Boxed Warnings:
Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurs 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 serious, life-threatening, or fatal, occurred in individuals receiving Blincyto. Interrupt or stop treatment with Blincyto injection as recommended.
Medication Guide:
Indication: Blincyto, a bispecific CD19-directed CD3 T-cell engager, is prescribed for treating both adult and pediatric patients 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%.
Acute lymphoblastic leukemia (ALL) that has returned after treatment or does not respond to treatment and is characterized by CD19-positive B-cell precursors.
Dosage and Administration: The recommended dosage of Blincyto (blinatumomab) depends on the specific condition being treated and the patient’s body weight. It is typically administered as a continuous intravenous infusion at a specified dose and schedule determined by the healthcare provider. It’s important for patients to follow their healthcare provider’s instructions carefully and to receive treatment under medical supervision.
Adverse Reactions: The most commonly reported adverse reactions (≥ 20%) are pyrexia, hypokalemia, headache, peripheral edema, febrile neutropenia, nausea, rash, tremor, diarrhea and constipation. The most common serious adverse reactions (≥ 2%) are device-related infection, febrile neutropenia, sepsis, pyrexia, pneumonia, neutropenia, confusion, encephalopathy, infection, Staphylococcal bacteremia, tremor, and headache.
Contraindications: Blincyto should not be used in patients who have had a hypersensitive reaction to blinatumomab or any ingredients in the medication.
Storage Guidelines: Blincyto should be stored in its original carton in the refrigerator at a temperature between 36°F to 46°F (2°C to 8°C). Do not freeze or shake. Protect from light. Once removed from the refrigerator, Blincyto can be stored at room temperature up to 77°F (25°C) for up to 48 hours. Avoid returning to the refrigerator once it has been stored at room temperature.
Reference:
https://www.blincyto.co
