE REACTIONS

The most commonly reported adverse reactions (≥ 20%) in clinical trials were pyrexia (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%), diarrhea (20%), and constipation (20%).1

Adverse Reactions ≥ 10% Incidence, All Grades1
  • Blood and lymphatic system disorders
  • Febrile neutropenia (25%)
  • Anemia (18%)
  • Neutropenia (16%)
  • Thrombocytopenia (11%)
  • Gastrointestinal disorders
  • Nausea (25%)
  • Constipation (20%)
  • Diarrhea (20%)
  • Abdominal pain (15%)
  • Vomiting (13%)
  • General disorders and administration site conditions
  • Pyrexia (62%)
  • Peripheral edema (25%)
  • Fatigue (17%)
  • Chills (15%)
  • Chest pain (11%)
  • Immune system disorders
  • Cytokine release syndrome (11%)
  • Infections and infestations
  • Other pathogen infections (44%)
  • Bacterial infections (19%)
  • Fungal infections (15%)
  • Viral infections (13%)
  • Investigations
  • Increased alanine aminotransferase (12%)
  • Increased aspartate aminotransferase (11%)
  • Increased weight (11%)
  • Metabolism and nutrition disorders
  • Hypokalemia (23%)
  • Hypomagnesemia (12%)
  • Hyperglycemia (11%)
  • Decreased appetite (10%)
  • Musculoskeletal and connective tissue disorders
  • Back pain (14%)
  • Pain in extremity (12%)
  • Bone pain (11%)
  • Arthralgia (10%)
  • Nervous system disorders
  • Headache (36%)
  • Tremor (20%)
  • Dizziness (14%)
  • Psychiatric disorders
  • Insomnia (15%)
  • Respiratory, thoracic, and mediastinal disorders
  • Cough (19%)
  • Dyspnea (15%)
  • Skin and subcutaneous tissue disorders
  • Rash (21%)
  • Vascular disorders
  • Hypotension (11%)
ADDITIONAL CONSIDERATIONS
Discontinuation Due to Adverse Reactions

Occurred in 18% of patients treated with BLINCYTO®.1
The most frequent reasons reported for discontinuation of treatment included
encephalopathy and sepsis.1

Fatal Adverse Reactions

Occurred in 15% of patients. The majority of these reactions were infections. No fatal adverse reactions occurred on treatment among patients in remission.1

Adverse Reactions

Grade 3 or higher adverse reactions were reported in 80% of patients.1

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Reference:
  1. BLINCYTO® (blinatumomab) Prescribing Information, Amgen.