*
While stored, protect BLINCYTO and IV Solution Stabilizer vials from light.
†
Storage time includes infusion time. If IV bag containing BLINCYTO solution for infusion is not administered within the time frames and temperatures indicated, it must be discarded; it should not be refrigerated again.
Maximum Storage Time
of Reconstituted BLINCYTO Vial*
Maximum Storage Time
of Prepared IV Bag Containing
BLINCYTO Solution for Infusion
Room Temperature
23°C to 27°C
(73°F to 81°F)
Refrigerated
2°C to 8°C
(36°F to 46°F)
Room Temperature
23°C to 27°C
(73°F to 81°F)
Refrigerated
2°C to 8°C
(36°F to 46°F)
4 hours
24 hours
48 hours†
8 days
3. DOSAGE FORMS AND STRENGTHS
For injection: 35 mcg of lyophilized powder in a single-use vial for reconstitution.
4. CONTRAINDICATIONS
BLINCYTO is contraindicated in patients with known hypersensitivity to blinatumomab or to any component of the product formulation.
5. WARNINGS AND PRECAUTIONS
5.1 Cytokine Release Syndrome
Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO.
Infusion reactions have occurred with the BLINCYTO infusion and may be clinically indistinguishable from manifestations of CRS.
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; these events infrequently led to BLINCYTO discontinuation. Life-threatening or fatal CRS was infrequently reported in patients receiving BLINCYTO. In some cases, disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) have been reported in the setting of CRS.
Patients should be closely monitored for signs or symptoms of these events. Management of these events may require either temporary interruption or discontinuation of BLINCYTO [see Dosage and Administration (2.3)].
5.2 Neurological Toxicities
In patients receiving BLINCYTO in clinical trials, neurological toxicities have occurred in approximately 50% of patients. The median time to onset of any neurological toxicity was 7 days. Grade 3 or higher (severe, life-threatening, or fatal) neurological toxicities following initiation of BLINCYTO administration occurred in approximately 15% 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 receiving BLINCYTO for signs and symptoms of neurological toxicities, and interrupt or discontinue BLINCYTO as recommended [see Dosage and Administration (2.3)].
5.3 Infections
In patients receiving BLINCYTO in clinical trials, serious infections such as sepsis, pneumonia, bacteremia, opportunistic infec
