Blincyto:for the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia

Blincyto (blinatumomab)Approved Dec. 2014: is an immunotherapy. It engages the body’s T-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. The drug acts as a connector between a protein called CD19, which is found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes.
Blincyto is specifically indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Blincyto is supplied as a solution for intravenous infusion. Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and reinitiation (eg, if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended. Do not flush the Blincyto infusion line, especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications. The recommended dosing schedule is as follows:
A single cycle of treatment of Blincyto consists of 4 weeks of continuous intravenous infusion followed by a 2-week treatment-free interval.
• For patients at least 45 kg in weight:
- In Cycle 1, administer Blincyto at 9 mcg/day on Days 1–7 and at 28 mcg/day on Days 8–28.
- For subsequent cycles, administer Blincyto at 28 mcg/day on Days 1–28.
• Allow for at least 2 weeks treatment-free between cycles of Blincyto.
• A treatment course consists of up to 2 cycles of Blincyto for induction followed by 3 additional cycles for consolidation treatment (up to a total of 5 cycles).

Adverse effects associated with the use of Blincyto may include, but are not limited to, the following:

• pyrexia
• headache
• peripheral edema
• febrile neutropenia
• nausea
• hypokalemia
• tremor
• rash
• constipation

In addition, Cytokine Release Syndrome (CRS) and neurological toxicities, both of which may be severe, life-threatening, or fatal, occurred in patients receiving Blincyto. Interrupt or discontinue Blincyto as recommended.

For additional information regarding Blincyto or Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia, please visit www.amgen.com