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What is the BLINCYTO® REMS?

A Risk Evaluation and Mitigation Strategy (REMS) is a program to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.

The purpose of the BLINCYTO REMS is to inform Healthcare Providers about the following serious risks:

BOXED WARNING: Cytokine Release Syndrome

  • Serious adverse events that may be associated with CRS included pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase, increased aspartate aminotransferase, and increased
    total bilirubin
    .
  • The highest elevation of cytokines was observed in the first 2 days following start of BLINCYTO infusion
  • Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle.

BOXED WARNING: Neurological Toxicities

  • In patients receiving BLINCYTO in clinical trials, neurological toxicities have occurred in approximately 64% of patients.
  • The median time to onset of any neurological toxicity was 4 days.
  • Grade 3 or higher (severe, life-threatening or fatal) neurological toxicities
    following initiation of BLINCYTO administration occurred in approximately 17% of
    patients and included encephalopathy, convulsions, speech disorders,
    disturbances in consciousness, confusion and disorientation, and
    coordination and balance disorders
    . The majority of events resolved following
    interruption of BLINCYTO, but some resulted in treatment discontinuation.

Monitor patients closely for signs and symptoms of these events and interrupt
or discontinue dosing of Blincyto.

Preparation and Administration Errors

  • Preparation and administration errors have occurred with BLINCYTO treatment.
  • It is very important that the instructions for preparation (including
    admixing) and administration are strictly followed to minimize medication errors (including underdose and overdose)
    .
  • Please note that the recommended dose for BLINCYTO is by patient weight. Patients greater than or equal to 45 kg receive a fixed-dose and for patients less than 45 kg, the dose is calculated using the patient’s body surface area (BSA).

BLINCYTO Fact Sheet:

A non-promotional REMS Fact Sheet reviewed by the FDA, with more detailed information on the serious risks associated with BLINCYTO is available in the
“Materials for Healthcare Providers” section above.

INDICATION:

BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the
treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

You are encouraged to report negative side effects of BLINCYTO to Amgen at 1-800-77-AMGEN (1-800-772-6436) and/or the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088

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