ing BLINCYTO infusion. Interrupt BLINCYTO if prolonged neutropenia occurs.
5.6 Effects on Ability to Drive and Use MachinesDue to the potential for neurologic events, including seizures, patients receiving BLINCYTO are at risk for loss of consciousness [see Warnings and Precautions (5.2)]. Advise patients to refrain from driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO is being administered.
5.7 Elevated Liver EnzymesTreatment with BLINCYTO was associated with transient elevations in liver enzymes. Although the majority of these events were observed in the setting of CRS, some were observed outside of this setting. For these events, the median time to onset was 15 days. In patients receiving BLINCYTO in clinical trials, Grade 3 or greater elevations in liver enzymes occurred in approximately 6% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients.
Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and total blood bilirubin prior to the start of and during BLINCYTO treatment. Interrupt BLINCYTO if the transaminases rise to greater than 5 times the upper limit of normal or if bilirubin rises to more than 3 times the upper limit of normal.
5.8 LeukoencephalopathyCranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO, especially in patients with prior treatment with cranial irradiation and antileukemic chemotherapy (including systemic high-dose methotrexate or intrathecal cytarabine). The clinical significance of these imaging changes is unknown.
5.9 Preparation and Administration ErrorsPreparation and administration errors have occurred with BLINCYTO treatment. Follow instructions for preparation (including admixing) and administration strictly to minimize medication errors (including underdose and overdose) [see Dosage and Administration (2.2) and (2.4)].
6. ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
Cytokine Release Syndrome [see Warnings and Precautions (5.1)]
Neurological Toxicities [see Warnings and Precautions (5.2)]
Infections [see Warnings and Precautions (5.3)]
Tumor Lysis Syndrome [see Warnings and Precautions (5.4)]
Neutropenia and Febrile Neutropenia [see Warnings and Precautions (5.5)]
Effects on Ability to Drive and Use Machines [see Warnings and Precautions (5.6)]
Elevated Liver Enzymes [see Warnings and Precautions (5.7)]
Leukoencephalopathy [see Warnings and Precautions (5.8)]
Preparation and Administration Errors [see Warnings and Precautions (5.9)]
6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described in this section reflect exposure to BLINCYTO in clinical trials in which 212 patients with relapsed or refractory ALL received up to 28 mcg/day. All patients received |
